Conference abstract booklet - ANZGOG
Transcription
Conference abstract booklet - ANZGOG
AUSTRALIA NEW ZEALAND GYNAECOLOGICAL ONCOLOGY GROUP Conference abstract booklet Sofitel, Gold Coast Wednesday 22- Saturday 25 February 2012 Proudly sponsored by: Platinum sponsors: Educational/Research sponsors Exhibitors: Supporters: WELCOME Professor Michael Quinn (Chair of ANZGOG) Welcome to ANZGOG 2012 which brings together national and international experts in medical radiation and surgical oncology. Our focus is on clinical trials. The programme is varied, challenging and exciting. We hope you go away from this meeting with up to date information on current and future trials in gynaecological oncology and with a clearer understanding of how targeted therapies are going to fit into the care of our patients in the near future. Organising Committee Prof Andreas Obermair – Chair ASM Meeting Committee Dr Julie Martyn Prof Michael Quinn – Chair of ANZGOG Dr Jeffery Goh Prof Michael Friedlander – Director of Research Dr Pearly Khaw Dr Alison Brand – Chair Program Committee Ms Pauline Tanner Ms Karen Livingstone Ms Judy Eddy Ms Sue Brew Dr Clare Scott Ms Alison Evans – Executive Officer ANZGOG Mrs Kate Murphy Secretariat The registration desk will be open throughout the conference to answer any questions you may have. Wednesday 22nd February 2.00pm – 6.00pm Lobby Thursday 23rd February 7.30am – 5.00pm Friday 24th February 7.30am – 4.00pm Saturday 25th February 7.30am – 11.45pm Kate Murphy and Mary Sparksman YRD (Aust) Pty Ltd PO Box 717 Indooroopilly Q 4068 Ph: + 61 7 3368 2422 Fax: + 61 7 3368 2433 Mobile: 0408 732 277 / 0418 877 279 Keynote Speakers ANZGOG is pleased to welcome the conference international keynote speakers: Prof Gillian Thomas Professor of Radiation Oncology and Obstetrics and Gynaecology, University of Toronto, Consultant Radiation Oncologist Odette Sunnybrook Cancer Center. Prof Rob Coleman Professor, Department of Gynaecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX Dr Pedro Ramirez Associate Professor, Department of Gynaecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX Continuing Professional Development Program This meeting has been approved as a RANZCOG Approved O&G Meeting. Eligible Fellows of this College will earn 7 CPD points for their attendance. Social Functions Welcome Reception/Trade Networking Function Wednesday 22nd February 7:00pm – 9:00pm Sofitel Poolside Conference Dinner Friday 24th February 7:00pm - 11.00pm Sofitel Poolside Disclaimer: The Australian and New Zealand Gynaecological Oncology Group (ANZGOG) make no representations about the content and suitability of ANZGOG materials presented for any purpose. Specifically, ANZGOG does not warrant, guarantee or make any representations regarding the correctness, accuracy, reliability, currency, or any other aspect regarding characteristics or use of the information presented in ANZGOG materials. The user accepts sole responsibility and risk associated with the use and results of ANZGOG materials, irrespective of the purpose to which such use or results are applied. In no event shall ANZGOG be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or tort, rising out of or in connection with the use or performance of ANZGOG. This program is correct at the time of printing however the committee has the right to make changes AUSTRALIA NEW ZEALAND GYNAECOLOGICAL ONCOLOGY GROUP ANZGOG 2012 Program Individualized Gynaecological Cancer Medicine WEDNESDAY 22 February 12.15-2.45 pm RAC Meeting 1 Paradise 1 2.00-6.30 pm Registration Open 3.00-5.00 pm Radiation Oncology Workshop: Gillian Thomas Chair: Pearly Khaw Sovereign 3.00-6.00 pm ANZGOG Board Meeting Paradise 1 7.00 – 9.00 pm Welcome reception of trade networking function Poolside Level 3 THURSDAY 23 February 8.00 – 8.45am Keynote Gillian Thomas Key unanswered questions in radiation treatment of gynaecological oncology Sponsored by: Chair: Michael Quinn Ballroom Level 1 8.45-11.00am Scientific Session 1: Case Based Session (Tailored for real life situations): Sponsored by: Chair: Michael Quinn and Pearly Khaw 1. IP therapy 2. Dose dense therapy in Ovarian Cancer. 3. High risk node neg endometriod endometrial cancer 4. Serous cancer of the endometrium 5. Early stage vulvar cancer 6. Early stage cervix cancer Panel: Radiation Oncology: Gillian Thomas Gynaecological Oncology : Rob Coleman Nurse Care: Judy Eddy Ballroom Level 1 11.00–11.30am Morning tea continued over... Surgical Oncology: Pedro Ramirez Medical Ethics: Conor Brophy THURSDAY 23 February 11.30–12.30pm Trials Update Chair: Julie Martyn Ballroom Level 1 12.30–1.30pm Lunch/Poster session Paradise 1&2 Nurses Special Interest Group Fundraising Committee Meeting Chair: Judy Eddy Sovereign 2 Chair: David Bernshaw Ballroom 1 1.00–3.30pm Investigator Site roles and responsibilities training workshop Are the right people doing the right things?–Eleanor Allan Sovereign 1 1.30–3.30pm Scientific Session2/Free Abstract Chair: Andreas Obermair Presenter Title Andreas Hackethal Triaging ovarian masses: Discriminating stage I ovarian cancer vs. benign ovarian lesions. Aung Ko Win Risks of primary cancers following endometrial cancer in Lynch syndrome Esther Moss Neuroendocrine carcinoma of the cervix: a review of clinical management and survival George Au-Yeung Radiation with or without cisplatin or carboplatin for locally advanced cervix cancer: a single institution experience Amanda Spurdle Genetic approaches to assess shared aetiology of endometriosis and endometrial cancer. Alik Zakaria Is conservative surgery an option in borderline ovarian tumours? Anna DeFazio Patterns of treatment and response for relapsed ovarian cancer Yen Tan Under referral of women with hereditary endometrial cancer to genetic services in Queensland: Suggestions to facilitate referral of patients at increased risk of Lynch syndrome Sandi Hayes Factors associated with occurrence of lymphoedema following treatment for gynaecological cancer Ballroom Level 1 3.30-4.00 pm “Afternoon Teal” 4.00-5.00 pm Debate 1 CA125 should be routinely measured in Ovarian Cancer follow-up: “Battle of the Sexes” Sponsored by: Chair: Michelle Vaughan Affirmative Team: Michael Friedlander, Jim Nicklin Ballroom Level 1 5.00-7.00pm Negative Team: Linda Mileshkin, Sumitra Ananda Consumer /Nurses workshop: What do consumers want/ What do they get? Chairs: Judy Eddy & Helene O’Neill Sovereign 1 Free Evening Working Dinner for Nurses/Consumers/Study Coordinators FRIDAY 24 February 7:30–8:15am Clinical Trials-A Consumer Perspective (the consumers invite you for a healthy breakfast) Ballroom Level 1 8.30–10.15am Scientific Session 3: The Cutting Edge Chair: Clare Scott 1. Future Direction in Minimally Invasive Trial design: Pedro Ramirez 2. Is Histopathology dead in ovarian trials? : Nik Zeps 3. Should Molecular Imaging be the standard imaging for gyn cancer trials?: Paul Thomas 4. What trials need to be done assessing IMRT in gynaecological cancer? : Gillian Thomas 5. Maintenance Therapy: Trial design and assessment and clinical trial design based around biomarkers: Chee Lee Ballroom Level 1 10.15–10.45am Morning tea 10.45–12.45pm Scientific Session 4 – New Trial Concepts 1. Michael Friedlander A phase 2 study to evaluate the efficacy of Nintedanib (BIBF1120) in controlling ascites in patients with platinum resistant carcinoma of the ovary 2. Vivek Arora National registry for complex atypical hyperplasia of endometrium 3. Alison Brand Randomised Phase II pilot study of the use of vaginal oestrogen to prevent vaginal stenosis in patients treated with pelvic radiotherapy for gynaecological malignancies 4. Michael Friedlander A Phase 2 open label study of Nintedanib (BIBF1120) in asymptomatic patients with CA125 progression after 1st line or 2nd line chemotherapy for ovarian cancer 5. Huda Ismail Carboplatin administration with prophylactic premedication in patients with recurrent cancer of Ovary, Fallopian Tube and Peritoneal Cancer 6. Linda Mileshkin A Survey of Symptoms and Concerns in Ovarian Cancer Survivors following Chemotherapy Treatment 7. Michael Friedlander Prospective pilot study to evaluate the utility of the MOST questionnaire to detect symptoms of recurrent ovarian cancer in patients in follow up after 1st line chemotherapy as well as to document the incidence, severity and duration of adverse effects after completion of treatment Chair: Linda Mileshkin Ballroom Level 1 11.45-12.45 Consumer and Community Meeting Chair: Karen Livingstone Sovereign 1 12.45 – 1.30pm Lunch/Poster/Trade session Quality Assurance Committee Meeting (working Lunch) Study Coordinator Committee Meeting (working Lunch) Chair: Jeff Goh Sovereign 1 Chair: Sue Brew Sovereign 2 1.30 – 3.30pm Scientific Session 5 - Panel Discussion Personalised treatments in Gynaecological Malignancies – lessons from other malignancies Advances in melanoma: Mark ShackletonBreast: Nicole McCarthy Lung: Ben Solomon GI Malignancies: Matt Burge Primo BioMed & Cvac™:: Neil Frazer Chair: Jeff Goh Ballroom Level 1 3.30-4.00pm Afternoon Tea 4.00-4.45pm ANZGOG AGM Ballroom Level 1 4.45-5.45pm Political Landscape of Medical Research: Doug Hilton Chair: Clare Scott Ballroom Level 1 7.00 – 11.00pm Conference Dinner: Sofitel Poolside Level 3 Sponsored by: SATURDAY 25 February 7.30-8.45am RAC 2 Meeting Ballroom Level 1 7.30-8.30am Breakfast Symposium Angiogenesis in Ovarian Cancer–Rob Coleman Ballroom Level 1 9.00-9.30am Scientific Session 6 How to best assess quality life in clinical trials–Martin Stockler Ballroom Level 1 9.30-10.30am Keynote Maintenance therapy: can we afford it?–Rob Coleman The evolution of cervical cancer surgery.–Pedro Ramirez Sponsored by Sponsored by Chair: Ken Jaaback Ballroom Level 1 10.30-10.45pm Morning Tea 10.45-11.45pm Scientific Session 7 Chair: Alison Brand Are Clinical Trial outcomes relevant to elderly patients? Surgical : Geoff Otton Radiation: Gillian Thomas Medical: Christopher Steer Ballroom Level 1 11.45-12.45pm Lunch 12.05pm Bus transfer to Gold Coast Airport departs the Sofitel 1.00-3.30pm Community Engagement-Consumer Information Session Sorrento Room 27,000,000 The number of new cancer cases expected globally by 2030 As the Janssen Pharmaceutical Companies of Johnson & Johnson, we are dedicated to addressing and solving the most important unmet medical needs of our time. In 2012 Johnson & Johnson celebrates over 125 years of delivering innovative healthcare solutions to patients around the world, from our first pioneering sterile surgical products through to the latest treatments in oncology. Janssen continues to be committed to making cancer a preventable, chronic or curable disease by pursuing innovative ideas wherever they are – inside or outside our company. We work hand in hand with the best scientific minds in oncology today to bring cancer prevention, diagnosis and treatments to patients worldwide. Janssen is supporting ongoing research and development of innovative medications for prostate cancer, multiple myeloma and non-Hodgkin’s lymphoma. For more information please visit www.janssen.com.au Janssen-Cilag Australia Pty Ltd Session: Wednesday 22nd February 3.00pm – 5.00pm Presenter: Gillian Thomas Session chair: Pearly Khaw Topic: Radiation Oncology Workshop Abstract: This session will provide radiation oncologists with the opportunity to discuss and explore areas of interest in the management of Gynaecological Malignancies. For the inaugural event, Professor Gillian Thomas has offered to present and discuss those controversial clinical management cases. This will be an open session focusing on difficult technical radiation issues, e.g. vaginal recurrence of endometrial cancer after pelvic RT - how would you treat? Brachytherapy (how?) More EBRT? Both? Bring along your questions and be prepared for an informative and challenging discussion. Notes: 7.00pm – 9.00pm Welcome reception of trade networking function Session: Thursday 23rd February 8.00am – 8.45am Presenter: Gillian Thomas Session chair: Michael Quinn Topics: Key unanswered questions in radiation treatment of gynaecological oncology Sponsored by: Constant curiosity and vigilance is required in the use of radiation (RT) including situations considered “standard of care” e.g., definitive treatment of advanced cervical cancer, adjuvant treatment of high-risk endometrial cancer, and in palliation. In advanced cervical cancer: How to improve outcomes? Will adjuvant treatments with standard or molecular targeting agents be beneficial? Should loco-regional treatments be intensified? What gains in using highly conformal techniques? What is optimal treatment for stage 1B2? What of prophylactic irradiation to para aortic nodes? How to best palliate with RT? In endometrial cancer: What is the role of adjuvant radiation and using what technique in clinically early “high-risk” disease and of radiation in FIGO stage III disease of all sub-types? Many of the key questions posed cannot be answered with level 1 evidence from randomized clinical trials. Notes: PKS™ Cutting Forceps All you need is one CUTTING . GRASPING . DISSECTING . C O A G U L AT I N G Tip design with serrated jaws for secure tissue grasping OLY0225 Rotation wheel provides control for up to 330 degrees of rotation Visit your Olympus Representative at the ANZGOG Meeting 2012 - Table 7 Easy-to-access hand activation button eliminates the need for a foot pedal Session: Thursday 23rd February 8.45am – 11.00am Panel: Gillian Thomas (Radiation Oncology), Pedro Ramirez (Surgical Oncology), Rob Coleman (Gynaecological Oncology), Conor Brophy (Medical Ethics) & Judy Eddy (Nurse Care) Session chair: Co-ord Michael Quinn and Pearly Khaw Topics: Scientific Session 1 - Case Based Session (Tailored for real life situation) 1. IP therapy 2. Dose dense therapy in Ovarian Cancer 3. High risk node neg endometriod endometrial cancer 4. Serous cancer of the endometrium 5. Early stage vulvar cancer 6. Early stage cervix cancer Sponsored by: Notes: Session: Thursday 23rd February 11.30am - 12.30pm Session chair: Topic: Notes: Julie Martyn Trials Update Session: Thursday 23rd February 12:30pm – 1:30pm Topic: Lunch/Poster/Trade Presenter Title 1 Bei Zhiang Anticancer effects of salinomycin on human ovarian cancer cells are associated with modulating IkB-a and p38 MAPK 2 Cassie Riley Step by Step: the journey to an ovarian cancer diagnosis and treatment 3 Catherine Bettington Long-term control of Aggressive Angiomyxoma treated with pelvic radiotherapy: a report of 3 cases 4 Donal Brennan RBM3-Regulated genes promote DNA integrity and affect clinical outcome in epithelial ovarian cancer 5 George Au-Yeung Impact of obesity on ovarian cancer and chemotherapy dosing 6 Huda Ismail Adjuvant Chemotherapy for Epithelial Ovarian Cancer– What Is Happening In Routine Practice? 7 Taryn Robinson Audit of Usual Care provided at Australian radiotherapy treatment centres for women with gynaecological cancer. Notes: Session: Thursday 23rd February 12:30pm – 1:30pm Session chair: Topic: Judy Eddy Nurses Special Interest Group Abstracts: QCGC has developed referral guidelines to ensure all women with diagnosed Gynaecologic Cancer or suspected cancer have access to a dedicated service for the right care at the right time and with the right team. All patients are presented at the Multi Disciplinary Team Meeting (MDTM) to ensure the most appropriate evidenced based care with the best outcome for individual patients is planned and implemented. Notes: Session: Thursday 23rd February 12:30pm – 1:30pm Session chair: Topic: Notes: David Bernshaw Fundraising Committee Meeting Session: Thursday 23rd February 1.00pm – 3.30pm Session chair: Topic: Eleanor Allan Investigator Site roles and responsibilities training workshop Responsibilities in Research – Are the Right People Doing the Right Things? Abstract: One of the most common findings by international regulators is a failure by the Principal Investigator to supervise the conduct of the clinical trial adequately. How can you make sure that this is not an issue for your site? This interactive workshop, aimed at Study Coordinators and Investigators, address two common conundrums in clinical trials: what is adequate oversight and what is appropriate delegation? The workshop will explore the roles and responsibilities of the different site staff and the limitations on these roles. We will examine how you can work with Sponsor representatives to better meet your responsibilities and how to delegate effectively. What activities cannot be delegated by a PI? We will deal with issues such as over-delegation and lack of successful communication between the monitor and investigators. Finally the workshop will examine the need for site staff to be “qualified, trained and experienced”. What does this mean? What topics need to be covered and what types of training will be most suitable for your site? How do you demonstrate to an auditor that the right people are doing the right things? Notes: Session: Thursday 23rd February 1.30pm – 3.30pm Session Chair: Topic: Andreas Obermair Free Abstract Presenter Title 1 Andreas Hackethal Triaging ovarian masses: Discriminating stage I ovarian cancer vs. benign ovarian lesions. 2 Aung Ko Win Risks of primary cancers following endometrial cancer in Lynch syndrome 3 Esther Moss Neuroendocrine carcinoma of the cervix: a review of clinical management and survival 4 George Au-Yeung Radiation with or without cisplatin or carboplatin for locally advanced cervix cancer: a single institution experience 5 Amanda Spurdle Genetic approaches to assess shared aetiology of endometriosis and endometrial cancer. 6 Alik Zakaria Is conservative surgery an option in borderline ovarian tumours? 7 Anna DeFazio Patterns of treatment and response for relapsed ovarian cancer 8 Yen Tan Under referral of women with hereditary endometrial cancer to genetic services in Queensland: Suggestions to facilitate referral of patients at increased risk of Lynch syndrome 9 Sandi Hayes Factors associated with occurrence of lymphoedema following treatment for gynaecological cancer 1. Triaging ovarian masses: Discriminating stage I ovarian cancer vs. benign ovarian lesions. Authors: Andreas Hackethal, Srinivas Kondalsamy-Chennakesavan, Andreas Obermair, Abstract: Introduction: Whilst premenopausal women often present with functional cysts of the ovaries, the risk for malignancy increases with age. Non-surgical discrimination between benign and early malignant changes are insufficient. Therefore, definite diagnosis of ovarian masses can only be achieved by histological evaluation. We present Human Epididymal Protein 4 (HE4) antigen in combination with other markers as a new approach for evaluating these findings to enhance non surgical diagnosis and compare these findings to the previously suggested Risk of Ovarian Malignancy Algorithm (ROMA) score. Material & Methods: This study is based on an analysis of prospectively collected biospecimens held by the Australian Ovarian Cancer Study (AOCS). Enrolled in this study were female patients, 25 years of age or older who underwent surgery for a pelvic mass and were confirmed as stage 1 ovarian cancer or as a benign condition. Retrieved serum blood samples were measured by two-step immunoassay for the quantitative determination of HE4 antigen. The findings were compared to previous estimated CA-125 II and CEA concentrations. Results: A total of 158 patients with proven stage 1 epithelial ovarian cancer (n=57) or a benign pelvic mass (n=101) were included. HE4 levels were significantly elevated among post-menopausal women when compared to premenopausal women (p=0.001) whereas CA125 and CEA levels did not differ between these groups. The median levels of HE4 and CA125 were significantly higher among patients with malignancy (p<0.001 for both) whereas CEA levels did not differ (p=0.587). All three biomarkers along with age at the time of diagnosis showed significantly higher area under the ROC curve when compared to the ROMA model HE4+CA125+CEA+Age AUC of 0.823 (95% CI: 0.734 to 0.911). Discussion: Different algorithms have been proposed previously to enhance the differential diagnosis of ovarian masses. Today, still no conservative tool is available to securely differentiate between benign and malignant changes and therefore, surgery continuous to be the gold standard for securing diagnosis. The combination of HE4, current tumour markers and age has a higher prognostic value compared to the standard ROMA algorithm or CA125 alone. It should therefore be considered for continuous evaluation in patients with adnexal masses. Notes: 2. Risks of primary cancers following endometrial cancer in Lynch syndrome Authors: Aung Ko Win1, Noralane M. Lindor2, Robert W. Haile3, Polly A. Newcomb4, Loic Le Marchand5, Steven Gallinger6,7, John L. Hopper1, Mark A. Jenkins1 Affiliations 1 Centre for Molecular, Environmental, Genetic and Analytic Epidemiology, The University of Melbourne, Parkville, Victoria, Australia 2 Department of Medical Genetics, Mayo Clinic, Rochester, Minnesota, USA 3 Department of Preventive Medicine, University of Southern California, Los Angeles, California, USA 4 Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA 5 University of Hawaii Cancer Center, Honolulu, Hawaii, USA 6 Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada 7 Cancer Care Ontario, Toronto, Ontario, Canada Abstract: Background: Lynch syndrome is an autosomal dominantly inherited disorder of cancer caused by germline mutations in DNA mismatch repair genes. Previous studies have shown that mismatch repair gene mutation carriers are at increased risk of first primary colorectal, endometrial and several additional cancers. Objective: To estimate the risks of primary cancers following endometrial cancer for mutation carriers to determine if those with initial endometrial cancer might have higher subsequent risks for new primary cancers. Methods: We obtained data from the Colon Cancer Family Registry for a cohort of 99 women carrying a pathogenic mutation in a mismatch repair gene (35 MLH1, 58 MSH2, 4 MSH6 and 2 PMS2) who had a previous diagnosis of primary endometrial cancer. We estimated the age-, sex-, country- and calendar period-specific standardized incidence ratios (SIRs) of subsequent primary cancers following endometrial cancer, compared with the general population. Kaplan-Meier method was used to estimate 10- and 20-year cumulative risk (penetrance) for each cancer. Results: For carriers of mismatch repair gene mutations who had a previous diagnosis of endometrial cancer, we observed significant increased risks of colorectal cancer (SIR 49.35; 95% confidence interval 34.15-70.37, p<0.001), small intestinal cancer (43.85, 5.31-158.40, p<0.001), urinary bladder cancer (26.18, 10.53-53.94, p<0.001), renal cancer (15.96, 5.18-37.24, p<0.001), hepatobiliary cancer (19.45, 5.30-49.81, p<0.001), and breast cancer (2.97, 1.58-5.08, p<0.001). The cumulative risks at 10-year after diagnosis of endometrial cancer were as follow: colorectal cancer (26%, 95% confidence interval 18-38%), urinary bladder cancer (3%, 1-9%), renal cancer (1%, 0.2-7%), and breast cancer (8%, 4-17%). Conclusions: For Lynch syndrome patients, the estimated risks of subsequent primary cancers may inform appropriate cancer screening and risk reducing strategies following an endometrial cancer diagnosis. Notes: 3. Neuroendocrine Carcinoma of the cervix: A review of clinical management and survival Authors: EL Moss1, P Pearmain2, S Askew 2, P Dawson2, K Singh1, KK Chan1, R Ganesan1, L Hirschowitz1 1 Pan-Birmingham Gynaecological Cancer Centre, West Midlands, UK 2 West Midlands Cancer Intelligence Unit, West Midlands, UK Abstract: Background: Neuroendocrine carcinomas (NEC) of the cervix are uncommon and very little has been reported on the diagnosis and clinical management of these tumours Methods: All patients diagnosed as having an NEC in the West Midlands between 1998-2009 were reviewed. A blinded review of all pathology specimens and immunohistochemistry was performed to confirm the diagnosis. Results: 45 cases were identified, 1.3% of all the cervical cancers registered in the West Midlands. Pathological review confirmed only 31/45 cases to be NECs. The median age at diagnosis was 43 years (range 22-94 years) with 25% being ≤30 years. Only 5/31 cases were stage 1 at diagnosis. Irregular vaginal bleeding was the most frequent presenting symptom (67.7%) and 18/31 cases were classified as screening interval cancers. Chemotherapy was the most common primary treatment (64.5%). A platinum/etoposide combination was the most frequently used regimen (70.8%), with women receiving a median of 4 cycles (range 2-8). Only 2 women underwent a hysterectomy as primary treatment and one following chemotherapy/radiotherapy. Eighteen women (66.7%) underwent pelvic radiotherapy and 13 (41.9%) received vaginal brachytherapy. Four women were not fit for treatment and received palliative care alone. The overall survival was very poor, 54% at 1-year and only 8/31 women were alive at 2 years. Conclusions: Neuroendocrine cancers of the cervix are not typically detected through cervical screening and present with advanced disease. Despite multi-modal therapy the long-term prognosis is very poor. Research needs to be focused on new therapies to try and improve the outcome of this disease. Notes: 4. Radiation with cisplatin or carboplatin for locally advanced cervix cancer: the experience of a tertiary cancer centre. Authors: George Au-Yeung, Linda Mileshkin, David Bernshaw, Srinivas Kondalsamy-Chennakesavan, Danny Rischin, Kailash Narayan. Abstract: Background: Definitive treatment with concurrent cisplatin and radiation is the standard of care for locally advanced cervix cancer. The optimal management of patients with a contraindication to cisplatin has not been established. Objectives:To review the impact of concurrent chemoradiation in a cohort of patients with locally advanced cervical cancer. Methods: All patients with locally advanced cervical cancer treated with definitive radiation were entered into a prospective database. Demographics, stage, histology, recurrence and survival were recorded. Pharmacy records were reviewed to determine concurrent chemotherapy use. The primary endpoint was overall survival (OS), and secondary endpoints were disease free survival (DFS) and rates of primary, nodal or distant failure. Univariate and multivariate analyses were performed. Results: 442 patients were treated from Jan 1996 to Feb 2011. 269 patients received cisplatin, 59 received carboplatin and 114 received no concurrent chemotherapy. OS was significantly improved with use of concurrent cisplatin compared to radiation alone (adjusted HR 0.53, p=0.001), as was DFS and the rate of distant failure. Use of concurrent carboplatin was not associated with any significant benefit compared to radiation alone in terms of OS or DFS on univariate or multivariate analyses. Conclusions: The results of this audit are consistent with the known significant survival benefit with concurrent cisplatin chemoradiation. However, concurrent carboplatin did not have a statistically significant benefit although there are potential confounding factors in this small cohort. The available evidence in the literature favors the use of non-platinum chemotherapy rather than carboplatin in patients with contraindications to cisplatin. Notes: 5. Genetic approaches to assess shared aetiology of endometriosis and endometrial cancer. Jodie Painter1, Stuart MacGregor1, Grant Montgomery1, Penny Webb1, Krina Zondervan2, Douglas Easton3, Alison Dunning3, Paul Pharoah3, Deborah Thompson3, Nick Martin1, Rodney J Scott 4,5, Liz Holliday4,5, Mark McEvoy4,5, John Attia5, ANECS Group, SEARCH collaborators, Amanda Spurdle1* 1 Queensland Institute of Medical Research 2 Oxford University 3 Cambridge University 4 The University of Newcastle 5 John Hunter Hospital * Presenting author, Amanda.Spurdle@qimr.edu.au Background: There is conflicting evidence regarding the relationship between report of endometriosis and endometrial cancer risk, with traditional case-control analyses potentially confounded by bias in co-incidental diagnoses of endometriosis and endometrial cancer in cases versus controls. Objectives: To use existing endometriosis and endometrial cancer genome-wide association datasets to estimate the proportion of genetic variants associated with risk of one disease that also contribute to risk of the other disease. Further, to identify specific genes that underly this shared genetic aetiology. Methods: Cross-disease prediction analysis was conducted to assess the proportion of the 500K genetic variants within the genome-wide dataset that most significantly accounted for shared genetic aetiology of endometriosis and endometrial cancer. Meta-analysis of the pooled endometriosis-endometrial cancer dataset, followed by gene-based analysis, was used to highlight specific variants and genes worthy of future investigation. Results: Cross-disease prediction revealed a shared genetic background between endometriosis and endometrial cancer (prediction P value < 1 x 10-8 using the top 1% of variants assayed). Meta-analysis of the two datasets revealed 8 loci of interest, captured by 20 variants at/near genome-wide significance levels. Additional analyses that accounted for the location of variants in/near genes highlighted 7 genes of interest for further study, each harbouring multiple variants associated with risk of both diseases. Notably, these included a logical candidate gene encoding a hormone receptor known to be dysregulated in both diseases. Conclusions: Cross-disease prediction analysis confirms shared genetic prediction to endometriosis and endometrial cancer, and identifies loci of interest for future study. Notes: 6. Is conservative surgery an option in borderline ovarian tumours? Authors: Zakaria AR, McNally OM, MA Quinn Oncology Unit, The Royal Women’s Hospital, Parkville, VIC 3052 Abstract: Background: Borderline ovarian tumours (BOTs) comprise 10-15% of all ovarian cancers and recurrence rate ranges from 7-15%. There is a growing interest in conservative surgery for fertility preservation however, this has to be balanced against the risk of tumour recurrence associated with this approach. Objectives: To evaluate the risk of recurrence in various types of surgery for borderline ovarian tumours (BOTs). Material and methods: A retrospective review of 223 patients with BOTs seen in The Royal Women’s Hospital from 1994 to 2007. The clinicopathological characteristics were evaluated for association with recurrence. Results: Median age was 43.0 years (range, 17-93 years). The histological subtypes were serous 45.8% (n=102), mucinous 45.8% (n=102), mixed 5.8 %( n=13), endometroid 2.2% (n=5) and others 0.4% (n=1). The majority, 93.3% (n= 208) was FIGO stage 1 where 64.1% (n=143), 5.8% (n=13) and 23.4% (n=52) were 1A, 1B and 1C respectively. 0.4% (n=1) were stage FIGO 2C; 1.8% (n=4) FIGO 3A; 0.9% (n=2) FIGO 3B and 1.8% (n=4) FIGO 3C .The remaining 1.8% of patients (n=4) were unstaged. Fertility sparing surgery was performed in 103 patients (46.2%). The overall recurrence rate was 9.4% and the median time to recurrence was 50 months. Univariate analysis revealed that age 40 years and less (p=0.001) and cystectomy (p=0.001) were associated with higher risk of recurrence. Bilateral salpingo-oophorectomy (p=0.001), hysterectomy (p= 0.001) and omentectomy and/or biopsy (p=0.018) were associated with lower risk of recurrence. However, logistic regression analysis showed none of the above factors were an independent risk factor for tumour recurrence. Conclusions: In women with BOTs, hysterectomy, bilateral salpingo-oophorectomy and omentectomy and/or biopsy should be standard management. However, in women who wish fertility preservation or with significant medical co-morbidities, less radical surgery i.e. cystectomy or unilateral salpingo-oophorectomy can be a safe alternative. Notes: 7: Patterns of treatment and response for relapsed ovarian cancer Authors: Anna DeFazio, Sian Fereday1, Catherine Emmanuel2,3, Jillian Hung2,3, Paul Harnett3,4, Debra Giles1, Nadia Traficante1, Georgia ChenevixTrench5, Penny Webb5, David Bowtell1, AOCS Study Group Dept Gynaecological Oncology, Westmead Hospital and Westmead Institute for Cancer Research, WMI, Westmead NSW , 2145 1 Peter MacCallum Cancer Centre, Melbourne, Vic 2 Dept Gynaecological Oncology Westmead Hospital 3 Westmead Institute for Cancer Research, Uni of Sydney at WMI, Sydney, NSW 4 Dept Medical Oncology; 5Queensland Institute of Medical Research, Brisbane, Qld. Abstract: Background: Response to primary treatment for ovarian carcinoma is generally high, however most women relapse within 2 years. Diverse treatment options are available at recurrence, but there are few markers to guide clinical decision-making. Recurrence <6 months after primary treatment is associated with ‘platin-resistance’ and alternative treatments have been suggested. Objectives: We reviewed patterns of treatment for relapsed ovarian cancer, and response, in women diagnosed between 2002-2006. Methods (including type of data collected): Our cohort included 1454 women with ovarian, fallopian tube or primary peritoneal carcinoma recruited to the Australian Ovarian Cancer Study. Disease progression and treatment response were determined using CA125/GCIG criteria. Complete response (CR) was defined as CA125 normalisation from an elevated pre-treatment level, maintained for ≥28 days. Results: Overall, 795 patients (55%) progressed and were treated with chemotherapy. The most common second-line treatments were carboplatin regimens (n=435, 55%) and CR ranged from 38 to 76% of evaluable cases, for different combinations. The most common single agent treatment was liposomal doxorubicin (n=216, 27%) and response was generally low (CR, 11/165 (7%) evaluable cases). Chemotherapy response was lower in patients that relapsed early (<6 months after treatment). However, importantly, 16% (10/61) of patients with early progression had a CR to platin re-treatment compared with CR in only 6% (10/164) women who received a non-platin regimen. Conclusions: Our data suggests better responses to platin-regimens compared with non-platins at first relapse, regardless of the progressionfree interval. Although response to non-platins was generally low, subsets of patients responded well, highlighting the need for molecular and clinical markers to help select treatments most likely to succeed in individual patients. Notes: 8. Under-referral of women with hereditary endometrial cancer to genetic services: suggestions to facilitate referral of patients at increased risk of lynch syndrome. Authors: Yen Y. Tan1,3,4, Julie McGaughran1,2, Kaltin Ferguson4, Michael D. Walsh1,4, Daniel D. Buchanan4, ANECS Group, Joanne P. Young4, Penelope M. Webb4, Andreas Obermair1,3, Amanda B. Spurdle4 1 The University of Queensland School of Medicine, Brisbane, Queensland, Australia. 2 Genetic Health Queensland, Brisbane, Queensland, Australia. 3 Queensland Centre for Gynecological Cancer Research, Royal Brisbane & Women’s Hospital, Brisbane, Queensland, Australia. 4 Genetics Department, Cancer Program, Queensland Institute of Medical Research, Brisbane, Queensland, Australia. Abstract Purpose: Current evidence suggests many individuals at risk of carrying an inherited mutation in a cancer-associated gene based on their personal/family history of cancer are not referred for genetic assessment. This study evaluated the rates and patterns of referral of women diagnosed with endometrial cancer to genetic services in Queensland, Australia. Methods: For women diagnosed with endometrial cancer between May 2005 and December 2007, data were linked from three sources: a research study with detailed family history information; a major public hospital clinical database; and the public genetic service provider referral database. We determined the percentage of women who could have been referred to genetic services based on hereditary cancer syndrome criteria, and the percentage of women who were referred and who attended their scheduled appointments. Results: Clinical records were identified for 397 endometrial cancer patients. Research data indicated that 236 (59%) had a personal/family history of cancer, including 45 (11%) who fulfilled Amsterdam II Lynch syndrome criteria indicative of hereditary cancer. However, any form of family history was noted in the hospital records of only 61 (15%) women, including 22 (6%) of those meeting Lynch criteria. Only 13 (3%) patients (4 meeting Lynch criteria) were referred for genetic assessment, and all 12 patients remaining alive attended their appointments. Most referrals (39%) were by general practitioners. Conclusions: Clinical records indicate poor recognition of family history and referral to genetic services for women with endometrial cancer. Application of research methods to document family history may facilitate automated referral for genetic assessment. Notes: 9. Factors associated with occurrence of lymphoedema following treatment for gynaecological cancer Authors: S.C. Hayes1, M. Janda1, H. Reul-Hirche2, L. Ward3, A. Obermair4 1 School of Public Health, Queensland University of Technology 2 Royal Brisbane and Women’s Hospital, Physiotherapy 3 Physiology, University of Queensland 4 Royal Brisbane and Women’s Hospital, Queensland Centre of Gynaecological Research, Brisbane, QLD, Australia Background: Lower limb lymphoedema is a serious and feared sequelae after treatment for gynaecological cancer. Given limited prospective data on incidence of and risk factors for lymphoedema after treatment for gynaecological cancer we intitiated a prospective cohort study in 2008. Methods: Overall, 672 women were assessed before treatment and at regular intervals after treatment for two years. Logistic regression was used to assess risk of developing lymphoedema measured by 5% increase in sum of leg circumference (SOC)/weight from baseline among different cancer groups; 419 patients with follow-up SOC/weight measurements were included. Results: Proportions of patients and estimated odds ratios for developing lymphoedema in each cancer type group (reference benign) are shown in Table1. Conclusions: Patients with vulval cancer and those receiving adjuvant therapy appear most at risk of developing lymphoedema following gynaecological cancer treatment. Table1: Risk of developing lymphoedema measured by 5% increase in SOC*/weight ratio, age-adjusted 95% CI N(%) with LE** Age Odds ratio Lower limit Upper limit P value 1.023 1.003 1.044 0.023 New cancer type categories by treatment: Benign LND‡ (%) 0.005 20/103 (19%) 1.000 - - - 22% - - - - 86% 2.104 0.578 7.653 0.259 77% Surgery only 4/9 (44%) 2.887 0.697 11.951 0.144 56% Surgery + chemo or radiotherapy 5/7 (71%) 9.960 1.788 55.498 0.009 100% Stage I or II 13/35 (37%) 2.240 0.957 5.241 0.063 49% Stage III or IV 20/46 (43%) 2.615 1.198 5.710 0.016 28% Surgery only without LN dissection 14/43 (33%) 1.593 0.695 3.650 0.271 0% Surgery only with LN dissection 10/31 (32%) 1.531 0.606 3.867 0.367 100% <0.0001 52% Cervical Surgery only -/7 (0%) Surgery + chemo or radiotherapy 4/13 (31%) Vulval Ovarian Endometrial Surgery + chemo or radiotherapy 65/125 (52%) 3.726 2.001 6.937 *sum of circumferences **lymphoedema measured by 5% increase in SOC/weight ratio from baseline ‡Proportion in each cancer type category that had lymph node dissection performed †Odds ratio estimation not possible as no patients in this group developed lymphoedema Notes 3.30-4.00pm Afternoon Teal Session: Thursday 23rd February 4.00pm – 5.00pm Session chair: Michelle Vaughan Presenter: Con – Linda Mileshkin, Sumitra Ananda Pro – Michael Friedlander, Jim Nicklin Topic: Notes: Debate: CA125 should be routinely measured in Ovarian Cancer follow-up: “Battle of the Sexes” Session: Thursday 23rd February 5.00pm – 7.00pm Session chair: Judy Eddy & Helene O’Neill Presenters: Penny Schofield, Cassie Riley, Glynis Cumming, Merran Williams: Topic: Consumer/ Nurses workshop Intensive training methods for Nurses and Peer volunteers who deliver a complex, psychosocial intervention in a Phase III trial. Penelope Schofield1, Ilona Juraskova2, Rebecca Bergin1, Trish Waters3, Suzi Grogan1, Kate White2, Stella Bu2, Annette Beattie4, Rachel Murray1, Meinir Krishnasamy1, Alison Hocking1, Taryn Robinson1, Sanchia Aranda1.5 1 Peter MacCallum Cancer Centre, Melbourne, Australia 2 3 Cancer Council Victoria, Melbourne Australia, 4Cancer Council NSW, Sydney Australia 5 Cancer Institute NSW Department of Psychology, University of Sydney, Sydney, Australia Background: All clinical trials require strict adherence to study protocol and processes. Non-pharmacological, complex intervention trials can only be successful if the intervention is delivered in a standard manner and according to protocol. This can be achieved by selecting appropriate individuals and providing comprehensive, evidence-based training and ongoing supervision. Objective: To describe an intensive program of recruitment, training and supervision of nurses and peers (survivors of gynaecological cancer) delivering a complex, psychosocial intervention in PENTAGON, a national Phase III trial. Methods: Two standardised manuals were developed for both nurses and peers specifying (a) the intervention content and (b) the training and supervision procedures. Nurses and potential peer volunteers were identified via the gynaecological multidisciplinary team at each site. Potential peers were sent invitation letters, interviewed by Cancer Council experts and those identified as appropriate were invited to attend training. Both nurses and peers attended separate two-day training workshops which incorporated evidence-based modules on gynaecological cancer treatment and side-effects, psychosexual issues, promoting adherence, communication skills and motivational interviewing (nurses only). Training, which was facilitated by experts, emphasised adherence to protocol, prevention of intervention diffusion and, for peers, confidentiality, boundaries and self-care. Interactive discussion, audio or video taped examples of intervention delivery and facilitated group role-play with simulated patients were used to deliver the training. Expectation and evaluation forms assessed perceived improvement in key skills and provide feedback on workshop delivery and content. Post-workshop nurse and peers completed practice phone calls with a simulated patient. A communications skills expert provided written and verbal feedback. Ongoing supervision of intervention sessions is being provided. Results: In total, 9 nurses and 15 peers have completed training. Workshop participants reported improvement in skills, high approval of facilitators, no aspects of the workshops were identified as ‘least valuable’ and the peers particularly, enjoyed meeting other participants. Expert assessment of practice calls demonstrated use of communication skills, general adherence to study processes and correct completion of documentation. Conclusions: A rigorous, multi-stage process of recruitment, training and supervision for individuals delivering a psychosocial intervention was designed and found to be acceptable and effective. Such programs underpin standardizing the delivery of complex interventions and are critical to the success these types of trials. Notes: What do consumers want, what do they get?– Cassie Riley • Overview of the patient’s journey through the system in Western Australia • Discuss the challenges within the WA system & the future direction of gynae oncology • Partnerships in care - how can consumers & medical teams work together to influence the future direction of cancer care. Notes: Glynis Cumming In New Zealand in 2008 there were 987 gynaecological cancers registered, accounting for approximately 10% of all cancer cases and 10% of all cancer deaths. Gynae-oncology services operate within 21 districts health boards (DHBs) in New Zealand and access for women with gynaecological cancer to evidence-based multidisciplinary care is inconsistent. Other challenges to providing optimal gynae-oncology services include work force shortages and lack of formal referral processes. Nurses play a vital key role in coordinating care between departments and regional services. The specialist gynaecological cancer nursing workforce in New Zealand is small and in this presentation I will discuss the role of the Gynaecological Oncology Clinical Nurse Specialist (GOCNS) in New Zealand Notes: Merran Williams: I was diagnosed with Stage 3B epithelial ovarian cancer in December 2008, an incidental finding, and underwent radical surgery followed by 6 cycles of chemotherapy. At the time, I was working full time as a quality clinical nurse consultant at Prince Charles Hospital, in Brisbane. Being both an experienced nurse as well as a gynaecological cancer survivor, has led me on a most interesting and rewarding journey. I have had to adjust to a new sense of what is “normal”, and have learned to actively include wellness activities into my daily routine. I have to manage late side effects from my surgery (lymphoedema) as well as numbness from chemotherapy. Striking the right work/life balance has been a challenge. In 2011 I was awarded a Churchill Fellowship and visited several premier cancer services in America, examining their survivor models of care. In my presentation, I will discuss how we could incorporate aspects of these models to fill gaps in current gynae cancer service delivery. Notes: At Amgen, we believe the answers to medicine’s most pressing questions are written in the language of our DNA. As pioneers in biotechnology, we use our deep understanding of that language to create vital medicines that address the unmet needs of patients fighting serious illness. Amgen is proud to support ANZGOG. Amgen Australia Pty Ltd ABN 31 051 057 428. 123 Epping Road, North Ryde NSW 2113 In 2011, Amgen Australia conducted 74 different studies at 388 sites, involving over 1200 patients trialling Amgen’s innovative medicines. Visit our stand for more information on our clinical trial program Free Evening 7.15pm Working Dinner for Nurses/Consumers/Study Coordinator Mario’s Restaurant, Oasis Shopping Centre Session: Friday 24th February 7.30am-8.15am Topic: Notes: Working Breakfast: Clinical Trials – A Consumer Perspective Session: Friday 24th February 8.30am – 10.15am Session chair: Clare Scott Presenter: Pedro Ramirez, Nik Zeps, Paul Thomas, Gillian Thomas & Chee Lee Topic: Scientific Session 3 – The Cutting Edge Future Direction in Minimally Invasive Trial design : Pedro Ramirez Abstract: The presentation will focus on the importance of surgical research in the field of gynecologic oncology and the current lack of major prospective randomized trials with a surgical focus. An overview of the barriers to developing, implementing, and completing surgical trials will be discussed. Emphasis on protocol requirements for collaborative trials will be reviewed as well as important end-points of such surgical trials. An update will be provided on the progress of an important multi-institutional trial comparing laparotomy to minimally invasive surgery in the management of patients with early-stage cervical cancer undergoing radical hysterectomy. Notes: Is Histopathology dead in ovarian trials? : Nik Zeps Abstract: Whilst the death knell for the role of histopathology has been sounding since the first molecular portraits were painted back in the late 90’s, the reality has been somewhat different. Despite some encouraging initial results in breast cancer and lymphoma the use of molecular, rather than classical histological and clinical, criteria has been somewhat underwhelming. Nevertheless, the introduction of targeted therapies such as herceptin and erbitux has led to the use of companion molecular diagnostic tools to stratify patients both for trials and in clinical practice. Most recently, so called next generation sequencing technologies (better regarded as massively parallel sequencing), has led to a huge reduction in sequencing cost and time. The promise of sub $1000 whole human genomes within the next 5 years hints at a possibility that such analyses will be within reach of routine diagnostics in the very near future. Will this be the revolution we have been waiting for or will it be like expression arrays, more of a curiosity than core business? What will it mean for how we do clinical trials? Will the histopathologist really be able to hang up the microscope? Notes: Should Molecular Imaging be the standard imaging for gynaecological cancer trials? : Paul Thomas Abstract: PET imaging is increasingly used in a variety of malignancies as standard clinical practice. In gynaecologic malignancies, FDG-PET/CT can improve staging (particularly in the detection of more distant metastases), is sensitive for the early detection of recurrence, and may provide earlier response assessment than conventional imaging. These PET characteristics could reduce the cost and length of clinical trials by providing surrogate outcome and response markers. In addition, a variety of non-FDG PET tracers can provide insights into tumour biology, such as hypoxia, proliferation, apoptosis and angiogenesis. Notes: What trials need to be done assessing IMRT in gynaecological cancer? : Gillian Thomas Abstract: Conformal radiation techniques for all cancers have become “soup de jour”. Technologically focuses publications overwhelm our specialty. To quote Winston Churchill “However beautiful the strategy, you should occasionally look at the results.” Theoretically diminishing complications by applying tight margins around tumours using inaccurate imaging may actually compromise outcomes. Barriers to implementing controlled clinical trials of IMRT include appropriate quality assurance (QA) measures, routine uptake of IMRT based only on dosimetric studies, unlikely patient acceptance of randomization and low event rates. The limitations of current guidelines for adjuvant postoperative IMRT for endometrial and cervix cancers and delivery of IMRT to the intact cervix will be discussed. If IMRT is used how should it be and are QA measures sufficiently stringent to incorporate it into clinical trials? Notes: Maintenance Therapy: Trial design and assessment and clinical trial design based around biomarkers. : Chee Lee Abstract: Patients with a particular gynaecological cancer are a heterogeneous group with variable prognosis and response to anti-neoplastic treatments. Recent advancement in the understanding of tumour biology potentially enables the genetic makeup of the tumour and the genotype of the patient to guide patient-specific treatment selection. The use of molecular biomarkers to supplement or replace conventional clinico-pathological factors has the potential to transform the practice of medicine by creating new opportunities for developing and tailoring treatments to individual patients. However, evidence from randomized clinical trials (RCTs) is required to demonstrate the clinical utility of molecular biomarkers before these medical advances could be implemented into clinical practice. In order to guide design and interpretation of RCTs that evaluate biomarkers, a brief overview commonly used trial designs will be presented. The theoretical considerations and the practical challenges of these designs will also be discussed. Notes: Session: Friday 24th February 10.45am – 12.45pm Session chair: Linda Mileshkin Presenters: Michael Friedlander, Vivek Arora, Alison Brand, Huda Ismail, Linda Mileshkin Topic: New Trial Concepts 1. Michael Friedlander A phase 2 study to evaluate the efficacy of Nintedanib (BIBF1120) in controlling ascites in patients with platinum resistant carcinoma of the ovary 2. Vivek Arora National registry for complex atypical hyperplasia of endometrium 3. Alison Brand Randomised Phase II pilot study of the use of vaginal oestrogen to prevent vaginal stenosis in patients treated with pelvic radiotherapy for gynaecological malignancies 4. Michael Friedlander A Phase 2 open label study of Nintedanib (BIBF1120) in asymptomatic patients with CA125 progression after 1st line or 2nd line chemotherapy for ovarian cancer 5. Huda Ismail Carboplatin administration with prophylactic premedication in patients with recurrent cancer of Ovary, Fallopian Tube and Peritoneal Cancer 6. Linda Mileshkin A Survey of Symptoms and Concerns in Ovarian Cancer Survivors following Chemotherapy Treatment 7. Michael Friedlander Prospective pilot study to evaluate the utility of the MOST questionnaire to detect symptoms of recurrent ovarian cancer in patients in follow up after 1st line chemotherapy as well as to document the incidence, severity and duration of adverse effects after completion of treatment Notes: Session: Friday 24th February 11.45-12.45pm Session chair: Karen Livingstone Topic: Consumer and Community Meeting Notes: 12:45pm – 1:30pmLunch/Poster/Trade Networking Session: Friday 24th February Session: 12.45pm-1.30pm Friday 24th February 12.45pm-1.30pm Session chair: Jeff Goh Sue Brew Topic: Notes: Quality Assurance Committee Meeting Session chair: Topic: Study Coordinators Committee Meeting Session: Friday 24th February 1.30pm – 3.30pm Session chair: Jeff Goh Presenters: Mark Shackleton, Nicole McCarthy, Ben Solomon, Matt Burge Topic: Personalised treatments in Gynaecological Malignancies - Lessons from other Cancers Advances in melonoma–Mark Shackleton Abstract: The management of cancer is undergoing revolutionary change. In the melanoma field, this is based on dramatically improved understanding of the molecular basis of melanoma formation and progression, such as the key role played by specific, targetable oncogenes, including BRAF. This progress has resulted from the convergence of advances in genomics technologies, the banking of clinically annotated human tumors, and the development of pre-clinical modelling tools. Underpinned by these resources and to the great benefit of melanoma patients, the pace continues to increase astoundingly of progress from melanoma gene discovery to clinical application of new therapies. Notes: Lessons from breast cancer–Nicole McCarthy Abstract: Standard breast cancer histopathology provides prognostic and predictive information including the hormone receptor and HER2 status. This information helps direct systemic therapies. Sadly, metastatic breast cancer remains an incurable disease and this drives the need for more effective treatment The original hormonal therapies including ovarian ablation and tamoxifen are effective and incremental survival improvements have been seen with the aromatase inhibitors and more recently the incorporation of a mTOR inhibitor. Trastuzumab is a vital component of the HER2 positive breast cancer treatment algorithm. Optimisation of anti-HER2 therapy is being achieved by combining trastuzumab with newer agents such as lapatinib and pertuzumab and new anti-Her2 agents such as T-DM1 are also becoming available. Notes: Lessons from lung malignancies–Ben Solomon Abstract: Non-small cell lung cancer is not one disease but a collection of distinct clinico-pathological entities with frequently identifiable molecular drivers. The efficacy of identifying and therapeutically targeting molecularly-defined subsets of NSCLC has been provided in tumors driven in tumors driven by EGFR mutations or ALK gene rearrangement. Additional molecular targets for which drugs are in various stages of clinical development have been identified in subsets of both adenocarcinoma and squamous cell carcinoma in non-smokers and smokers. Current challenges include identification of molecular targets which may be present in small subsets of tumours and overcoming acquired resistance to targeted agents. Notes: Lessons from GI malignancies –Matt Burge Abstract: Survival times have significantly increased over the past 10 years with the introduction of new agents to clinical practice, including oxaliplatin, irinotecan, bevacizumab, cetuximab, panitumumab and, most recently, aflibercept and regorafenib. With this has come a burgeoning complexity in treatment algorithms. However, there is a broad range of outcomes experienced by individual patients when exposed to these drugs. Determinants of the predictors of an individuals benefit (or lack thereof) to a specific therapy (predictive biomarker) have been intensively researched in mCRC in recent years. This lecture will summarise current knowledge as it impacts clinical practice and highlight the major challenges which lie ahead to advance the goal of individualised care in metastatic colorectal cancer. Notes: Session: Friday 24th February 3.15pm – 3.30pm Session chair: Jeff Goh Presenter: Neil Frazer Topic: Primo BioMed & Cvac™ Primo BioMed & Cvac™ –Neil Frazer Abstract: Interest in revitalizing the immune system to attack malignancies has increased substantially in recent years. With the approval of Provenge ® to treat hormone refractory prostatic malignancy, the concept of cellular immune therapeutics has been validated. Several products are in development based on tumor lysate, or other antigens to treat ovarian cancer. Cvac™ autologous cell vaccine is in advanced research, with first patients being recruited in the Phase III CANVAS (CANcer VAccine Study) double blind placebo controlled study globally in Q1 2012. This talk will address the concept of autologous cell therapy, and will compare and contrast different therapeutic approaches to immune therapy for gynaecological malignancies. Notes: Session: Friday 24th February 4.45pm – 5.45pm Session chair: Clare Scott Presenter: Doug Hilton Topic: Political Landscape of Medical Research Political Landscape of Medical Research–Doug Hilton Abstract: In Australia, the general public ultimately funds the vast majority of health and medical research: either from taxes via state and federal governments or from donations via charitable organisations, such as the Cancer Councils. With funding comes responsibility to spend money wisely. The review of the health and medical research sector announced by Minister Mark Butler and chaired by 2011 Australian of the Year, Simon McKeon provides the sector an opportunity to communicate the importance of medical research to the Australian community and to articulate what is needed to maximize benefits that can accrue from health and medical research. I will discuss these issues. Notes: 7.00-11.00pm Conference Dinner Session: Saturday 25th February 7.30am – 8.45am Presenter: Rob Coleman Topic: Angiogenesis in Ovarian Cancer Sponsored by: Angiogenesis in Ovarian Cancer–Rob Coleman Abstract: In response to mounting evidence that vascular endothelial growth factor among other pro-angiogenic cytokines play a critical role in ovarian cancer biology, clinical investigation of agents targeting these elements was pursued and revealed promising activity in early investigation. Subsequent phase III studies have now documented improved outcomes in several different patient cohorts. However, controversy regarding dose and duration of therapy, subgroups likely to benefit most, toxicity, and cost linger. In addition, mechanisms for target resistance are not clear, further clouding optimal management strategies. These topics will be presented, reviewed and discussed. Notes: For Oncology & Haematology resources hand Events – covering the latest in oncology & haematology. Register for Roche symposiums and events and search for content from HOTT, ASCO, ESMO, WCLC, ASH and more. Medline – with free full text access. Access to oncology and haematology journals such as: The Oncologist, International Journal of Clinical Oncology, European Journal of Haematology. Contacts – your Roche Oncology & Haematology Team. Know who to contact and how. Resources – at hand when you need them. Latest Roche product slide sets, national and overseas treatment guidelines and Roche Access Programs. visit www. .com.au Roche Products Pty Limited, ABN 70 000 132 865, 4-10 Inman Road, Dee Why 2099 EMVAVA0169 01/12 MN37544227 Session: Saturday 25th February 9.00am – 9.30am Presenter: Martin Stockler Topic: How to best assess quality life in clinical trials How to best assess quality life in clinical trials –Martin Stockler Abstract: Most people agree that quality of life is a major consideration for people with cancer, and a crucial outcome of anticancer treatment. Decisions about anticancer treatments typically involve trade-offs between beneficial effects on survival and cancer related symptoms, versus detrimental effects of treatment toxicities and inconvenience. While contemporary trials of cancer treatments often include measures of quality of life, their reported results often leave readers underwhelmed. This presentation will propose a more informative and clinically useful approach to measuring, analysing and interpreting quality of life and preferences data in cancer clinical trials using examples of ongoing and previous ANZGOG studies. Notes: Session: Saturday 25th February 9.30am – 10.30am Session chair: Ken Jaaback Presenters: Rob Coleman, Pedro Ramirez Topic: Scientific Session 7 Maintenance therapy: can we afford it? –Rob Coleman Abstract: It has been well documented that advanced-stage ovarian cancer patients who achieve a complete clinical remission following surgical cytoreduction and adjuvant chemotherapy have a high risk for subsequent relapse. In part, this is due to the insensitivity of non-invasive imaging and biomarker clinical assessment as many patients undergoing second-look assessment procedures are found with small volume disease. However, even patients found with pathological complete response to frontline therapy are found with subsequent relapse in up to 40% of such cases. The reason for this phenomena is not well understood but several randomized clinical trials to reduce this risk have failed. Recent analyses of anti-VEGF treatment trials suggest that continuous exposure of these agents may be of value. However, concerns of toxicity and cost without clear survival impact temper enthusiasm for this approach. These issues will be presented and discussed. Notes: The evolution of cervical cancer surgery – Pedro Ramirez Abstract: The presentation will review the most current surgical approaches in the management of patients with early-stage cervical cancer. An update on the latest literature pertaining to radical hysterectomy will be presented. The most recent information on ideal candidates and surgical outcomes in young patients seeking fertility preservation will be reviewed, focusing both on radical trachelectomy and more conservative management. A review of two important prospective trials evaluating conization or simple hysterectomy in select patients with stage IA2-IB1 will also be discussed. The presentation will also focus on recent surgical trials supporting surgical staging in patients with locally-advanced cervical cancer. Notes: Session: Saturday 25th February 10.45am – 11.45am Session chair: Alison Brand Presenters: Geoff Otton, Gillian Thomas, Christopher Steer Topic: Scientific Session 7: Are clinical trial outcomes relevant to elderly patients? Surgical –Geoff Otton Abstract: The population is getting older. Currently 3-4% of women are over the age of 80 in Australia. It is likely that the health of women reaching this age will improve with time and we will be faced with the challenge of managing older women with gynaecologic cancers. How important is age? Is the evidence of clinical trials relevant to older women? Surgical trials variably include women beyond the age of 80 years. Data would suggest that age alone is not best indicator of outcome. The presence of significant comorbidities is more relevant. Notes: Radiation – Gillian Thomas Abstract: There is no widely accepted definition of what chronological age defines the “older”/“elderly” patient. The WHO definition is evolving. Default definitions even include pensionable age (e.g., 60 or 65 years). In Africa 50 years is considered “elderly” as when active contribution to society or social role is not possible. Should “ageism” limit eligibility for trials? Clearly appropriate and functional definitions of “elderly” would include the use of multidisciplinary diagnostic instruments which collect data on the medical, psychosocial and functional capacity. Quality of life and performance status are important. Specific clinical trials will be discussed with reference to the chronological age distribution and performance status of study patients and whether it is representative of the distribution of disease. The predominant inclusion of younger patients with good performance status may limit the external validity of some trials. Notes: Medical – Christopher Steer Abstract: The median age of patients at the first diagnosis of epithelial ovarian cancer (EOC) is 64 years (Yancik R., SEER data 2000-3). This data also suggests that 47% of patients are over the age of 65 at diagnosis and 26% of patients are older than 75 years. Whilst the definition of “elderly” remains difficult on the basis of chronological age alone, it is generally accepted that patients over the age of 70 years can be considered in this group. The incidence of comorbidities and “geriatric syndromes” such as dementia, falls and incontinence increases after the age of 70 years. The fact that older patients are underrepresented in clinical trials of therapy for ovarian cancer is well documented. In the ICON3 trial only 29% (n = 591) of patients were over the age of 65 and the median age of all patients was 58.9 years. In GOG182/ICON5 17% (n=620) of patients were over the age of 70 years and the median age was 59 years. Whilst these data would suggest that it might be difficult to apply the results of such trials to an older population, the conundrum is made more complex by the fact that fit elderly patients have been shown to tolerate chemotherapy as well as younger patients. Despite this, older patients with ovarian cancer specifically have been shown to have an inferior survival even when treated as part of a clinical trial. Thus I would conjecture that this problem needs to be dissected into different components. Due to the heterogeneous nature of the older patient population with cancer it is impossible to provide just one answer to the question. Appropriate management of the older patient with ovarian cancer requires individualised care; the management of a frail older patient is very different from someone who is fit. Whilst we can opine that existing trial results cannot be applied to older adults we are really saying that we lack data to guide the therapy of frail or vulnerable individuals regardless of age. This problem is not restricted to gynaecological malignancies. The lack of clinical trial data in older patients is a major issue in the common cancers of older adults – colon, lung, breast and prostate. Organisations such as SIOG (International Society for Geriatric Oncology) are acting to highlight the issue and encourage clinical trial organisations around the globe to increase the numbers of older adults in existing trials and design studies to provide information on the appropriate treatment of the more frail elderly patient population. Notes: PRIMA BIOMED, boosting patient’s defenses against cancer. Prima BioMed proudly support members of ANZGOG in their service to medical innovation. Inactive T Cells Dendritic Cell Mucin-1 Customised Dendritic Cells targeted to Mucin-1 1. THE KEY CELLS 2. DESTRUCTION The immune system is primed to find “foreign” proteins and to send killer cells to destroy them. The cells that detect the foreign protein such as abnormal mucin-1 are antigen presenting cells, and dendritic cells are a key antigen presenting cell. The antigen presenting cell then picks up some of the abnormal mucin-1 protein, and presents it to T cells. The T cells are then primed to detect cells carrying abnormal mucin-1 and initiate their destruction. Dying Cancer Cell Activated T Cells Cancer Cell Therapy involves selectively harvesting cells from the patient‘s blood that can be matured into dendritic cells. These immature dendritic cells are then matured and primed with mucin-1 using mannan mucin-1 fusion protein, creating the Prima BioMed CVac™ product. www.primabiomed.com.au 4. TARGETING THE TUMOUR When the cells are injected intradermally, they locate naive T cells and present mucin-1 to them, creating activated killer T cells. The killer T cells then locate tumour cells overexpressing mucin-1 and initiate their destruction. © brandLOVERS.de 3. VACCINE THERAPY