Bendamustine Clinical Trial / Breast Screening by MRI / Advantages
Transcription
Bendamustine Clinical Trial / Breast Screening by MRI / Advantages
Tower Cancer Research Foundation SEPTEMBER 2008 A Promising Cancer Drug Emerges From Behind The Iron Curtain chemotherapeutic agent known as bendamustine was developed in East Germany in 1963 and first used there in 1969 for the treatment of multiple myeloma. Eventually, more than 20,000 patients with a variety of malignancies were treated with this drug (especially lymphoma, myeloma, and chronic lymphocytic leukemia). Despite widespread use and successes, the Iron Curtain was in place and there was essentially no scientific exchange between East and West Germany. With the fall of the Berlin Wall in 1989 and the gradual blending of science between the former East and West German medical communities, bendamustine emerged from the shadows and was identified as a potentially very important agent. However, as information about this drug became known in other parts of Europe and the US it was evident that the data acquired in the former East Germany did not satisfy rigorous statistical standards. Before bendamustine could be accepted and marketed in the US, clinical trials had to be repeated and the data confirmed. During the past few years the drug has been tested in several controlled Phase II and III trials. The most important thus far was an international, multicenter Phase III study of 301 C O N T E N T S previously untreated patients with chronic lymphocytic leukemia (CLL), comparing bendamustine to the single agent standard of care. Responses nearly doubled with bendamustine, and almost one-third of patients had a complete regression of their disease, as A Portion of the Berlin Wall Left Standing (c. 1995) Courtesy of David Rosenbaum, MD compared to 2% treated with standard drug therapy. In March of 2008, the FDA approved bendamustine for treatment of CLL in the US under the name TREANDA®. Impressive results also have been reported in studies of lymphoma patients who had become resistant to standard therapy. When bendamustine was given as a single “rescue” agent to those individuals resistant to rituximab (a Drug Emerges From Behind the Iron Curtain............1 Breast Screening by MRI ............................................2 Dr. Peter Lee Joins TCRF..............................................3 Ronnie Lippin Cancer Information & Resource Line...3 Altruist Enrolls on a Trial.............................................4 Leukemia Awareness Month..........................................4 Advantages of Clinical Trial Participation...................5 commonly administered monoclonal antibody), 77% responded positively. For lymphoma patients not yet resistant to rituximab, bendamustine given together with this antibody resulted in a 92% response rate. In addition, this drug currently is being tested in other malignancies such as multiple myeloma, sarcoma, and breast cancer, since preliminary data have indicated positive responses in these diseases. Thus far, the potential of bendamustine as initially described in East German medical publications has been validated by contemporary European and US studies. Tower Cancer Research Foundation is a participating site for an important Phase II study of this drug as part of a triple therapy regimen. We are offering this promising agent to lymphoma patients unresponsive to standard treatment, or having relapsed after initially responding to treatment. Hopefully, this will be a major breakthrough regimen for these patients. TCRF also is planning to open a similar trial for newly diagnosed and untreated lymphoma patients to assess response rates when the drug is administered right at the outset of their disease, rather than after heavy prior treatment. Frank E. Rosenfelt Drug Development Program............5 Foundation News...........................................................6 Notes from the Chairman of the Board...........................6 Going Green...................................................................6 2008 Spirit of Hope Luncheon......................................7 Tree of Life....................................................................8 Board of Directors..........................................................8 W h i c h Wo m e n N e e d B r e a s t S c r e e n i n g B y M R I ? David L. Rosenbaum, MD - Director of Medical Education At present, mass screening by mammography is the only imaging procedure proven statistically in controlled trials to decrease mortality rates from breast cancer. However, MRI imaging is the technique with the highest sensitivity for detecting abnormalities within the breast, causing experts to discuss its potential use for routine breast cancer screening. Due to certain important limitations, MRI has not been approved for mass population screening. The first limitation is cost, as this procedure is quite expensive. Another is the lack of procedure standardization. Equipment and techniques may vary widely from place to place thereby limiting accurate interpretation. Further, MRI of the breast is relatively new and the methodology is changing rapidly. In this regard, truly expert radiologist-readers are found at sites with high procedure volumes, while radiologists at low volume sites are still on a learning curve. Breast MRI Courtesy of: Dr. Steven Harmes Baylor UMC Perhaps the most significant and controversial problem with breast MRI is that, in a sense, it may be too sensitive. In women with normal breasts and no risk factors it may detect abnormalities that are unimportant. However, once these are identified, patients may have to undergo additional testing, biopsies, and even more extensive surgery just to prove that the findings were not cancer. In medical terms this is called a “lack of specificity”, which can frequently lead to unnecessary procedures. • Prior radiation to the chest between ages 10 and 30: These individuals, many of whom have been treated for Hodgkin’s Lymphoma, have a markedly increased risk for breast cancer later in life. Nonetheless, it is undeniable that the increased sensitivity of MRI is an important adjunct to mammography screening in women with high risk situations. The American Cancer Society recognized this when it issued 2007 guidelines that defined high risk individuals and recommended annual MRI screening for women in the following settings: • Newly diagnosed breast cancer: There is evidence that MRI may detect tumors in the opposite breast in a small percentage, and/or within the same breast, missed by mammograms. This also occurs in certain specific and unusual types of breast cancer. Further, MRI may be useful to determine the precise extent of cancer in order to facilitate better surgical planning. • BRCA breast cancer gene mutations, and/or a very strong family history: Carriers of BRCA mutations not only have an extremely high lifetime risk (up to 80%), but their cancers may have a benign appearance by mammography. A strong family history might be defined as a first degree relative (parent, sibling, or child) developing breast cancer before menopause, two or more first or second degree relatives with breast (or ovarian) cancer, two 2 Cancer cancers (breast or ovarian) in the same close relative, and male breast cancer in a first degree relative. Even with no identifiable mutation, individuals with these strong family histories are sufficiently at increased risk to consider an annual MRI possibly starting at an age as young as 30. • Breast reconstruction: Silicone leaks can mimic cancer on mammograms, whereas MRI is valuable in differentiating silicone changes from malignancy. • Inconclusive breast imaging: Mammography can be exceedingly difficult to interpret in women with dense breasts or other anatomical variations, including prior breast surgery with scarring. Therefore, sufficient evidence exists to recommend routine MRI screening in high risk patients (defined as greater than 20-25% lifetime risk for breast cancer) as well as for those with anatomic situations that cause mammography to be technically unsatisfactory. Of course patients must be able to lie prone and still in the unit for 30-45 minutes, will receive dye, and cannot have a pacemaker or metal anywhere near the breasts. Routine breast MRI screening of high risk women detects 4 to 5 cancers per 100 examinations that otherwise would have been missed by routine mammography. These figures do not apply to women at normal risk, and to date there are no data to support routine mass screening of the general population. There are gray areas, however, such as women with dense breast tissue, non-cancerous but abnormal prior breast biopsies, and a previous personal history of breast cancer. The American Cancer Society finds insufficient evidence to recommend for or against MRI screening in these situations, which must be decided on a case by case basis. Dr. Peter Lee Joins TCRF Tower Cancer Research Foundation is proud to announce that Dr. Peter Lee has been appointed Associate Medical Director He will join Dr. Peter Rosen in expanding our Foundation’s portfolio of clinical trials, especially in the exciting area of early phase studies. He looks forward to participating in developing programs for new treatments as well as the direct patient care of subjects enrolled in our studies. Dr. Lee was born in Hong Kong but was primarily educated in the US since nine years of age. He graduated from the University of California at Berkeley and then returned to Hong Kong in 1986 where he subsequently obtained a Ph.D in physiology. He returned to the US in 1992 and received his medical degree and performed internship and residency training at Jefferson Medical College and University Hospital in Philadelphia. Between 1999 and 2002 Dr. Lee was a fellow in the Hematology-Oncology program at UCLA. Upon completion of his fellowship he accepted a faculty position as Assistant Clinical Professor at UCLA where he remained until 2005. During that year he decided to leave academia to assume a position as a Clinical Research Director at Amgen Pharmaceutical. At Amgen his responsibilities included designing clinical trials, data analysis, and interacting with various regulatory agencies, especially the FDA. These are the exact skills that he will be exercising at TCRF, but in addition, he looks forward to having much more contact with patients. Dr. Lee’s background and training are perfectly suited to his new position as Associate Medical Director and he is certain to be an important asset to our Foundation. Ronnie Lippin Cancer Information & Resource Line a t To w e r C a n c e r R e s e a r c h F o u n d a t i o n Launches October 13th 2008 We are very excited to announce the beginning of a free cancer information and resource service for the Los Angeles community. Beginning October 13th, anyone in Los Angeles will be able to obtain free personalized cancer related information and resource referrals. Our trained professional staff will be available by phone or email to help direct cancer patients and their families through the often confusing world of cancer issues and resources. We can help find solutions to issues such as transportation needs, prescription drug assistance programs, attendant care and home health care agency referrals, food and nutrition programs, and more. Partially funded through the generosity of Dick Lippin and his daughter Alexandra in memory of their late wife and mother, Ronnie, the goal of this service is to relieve the burden and challenges of a cancer diagnosis by providing information and professional assistance sorting through the options and decisions that can be so overwhelming for a newly diagnosed cancer patient. Beginning on October 13th, this free community service can be accessed by calling 1-877-RLC-2120 (1-877-752-2120) or by visiting our website, www.LACancerInfo.org 3 A True Altruist Enrolls in a Clinical Trial antiestrogen. Both cancers were cured by decisive medical action. Lucy S. found her unusual blood disease to be much different and more frustrating than the two cancers she had dealt with previously. In 1980, she was cured of thyroid cancer after extensive neck surgery; in the same year her husband, an Air Force colonel, died suddenly. In 1986 she was shocked to find that she had breast cancer, which was treated successfully with surgery, radiation, and an However, this blood disease, called myelodysplastic syndrome (MDS), was different. It started two years ago when she was 84. It seemed simple enough at first. Anemia was the main symptom, and it was handled easily enough with shots. Although the MDS dragged on and on, it did not interfere at all with her lifestyle, which included going to the gym regularly, walking 4 to 5 miles and doing 50 sit-ups daily, as well as taking care of her home. Also, she was especially close to her three sons and their families. In December, 2007, there was a sudden change in her blood count. Another bone marrow procedure was performed, which showed that her mild blood disease had abruptly and unexpectedly undergone a transformation into acute September is Leukemia Awareness Month Although all cases of leukemia originate in the bone marrow, the four major types vary widely in signs, symptoms and ultimate outcomes. Essentially, each type is an entirely different disease having in common only the term “leukemia” and the presence of malignant cells in the bone marrow. About 39,000 new cases of leukemia are expected to be diagnosed in the US this year. The estimated 2008 incidence and survival rates vary widely according to type. Childhood acute lymphocytic leukemia (ALL) is cured in the majority of cases, while adults with the same condition have a much lower cure rate. Chronic lymphocytic leukemia (CLL) is an adult disease with a very high response rate to treatment and long survival. About a third or more cases of acute myelogenous leukemia (AML) are cured. The response rate of chronic myelogenous leukemia (CML) to therapy is greater than 90%, and recent major treatment advances have resulted in long-lasting disease regressions. To date, cures of CML have been documented only after bone marrow transplantation. However, recent progress with targeted drug therapy has been so impressive that some experts are hoping that cures will be possible with these agents only (although this is still quite speculative). These statistics were entirely different forty years ago. There were no cures of AML or adult ALL, and the cure rate of childhood ALL was very low. Five year survival of CML was less than half the present rate, and for CLL about 20% lower. The ability to cure and produce these dramatic advances in treatment was the result of intense basic research into molecular mechanisms of leukemic cells, which resulted in effective drug development, eventually culminating in breakthrough clinical trials. The development of bone marrow transplantation (Nobel Prize to Dr. E. Donnell Thomas), first as a rescue technique and later for certain high risk cases, played an important role as well. The evolution of the acute leukemias from nearly hopeless to potentially curable diseases, and the impressive improvement in survivals for the chronic leukemias, are testimonies to scientific persistence and illustrate the important transition from basic research to clinical trials to the bedside. 4 leukemia. Genetic studies on the marrow were abnormal indicating an unfavorable outlook, perhaps a few months at best. At age 86 there were very few options. She was too elderly to endure highly aggressive treatment, yet she had everything to live for. The situation seemed hopeless until her son discovered on the internet that Tower Cancer Research Foundation had a clinical trial designed especially for elderly individuals with acute leukemia. By this time bruising and transfusions had started, and her white blood count was very low creating a serious risk for infection. The disease was moving rapidly. Her attitude nevertheless remained positive. Lucy enrolled in the Tower clinical trial with reasonable expectations. She understood that this trial was a form of research, and the outcome of a new treatment could not be predicted. She had nothing to lose by trying, and no matter the outcome, it would please her to know that her case might make a contribution to medical science. Further, she felt “exceedingly comfortable and trusting at Tower”, and bonded with her doctor, many of the nurses, and especially the research coordinator who organized and monitored her treatment. Eight months have passed since the start of Lucy’s therapy. This constitutes almost three times the survival expectancy initially predicted. Although life definitely is more complicated now, with frequent treatments and constant monitoring of blood counts, she dutifully complies, always accompanied by one of her sons. Her situation is proceeding well enough that she has resumed walking several miles daily and may be permitted soon to return to the gym. One has the impression that with this positive response to the clinical trial and her personal drive and energy, Lucy will log many more miles. Advantages of Participating In a Clinical Trial Patients diagnosed with a serious disease such as cancer are understandably preoccupied with many concerns. Perhaps the last thing that they may wish to be confronted with is a recommendation to participate in a clinical trial with all the intimidation and surrounding buzz words such as being a “guinea pig” those trials imply. It turns out that, for a variety of reasons, in the United States only 3% of adults with malignant disease participate in trials, in contrast to Europe where the figure is close to 20%. This is unfortunate for a number of reasons: 1) The status quo will never improve unless new therapies are investigated. Cancer care in the US will become stagnant without adequate numbers of trial participants to facilitate the development and testing of novel agents. 2) Some patients may benefit more from the innovative treatments available only in a clinical trial than from the usual standard of care. Unfortunately, many of these individuals are never offered the chance to participate. 3) There is good reason to believe that patients in clinical trials actually receive enhanced medical care because of all the extra attention required, since research physicians and nurses/data coordinators all contribute to the management team. Peter J. Rosen, MD M e d i c a l D i re c t o r 4) Many individuals are indeed altruistic and would like part of their life’s legacy to be that their participation in a trial furthered the science of medicine and led to better therapy for future patients. Clinical trials may be offered to the patient at any stage of their disease. Why? Because there is continued room for improvement in almost every aspect of cancer management. Although great progress has been made there is still much to be learned and clinical trials are the only way to improve our current state of knowledge. Finally, it should be emphasized that no approved clinical trial ever offers patients anything less than the accepted standard of care! TCRF Names Clinical Trials Program Tower Cancer Research Foundation is pleased to announce the naming of its clinical trials program. It will be renamed as a tribute to Frank E. Rosenfelt (shown right), an individual who played an important role in its establishment. Frank Rosenfelt was an entertainment industry attorney, first at RKO, and later rising through the ranks of MGM to become general counsel and eventually president and CEO in 1972. His ten years as studio chief were exceedingly successful, and after leaving MGM he continued to work elsewhere in prestigious positions. He developed close friendships with a large number of important individuals in the industry, who held him in very high regard. As a result of this network and the Rosenfelt family’s deep commitment to cancer research, significant philanthropic contributions have been made to TCRF. This support has enabled the Foundation to double its clinical trials activity in just the past two years. TCRF is honored to name our clinical trials program The Frank E. Rosenfelt Drug Development program. Frank E. Rosenfelt 5 Foundation News From the Director of Administration, Pam Blattner We have spent a busy summer in preparation for launching some new programs and initiatives events this fall. Just a few of these are listed below: • Our second annual Spirit of Hope Luncheon, to be held on Monday, October 20th, will honor prominent local community members and long time friends of TCRF (see article, p.7). • The annual holiday breakfast for patients is scheduled for December 4th at Neiman Marcus. This feel good event is newly renamed “Judy’s Popover Breakfast” in memory of our beloved founding Board member, the late Judy Ruderman. • We have finalized the website design and are in the programming stage. It is anticipated that it will be up and running in October. We have expanded our patient support programs to include free acupressure workshops and have reinstituted our free public lecture series. The first was held in June on prostate cancer and the next is in the planning phase. As a reflection of our rapidly growing clinical trials program, particularly Phase 1 and Phase 2 studies, we have recently welcomed Dr. Peter Lee as our Associate Medical Director. Because these trials require increased medical oversight and are much more demanding in terms of patient care, we have also added three new research nurses, Deanna Black, RN; Jessie Conley, RN; and Eryn Ferdman, CCRC. As always, many thanks to the donors who have made our expanding programs and services possible. Notes from the Chairman of the Board Tower Cancer Research Foundation is becoming the model for a progressive, responsive and innovative 21st century foundation. We are able to provide clinical trials and community outreach in new and innovative ways without losing sight of how to care for patients. This year alone, our volunteers, physicians, research nurses and support staff have come up with more new ideas, clinical trials, and outreach programs than any other time in our history. Here are some of the things we are doing. This fall, our vastly improved website will be operational. It promises to be very user friendly and it will ultimately provide our community with information that is meaningful and informative. The Frank E. Rosenfelt Drug Development Program has deepened its collaborations with major research institutions such as The City of Hope, and TGen. Because of the time and support of the Rosenfelt family we have been able to expand the heart and core of our Foundation’s clinical trials. We will inaugurate the Ronnie Lippin Cancer Information & Resource Line this Fall to help those searching for information and referrals while dealing with a cancer diagnosis. It has been a year of great accomplishments, but we must not stop here. “Siempre Adelante” With your help and support, we can move forward. 6 GOING GREEN In an effort to help the environment, TCRF is joining the green movement and offering our quarterly newsletter electronically. If you wish to receive our future newsletters electronically please contact Sarah Watters with your email address at (310) 205-5768 or watterss@toweroncology.com. Please Join Us for Our Spirit of Hope Luncheon on October 20th Stacy D. Phillips, author and certified Family Law Specialist, who has been named one of the “Top 75 Female Litigators in California” by the Daily Journal for the past four years, will be receiving the Spirit of Hope Award. Stacy, managing partner of Phillips, Lerner, Lauzon & Jamra, LLP, is also among an elite group of attorneys named “Best of the Bar” by the LA Business Journal and one of “LA’s Best Lawyers” by LA Times’ West Magazine. Stacy and her family are thrilled to be able to give back to Tower after her mother was successfully treated for breast cancer several years ago. Nancy Kipper, will receive the inaugural Tower of Support Award in recognition of being a caregiver for her daughter, Sheryl Weissberg, when Sheryl struggled with Non-Hodgkins Lymphoma several years ago. Nancy is a native of Los Angeles and has been active in and recognized for her contributions to numerous community non profit organizations, including Cedars-Sinai and City of Hope, for many years. The featured speaker for the luncheon will be Ruth Peltason, author of I Am Not My Breast Cancer, a compendium of excerpts from a web chat for women diagnosed with breast cancer. Ruth, is a breast cancer survivor, and her book covers topics such as image, intimacy, work and family issues, and is a comfort to any woman living with breast cancer. There will also be a pre-holiday boutique with vendors selling purses, jewelry, children’s items and home goods. If you have not received an invitation and would like to attend, please contact FTA Events, 310-288-1755. TCRF Tree of Life Thank you to all of our donors who have contributed since March 2008. Every donation is meaningful and aids in our exploration of new treatment options for those fighting cancer and blood disorders. We greatly appreciate your continued support and generosity. Although we would like to publicly acknowledge every gift, due to space limitations, we are only able to list those donations of $1000 or more. Additionally, we engrave a leaf of our Tree of Life for donations of $2500 or more. Contributions of $2500-$4999 are engreaved on a copper leaf, $5000-$9999 on a gold leaf and $10,000 + on a platinum leaf. For more information regarding contributions please contact Pam Blattner at 310-285-7242. Barbara Meepos and Associates Bonnie and Barrett Bearson Bloom Hergott Diemer Rosenthal LaViolette & Feldman LLP John Chernin & Family Mimi and Raymond Diller Feintech Family Foundation Sylvia Firestone Judith Frankel - Menlo Foundation Friars Charitable Foundation Madeline Gussman Randall Katz - Katz Family Foundation Kara Klein and David Hurwitz Martha and Dr. Jack Matloff Al Merschen - Myriad Marketing Cheryl and Harry Nadjarian Ben Nickoll -Armstrong Nickoll Family Fdtn. Milton T. and Rosemary Okun Steven Paul Joe Rosen Nina Rosenthal Rebecca and Dr. Brett Roth Loren Rothschild Dr. Esther Sinclair Stern Family Foundation Harry Sherr and Cynthia Strauss 7 Tower Cancer Research Foundation PRSRT STD US Postage PAID Los Angeles, CA Permit #3344 310-285-7242 | www.towercancerfoundatin.org Administrative Offices: 9229 Wilshire Blvd | Beverly Hills, CA | 90210 Clinical Services: 9090 Wilshire Blvd | Ste 200 | Beverly Hills, CA | 90211 OFFICERS Steven Lee Yamshon, PhD, Chairman Solomon Hamburg, MD, PhD, President Fred Rosenfelt, MD, VP Scientific Affairs Steve Smith, Treasurer Abby Levy, Secretary David Ruderman, Chairman Emeritus BOARD OF DIRECTORS Wayne Baruch Elizabeth Drucker Julie Dunhill, MD Barbara Federman, Esq. David Hoffman, MD Randy Katz Alan D. Levy Sally Magaram Philomena McAndrew, MD Sandra D. Miller Jack Mishkin Nancy Mishkin Chris Rose, MD Rick Rosen Barry Rosenbloom, MD Saul Rosenzweig Heather Shuemaker James Shuemaker Deborah Smith Steve Smith MEDICAL DIRECTOR Peter J. Rosen, MD ASSOCIATE MEDICAL DIRECTOR Peter Lee, MD, PhD MEDICAL ADVISORS Robert Decker, MD Julie Dunhill, MD Leland Green, MD Solomon Hamburg, MD, PhD David Hoffman, MD Philomena McAndrew, MD Dorothy Park, MD Sepehr Rokhsar, MD Barry Rosenbloom, MD Fred Rosenfelt, MD RESEARCH STAFF Marie Fuerst, MS, RN Director of Clinical Research Services Pam Blattner, MBA Director of Administration David Rosenbaum, MD Director of Education Newsletter Editor-in-Chief RESEARCH COORDINATORS Linda Ford, PA-C Deanna Black, RN Jessie Conley, RN, BS Cheryl Elzinga Eryn Ferdman, CCRC Elizabeth Tran, CCRC 8 ADMINISTRATIVE ASSISTANTS Tiwana Broom-Harvey Dorothy Parker Sarah Watters Announcements Ronnie Lippin Cancer Information & Resource Line Launches October 13th 877-RLC-2120 - www.LaCancerInfo.org 2008 Spirit of Hope Luncheon October 20th - Beverly Hills Hotel Your Support is Appreciated Tower Cancer Research Foundation is a non-profit research foundation, dedicated to providing state of the art cutting edge clinical research in a private practice setting. We believe that patients are thereby treated in a more caring environment, while retaining the same physician and nursing team throughout their illnesses. We are committed to this concept and to the continued expansion of these capabilities. In addition, our close affiliation with the City of Hope allows us to access additional trials previously only available at that institution. Although many of our trials receive funding from pharmaceutical companies, these monies are insufficient to support the extensive infrastructure required. Therefore, we depend on outside contributions to continue to advance the cause of cancer research. Your tax deductible donation to Tower Cancer Research Foundation may be mailed directly to our office, or via our web site (www.towercancerfoundation.org). President, Tower Cancer Research Foundation MISSION STATEMENT Tower Cancer Research Foundation is committed to providing innovative research, community education and caring patient support while developing more effective treatments for cancer and blood disorders.