CONTACT: Kristi Hellmuth
Johanna Spangenberg; (202) 638-7222
NEWS ROOM: March 20-26, 1997
Pointe Hilton on South Mountain
Phoenix, AZ
(602) 431-6501
PATIENTS WITH PERSISTENT OR RELAPSED OVARIAN CANCER CHEMOTHERAPY TREATMENTS ARE AIDED BY REVOLUTIONARY CELL TRANSPLANT PROCEDURE
PHOENIX, AZ (March 26, 1997) -- Improvements for conventional therapy in women with advanced ovarian cancer have not significantly enhanced their survival rate. Platinum based chemotherapy for women in stage III and IV of the cancer at first showed promise; however, drug resistance develops rapidly, and responses to the therapy range from 10-40%. Loyola researchers believe that survival can be enhanced by increasing the dose of chemotherapy and then rescuing the patient by using stem cells or bone marrow support. The objective of the study was to identify patients that had survival benefit from aggressive chemotherapy with stem cell transplantation.
The study was lead by Dr. Robert A. Bayer and Dr. Patrick J. Stiff, and members of the Bone Marrow Transplant Program at the Cardinal Bernardin Cancer Center. Participating in the study were program colleagues C. Kerger, D. Malhotra, and D.J. Peace. Also listed as co-authors for this research are R.K. Potkul, D. Smith, and S.G. Fisher from the Medical Center's Gynecologic Oncology Division.
The results of this study were presented at the 28th Annual Meeting of the Society of Gynecologic Oncologists, at the Pointe Hilton on South Mountain, Phoenix, AZ. In addition to gynecologic oncologists, the organization's 800 members include medical oncologists, radiation therapists, and pathologists whose primary professional commitment is to the treatment of women with gynecologic malignancies, including cancers of the ovary, endometrium, uterus, cervix, vagina, and vulva, as well as trophoblastic disease.
The Study
The researchers reviewed their experience with their first 100 patients afflicted with recurrent or persistent ovarian cancer. The study subjects were required to be free of active infections, including HIV, and have an adequate stem cell harvest.
Patients underwent either autologous bone marrow harvest, or peripheral stem cell collection. The cells were frozen for preservation; in the interim, patients received high dose chemotherapy. Preserved bone marrow or peripheral blood stem cells were then reinfused after completion of the chemotherapy, followed by prophylactic antibiotics and growth factors.
Responses were defined as follows:
-- A complete response was the complete disappearance of all measurable and evaluable disease for a minimum of four weeks. The Cancer Antigen 125 (CA-125) test was required to be at a normal range with normal CT scans and physical exams.
-- A partial response was greater than or equal to 50% reduction of all measurable disease and greater or equal to 50% decrease of the CA-125 level for a minimum of four weeks.
-- Progression of disease was defined as the time from the date of transplant to either the date of the measurement of disease by scan or exam or the date of the first of two
CA-125 elevations.
.
-- Platinum-resistant disease: For this study, this term referred to disease that did not respond to the standard chemotherapy or that relapsed within six months of completion of standard platinum-based chemotherapy.
The Results
The high dose chemotherapy with transplantation proved to be effective in many cases.
Reviewing the first 100 patients between October 1989 and February 1996, the median progression free and overall survival for women with recurrent ovarian cancer was 7 and 13 months, respectively.
Overall response rate for 87 patients with measurable or evaluable disease was 74% with 52% complete remissions. Analyzing for best outcome, patients with platinum sensitive and low bulk disease at time of transplant had major improvements in survival with 30 month median overall survival. This is the greatest published improvement in survival in patients with relapsed ovarian cancer.
Dr. Bayer and the Loyola team recommend that patients with advanced ovarian cancer be evaluated for the national intergroup trial comparing prolonged standard chemotherapy against high dose chemotherapy and stem cell transplant.
Comment
According to Dr. Bayer, "We are encouraged by these preliminary findings in favor of dose-intensive therapy in the early management of ovarian cancer. We eagerly anticipate the results of a similar, but prospective randomized trial, opened under the auspices of the National Cancer Institute (NCI) and their Gynecologic Oncology Group."
Post Script
The NCI has announced a clinical trial on high-dose chemotherapy with stem cell transplantation. This trial (GOG-164) will compare the effectiveness of standard-dose chemotherapy to high-dose chemotherapy with autologous stem cell transplant (ASCT) in patients with stage III ovarian cancer disease.
While the results of high-dose chemotherapy have been encouraging in breast cancer patients, and may be equally beneficial in ovarian cancer, this procedure has only been tested in a limited number of ovarian cancer patients, and only with women who did not respond to primary therapy. NCI is sponsoring this trial to provide women and their health care professionals with definitive answers about the use of high-dose chemotherapy and stage III ovarian cancer.
To take part in this trial, you must:
-- Be a woman 65 years of age or younger and in good general health;
-- Have had chemotherapy to treat Stage III ovarian cancer that has spread within the abdomen and pelvis, and surgery to carefully examine the entire abdomen for evidence of cancer. You cannot take part in this study if you;
-- Are pregnant or breast feeding;
-- Have a cancer that is or was active in another part of the body, except non-invasive cervical cancer or skin cancer;
-- Have a history of heart disease.
You and your doctor can find more information about this clinical trial by calling NCI's Cancer Information Service (CIS) at 1-800-4-Cancer (1-800-422-6237). Edward L. Trimble, MD, MPH, NCI's Head of Surgery Section, Cancer Therapy Evaluation Program, is overseeing this project. - end -
The authors of this study are available to talk to the media regarding their study objectives, methodology, and results. Contact Kristi Hellmuth or Johanna Spangenberg at (202) 638-7222 for more information about this research or an interview with the authors. .
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