ATLANTA, May 16 /PRNewswire/ -- A landmark study shows that a new drug
combination, paclitaxel (Taxol)(R) and carboplatin (Paraplatin)(R), is better
for the chemotherapy treatment of advanced ovarian cancer because it is
significantly less toxic for patients. The combination also proved to
maintain the high level efficacy of paclitaxel-based chemotherapy. This
phase III, multi-centered study conducted by the Gynecologic Oncology Group
(GOG) was presented here today at the 35th annual meeting of the American
Society of Clinical Oncology (ASCO).
"There were concerns that carboplatin would be less effective when
compared to cisplatin, the drug that had been previously used with
paclitaxel," explained Robert F. Ozols, M.D., Ph.D., Senior Vice President,
Medical Science at Fox Chase Cancer Center, Philadelphia, Pa. "Not only does
this study prove that carboplatin is at least as effective as cisplatin, but
it presents fewer troublesome side effects for patients. Toxic side effects
such as nausea and weight loss are decreased."
In addition to proving carboplatin as the preferred choice to be used in
combination with paclitaxel in the treatment of ovarian cancer, the study also
confirms that these agents can safely and effectively be administered over a
three-hour infusion period. Previously, the paclitaxel/cisplatin compound was
administered over 24 hours requiring a hospital stay.
The paclitaxel/carboplatin regimen was well tolerated and also resulted in
significant decreases in side effects when compared to patients receiving the
paclitaxel/cisplatin combination. Patients receiving paclitaxel/carboplatin
experienced fewer gastrointestinal, genitourinary, and metabolic effects such
as nausea, vomiting, weight-loss and kidney damage. The decrease in toxicity
was not associated with any decrease in efficacy.
The GOG 158 study randomized 808 patients to receive either carboplatin
plus paclitaxel administered by a 3-hour infusion or cisplatin plus paclitaxel
administered by a 24-hour infusion. This trial was designed as a follow-up
study to the GOG 111 study.
The landmark GOG 111 study, completed in 1996, showed that the median
survival time of women with advanced ovarian cancer was extended by over 50
percent when patients received paclitaxel plus cisplatin as first-line
chemotherapy. The paclitaxel-based regimen in the study extended median
survival to 37.5 months, compared to 24.4 months with the standard
cisplatin/cyclophosphamide combination, adding a median of 13 more months to
This large, well-controlled GOG study represented the first trial in 15
years, since cisplatin was developed and incorporated as the initial therapy
of ovarian cancer, that showed a notable improvement in survival for ovarian
Over 25,000 new cases of ovarian cancer will be diagnosed and 14,500 women
will die from ovarian cancer in 1999, according to estimates from the American
Cancer Society. Ovarian cancer accounts for four percent of all cancers among
women and ranks second among gynecological cancers. Ovarian cancer is the
most deadly cancer of the female reproductive system. The five-year relative
survival rate for all stages is 50 percent.
The risk for ovarian cancer increases with age and peaks when women are in
their seventies. Other risk factors include women who have never had
children, family history, and a hereditary genetic syndrome most frequently
associated with mutations in tumor suppressor genes BRCA-1 and BRCA-2.
GOG 158 was coordinated by the Gynecologic Oncology Group (GOG), a national
organization dedicated to clinical research in the field of gynecologic
cancer. The purpose of the GOG is to improve the treatment of gynecologic
cancer. These goals are addressed through research encompassing surgery,
radiation therapy, chemotherapy, pathology, immunology and/or gynecologic
nursing. To promote this mission, the GOG receives support from the National
Cancer Institute (NCI) of the National Institutes for Health (NIH) and the
American College of Obstetricians and Gynecologists, which is the parent
organization for GOG.
Fox Chase Cancer Center is one of 35 National Cancer Institute-designated
comprehensive cancer centers in the nation. The Center's activities include
basic and clinical research; prevention, detection and treatment of cancer;
and community outreach programs.
SOURCE Fox Chase Cancer Center