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Higher doses of chemotherapy increase remission time and toxicity in ovarian cancer patients

While a regimen of moderately high dose systemic chemotherapy followed by additional chemotherapy placed in the abdomen produce longer remissions in women with advanced ovarian cancer, the strategy is too toxic and does not significantly prolong overall survival, a new study shows. Researchers said until the experimental regimen is perfected, standard dose chemotherapy should be used.

“We are encouraged because there was evidence that it took longer for the cancer to come back in patients using the experimental treatment,” said study leader Maurie Markman, M.D., Director of the Taussig Cancer Center at the Cleveland Clinic Foundation. “But toxicity, at this point, is too great to recommend this regimen.”

In a phase III, randomized clinical trial, researchers tested the concept of first shrinking ovarian tumors as much as possible by using two cycles of moderately high-dose carboplatin chemotherapy intravenously, then eliminating the remaining cancer with two other agents: six courses of intravenous paclitaxel and cisplatin delivered directly into the abdomen through a catheter.

Half of 462 patients received this experimental regimen, and half received six courses of intravenous cisplatin and paclitaxel, the standard treatment.

Patients using the experimental treatment had an average remission, or “progression-free survival,” of 28 months, compared to 22 months for patients receiving standard treatment. But improvement in overall survival from 52 months in the control group to 63 months for patients in the experimental group was “of borderline significance,” said Markman.

Furthermore, blood tests showed that patients receiving the higher-dose chemotherapy had lower blood cell counts, as well as increased nausea, vomiting, and fatigue, compared to control patients. The “excessive toxicity” caused 18 percent of patients to discontinue the experimental therapy. “The first two rounds of carboplatin had more effect on patient’s bone marrow than was anticipated,” Markman said.

Markman added, however, that results suggest delivering chemotherapy directly to the abdomen is a useful strategy to explore in the future.

“Phase III Trial of Standard Dose Intravenous Cisplatin Plus Paclitaxel Versus Moderately High Dose Carboplatin Followed By Intravenous Paclitaxel and Intraperitoneal Cisplatin in Small Volume Stage III Ovarian Carcinoma;” M. Markman, MD, et al.; Cleveland Clinic Foundation, Cleveland, OH. Vol. 19, No. 4, (February) 2001, pp. 1001-1007.

The Journal of Clinical Oncology is the semi-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO), the world's leading professional society representing physicians who treat people with cancer.

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