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Journal of Clinical Oncology, Vol 18, Issue 1 (January), 2000: 106
© 2000 American Society for Clinical Oncology

Phase III Randomized Study of Cisplatin Versus Paclitaxel Versus Cisplatin and Paclitaxel in Patients With Suboptimal Stage III or IV Ovarian Cancer: A Gynecologic Oncology Group Study

By Franco M. Muggia, Patricia S. Braly, Mark F. Brady, Gregory Sutton, Theodore H. Niemann, Samuel L. Lentz, Ronald D. Alvarez, Paul R. Kucera, James M. Small

From the Departments of Medicine and Medical Oncology, Kaplan Cancer Center, New York University, New York; and Roswell Park Cancer Institute, Buffalo, NY; Department of Obstetrics and Gynecology, Louisiana State University Medical Center, New Orleans, LA; Division of Gynecologic Oncology, Indiana University Medical School, Indianapolis, IN; Department of Pathology, Columbus Cancer Council, James Cancer Hospital, Ohio State University, Columbus, OH; Section on Gynecologic Oncology, Wake Forest University School of Medicine, Winston-Salem, NC; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, AL; Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Oregon Health Sciences University, Portland, OR; and Unipath, Limited Liability Corporation, and Department of Pathology, Presbyterian-St Luke’s Medical Center, Denver, CO.

Address reprint requests to GOG Administrative Office, Ste 1945, 1234 Market St, Philadelphia, PA 19107.

PURPOSE: To assess progression-free survival (PFS) and overall survival (OS) in patients with suboptimally debulked epithelial ovarian cancer receiving cisplatin (100 mg/m2) or 24-hour infusion paclitaxel (200 mg/m2) or the combination of paclitaxel (135 mg/m2) followed by cisplatin (75 mg/m2).

PATIENTS AND METHODS: After stratification for disease measurability, patients were randomized to receive six cycles of one of the treatments every 3 weeks. If measurable, complete response (CR) or partial response (PR) was determined.

RESULTS: Six hundred fourteen of 648 patients who entered onto the trial were eligible. Monotherapies were discontinued more frequently (cisplatin because of toxicity or patient refusal [17%], and paclitaxel because of progression [20%]) compared with the combination therapy (7% and 6%, respectively). Neutropenia, fever, and alopecia were more severe with paclitaxel-containing regimens; whereas anemia, thrombocytopenia, neurotoxicity, nephrotoxicity, and gastrointestinal toxicity were more severe with cisplatin-containing regimens. The CR/PR rates on paclitaxel monotherapy were significantly lower compared with the cisplatin regimens (42% v 67%, respectively; P < .001). The relative hazard (RH) of first progression or death was significantly greater among those randomized to paclitaxel (RH = 1.41; 95% confidence interval [CI], 1.15 to 1.73; P < .001) when compared with cisplatin; however, RH did not differ significantly between the two cisplatin regimens (RH = 1.06; 95% CI, 0.895 to 1.30). Relative to cisplatin, the death rate on paclitaxel was 15% greater (RH = 1.15; 95% CI, 0.929 to 1.42), and the death rate on the combination treatment was 1% less (RH = 0.99; 95% CI, 0.795 to 1.23). These differences among treatment groups were not statistically significant (P = .31).

CONCLUSION: Cisplatin alone or in combination yielded superior response rates and PFS relative to paclitaxel. However, OS was similar in all three arms, and the combination therapy had a better toxicity profile. Therefore, the combination of cisplatin and paclitaxel remains the preferred initial treatment option.


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