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Comparison of combination therapy with paclitaxel Taxol® and cisplatin versus cyclophosphamide and cisplatin in patients with suboptimal stage III and stage IV ovarian cancer: a Gynecologic Oncology Group study
  1. W. P. McGuire*,
  2. W. J. Hoskins,
  3. M. F. Brady,
  4. P. R. Kucera§,
  5. E. E. Partridge,
  6. K. Y. Look,
  7. D. L. Clarke-Pearson# and
  8. M. Davidson**
  1. *Department of Medicine, Emory University, Atlanta, GA
  2. Gynecology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, and the Department of Obstetrics and Gynecology, Cornell University Medical College, NY
  3. Gynecologic Oncology Group Statistical Office, Roswell Park Cancer Institute, Buffalo, NY
  4. §Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Oregon Health Sciences University, Portland, OR
  5. Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, AL
  6. Division of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN
  7. #Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, NC
  8. **Department of Pathology and Area Laboratory Sciences, Walter Reed Army Medical Center, Washington, DC, USA
  1. Address for correspondence: Dr W. P. McGuire, Division of Hematology/Oncology, Emory University, 1327 Clifton Road, Room 36192, Atlanta, GA 30322, USA.


In patients with advanced ovarian cancer, high response rates are achieved with chemotherapy combinations that include alkylating agents and platinum coordination complexes. However, few patients experience long-term control of disease, especially when primary resection leaves substantial residual mass. Paclitaxel (Taxol®), a new agent with documented activity in platinum-refractory ovarian cancer, has been shown to be well tolerated when given in combination with cisplatin. In this prospective study, we compared the combination of paclitaxel-cisplatin with a standard therapy of cyclophosphamide-cisplatin in patients with suboptimal stage III and stage IV disease. Of 410 patients with advanced ovarian cancer and <1-cm residual masses following initial surgery, 386 met all eligibility criteria. These patients were randomly assigned to receive a regimen of cisplatin (75 mg m-2) and cyclophosphamide (750 mg m-2) or cisplatin (75 mg m-2) and paclitaxel (135 mg m-2) delivered over 24 h. Dosage reductions in cyclophosphamide or paclitaxel were permitted for significant toxicity. Among 216 patients with measurable disease, responses were reported in 73% of those randomized to receive cisplatin-paclitaxel and in 60% of those who received cisplatin-cyclophosphamide. Median progression-free survival was significantly longer (P<0.001) with the cisplatin-paclitaxel combination compared with cisplatin-cyclophosphamide (17.9 vs 12.9 months, respectively). Median overall survival also was significantly longer (P < 0.001) with cisplatin-paclitaxel (37.5 vs 24.4 months). Thus, this study provides compelling evidence that giving the paclitaxel-cisplatin combination as first-line therapy for suboptimally debulked stage III or any stage IV ovarian cancer can increase both the duration of the progression-free interval and the overall survival while maintaining an acceptable toxicity profile.

  • ovarian cancer
  • paclitaxel
  • Taxol®

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