© 2000 by Oxford University Press
Journal of the National Cancer Institute, Vol. 92, No. 9, 699-708,
May 3, 2000
© 2000 Oxford University Press
Randomized Intergroup Trial of Cisplatin–Paclitaxel Versus Cisplatin–Cyclophosphamide in Women With Advanced Epithelial Ovarian Cancer: Three-Year Results
Affiliations of authors: M. J. Piccart, C. Mangioni, I. Vergote, M. Nardi, S. Tumolo, P. Timmers, J.-A. Roy, F. Lhoas, B. Baron, S. Pecorelli, European Organization for Research and Treatment of Cancer (EORTC)—Gynecological Cancer Cooperative Group, EORTC Data Center, Brussels, Belgium; K. Bertelsen, E. Simonsen, R. Blom, C. Trope, J. Kaern, B. Lindvall, J. E. Andersen, Nordic Gynecological Cancer Study Group Data Center, Odense University Hospital, Denmark; K. James, G. Stuart, R. Grimshaw, K. D. Swenerton, M. Bacon, B. Zee, National Cancer Institute of Canada Clinical Trials Group Data Center, Queen's University, Kingston, ON; J. Cassidy, S. Kaye, R. J. Atkinson, A. Birt, J. Paul, Scottish Group Data Center, Beatson Oncology Center, Western Infirmary, Glasgow, U.K.
Correspondence to: Martine J. Piccart, M.D., Jules Bordet Institute (Chemotherapy Unit), Rue Héger-Bordet 1, B-1000 Brussels, Belgium (e-mail: mpiccart{at}ulb.ac.be).
Background: A randomized trial conducted by the Gynecologic Oncology Group (GOG, study #111) in the United States showed a better outcome for patients with advanced ovarian cancer on the paclitaxel–cisplatin regimen than for those on a standard cyclophosphamide–cisplatin regimen. Before considering the paclitaxel–cisplatin regimen as the new "standard," a group of European and Canadian investigators planned a confirmatory phase III trial. Methods: This intergroup trial recruited 680 patients with broader selection criteria than the GOG #111 study and administered paclitaxel as a 3-hour instead of a 24-hour infusion; progression-free survival was the primary end point. Patient survival was analyzed by use of the Kaplan–Meier technique. Treatment effects on patient survival were estimated by Cox proportional hazards regression models. All statistical tests were two-sided. Results: The overall clinical response rate was 59% in the paclitaxel group and 45% in the cyclophosphamide group; the complete clinical remission rates were 41% and 27%, respectively; both differences were statistically significant (P = .01 for both). At a median follow-up of 38.5 months and despite a high rate of crossover (48%) from the cyclophosphamide arm to the paclitaxel arm at first detection of progression of disease, a longer progression-free survival (log-rank P = .0005; median of 15.5 months versus 11.5 months) and a longer overall survival (log-rank P = .0016; median of 35.6 months versus 25.8 months) were seen in the paclitaxel regimen compared with the cyclophosphamide regimen. Conclusions: There is strong and confirmatory evidence from two large randomized phase III trials to support paclitaxel–cisplatin as the new standard regimen for treatment of patients with advanced ovarian cancer.
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 H. M. McDaid and S. B. Horwitz Selective Potentiation of Paclitaxel (Taxol)-Induced Cell Death by Mitogen-Activated Protein Kinase Kinase Inhibition in Human Cancer Cell Lines Mol. Pharmacol., August 1, 2001; 60(2): 290 - 301. [Abstract] [Full Text] [PDF]
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M. S. Piver, P. J. Hoskins, and E. Eisenhauer Surgery in Advanced Epithelial Ovarian Cancer J. Clin. Oncol., April 15, 2001; 19(8): 2364 - 2364. [Full Text] [PDF]
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M. Markman, A. Kennedy, K. Webster, G. Peterson, B. Kulp, and J. Belinson Combination Chemotherapy With Carboplatin and Docetaxel in the Treatment of Cancers of the Ovary and Fallopian Tube and Primary Carcinoma of the Peritoneum J. Clin. Oncol., April 1, 2001; 19(7): 1901 - 1905. [Abstract] [Full Text] [PDF]
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M. Markman, B. N. Bundy, D. S. Alberts, J. M. Fowler, D. L. Clark-Pearson, L. F. Carson, S. Wadler, and J. Sickel 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: An Intergroup Study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group J. Clin. Oncol., February 15, 2001; 19(4): 1001 - 1007. [Abstract] [Full Text] [PDF]
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 L. B Silberstein, A. N Rosenthal, S. W Coppack, K. Noonan, and I. J Jacobs Ascites and a raised serum Ca 125--confusing combination J R Soc Med, January 11, 2001; 94(11): 581 - 582. [Full Text] [PDF]
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P. Hoskins, E. Eisenhauer, I. Vergote, J. Dubuc-Lissoir, B. Fisher, R. Grimshaw, A. Oza, M. Plante, G. Stuart, and J. Vermorken Phase II Feasibility Study of Sequential Couplets of Cisplatin/Topotecan Followed by Paclitaxel/Cisplatin as Primary Treatment for Advanced Epithelial Ovarian Cancer: A National Cancer Institute of Canada Clinical Trials Group Study J. Clin. Oncol., December 15, 2000; 18(24): 4038 - 4044. [Abstract] [Full Text] [PDF]
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C. D. Atkins Re: Randomized Intergroup Trial of Cisplatin-Paclitaxel Versus Cisplatin-Cyclophosphamide in Women With Advanced Epithelial Ovarian Cancer: Three-Year Results J Natl Cancer Inst, September 6, 2000; 92(17): 1446 - 1446. [Full Text] [PDF]
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M. J. Piccart RESPONSE: Re: Randomized Intergroup Trial of Cisplatin-Paclitaxel Versus Cisplatin-Cyclophosphamide in Women With Advanced Epithelial Ovarian Cancer: Three-Year Results J Natl Cancer Inst, September 6, 2000; 92(17): 1446a - 1447a. [Full Text] [PDF]
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P. G. Rose, M. Rodriguez, S. Waggoner, B. E. Greer, I. R. Horowitz, J. M. Fowler, and W. P. McGuire Phase I Study of Paclitaxel, Carboplatin, and Increasing Days of Prolonged Oral Etoposide in Ovarian, Peritoneal, and Tubal Carcinoma: A Gynecologic Oncology Group Study J. Clin. Oncol., August 16, 2000; 18(16): 2957 - 2962. [Abstract] [Full Text] [PDF]
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W. P. McGuire Confirmation of the "Old" Standard of Care for Ovarian Cancer and a Challenge J Natl Cancer Inst, May 3, 2000; 92(9): 674 - 675. [Full Text] [PDF]
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