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A correction has been published: N Engl J Med 1996;334(16):1070.

A correction has been published: N Engl J Med 1996;334(19):1268.

Original Article
Volume 334:1-6 January 4, 1996 Number 1
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Cyclophosphamide and Cisplatin Compared with Paclitaxel and Cisplatin in Patients with Stage III and Stage IV Ovarian Cancer
William P. McGuire, M.D., William J. Hoskins, M.D., Mark F. Brady, B.S., Paul R. Kucera, M.D., Edward E. Partridge, M.D., Katherine Y. Look, M.D., Daniel L. Clarke-Pearson, M.D., and Martin Davidson, M.D.

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 by Parmar, M. K.B.
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ABSTRACT

Background Chemotherapy combinations that include an alkylating agent and a platinum coordination complex have high response rates in women with advanced ovarian cancer. Such combinations provide long-term control of disease in few patients, however. We compared two combinations, cisplatin and cyclophosphamide and cisplatin and paclitaxel, in women with ovarian cancer.

Methods We randomly assigned 410 women with advanced ovarian cancer and residual masses larger than 1 cm after initial surgery to receive cisplatin (75 mg per square meter of body-surface area) with either cyclophosphamide (750 mg per square meter) or paclitaxel (135 mg per square meter over a period of 24 hours).

Results Three hundred eighty-six women met all the eligibility criteria. Known prognostic factors were similar in the two treatment groups. Alopecia, neutropenia, fever, and allergic reactions were reported more frequently in the cisplatin–paclitaxel group. Among 216 women with measurable disease, 73 percent in the cisplatin–paclitaxel group responded to therapy, as compared with 60 percent in the cisplatin–cyclophosphamide group (P = 0.01). The frequency of surgically verified complete response was similar in the two groups. Progression-free survival was significantly longer (P<0.001) in the cisplatin–paclitaxel group than in the cisplatin–cyclophosphamide group (median, 18 vs. 13 months). Survival was also significantly longer (P<0.001) in the cisplatin–paclitaxel group (median, 38 vs. 24 months).

Conclusions Incorporating paclitaxel into first-line therapy improves the duration of progression-free survival and of overall survival in women with incompletely resected stage III and stage IV ovarian cancer.


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From the Department of Medicine, Emory University, Atlanta (W.P.M.); the Gynecology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, and the Department of Obstetrics and Gynecology, Cornell University Medical College, New York (W.J.H.); the Gynecologic Oncology Group Statistical Office, Roswell Park Cancer Institute, Buffalo, N.Y. (M.F.B.); the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Oregon Health Sciences University, Portland (P.R.K.); the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham (E.E.P.); the Division of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis (K.Y.L.); the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, N.C. (D.L.C.-P.); and the Department of Pathology and Area Laboratory Sciences, Walter Reed Army Medical Center, Washington, D.C. (M.D.).

Address reprint requests to Dr. McGuire at the GOG Administrative Office, Suite 1945, 1234 Market St., Philadelphia, PA 19107.

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Related Letters:

Chemotherapy for Ovarian Cancer
Parmar M. K.B., Sandercock J., Cvitkovic E., Misset J.-L., Lacave A. J., Peláez I., Palacio I., McGuire W.P., Hoskins W.J., Brady M.F.
Extract | Full Text  
N Engl J Med 1996; 334:1268-1270, May 9, 1996. Correspondence

BRCA1 Mutations and Survival in Women with Ovarian Cancer
Cannistra S. A., Whitmore S. E., Burk R. D., Modan B., Johannsson O., Ranstam J., Borg A., Olsson H., Brunet J.-S., Narod S. A., Tonin P., Foulkes W. D., Rubin S. C.
Extract | Full Text  
N Engl J Med 1997; 336:1254-1257, Apr 24, 1997. Correspondence

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