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.
Background Chemotherapy combinations that include an alkylatingagent and a platinum coordination complex have high responserates in women with advanced ovarian cancer. Such combinationsprovide long-term control of disease in few patients, however.We compared two combinations, cisplatin and cyclophosphamideand cisplatin and paclitaxel, in women with ovarian cancer.
Methods We randomly assigned 410 women with advanced ovariancancer and residual masses larger than 1 cm after initial surgeryto receive cisplatin (75 mg per square meter of body-surfacearea) 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 eligibilitycriteria. Known prognostic factors were similar in the two treatmentgroups. Alopecia, neutropenia, fever, and allergic reactionswere reported more frequently in the cisplatinpaclitaxelgroup. Among 216 women with measurable disease, 73 percent inthe cisplatinpaclitaxel group responded to therapy, ascompared with 60 percent in the cisplatincyclophosphamidegroup (P = 0.01). The frequency of surgically verified completeresponse was similar in the two groups. Progression-free survivalwas significantly longer (P<0.001) in the cisplatinpaclitaxelgroup than in the cisplatincyclophosphamide group (median,18 vs. 13 months). Survival was also significantly longer (P<0.001)in the cisplatinpaclitaxel group (median, 38 vs. 24 months).
Conclusions Incorporating paclitaxel into first-line therapyimproves the duration of progression-free survival and of overallsurvival in women with incompletely resected stage III and stageIV ovarian cancer.
Source Information
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.
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.
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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.
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N Engl J Med 1997;
336:1254-1257, Apr 24, 1997.
Correspondence
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Chen, T., Pengetnze, Y., Taylor, C. C.
(2005). Src inhibition enhances paclitaxel cytotoxicity in ovarian cancer cells by caspase-9-independent activation of caspase-3. Molecular Cancer Therapeutics
4: 217-224
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Hashimoto, K., Morishige, K.-i., Sawada, K., Tahara, M., Kawagishi, R., Ikebuchi, Y., Sakata, M., Tasaka, K., Murata, Y.
(2005). Alendronate Inhibits Intraperitoneal Dissemination in In vivo Ovarian Cancer Model. Cancer Res.
65: 540-545
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Rose, P. G., Nerenstone, S., Brady, M. F., Clarke-Pearson, D., Olt, G., Rubin, S. C., Moore, D. H., Small, J. M., the Gynecologic Oncology Group,
(2004). Secondary Surgical Cytoreduction for Advanced Ovarian Carcinoma. NEJM
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Cannistra, S. A.
(2004). Cancer of the Ovary. NEJM
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Penson, R. T., Sahani, D., Bell, D. A.
(2004). Case 37-2004 - A 52-Year-Old Woman with Postmenopausal Bleeding and a Cystic Ovarian Mass. NEJM
351: 2531-2538
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Spentzos, D., Levine, D. A., Ramoni, M. F., Joseph, M., Gu, X., Boyd, J., Libermann, Towia. A., Cannistra, S. A.
(2004). Gene Expression Signature With Independent Prognostic Significance in Epithelial Ovarian Cancer. JCO
22: 4700-4710
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Vasey, P. A., Jayson, G. C., Gordon, A., Gabra, H., Coleman, R., Atkinson, R., Parkin, D., Paul, J., Hay, A., Kaye, S. B., On behalf of the Scottish Gynaecological Cancer Tr,
(2004). Phase III Randomized Trial of Docetaxel-Carboplatin Versus Paclitaxel-Carboplatin as First-line Chemotherapy for Ovarian Carcinoma. JNCI J Natl Cancer Inst
96: 1682-1691
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Sabbatini, P., Aghajanian, C., Dizon, D., Anderson, S., Dupont, J., Brown, J. V., Peters, W. A., Jacobs, A., Mehdi, A., Rivkin, S., Eisenfeld, A. J., Spriggs, D.
(2004). Phase II Study of CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma. JCO
22: 4523-4531
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Bezjak, A., Tu, D., Bacon, M., Osoba, D., Zee, B., Stuart, G., Roy, J.-A., Piccart, M., Eisenhauer, E.
(2004). Quality of Life in Ovarian Cancer Patients: Comparison of Paclitaxel Plus Cisplatin, With Cyclophosphamide Plus Cisplatin in a Randomized Study. JCO
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Herzog, T. J.
(2004). Recurrent Ovarian Cancer: How Important Is It to Treat to Disease Progression?. Clin. Cancer Res.
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Mabuchi, S., Ohmichi, M., Nishio, Y., Hayasaka, T., Kimura, A., Ohta, T., Kawagoe, J., Takahashi, K., Yada-Hashimoto, N., Seino-Noda, H., Sakata, M., Motoyama, T., Kurachi, H., Testa, J. R., Tasaka, K., Murata, Y.
(2004). Inhibition of Inhibitor of Nuclear Factor-{kappa}B Phosphorylation Increases the Efficacy of Paclitaxel in in Vitro and in Vivo Ovarian Cancer Models. Clin. Cancer Res.
10: 7645-7654
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Sironi, S., Messa, C., Mangili, G., Zangheri, B., Aletti, G., Garavaglia, E., Vigano, R., Picchio, M., Taccagni, G., Maschio, A. D., Fazio, F.
(2004). Integrated FDG PET/CT in Patients with Persistent Ovarian Cancer: Correlation with Histologic Findings. Radiology
233: 433-440
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Huang, G.-C., Liu, S.-Y., Lin, M.-H., Kuo, Y.-Y., Liu, Y.-C.
(2004). The Synergistic Cytotoxicity of Cisplatin and Taxol in Killing Oral Squamous Cell Carcinoma. Jpn J Clin Oncol
34: 499-504
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Onda, T., Katsumata, N., Tsunematsu, R., Yasugi, T., Mushika, M., Yamamoto, K., Fujii, T., Hirakawa, T., Kamura, T., Saito, T., Yoshikawa, H.
(2004). Cisplatin, Paclitaxel and Escalating Doses of Doxorubicin (TAP) in Advanced Ovarian Cancer: a Phase I Trial. Jpn J Clin Oncol
34: 540-546
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Berek, J. S., Taylor, P. T., Gordon, A., Cunningham, M. J., Finkler, N., Orr, J. Jr, Rivkin, S., Schultes, B. C., Whiteside, T. L., Nicodemus, C. F.
(2004). Randomized, Placebo-Controlled Study of Oregovomab for Consolidation of Clinical Remission in Patients With Advanced Ovarian Cancer. JCO
22: 3507-3516
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Thaker, P. H., Deavers, M., Celestino, J., Thornton, A., Fletcher, M. S., Landen, C. N., Kinch, M. S., Kiener, P. A., Sood, A. K.
(2004). EphA2 Expression Is Associated with Aggressive Features in Ovarian Carcinoma. Clin. Cancer Res.
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Cao, Z., Fang, J., Xia, C., Shi, X., Jiang, B.-H.
(2004). trans-3,4,5'-Trihydroxystibene Inhibits Hypoxia-Inducible Factor 1{alpha} and Vascular Endothelial Growth Factor Expression in Human Ovarian Cancer Cells. Clin. Cancer Res.
10: 5253-5263
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De Placido, S., Scambia, G., Di Vagno, G., Naglieri, E., Lombardi, A. V., Biamonte, R., Marinaccio, M., Carteni, G., Manzione, L., Febbraro, A., de Matteis, A., Gasparini, G., Valerio, M. R., Danese, S., Perrone, F., Lauria, R., De Laurentiis, M., Greggi, S., Gallo, C., Pignata, S.
(2004). Topotecan Compared With No Therapy After Response to Surgery and Carboplatin/Paclitaxel in Patients With Ovarian Cancer: Multicenter Italian Trials in Ovarian Cancer (MITO-1) Randomized Study. JCO
22: 2635-2642
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Gelmon, K. A., Stewart, D., Chi, K. N., Chia, S., Cripps, C., Huan, S., Janke, S., Ayers, D., Fry, D., Shabbits, J. A., Walsh, W., McIntosh, L., Seymour, L. K.
(2004). A phase I study of AMD473 and docetaxel given once every 3 weeks in patients with advanced refractory cancer: a National Cancer Institute of Canada-Clinical Trials Group trial, IND 131. Ann Oncol
15: 1115-1122
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Duan, Z., Brakora, K. A., Seiden, M. V.
(2004). Inhibition of ABCB1 (MDR1) and ABCB4 (MDR3) expression by small interfering RNA and reversal of paclitaxel resistance in human ovarian cancer cells. Molecular Cancer Therapeutics
3: 833-838
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Rustin, G. J. S., Bast, R. C. Jr., Kelloff, G. J., Barrett, J. C., Carter, S. K., Nisen, P. D., Sigman, C. C., Parkinson, D. R., Ruddon, R. W.
(2004). Use of CA-125 in Clinical Trial Evaluation of New Therapeutic Drugs for Ovarian Cancer. Clin. Cancer Res.
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Sabbatini, P., Aghajanian, C., Leitao, M., Venkatraman, E., Anderson, S., Dupont, J., Dizon, D., O'Flaherty, C., Bloss, J., Chi, D., Spriggs, D.
(2004). Intraperitoneal Cisplatin with Intraperitoneal Gemcitabine in Patients with Epithelial Ovarian Cancer: Results of a Phase I/II Trial. Clin. Cancer Res.
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Sudo, T., Nitta, M., Saya, H., Ueno, N. T.
(2004). Dependence of Paclitaxel Sensitivity on a Functional Spindle Assembly Checkpoint. Cancer Res.
64: 2502-2508
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Hess, V., A'Hern, R., Nasiri, N., King, D. M., Blake, P. R., Barton, D. P.J., Shepherd, J. H., Ind, T., Bridges, J., Harrington, K., Kaye, S. B., Gore, M. E.
(2004). Mucinous Epithelial Ovarian Cancer: A Separate Entity Requiring Specific Treatment. JCO
22: 1040-1044
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Reinartz, S., Kohler, S., Schlebusch, H., Krista, K., Giffels, P., Renke, K., Huober, J., Mobus, V., Kreienberg, R., duBois, A., Sabbatini, P., Wagner, U.
(2004). Vaccination of Patients with Advanced Ovarian Carcinoma with the Anti-Idiotype ACA125: Immunological Response and Survival (Phase Ib/II). Clin. Cancer Res.
10: 1580-1587
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Apte, S. M., Fan, D., Killion, J. J., Fidler, I. J.
(2004). Targeting the Platelet-Derived Growth Factor Receptor in Antivascular Therapy for Human Ovarian Carcinoma. Clin. Cancer Res.
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Markman, M.
(2004). Ethical Conflict in Providing Informed Consent for Clinical Trials: A Problematic Example from the Gynecologic Cancer Research Community. The Oncologist
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Hochster, H., Plimack, E. R., Runowicz, C. D., Speyer, J., Wallach, R. C., Sorich, J., Mandeli, J., Wadler, S., Wright, J., Muggia, F. M.
(2004). Biweekly 72-Hour 9-Aminocamptothecin Infusion As Second-Line Therapy for Ovarian Carcinoma: Phase II Study of the New York Gynecologic Oncology Group and the Eastern Cooperative Oncology Group. JCO
22: 120-126
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Mabuchi, S., Ohmichi, M., Kimura, A., Nishio, Y., Arimoto-Ishida, E., Yada-Hashimoto, N., Tasaka, K., Murata, Y.
(2004). Estrogen Inhibits Paclitaxel-Induced Apoptosis via the Phosphorylation of Apoptosis Signal-Regulating Kinase 1 in Human Ovarian Cancer Cell Lines. Endocrinology
145: 49-58
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Yoshida, Y., Kurokawa, T., Kawahara, K., Tsuchida, T., Okazawa, H., Fujibayashi, Y., Yonekura, Y., Kotsuji, F.
(2004). Incremental Benefits of FDG Positron Emission Tomography over CT Alone for the Preoperative Staging of Ovarian Cancer. Am. J. Roentgenol.
182: 227-233
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Moore, D. H., Donnelly, J., McGuire, W. P., Almadrones, L., Cella, D. F., Herzog, T. J., Waggoner, S. E.
(2003). Limited Access Trial Using Amifostine for Protection Against Cisplatin- and Three-Hour Paclitaxel-Induced Neurotoxicity: A Phase II Study of the Gynecologic Oncology Group. JCO
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Mendez, L. E., Mueller, A., Salom, E., Gonzalez-Quintero, V. H.
(2003). Paclitaxel and Carboplatin Chemotherapy Administered During Pregnancy for Advanced Epithelial Ovarian Cancer. Obstet Gynecol
102: 1200-1202
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