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Phase III Study of Cisplatin With or Without Paclitaxel in Stage IVB, Recurrent, or Persistent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

From the Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo; Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC; Psychiatry and Behavioral Science, Institute for Health Services Research and Policy Studies, Northwestern University; Center on Outcomes, Research and Education, Evanston Northwestern Healthcare, Evanston, IL; Department of Pathology and Obstetrics and Gynecology, University of Iowa, Iowa City, IA; Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX; Department of Gynecology, Milton S. Hershey Medical Center/Pennsylvania State University School of Medicine, Hershey; Division of Gynecologic Oncology, Thomas Jefferson University Hospital, Philadelphia, PA; and Division of Gynecologic Oncology, Robert Wood Johnson Medical School at Camden, Camden, NJ

Address reprint requests to David H. Moore, MD, Indiana University School of Medicine, 3535 Barnhill Dr, RT433, Indianapolis, IN 46202-5274; e-mail: dhmoore{at}uipui.edu

PURPOSE: To determine whether cisplatin plus paclitaxel (C+P) improved response rate, progression-free survival (PFS), or survival compared with cisplatin alone in patients with stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix.

PATIENTS AND METHODS: Eligible patients with measurable disease, performance status (PS) 0 to 2, and adequate hematologic, hepatic, and renal function received either cisplatin 50 mg/m² or C+P (cisplatin 50 mg/m² plus paclitaxel 135 mg/m²) every 3 weeks for six cycles. Tumor measurements and quality-of-life (QOL) assessments were obtained before each treatment cycle.

RESULTS: Of 280 patients entered, 6% were ineligible. Among 264 eligible patients, 134 received cisplatin and 130 received C+P. Groups were well matched with respect to age, ethnicity, PS, tumor grade, disease site, and number of cycles received. The majority of all patients had prior radiation therapy (cisplatin, 92%; C+P, 91%). Objective responses occurred in 19% (6% complete plus 13% partial) of patients receiving cisplatin versus 36% (15% complete plus 21% partial) receiving C+P (P = .002). The median PFS was 2.8 and 4.8 months, respectively, for cisplatin versus C+P (P < .001). There was no difference in median survival (8.8 months v 9.7 months). Grade 3 to 4 anemia and neutropenia were more common in the combination arm. There was no significant difference in QOL scores, although a disproportionate number of patients (cisplatin, n= 50; C+P, n = 33) dropped out of the QOL component, presumably because of increasing disease, deteriorating health status, or early death.

CONCLUSION: C+P is superior to cisplatin alone with respect to response rate and PFS with sustained QOL.

Supported by National Cancer Institute grants of the Gynecologic Oncology Group Administrative Office (grant No. CA 27469) and the Gynecologic Oncology Group Statistical and Data Cancer (grant No. CA 37517).

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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Related Correspondence

• Optimal Therapy for Relapsed Carcinoma of the Cervix After Primary Chemoradiation
  Max Mano and Janet Kerr
  JCO 2004 22: 5021-5022 [Full Text]

Related Reply

• In Reply:
  David H. Moore
  JCO 2004 22: 5022 [Full Text]

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