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

David H. Moore*, John A. Blessing, Richard P. McQuellon, Howard T. Thaler, David Cella, Jo Benda, David S. Miller, George Olt, Stephanie King, John F. Boggess, Thomas F. Rocereto

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

424 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)3113-3119
Number of pages7
JournalJournal of Clinical Oncology
Volume22
Issue number15
DOIs
StatePublished - 2004

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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