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

抄録

<jats:sec><jats:title>Purpose</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Eligible patients with measurable disease, performance status (PS) 0 to 2, and adequate hematologic, hepatic, and renal function received either cisplatin 50 mg/m<jats:sup>2</jats:sup> or C+P (cisplatin 50 mg/m<jats:sup>2</jats:sup> plus paclitaxel 135 mg/m<jats:sup>2</jats:sup>) every 3 weeks for six cycles. Tumor measurements and quality-of-life (QOL) assessments were obtained before each treatment cycle. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> C+P is superior to cisplatin alone with respect to response rate and PFS with sustained QOL. </jats:p></jats:sec>

収録刊行物

被引用文献 (21)*注記

もっと見る

キーワード

詳細情報 詳細情報について

問題の指摘

ページトップへ