Evaluation of vinorelbine in persistent or recurrent squamous cell carcinoma of the cervix: A Gynecologic Oncology Group study

Franco M. Muggia, John A. Blessing, Michael Method, David Scott Miller, Gary A. Johnson, Roger B. Lee, Andrew Menzin

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Purpose. Vinorelbine is being explored by the Gynecologic Oncology Group (GOG) for its possible use in advanced or recurrent squamous cell carcinoma of the uterine cervix. The objective of this Phase II trial was to evaluate a days 1 and 8 every-21-days schedule and determine its activity in patients who had failed standard chemotherapy. Patients and methods. Eligible patients with measurable disease and satisfactory baseline bone marrow, liver, and kidney functions were treated with vinorelbine 30 mg/m2 given on days 1 and 8 every 21 days. A two-stage sampling design was used, proceeding to a second stage accrual if sufficient activity was documented in the first 25 patients. Results. The study did proceed to the second stage and accrued 44 patients. There were six objective responses (one complete, five partial) for a response rate of 13.7% (95% confidence interval: 5.2-27.4%). There were three patients with response in extra-pelvic sites (including the complete response) and three with response in the pelvis. The overall frequency of grades 3 and 4 neutropenia was 41%, whereas neuropathy was reported in 27% and was severe in three. Treatment-related pain, very severe in two instances, was also reported in 27%. Conclusion. Vinorelbine has moderate activity in a pretreated population with squamous cell carcinoma of the cervix. Accordingly, vinorelbine in this days 1 and 8 schedule is being studied further in combination with cisplatin by the GOG.

Original languageEnglish (US)
Pages (from-to)639-643
Number of pages5
JournalGynecologic Oncology
Volume92
Issue number2
DOIs
StatePublished - Feb 2004

Fingerprint

Cervix Uteri
Squamous Cell Carcinoma
Appointments and Schedules
Neutropenia
Pelvis
Cisplatin
vinorelbine
Bone Marrow
Confidence Intervals
Kidney
Drug Therapy
Pain
Liver
Population

Keywords

  • Squamous cell carcinoma of the cervix
  • Vinorelbine

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Evaluation of vinorelbine in persistent or recurrent squamous cell carcinoma of the cervix : A Gynecologic Oncology Group study. / Muggia, Franco M.; Blessing, John A.; Method, Michael; Miller, David Scott; Johnson, Gary A.; Lee, Roger B.; Menzin, Andrew.

In: Gynecologic Oncology, Vol. 92, No. 2, 02.2004, p. 639-643.

Research output: Contribution to journalArticle

Muggia, Franco M. ; Blessing, John A. ; Method, Michael ; Miller, David Scott ; Johnson, Gary A. ; Lee, Roger B. ; Menzin, Andrew. / Evaluation of vinorelbine in persistent or recurrent squamous cell carcinoma of the cervix : A Gynecologic Oncology Group study. In: Gynecologic Oncology. 2004 ; Vol. 92, No. 2. pp. 639-643.
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