Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m2) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel: Follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial

Maurie Markman, P. Y. Liu, James Moon, Bradley J. Monk, Larry Copeland, Sharon Wilczynski, David S Alberts

Research output: Contribution to journalArticle

87 Citations (Scopus)

Abstract

Objectives: A SWOG/GOG phase 3 trial exploring the impact of 12-monthly cycles of paclitaxel given to patients with advanced ovarian cancer who achieved a complete response to primary chemotherapy was discontinued by the Data Safety and Monitoring Committee when a prospectively defined interim analysis revealed a highly statistically significant improvement in progression-free survival (PFS). At study closure, it was too early to assess the impact on overall survival. Methods: Patients (n = 296) received either 3 or 12 monthly cycles of paclitaxel (175 mg/m2 over 3 h). Results: Of the 146 patients on the 3-cycle arm, 9 (6%) received > 3 cycles. Median (12 versus 3 cycles; intention-to-treat analysis) updated PFS (all pts) 22 versus 14 months, p = 0.006; overall survival (all pts) 53 versus 48 months, p = 0.34. Conclusion: Twelve cycles of single agent maintenance paclitaxel significantly improves PFS. Explanations for the lack of a favorable influence on overall survival include: (a) treatment at relapse equalized outcome; (b) the sample size was insufficient to reveal a difference; (c) "crossover" of patients from 3 cycles to longer treatment masked a potential difference. An ongoing phase 3 trial will hopefully provide a definitive answer to the question of the impact of this maintenance strategy on overall survival.

Original languageEnglish (US)
Pages (from-to)195-198
Number of pages4
JournalGynecologic Oncology
Volume114
Issue number2
DOIs
StatePublished - Aug 2009

Fingerprint

Paclitaxel
Platinum
Ovarian Neoplasms
Disease-Free Survival
Survival
Clinical Trials Data Monitoring Committees
Maintenance
Intention to Treat Analysis
Sample Size
Safety
Recurrence
Drug Therapy
Therapeutics

Keywords

  • Advanced ovarian cancer
  • Chemotherapy
  • Maintenance chemotherapy
  • Phase 3 trial

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

@article{f115fd789653469c85a1352beb21ee62,
title = "Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m2) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel: Follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial",
abstract = "Objectives: A SWOG/GOG phase 3 trial exploring the impact of 12-monthly cycles of paclitaxel given to patients with advanced ovarian cancer who achieved a complete response to primary chemotherapy was discontinued by the Data Safety and Monitoring Committee when a prospectively defined interim analysis revealed a highly statistically significant improvement in progression-free survival (PFS). At study closure, it was too early to assess the impact on overall survival. Methods: Patients (n = 296) received either 3 or 12 monthly cycles of paclitaxel (175 mg/m2 over 3 h). Results: Of the 146 patients on the 3-cycle arm, 9 (6{\%}) received > 3 cycles. Median (12 versus 3 cycles; intention-to-treat analysis) updated PFS (all pts) 22 versus 14 months, p = 0.006; overall survival (all pts) 53 versus 48 months, p = 0.34. Conclusion: Twelve cycles of single agent maintenance paclitaxel significantly improves PFS. Explanations for the lack of a favorable influence on overall survival include: (a) treatment at relapse equalized outcome; (b) the sample size was insufficient to reveal a difference; (c) {"}crossover{"} of patients from 3 cycles to longer treatment masked a potential difference. An ongoing phase 3 trial will hopefully provide a definitive answer to the question of the impact of this maintenance strategy on overall survival.",
keywords = "Advanced ovarian cancer, Chemotherapy, Maintenance chemotherapy, Phase 3 trial",
author = "Maurie Markman and Liu, {P. Y.} and James Moon and Monk, {Bradley J.} and Larry Copeland and Sharon Wilczynski and Alberts, {David S}",
year = "2009",
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doi = "10.1016/j.ygyno.2009.04.012",
language = "English (US)",
volume = "114",
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T1 - Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m2) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel

T2 - Follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial

AU - Markman, Maurie

AU - Liu, P. Y.

AU - Moon, James

AU - Monk, Bradley J.

AU - Copeland, Larry

AU - Wilczynski, Sharon

AU - Alberts, David S

PY - 2009/8

Y1 - 2009/8

N2 - Objectives: A SWOG/GOG phase 3 trial exploring the impact of 12-monthly cycles of paclitaxel given to patients with advanced ovarian cancer who achieved a complete response to primary chemotherapy was discontinued by the Data Safety and Monitoring Committee when a prospectively defined interim analysis revealed a highly statistically significant improvement in progression-free survival (PFS). At study closure, it was too early to assess the impact on overall survival. Methods: Patients (n = 296) received either 3 or 12 monthly cycles of paclitaxel (175 mg/m2 over 3 h). Results: Of the 146 patients on the 3-cycle arm, 9 (6%) received > 3 cycles. Median (12 versus 3 cycles; intention-to-treat analysis) updated PFS (all pts) 22 versus 14 months, p = 0.006; overall survival (all pts) 53 versus 48 months, p = 0.34. Conclusion: Twelve cycles of single agent maintenance paclitaxel significantly improves PFS. Explanations for the lack of a favorable influence on overall survival include: (a) treatment at relapse equalized outcome; (b) the sample size was insufficient to reveal a difference; (c) "crossover" of patients from 3 cycles to longer treatment masked a potential difference. An ongoing phase 3 trial will hopefully provide a definitive answer to the question of the impact of this maintenance strategy on overall survival.

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