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Clinical Trial
. 2009 Aug;114(2):195-8.
doi: 10.1016/j.ygyno.2009.04.012. Epub 2009 May 17.

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  1 , P Y Liu, James Moon, Bradley J Monk, Larry Copeland, Sharon Wilczynski, David Alberts
Affiliations
Clinical Trial

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 et al. Gynecol Oncol. 2009 Aug.

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/m(2) 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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Conflict of interest statement

Conflict of Interest Statement

The authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Updated PFS (12 versus 3 cycles of single agent paclitaxel)
Figure 2
Figure 2
Overall survival (12 versus 3 cycles of single agent paclitaxel)
Figure 3
Figure 3
Overall survival by CA-125 (≤10 versus >10 – 35)
See this image and copyright information in PMC

References

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