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Clinical Trial
. 2011 Jul;122(1):89-94.
doi: 10.1016/j.ygyno.2011.03.013. Epub 2011 May 6.

A randomized phase III trial of IV carboplatin and paclitaxel × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study

Robert S Mannel  1 , Mark F Brady, Elise C Kohn, Parviz Hanjani, Masamichi Hiura, Roger Lee, Koen Degeest, David E Cohn, Bradley J Monk, Helen Michael
Affiliations
Clinical Trial

A randomized phase III trial of IV carboplatin and paclitaxel × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study

Robert S Mannel et al. Gynecol Oncol. 2011 Jul.

Abstract

Objective: To compare the recurrence-free interval (RFI) and safety profile in patients with completely resected high-risk early-stage ovarian cancer treated with intravenous (IV) carboplatin and paclitaxel with or without maintenance low-dose paclitaxel for 24 weeks.

Methods: Eligibility was limited to patients with stage IA/B (grade 3 or clear cell), all IC or II epithelial ovarian cancer. All patients were to receive carboplatin AUC 6 and paclitaxel 175 mg/m² q3 weeks × 3 courses with random assignment to either observation or maintenance paclitaxel 40 mg/m²/week × 24 weeks. Recurrence required clinical or radiological evidence of new tumor.

Results: There were 571 patients enrolled onto this study, of whom 29 were deemed ineligible due to inappropriate stage or pathology, leaving 542 patients. At least 3 cycles of treatment were administered to 524/542 (97%) of patients, and among those assigned to maintenance paclitaxel, 80% completed the regimen. The incidence of grade 2 or worse peripheral neuropathy (15.5% vs. 6%), infection/fever (19.9% vs. 8.7%), and dermatologic events (70.8% vs. 52.1%) was higher on the maintenance regimen (p<0.001). The cumulative probability of recurring within 5 years for the maintenance paclitaxel regimen is 20% vs. 23% for surveillance (hazard ratio 0.807; 95% CI: 0.565-1.15). The probability of surviving 5 years was 85.4% and 86.2%, respectively.

Conclusion: Maintenance paclitaxel at 40 mg/m²/week × 24 weeks added to standard dose AUC6 and paclitaxel 175 mg/m² × 3 doses provides no significant increase in RFI.

Trial registration: ClinicalTrials.gov NCT00003644.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT

The authors wish to report that there are no conflicts of interest with the exception of Dr. Helen Michael who reports that, although she is not aware of any financial relationships involving this study, she does hold stocks and/or bonds in the following companies: Johnson & Johnson, Amgen, Teva Pharmaceutical Industries ADR, Medtronic, Roche Holding ADR, Eli Lilly & Co, Pfizer, Abbott Laboratories, Becton Dickinson. Dr. Michael also reports that she does not select or manage her investments but rather an asset management company does that for her.

Figures

Figure 1
Figure 1
GOG – 175 Consort Diagram
Figure 2
Figure 2
C = carboplatin, T = paclitaxel, wkly = weekly
Figure 3
Figure 3
C = carboplatin, T = paclitaxel
See this image and copyright information in PMC

Comment in

References

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