abstract: 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 - GOG

Note: although a 3% difference of estimated recurrence rates (542 patients @ 3% = 16.26 patients/lives), the abstract does not allow for a description of the patient demographics eg. cell type, stage..., note also that as in past blogs the GOG studies include stage 1 and stage 11

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 24weeks.

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 175mg/m(2) q3 weeks×3 courses with random assignment to either observation or maintenance paclitaxel 40mg/m(2)/week×24weeks. 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 5years 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 5years was 85.4% and 86.2%, respectively.

CONCLUSION:

Maintenance paclitaxel at 40mg/m(2)/week×24weeks added to standard dose AUC6 and paclitaxel 175mg/m(2)×3 doses provides no significant increase in RFI.