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.
