Back

GOG 178

Phase III Randomized Trial of 12 Versus 3 Months of Maintenance Paclitaxel in Patients With Advanced Ovarian Cancer After Complete Response to Platinum and Paclitaxel-Based Chemotherapy: A Southwest Oncology Group and Gynecologic Oncology Group Trial

Date of Publication:

July 1, 2003

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/12829663/
Hypothesis:

Do 3 or 12 cycles of maintenance paclitaxel improve PFS in women who achieved compete response to primary platinum-based therapy?

Control Arm(s):

paclitaxel 175mg/m2 over 3hrs q28 days x3 cycles

Experimental Arm(s):

paclitaxel 175mg/m2 over 3hrs q28 days x12 cycles

Primary End Point:

PFS

Inclusion Criteria:

stage III/IV epithelial ovarian cancer5-6 cycles of platinum-based chemotherapycomplete response

Exclusion Criteria:
Results:

interim analysis, early termination boundary crossedpaclitaxel 3 cycles (n=128) vs paclitaxel 12 cycles (n=134):grade 2/3 neuropathy: 15% vs 23%median PFS: 21 vs 28 mos (SS)no OS difference

Conclusions:

12 cycles of maintenance paclitaxel administered to women who achieved complete response improves PFS

Reviewer:
Olga T Filippova