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GOG 175

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
Date of Publication:

May 1, 2011

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/21529904/
Hypothesis:

The addition of paclitaxel maintenance reduces recurrence in women with early stage ovarian cancer

Control Arm(s):

Carboplatin AUC 6
Paclitaxel 175mg/m2 IV over 3hrs
- q3wks x3 cycles
- followed by observation

Experimental Arm(s):

Carboplatin AUC 6
Paclitaxel 175mg/m2 IV over 3hrs
- q3wks x3 cycles
- followed by maintenance paclitaxel 40mg/m2 q1wk x24wks

Primary End Point:

Recurrence rate (by clinical or radiographic evidence)

Inclusion Criteria:

Completely resected stage IA/B grade 3 or clear cell
Any stage IC or II
Definitive staging following GOG guidelines (TAH/BSO, omx, selective PPLAND, biopsies, washings, CGR)
No prior treatment
Adequate health

Exclusion Criteria:

Borderline tumors

Results:

Stage I: 72%
Median f/u: 6.7yrs

Paclitaxel maintenance (n=274) vs observation (n=268):
5yr recurrence: 20.4% vs 23.2% (NS)
5yr OS: 86.2% vs 85.4% (NS)
grade 2+ neuropathy: 15.5% vs 6.0% (SS)

Conclusions:

Addition of maintenance paclitaxel to women with early stage ovarian cancer does not decrease recurrence.

Reviewer:
Olga T Filippova