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GOG 157

Randomized phase III trial of three versus six cycles of adjuvant carboplatin and paclitaxel in early stage epithelial ovarian carcinoma.

Date of Publication:

September 1, 2006

Pubmed Link:
http://www.ncbi.nlm.nih.gov/pubmed/16860852
Hypothesis:

Does 6 cycles of carboplatin/paclitaxel improve survival compared to 3 cycles in women with early stage ovarian cancer?

Control Arm(s):

carboplatin AUC 7.5  + paclitaxel 175 mg/m2

q3wks x6 cycles

Experimental Arm(s):

carboplatin AUC 7.5  + paclitaxel 175 mg/m2

q3wks x3 cycles

Primary End Point:

PFS

Inclusion Criteria:

Stage IA/IB (Grade 3 or clear cell) or stage II ovarian cancer

Completely resected

Exclusion Criteria:
Results:

6 cycles vs 3 cycles (total n=427):

69% were stage I

median f/u: 6.8 yrs

5yr recurrence: 20.1% vs. 25.4% (NS)

Grade 3/4 Neurotoxicity: 11% vs. 2% (SS)

Grade 4 Neutropenia: 66% vs. 52% (SS)

Anemia: 48% vs. 32% (SS)

Conclusions:

3 cycles of carbo/paclitaxel are non-inferior to 6 cycles after complete surgical staging for women with early stage ovarian cancer.

Reviewer:
Shitanshu Uppal, OTF