GYOEDU

GOG 158

Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer

Date of Publication:

September 1, 2003

Pubmed Link:

Hypothesis:

Carboplatin/ Paclitaxel is non-inferior in PFS to cisplatin/paclitaxel in optimally resected, stage III epithelial ovarian cancer.

Control Arm(s):

Cisplatin 75 mg/m2

Paclitaxel 135 mg/m2 over 24 hrs

q3 wks x6 cycles

Experimental Arm(s):

Carboplatin AUC 7.5

Paclitaxel 175 mg/m2 over 3 hrs

q3wks x6 cycles

Primary End Point:

PFS (non-inferiority)

Inclusion Criteria:

Stage III epithelial ovarian cancer

optimally cytoreduced (<1cm)

Exclusion Criteria:

Results:

Carbo/paxlitaxel (n=392) vs Cisplatin/paclitaxel (n=400):

median PFS: 20.7 vs 19.4 mos (NS)

median OS: 57.4 vs 48.7 mos (NS)

Completion of 6 cycles: 87 % vs 85% (NS)

Carbo/taxol had less grade 3/4 leukopenia, GI, renal, metabolic toxicities than Cis/taxol but more thrombocytopenia (SS)

Conclusions:

Carbo/paclitaxel is not inferior to cis/paclitaxel with regard to PFS in patients with optimally resected, stage III epithelial ovarian cancer.

Reviewer:

Courtney Bailey, OTF