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GOG 182 / ICON5

Evaluation of New Platinum-Based Treatment Regimens in Advanced-Stage Ovarian Cancer: A Phase III Trial of the Gynecologic Cancer Intergroup

Date of Publication:

March 20, 2009

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/19224846/
Hypothesis:

Does the addition of a third cytotoxic agent to 8 cycles of carboplatin/paclitaxel improve OS in women with residual disease?

Control Arm(s):

carboplatin AUC 6+ paclitaxel 175mg/m2 over 3hrs q3 wks x8 cycles

Experimental Arm(s):

(1) carboplatin AUC 5 + paclitaxel 175mg/m2 day 1 q3wks x8 cyclesgemcitabine 800mg/m2 over 30 min days 1 and 8 (2) carboplatin AUC 6 day 8 + gemcitabine 1000mg/m2 day 1 and 8 q3wks x4 cyclescarboplatin AUC 6 + paclitaxel 175mg/m2 day 1 q3wks x4 cycles(3) carboplatin AUC 5 + paclitaxel 175mg/m2 day 1 q3wks x8 cyclesliposomal doxorubicin 30mg/m2 day 1 cycle 1, 3, 5, 7(4) topotecan 1.25mg/m2 day 1, 2, 3 + carboplatin AUC 5 day 3 q3wks x4 cyclescarboplatin AUC 6 + paclitaxel 175mg/m2 q3wks x4 cycles

Primary End Point:

OS

Inclusion Criteria:

stage III/IB epithelial ovarian cancerany residual disease (IDS allowed for suboptimal)

Exclusion Criteria:
Results:

79% complete 8 cyclesmedian f/u: 3.7 yrsno PFS benefit - adjusted RR 0.984 - 1.066 for armsno OS benefit - adjusted RR 0.952 - 1.114 for armsresidual disease predictive of OS

Conclusions:

Addition of third cytotoxic agent did not improve OS over 8 cycles of carboplatin/paclitaxel in women with any residual disease

Reviewer:
Olga T Filippova