GOG 157

Randomized phase III trial of three versus six cycles of adjuvant carboplatin and paclitaxel in early stage epithelial ovarian carcinoma: a Gynecologic Oncology Group study.

Pubmed

Hypothesis: 6 cycles of carboplatin (AUC 7.5) and paclitaxel (175mg/m2) improves survival compared to 3 cycles.

Site: Ovary

Eligibility: Stage IA/IB (Grade 3 or clear cell) or stage II completely resected

Experimental arm: 6 cycles of AUC 7.5 carboplatin and 175 mg/m2 of Paclitaxel

Standard Arm: 3 cycles of AUC 7.5 carboplatin and 175 mg/m2 of Paclitaxel

Primary Outcome:

Results:
n=457 enrolled; 427 final cohort
69% were stage 1
31% were stage 2

Parameter 3 cycles 6 cycles p-value
5-year recurrence rate 25.4% 20.1% ns
Adjusted Recurrence rate 1 ref 0.761 (0.51 – 1.13) 0.18
Neurotoxicity G4 2% 11% ss
Neutropenia G4 52% 66% ss
Anemia 32% 48% ss

ss: statistically significant
ns: not statistically significant

Conclusions:

  • 3 cycles of chemotherapy are non-inferior to 6 cycles after complete surgical staging
  • Post-hoc analysis PubmedSerous tumors 6 cycles improve survival

Limitations:

  • High dose of Carboplatin (AUC 7.5)
  • High proportion of incompletely staged patients (about 30%)
  • Study likely underpowered to show difference between 3 and 6 cycles, so although the null hypothesis is no difference, there may be a difference which would have been seen in a fully powered study

  1. Adjusted for FIGO stage and grade ↩︎