Group 1: Carboplatin (AUC 5-6) + Paclitaxel 175mg/m^2 q3w (C/T)
Primary End Point:
PFS and OS
Inclusion Criteria:
Stage IC-IV histologically confirmed epithelial ovarian/PP/FT carcinoma
(Those with Stage IC or IIA- mandatory high-risk subtypes (HGS, CC, G3)
PS 0-2, Adequate hematologic, renal, hepatic fxn
Must be able to start chemo w/in 8 weeks of IPS (immediate primary surgery)
\*Neoadjuvant chemo and DPS (delayed primary surgery) allowed
\*No planned surgery allowed
Exclusion Criteria:
Results:
C/T (Group 1) vs C/DDT (Group 2) vs WC/DDT (group 3)
- 1566 women- 522 vs 523 vs 521
- PFS/death at 3 years: 24.4 vs 24.9 vs 25.3 mos (NS) (Restricted Mean Survival Time)
- Median PFS 17.7 mos vs 20.8 mos vs 21 mos (NS)
- Grade 3 or 4 toxic effects: 42% vs 62% vs 53% (NS)
- ≥ Grade 2 neuropathy: 27% vs 24% vs 22% (NS)
Preplanned subgroup: IPS vs DPS:
- IPS PFS 32.6 vs 33 vs 33 mos (NS) (Restricted Mean Survival Time)
- DPS PFS 18.6 vs 19.1 vs 19.6 mos (NS) (Restricted Mean Survival Time)
Conclusions:
Weekly dose-dense paclitaxel should not be incorporated as a standard-of-care component of first-line multimodality treatment of epithelial ovarian cancer for women who are not of Japanese ethnic origin.