- In women with stage III-IV or recurrent, HER2/neu-positive uterine serous carcinoma, the addition of trastuzumab to carboplatin+paclitaxel yielded a significant improvement in survival.
Why this matters
- The National Comprehensive Cancer Network recommended the chemotherapy/trastuzumab combination as the preferred treatment in this setting based on preliminary PFS data.
- Updated analysis of phase 2 randomized trial.
- 61 patients who had stage III-IV or recurrent uterine serous carcinoma were randomly assigned to receive carboplatin+paclitaxel with or without trastuzumab followed by maintenance trastuzumab until progression or toxicity.
- Funding: None disclosed.
- The median follow-up was 25.9 months.
- 43 progressions and 38 deaths were reported in 58 evaluable patients.
- Trastuzumab significantly prolonged median PFS:
- Overall: 12.9 vs 8.0 months (HR, 0.46; P=.005).
- Stage III-IV disease: 17.7 vs 9.3 months (HR, 0.44; P =.015).
- Recurrent disease: 9.2 vs 7.0 months (HR =0.12; P =.004).
- OS significantly improved in the add-on trastuzumab group:
- Overall: 29.6 vs 24.4 months (HR, 0.58; P=.046).
- Stage III-IV disease: not reached vs 24.4 months (HR, 0.49; P=.041).
- No significant OS benefit from trastuzumab was observed in patients with recurrent disease.
- Toxicity was not significantly different between the 2 groups (P=.49).
- Small size.