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Randomized phase III trial of sequential adjuvant chemoradiotherapy with or without erythropoietin alfa in patients with high-risk cervical cancer: Results of the NoGGO-AGO Intergroup Study
Journal of Clinical Oncology, 08/24/2011
Clinical Article
Blohmer JU et al. – This study confirms that EPO can be added safely to CRT in patients with cervical cancer, but it failed to demonstrate a significant benefit in RFS and OS.
Methods- 257 patients randomly assigned to 4 cycles of carboplatin/ifosfamide chemotherapy followed by external-beam pelvic radiotherapy (CRT group) or 4 cycles of carboplatin/ifosfamide chemotherapy and EPO followed by pelvic radiotherapy and EPO (CRT + EPO group)
- Primary end point was RFS
- Secondary end points included OS, change in hemoglobin levels, and safety, including thromboembolic events
- Estimated 5-year RFS rates 78% for patients receiving CRT + EPO and 70% for patients receiving CRT
- No statistically significant difference in RFS, although a trend favoring patients treated with CRT + EPO observed (HR, 0.66; 95% CI, 0.39 to 1.12; log-rank P = .06)
- Exploratory analyses suggest a benefit with CRT + EPO for patients with stage IB to IIA disease (HR, 0.39; 95% CI, 0.18 to 0.85; P = .014) or patients with complete resection (HR, 0.55; 95% CI, 0.31 to 0.98; P = .039)
- OS similar in both groups (HR, 0.88; 95% CI, 0.51 to 1.50; log-rank P = .63)
- Patients treated with EPO maintained higher hemoglobin levels throughout CRT
- No significant differences in safety profiles observed between 2 groups
- Incidence of thrombovascular events was low (2%) and comparable between both groups