A Phase 2 Study of 5-Fluorouracil (5-FU), Ziv-Aflibercept, and Radiation for the Preoperative and Adjuvant Treatment of Patients with Stage II/III Rectal Cancer.

BACKGROUND: This phase II study combined aflibercept with preoperative chemoradiation for patients with stage II/III rectal cancer, followed by mFOLFOX6/aflibercept.

METHODS: Patients received preoperative 5-FU (days 1-43), radiation (weeks 1-6), and aflibercept (days 1-15) each 28 day cycle for 6 weeks. Six weeks following the last aflibercept dose, patients underwent surgical resection. Four cycles of mFOLFOX6 plus aflibercept began 8 weeks after surgery.

RESULTS: Common treatment-related toxicities included diarrhea, fatigue, and mucositis. The pCR rate was 23%.

DISCUSSION: Afilbercept plus 5-FU-based chemoradiation was tolerated in patients with localized rectal cancer and showed a pCR rate within range of historical data.