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

ABSTRACT

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.

KEYWORDS:

• Rectal cancer
• Clinical trial
• Pre-operative treatment
• Adjuvant treatment

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the article.

Funding

This study was funded in part by a grant from Sanofi-Aventis.