Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in MRI-Defined Locally Advanced T3 Resectable Rectal Cancer: Final Results of a Randomized, Noncomparative Phase 2 INOVA Study.

摘要: Abstract Background Recurrence and distant metastases remain a significant issue in locally advanced rectal cancer (LARC). Several multimodal strategies are assessed clinical trials. Patients Methods with mid/low magnetic resonance imaging–defined high-risk LARC were randomized to arm A (12-week bevacizumab + FOLFOX-4 then bevacizumab–5-fluorouracil [5-FU]–radiotherapy [RT] before total mesorectal excision [TME]) or B (bevacizumab-5-FU–RT TME). Long-term efficacy safety up 5 years’ follow-up reported. No comparison between arms was planned. Results Overall, 91 patients (46 45 B) included. Main results have been presented previously. During the late period (> 4 weeks after surgery), (8.7%) (8.9%) experienced grade 3/4 adverse events related bevacizumab; most frequent 2 anastomotic fistulas (both A) abscesses (1 B). At follow-up, 9 (19.6%) 11 (24.4%) developed fistula year surgery, (4.3%) at > 1 surgery. Most resolved study end. Five-year disease-free survival 70% 64.3% B, respectively. overall 90.5% (95% confidence interval, 76.7, 96.3) 72.7% 56.0, 83.9) B. Conclusion Neoadjuvant may potential increase outcomes when followed by bevacizumab–5-FU–RT TME LARC. Bevacizumab–5-FU–RT associated higher-than-projected rate of fistulas. Further research neoadjuvant is encouraged.