Phase II Trial of Neoadjuvant Chemotherapy, Chemoradiotherapy, and Laparoscopic Surgery with Selective Lateral Node Dissection for Poor-Risk Low Rectal Cancer
- Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Department of Gastroenterological Surgery (Japan)
- Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Department of Gastroenterological Oncology (Japan)
- University of Tsukuba, Department of Radiation Oncology and Proton Medical Research Center (Japan)
- Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Department of Radiation Oncology (Japan)
- Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Department of Gastroenterology (Japan)
- Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Department of Pathology (Japan)
- Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Clinical Research Center (Japan)
Purpose: The aim of this study is to evaluate the safety and efficacy of induction modified 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus bevacizumab followed by S− 1-based chemoradiotherapy in magnetic resonance imaging (MRI)-defined poor-risk locally advanced low rectal cancer. Patients and Methods: This was a prospective phase II trial at a single comprehensive cancer center. The primary endpoint was the pathological complete response (pCR) rate. Eligible patients had clinical stage II–III low rectal adenocarcinoma with any of the following MRI-defined poor-risk features: circumferential resection margin (CRM) ≤ 1 mm, cT4, positive lateral nodes, mesorectal N2 disease, and/or requiring abdominoperineal resection. Patients received six cycles of mFOLFOX6 with 5 mg/kg bevacizumab followed by oral S-1 (80 mg/m{sup 2}/day on days 1–14 and 22–35) plus radiotherapy (50.4 Gy). Surgery was conducted through a laparoscopic approach. Lateral node dissection was selectively added when the patient had enlarged lateral nodes. Results: A total of 43 patients were enrolled. Grade 3–4 adverse events occurred in nine patients during induction chemotherapy and in five patients during chemoradiotherapy. One patient declined surgery with a clinical complete response. Forty-two patients underwent surgery, and 16 had pCR [37.2%, 95% confidence interval (CI) 24.4–52.1%]. All underwent R0 resection without conversion, including combined resection of adjacent structures (n = 14) and lateral node dissection (n = 30). Clavien–Dindo grade 3–4 complications occurred in six patients (14.3%). With median follow-up of 52 months, six developed recurrences (lung n = 5, local n = 1; 3-year relapse-free survival 86.0%). Conclusions: This study achieved a high pCR rate with favorable toxicity and postoperative complications in poor-risk locally advanced low rectal cancer. Multicenter study is warranted to evaluate this regimen.
- OSTI ID:
- 22927650
- Journal Information:
- Annals of Surgical Oncology (Online), Vol. 26, Issue 8; Other Information: Copyright (c) 2019 Society of Surgical Oncology; Country of input: International Atomic Energy Agency (IAEA); ISSN 1534-4681
- Country of Publication:
- United States
- Language:
- English
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