【国際学会】賀川義規医師がASCO-GI 2023で共同演者で発表しました。


大阪 急性期 大腸癌 部位別 症例数 手術件数 ISR 肛門温存 仕事 就労支援 大腸癌 大腸がん 結腸癌 結腸がん 直腸癌 直腸がん コロレクくん ロボット手術 大阪 消化器外科 ランキング 腹腔鏡手術 低侵襲 おすすめ 名医 賀川義規

演題名は、「BAYONET trial: A multicenter phase II trial of staged combination with encorafenib + binimetinib + cetuximab following encorafenib + cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer.」

Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan; Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan; Department of Gastroenterological Surgery, Osaka General Medical Center, Osaka, Japan; Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan; Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan; Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan; Cancer Treatment Center, Kansai Medical University Hospital, Osaka, Japan; Division for the Promotion of Drug and Diagnostic Development, National Cancer Center Hospital East, Kashiwa, Japan

Background: Addition of perioperative multi-agent chemotherapy to the treatment strategy for locally advanced rectal cancer (LARC) may be a promising option. We conducted a multicenter single-arm phase II study to evaluate the safety and efficacy of capecitabine combined with oxaliplatin and irinotecan (CAPOXIRI) as triplet neoadjuvant chemotherapy in patients with LARC. Methods: The key eligibility criteria were as follows: (1) age over 20 years; (2) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; (3) resectable clinical stage II (T3 or T4 with N0) or III (any T and N1–3), with the primary tumor located within 12 cm of the anal verge. Patients received intravenous oxaliplatin (85 mg/m2) and intravenous irinotecan (150 mg/m2) on day 1 and oral capecitabine (1,000 mg/m2) twice daily on days 1–7 followed by 7 days of rest, repeated every 2 weeks for six cycles. Total mesothelial resection was performed 4–8 weeks after chemotherapy ended. In addition to the treatment protocol, patients received adjuvant chemotherapy for four cycles. The primary study endpoint was the pathological complete response (pCR) rate. We based the sample size of the study described herein on an expected pCR rate of 18% and a threshold pCR rate of 5% to detect differences at a two-sided alpha error of 0.05 and a statistical power of 0.2. Results: Between June 2013 and December 2016, 55 patients were enrolled in the study. Forty-five (83.3%) of the 54 patients who underwent NAC received the full six courses. Fifty-two (94.5%) patients underwent tumor resection. Laparoscopic surgery was performed in 47 (90.4%) patients, and lateral lymph node dissection was performed in 35 (67.3%) patients. Forty-nine (94.2%) patients underwent R0 resection. The pCR rate was 7.7% (95% CI 3.0% to 18.2%). The 3-year local recurrence rate was 3.9%, the 3-year disease-free survival (DFS) rate was 77.3, and the 3-year overall survival rate was 96.0%. NAC-related grade 3/4 adverse event rates were as follows: neutropenia (25.9%), anorexia (13.0%), diarrhea (11.1%) and anemia (7.4%). Conclusions: CAPOXIRI neoadjuvant chemotherapy appears to be feasible and efficacious for patients with LARC. Although neoadjuvant XELOXIRI alone did not yield our expected pCR rate, the local recurrence rate, 3-year DFS and measures of safety met current standards. Clinical trial information: UMIN000009974.