Neoadjuvant chemotherapy in locally advanced colon cancer.A phase II trial

医学 结直肠癌 帕尼单抗 奥沙利铂 内科学 卡培他滨 克拉斯 化疗 肿瘤科 临床终点 外科 癌症 临床试验 氟尿嘧啶
作者
Anders Jakobsen,Fahimeh Andersen,Anders Fischer,Lars Henrik Jensen,Jens Christian Riis Jørgensen,Olav Larsen,Jan Lindebjerg,John Pløen,Søren Rafael Rafaelsen,Jesper Vilandt
出处
期刊:Acta Oncologica [Taylor & Francis]
卷期号:54 (10): 1747-1753 被引量:85
标识
DOI:10.3109/0284186x.2015.1037007
摘要

Background. Neoadjuvant chemotherapy has proven valuable in several tumors, but it has not been elucidated in colon cancer. The present phase II trial addressed the issue in high-risk patients selected by computed tomography (CT) scan.Material and methods. Patients with resectable colon cancer fulfilling the following criteria were offered inclusion; Histopathological verification of adenocarcinoma, T3 tumor on CT scan with extramural tumor invasion > 5 mm or T4 tumor, age ≥ 18 years, PS ≤ 2, adequate hematology, and informed consent. Patients with KRAS, BRAF or PIK3CA mutation or unknown mutational status received three cycles of capecitabine 2000 mg/m2 days 1-14 q3w and oxaliplatin 130 mg iv day 1 q3w. Wild-type patients received the same chemotherapy supplemented with panitumumab 9 mg/kg iv q3w. After the operation, patients fulfilling the international criteria for adjuvant chemotherapy, i.e. high-risk stage II and III patients, received five cycles of the same chemotherapy without panitumumab. Patients not fulfilling the criteria were offered follow-up only. The primary endpoint was the fraction of patients not fulfilling the criteria for adjuvant chemotherapy (converted patients). Secondary endpoints were recurrence rate, disease-free survival (DFS), and toxicity.Results. The study included 77 patients. The conversion rate was 42% in the wild-type group compared to 51% in patients with a mutation. The cumulative recurrence rate in converted versus unconverted patients was 6% versus 32% (p = 0.005) translating into a three-year DFS of 94% versus 63% (p = 0.005).Conclusion. Neoadjuvant chemotherapy in colon cancer is feasible and the results suggest that a major part of the patients can be spared adjuvant chemotherapy. Validation in a randomized trial is warranted.
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