Phase II trial of capecitabine plus oxaliplatin (CAPOX) as perioperative therapy for locally advanced rectal cancer
Phase II trial of capecitabine plus oxaliplatin (CAPOX) as perioperative therapy for locally advanced rectal cancer
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DOI：
10.1007/s00280-018-3663-z
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发表时间：
2018-10-01
影响因子：
3
通讯作者：
Mori, Masaki
中科院分区：
文献类型：
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作者：
Nishimura, Junichi;Hasegawa, Junichi;Mori, Masaki
局部晚期低位直肠癌的标准治疗策略是在西方国家进行放化疗后进行全直肠系膜切除术（TME），在日本进行TME后进行辅助化疗而无需术前治疗。本II期试验评估了术前CAPOX化疗方案对局部晚期直肠癌患者的疗效，无放疗。主要终点为2年无病生存期，该试验在2012年至2014年期间从9家机构招募了45名患者。平均年龄为63.5（29-74）岁; 31例患者为男性。大部分患者（n = 41）接受术前化疗（CTx），术前CTx完成率为95.2%。41例患者在CTx后进行了R 0切除。病理完全缓解率为7.3%（3/41）。手术后，35例患者（85.3%）接受了辅助CTx治疗，其中22例完成了方案治疗。随访时间为0.71 - 4.68年（中位数2.86年）。在40例接受R 0切除术的患者中，有13例复发，2年无病生存率和总生存率分别为71.6%和92.7%，我们报告了新辅助CTx和辅助CTx的完成率、病理完全缓解率和中期预后。结果表明，CAPOX后TME可能是局部晚期直肠癌的一种安全的治疗策略。
The standard strategy for locally advanced lower rectal cancer is chemoradiotherapy followed by total mesorectal excision (TME) in Western countries and TME followed by adjuvant chemotherapy without preoperative treatment in Japan.This phase II trial evaluated the efficacy of a preoperative CAPOX chemotherapy regimen without radiation therapy for patients with locally advanced rectal cancer. The primary endpoint was 2-year disease-free survival.The trial enrolled 45 patients from 9 institutions between 2012 and 2014. The mean age was 63.5 (29-74) years; 31 patients were male. Most patients (n = 41) received preoperative chemotherapy (CTx), and the preoperative CTx completion rate was 95.2%. R0 resection after CTx was performed in 41 patients. The pathological complete response rate was 7.3% (3/41). After surgery, 35 patients (85.3%) received adjuvant CTx, and 22 of 35 completed the protocol treatment. The follow-up period ranged from 0.71 to 4.68 years (median 2.86 years). There was recurrence in 13 of 40 patients who underwent R0 resection, and the 2-year disease-free survival rate and overall survival rate were 71.6 and 92.7%, respectively.Here we report the completion rates for neoadjuvant CTx and adjuvant CTx, the pathological complete response rate, and the mid-term prognosis. The results indicate that CAPOX followed by TME may be a safe treatment strategy for locally advanced rectal cancer.