A pilot phase II study of neoadjuvant triplet chemotherapy regimen in patients with locally advanced resectable colon cancer.
A pilot phase II study of neoadjuvant triplet chemotherapy regimen in patients with locally advanced resectable colon cancer.
复制标题
局部晚期可切除结肠癌患者新辅助三联化疗方案的试点 II 期研究。
DOI：
10.21147/j.issn.1000-9604.2016.06.06
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发表时间：
2016-12
期刊：
影响因子：
--
通讯作者：
Huang J
中科院分区：
文献类型：
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作者：
Zhou H;Song Y;Jiang J;Niu H;Zhao H;Liang J;Su H;Wang Z;Zhou Z;Huang J
本研究旨在探讨三联方案新辅助化疗治疗局部晚期可切除结肠癌的可行性、安全性和有效性。临床IIIb期结肠癌患者接受围手术期三联化疗方案（奥沙利铂85 mg/m2和伊立替康150 mg/m2，联合亚叶酸200 mg，5-氟尿嘧啶500 mg推注，然后2,400 mg/m2输注44 h，或卡培他滨1 g/m2或S-1 40-60 mg b.i.d口服，第1-10天，以2周间隔重复）4个周期。新辅助治疗完成后2-6周计划进行完全结肠系膜切除，随后再进行6个周期的FOLFOXIRI或XALIX治疗。该II期试验的主要结局指标为新辅助治疗的可行性、安全性、耐受性和有效性。 所有23例患者均接受了新辅助化疗并接受了手术。21例患者（91.3%）在新辅助治疗后肿瘤体积缩小，13例患者（56.5%）出现3-4级毒性。无患者发生严重手术并发症。与基线临床分期相比，术前治疗导致T分期和N分期显著降低，包括1例病理完全缓解。新辅助三联化疗对局部晚期可切除结肠癌具有较高的活性，且毒副反应和围手术期并发症可接受，是可行、耐受和有效的。
This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced resectable colon cancer. Patients with clinical stage IIIb colon cancer received a perioperative triple chemotherapy regimen (oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with folinic acid 200 mg, 5-fluorouracil 500 mg bolus and then 2,400 mg/m2 by 44 h infusion or capecitabine 1 g/m2 or S-1 40–60 mg b.i.d orally d 1–10, repeated at 2-week intervals) for 4 cycles. Complete mesocolic excision was scheduled 2–6 weeks after completion of neoadjuvant treatment and followed by a further 6 cycles of FOLFOXIRI or XELOX. Primary outcome measures of this stage II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment. All 23 patients received neoadjuvant chemotherapy and underwent surgery. Twenty-one patients (91.3%) had reductions in tumor volume after neoadjuvant treatment, and 13 patients (56.5%) had grade 3–4 toxicity. No patients had severe complications from surgery. Preoperative therapy resulted in significant down-staging of T-stage and N-stage compared with the baseline clinical stage including one pathological complete response. Neoadjuvant triple chemotherapy has high activity and acceptable toxicity and perioperative morbidity, and is feasible, tolerable and effective for locally advanced resectable colon cancer.