Phase II feasibility study of preoperative chemotherapy with docetaxel, cisplatin, and fluorouracil for esophageal squamous cell carcinoma
Phase II feasibility study of preoperative chemotherapy with docetaxel, cisplatin, and fluorouracil for esophageal squamous cell carcinoma
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DOI：
10.1111/cas.12274
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发表时间：
2013-11-01
期刊：
影响因子：
5.7
通讯作者：
Hosoya, Yoshinori
中科院分区：
文献类型：
--
作者：
Hara, Hiroki;Tahara, Makoto;Hosoya, Yoshinori
尚未研究多西他赛、顺铂和5-氟尿嘧啶（DCF）联合作为食管鳞状细胞癌（ESCC）的术前治疗。我们进行了一项多中心的II期可行性研究，术前化疗与DCF的ESCC。临床II/III期ESCC（国际抗癌联盟TNM分类系统，第6版）患者符合条件。化疗包括第1天静脉注射多西他赛（70- 75 mg/m2）和顺铂（70- 75 mg/m2），第1-5天持续输注氟尿嘧啶（750 mg/m2/天）。第5-15天的抗生素预防是强制性的。该方案每3周重复一次，最多允许3个周期。完成化疗后，进行了食管切除术和扩大淋巴结切除术。主要终点是方案治疗的完成率。入组了42例合格患者。化疗期间，最常见的3级或4级毒性反应为中性粒细胞减少（83%）、厌食（7%）和口腔炎（5%）。41例（98%）患者接受了手术。方案治疗完成率为90.5%（38/42）。未观察到治疗相关死亡，手术并发症的发生率可耐受。根据RECIST，DCF完成后的总体有效率为64.3%。病理完全缓解率为17%。估计2年无进展生存率和总生存率分别为74.5%和88.0%。虽然这些数据是初步的，但术前DCF耐受良好。抗肿瘤活性是非常有前途的，值得进一步研究。本试验已在大学医院医学信息网注册（编号UMIN 000002396）。
The combination of docetaxel, cisplatin, and 5-fluorouracil (DCF) as preoperative treatment for esophageal squamous cell carcinoma (ESCC) has not been investigated. We carried out a multicenter phase II feasibility study of preoperative chemotherapy with DCF for ESCC. Patients with clinical stage II/III ESCC (International Union Against Cancer TNM classification system, 6th edition) were eligible. Chemotherapy consisted of i.v. docetaxel (70-75mg/m(2)) and cisplatin (70-75mg/m(2)) on day 1, and continuous infusion of fluorouracil (750mg/m(2)/day) on days 1-5. Antibiotic prophylaxis on days 5-15 was mandatory. This regimen was repeated every 3weeks with a maximum of three cycles allowed. After completion of chemotherapy, esophagectomy with extended lymphadenectomy was carried out. The primary endpoint was the completion rate of protocol treatment. Forty-two eligible patients were enrolled. During chemotherapy, the most common grade 3 or 4 toxicities were neutropenia (83%), anorexia (7%), and stomatitis (5%). Forty-one (98%) patients underwent surgery. The completion rate of protocol treatment was 90.5% (38/42). No treatment-related death was observed and the incidence of operative morbidity was tolerable. According to RECIST, the overall response rate after the completion of DCF was 64.3%. Pathological complete response was achieved in 17%. The estimated 2-year progression-free survival and overall survival were 74.5% and 88.0%, respectively. Although these data are preliminary, preoperative DCF was well tolerated. Antitumor activity was highly promising and warrants further investigation. This trial was registered with University Hospital Medical Information Network (no. UMIN000002396).