Lee Su Jin, Kim Sungmin, Kim Moonjin, Lee Jeeyun, Park Yeon Hee, Im Young-Hyuck, Park Se Hoon
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
BMC Cancer. 2015 Oct 14;15:693. doi: 10.1186/s12885-015-1716-9.
The aim of this study was to assess the efficacy and safety of a combination regimen of capecitabine plus cisplatin (CC) or capecitabine plus paclitaxel (CP) as a first-line treatment in patients with metastatic esophageal squamous cell carcinoma.
Patients with recurrent or metastatic esophageal squamous cell carcinoma were enrolled in this open-label, phase II, randomized trial. Patients were assigned to either the CC arm (days [D]1-14 capecitabine 1000 mg/m(2) twice daily + D1 cisplatin 75 mg/m(2), every 3 weeks) or the CP arm (D1-14 capecitabine 1000 mg/m(2) twice daily + D1, 8 paclitaxel 80 mg/m(2), every 3 weeks). The primary endpoint of the study was response rate and secondary endpoints were progression-free survival (PFS), overall survival (OS), toxicity and quality of life.
A total of 94 patients were entered into this study between October 2008 and October 2012, 46 patients in the CC arm and 48 in the CP arm. Patients in both arms received a median of six cycles of treatment (range, 1-14) and the response rates were 57 and 58 % in the cisplatin and paclitaxel arm, respectively. With a median follow-up of 23 months, the median PFS was 5.1 months (95 % CI 4.0-6.2 months) in the cisplatin arm and 6.7 months (95 % CI 4.9-8.5 months) in the paclitaxel arm, whereas the median OS was 10.5 months (95 % CI 9.2-11.9 months) in the cisplatin arm and 13.2 months (95 % CI 9.4-17.0 months) in the paclitaxel arm. Patients in the cisplatin arm were more likely to experience neutropenia and thrombocytopenia, whereas patients in the paclitaxel arm had a higher frequency of neuropathy and alopecia. Quality of life was similar between treatment arms.
Both CC and CP regimens were effective and well tolerated as a first-line treatment in patients with metastatic esophageal squamous cell carcinoma.
本研究旨在评估卡培他滨联合顺铂（CC）或卡培他滨联合紫杉醇（CP）方案作为转移性食管鳞状细胞癌患者一线治疗的疗效和安全性。
复发性或转移性食管鳞状细胞癌患者被纳入这项开放标签的II期随机试验。患者被分配至CC组（第1 - 14天，卡培他滨1000 mg/m²，每日两次 + 第1天，顺铂75 mg/m²，每3周一次）或CP组（第1 - 14天，卡培他滨1000 mg/m²，每日两次 + 第1、8天，紫杉醇80 mg/m²，每3周一次）。研究的主要终点是缓解率，次要终点是无进展生存期（PFS）、总生存期（OS）、毒性和生活质量。
2008年10月至2012年10月期间，共有94例患者进入本研究，CC组46例，CP组48例。两组患者均接受了中位数为6个周期的治疗（范围1 - 14），顺铂组和紫杉醇组的缓解率分别为57%和58%。中位随访23个月时，顺铂组的中位PFS为5.1个月（95%CI 4.0 - 6.2个月），紫杉醇组为6.7个月（95%CI 4.9 - 8.5个月）；顺铂组的中位OS为10.5个月（95%CI 9.2 - 11.9个月），紫杉醇组为13.2个月（95%CI 9.4 - 17.0个月）。顺铂组患者更易发生中性粒细胞减少和血小板减少，而紫杉醇组患者神经病变和脱发的发生率更高。各治疗组间生活质量相似。
CC和CP方案作为转移性食管鳞状细胞癌患者的一线治疗均有效且耐受性良好。
