Randomized phase II study of docetaxel versus paclitaxel in patients with esophageal squamous cell carcinoma refractory to fluoropyrimidine- and platinum-based chemotherapy: OGSG1201

多西紫杉醇 医学 中性粒细胞减少症 内科学 发热性中性粒细胞减少症 胃肠病学 白细胞减少症 化疗 危险系数 临床终点 紫杉醇 无进展生存期 肿瘤科 随机对照试验 外科 置信区间
作者
Sachiko Yamamoto,Hisato Kawakami,Takayuki Kii,Hiroki Hara,Ryohei Kawabata,Junji Kawada,Atsushi Takeno,Jin Matsuyama,Shugo Ueda,Yoshihiro Okita,Shunji Endo,Yutaka Kimura,Kazuhiro Yanagihara,Tatsuya Okuno,Yukinori Kurokawa,Toshio Shimokawa,Taroh Satoh
出处
期刊:European Journal of Cancer [Elsevier]
卷期号:154: 307-315 被引量:7
标识
DOI:10.1016/j.ejca.2021.06.035
摘要

There is no standard chemotherapy for esophageal squamous cell carcinoma (ESCC) refractory to first-line fluoropyrimidine- and platinum-based chemotherapy. We therefore performed a randomized, selection-design phase II trial to compare docetaxel (DTX) and paclitaxel (PTX) in this setting.Eligible patients were randomly assigned to receive either DTX (70 mg/m2 on day 1 of each 21-day cycle) or PTX (100 mg/m2 on days 1, 8, 15, 22, 29 and 36 of each 49-day cycle). The primary end-point was overall survival (OS), and secondary end-points included progression-free survival (PFS), time to treatment failure (TTF), response rate (RR) and safety.Seventy-eight eligible patients (N = 39 in each group) were included for efficacy analysis. OS was significantly longer in the PTX group than in the DTX group (median, 8.8 versus 7.3 months; hazard ratio [HR], 0.62; P = 0.047). A significant benefit of PTX over DTX was also apparent in PFS (median, 4.4 versus 2.1 months; HR, 0.49; P = 0.002) and TTF (median, 3.8 versus 2.1 months; HR, 0.45; P < 0.001). RR (25.6% versus 7.7%, P = 0.065) were higher in the PTX group than in the DTX group. Compared to the PTX group, neutropenia (28% versus 80%) and leukopenia (28% versus 76%) of grade ≥3 as well as febrile neutropenia (0% vs. 46%, P < 0.0001) occurred more frequently in the DTX group.PTX showed a significantly better efficacy as well as a more manageable toxicity compared with DTX.UMIN000007940.
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