Lessons learned: The 5-fluorouracil, docetaxel, and nedaplatin (UDON) regimen was well tolerated and showed promising antitumor activity in terms of both objective response rate and survival for patients with advanced or recurrent esophageal squamous cell carcinoma in the first-line setting.UDON may be an optimal treatment option for patients with advanced esophageal cancer who are unfit for docetaxel, cisplatin, and 5-fluorouracil regimens.The high response rate as well as the rapid and marked tumor shrinkage associated with UDON suggest that further evaluation of this regimen in the neoadjuvant setting is warranted.
Background: A phase II study was performed to evaluate the efficacy and safety of 5-fluorouracil (5-FU), docetaxel, and nedaplatin (UDON) combination therapy for untreated recurrent or metastatic esophageal cancer.
Methods: Patients received intravenous nedaplatin (90 mg/m2) on day 1, docetaxel (35 mg/m2) on days 1 and 15, and 5-fluorouracil (800 mg/m2) on days 1-5 of a 4-week cycle. The primary endpoint was response rate, with secondary endpoints including overall survival (OS), progression-free survival (PFS), dysphagia score, and adverse events.
Results: Between March 2015 and July 2017, 23 patients were enrolled. Of 22 evaluable patients, 16 and 4 individuals experienced a partial response and stable disease, respectively, yielding a response rate of 72.7% (95% confidence interval [CI], 49.8%-89.3%) and disease control rate of 90.9% (95% CI, 70.8%-98.9%). Median OS and PFS were 11.2 months (95% CI, 9.1 months to not reached) and 6.0 months (95% CI, 2.5-10.6 months), respectively. Eleven (64.7%) of the 17 patients with a primary lesion showed amelioration of dysphagia after treatment. Frequent adverse events of grade 3 or 4 included neutropenia (87.0%) and leukopenia (39.1%). Febrile neutropenia was observed in two patients (8.7%).
Conclusion: This phase II study demonstrated promising antitumor activity and good tolerability of UDON.
经验教训
• 5‐氟尿嘧啶、多西紫杉醇和奈达铂 (UDON) 方案耐受性良好，并且在一线治疗晚期或复发性食管鳞状细胞癌患者的客观反应率和生存率方面均显示出良好的抗肿瘤活性。
• 对于不适合多西紫杉醇、顺铂和 5‐氟尿嘧啶方案的晚期食管癌患者，UDON 可能是最佳治疗选择。
• 高响应率以及与 UDON 相关的快速且显著的肿瘤缩小表明，需要在新辅助治疗中进一步评估该方案。
摘要
背景。进行 II 期研究以评估 5‐氟尿嘧啶 (5‐FU)、多西紫杉醇和奈达铂 (UDON) 联合治疗对未治疗的复发或转移性食管癌的功效和安全性。
方法。患者在第 1 天通过静脉接受奈达铂 (90 mg/m2)，在第 1 天和第 15 天接受多西紫杉醇 (35 mg/m2)，并且在 4 周周期的第 1‐5 天接受 5‐氟尿嘧啶 (800 mg/m2)。主要终点是反应率，次要终点包括总生存期 (OS)、无进展生存期 (PFS)、吞咽困难评分和不良事件。
结果。2015 年 3 月至 2017 年 7 月期间，共招募了 23 名患者。在 22 名可评估的患者中，16 名患者出现部分反应，4 名患者病情稳定，反应率为 72.7%(95% 置信区间 [CI]，49.8%‐89.3%)，疾病控制率为 90.9% (95% CI, 70.8%–98.9%)。中位 OS 和 PFS 分别为 11.2 个月(95% CI，未达到 9.1 个月)和 6.0 个月(95% CI，2.5‐10.6 个月)。17 位原发病变患者中，有 11 位 (64.7%) 在治疗后表现出吞咽困难的改善。3 级或 4 级频繁发生的不良事件包括中性粒细胞减少症 (87.0%) 和白细胞减少症 (39.1%)。两名患者 (8.7%) 观察到发热性中性粒细胞减少。
结论。该 II 期研究证明了 UDON 具有良好的抗肿瘤活性和良好的耐受性。
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