Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan
Oncologist. 2019 Feb;24(2):163-e76. doi: 10.1634/theoncologist.2018-0653. Epub 2018 Oct 25.
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.
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.
Patients received intravenous nedaplatin (90 mg/m) on day 1, docetaxel (35 mg/m) on days 1 and 15, and 5-fluorouracil (800 mg/m) 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.
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%).
This phase II study demonstrated promising antitumor activity and good tolerability of UDON.
氟尿嘧啶、多西他赛和奈达铂（UDON）方案在一线治疗晚期或复发性食管鳞癌患者中具有良好的耐受性，并在客观缓解率和生存方面显示出有希望的抗肿瘤活性。UDON 可能是不适合多西他赛、顺铂和氟尿嘧啶方案的晚期食管癌患者的最佳治疗选择。UDON 高缓解率以及与肿瘤快速和显著缩小相关，提示在新辅助治疗环境中进一步评估该方案是合理的。
进行了一项 II 期研究，以评估氟尿嘧啶（5-FU）、多西他赛和奈达铂（UDON）联合治疗未经治疗的复发性或转移性食管癌的疗效和安全性。
患者在每 4 周周期的第 1 天接受静脉注射奈达铂（90mg/m），第 1 和 15 天接受多西他赛（35mg/m），第 1-5 天接受氟尿嘧啶（800mg/m）。主要终点是缓解率，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。
2015 年 3 月至 2017 年 7 月期间，共纳入 23 例患者。22 例可评估患者中，16 例和 4 例患者分别出现部分缓解和稳定疾病，缓解率为 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，9.1 个月至未达到）和 6.0 个月（95%CI，2.5-10.6 个月）。17 例有原发性病变的患者中，11 例（64.7%）在治疗后吞咽困难得到改善。频繁发生的 3 级或 4 级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%）出现发热性中性粒细胞减少症。
这项 II 期研究表明，UDON 具有有希望的抗肿瘤活性和良好的耐受性。
