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首页> 外文期刊>Esophagus >A phase II study of nedaplatin and 5-fluorouracil in metastatic squamous cell carcinoma of the esophagus: The Japan Clinical Oncology Group (JCOG) Trial (JCOG 9905-DI)
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A phase II study of nedaplatin and 5-fluorouracil in metastatic squamous cell carcinoma of the esophagus: The Japan Clinical Oncology Group (JCOG) Trial (JCOG 9905-DI)

机译：奈达铂和5-氟尿嘧啶在食道转移性鳞状细胞癌的II期研究：日本临床肿瘤学小组（JCOG）试验（JCOG 9905-DI）

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Background This phase II study evaluated the efficacy and toxicity of combination chemotherapy with nedaplatin and 5-fluorouracil (5-FU) for metastatic esophageal squamous cell carcinoma. Methods Eligibility criteria included squamous cell carcinoma with organ metastasis, ECOG performance status (PS) 0-2, < 75 years, measurable disease, and adequate organ function. Chemotherapy consisted of 5-FU (800 mg/ m2/day) on days 1-5 and a 2-h infusion of nedaplatin (90 mg/m2) on day 1, repeated every 4 weeks. Therapy was continued until disease progression or intolerable adverse events. The primary end point was response rate. Secondary end points included overall survival, progression-free survival, and toxicities. Results Forty-two patients (39 men, 3 women; median age 59 years; range 44-70 years) were enrolled. Twenty-one, 21, and 0 patients had PS 0, 1, and 2, respectively. 23, 6, 3, and 18 patients had a history of surgical resection, radiotherapy, adjuvant chemotherapy, and no therapy, respectively. Among the 38 eligible patients, 1 and 14 complete and partial responses were observed, respectively; the overall response rate was 39.5 % (90 % confidence interval: 26.1-54.1 %). The median survival time was 8.8 months. The one-year survival rate was 32.9 %. Grade 4 neutropenia and thrombocytopenia were observed in 7 and 2 % of 41 patients, respectively. Grade 3 nausea, diarrhea, and stomatitis were observed in 12, 2, and 2 %, respectively. Conclusion Combination therapy with nedaplatin and 5-FU is highly active and well tolerated in metastatic or recurrent esophageal squamous cell cancer and is therefore a chemotherapy option for esophageal squamous cell carcinoma.
机译：背景本II期研究评估了奈达铂和5-氟尿嘧啶（5-FU）联合化疗对转移性食管鳞癌的疗效和毒性。方法入选标准包括鳞状细胞癌器官转移，ECOG表现状态（PS）0-2，<75岁，可测量的疾病和适当的器官功能。化学疗法由第1-5天的5-FU（800 mg / m2 /天）和第1天的2小时输注奈达铂（90 mg / m2）组成，每4周重复一次。继续治疗直至疾病进展或无法忍受的不良事件。主要终点是反应率。次要终点包括总生存期，无进展生存期和毒性。结果招募了42例患者（男39例，女3例;中位年龄59岁;范围44-70岁）。 PS分别为21、21和0，分别为0、1和2。 23、6、3和18例患者分别有手术切除，放疗，辅助化疗和无治疗史。在38例合格患者中，分别观察到1和14例完全和部分反应。总体回应率为39.5％（90％置信区间：26.1-54.1％）。中位生存时间为8.8个月。一年生存率为32.9％。 41例患者中分别有7％和2％观察到4级中性粒细胞减少和血小板减少。分别以12％，2％和2％的比例观察到3级恶心，腹泻和口腔炎。结论奈达铂和5-FU联合治疗转移性或复发性食管鳞状细胞癌具有很高的活性，且耐受性良好，因此是食管鳞状细胞癌的化疗选择。

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