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奈达铂联合S-1化疗用于含铂方案治疗失败后的复发和转移性鼻咽癌患者的多机构前瞻性研究。

Multi-institutional prospective study of nedaplatin plus S-1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma patients after failure of platinum-containing regimens.

作者信息

Peng Pei-Jian, Lv Bao-Jun, Wang Zhi-Hui, Liao Hai, Liu Yu-Meng, Lin Zhong, Con Yun-Yan, Huang Pei-Yu

机构信息

Department of Medical Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Guangdong Province, People's Republic of China.

Department of Surgical Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhu Hai, Guangdong Province, China.

出版信息

Ther Adv Med Oncol. 2017 Feb;9(2):68-74. doi: 10.1177/1758834016675099. Epub 2016 Nov 2.

Abstract

BACKGROUND

In this multi-institutional prospective study, we aimed to assess the safety and efficacy of nedaplatin plus S-1 (NS) chemotherapy for patients with recurrent and metastatic nasopharyngeal carcinoma (NPC) when platinum-containing regimens failed.

METHODS

A total of 52 recurrent and metastatic NPC patients who previously received, but failed with platinum-containing chemotherapy, had oral S-1 chemotherapy (twice daily from the first day to the fourteenth day) and nedaplatin (80 mg/ m, day 1) every 3 weeks. The body surface area (BSA) decided the dose of S-1: 40 mg twice a day when BSA < 1.25 m; 50 mg twice daily when 1.25 m ⩽ BSA < 1.5 m; and 60 mg twice daily when BSA ⩾ 1.5 m.

RESULTS

Treatment was well tolerated. The main hematological adverse event was neutropenia. Five patients (9.6%) had grade 3 neutropenia. Three patients were found with grade 3 anemia (5.8%). One patient was found with grade 3 thrombocytopenia (1.9%). No patient was found with grade 3 or 4 nonhematological toxicity. The rates of complete response, partial response and overall response were 3.8%, 38.5% and 42.3%, respectively. Median time to progression was 6.2 months and median survival was 14.6 months. The rates of 1-year survival and 2-year survival were 63% and 27%, respectively.

CONCLUSIONS

NS chemotherapy provides a satisfactory and safe clinical activity for patients with recurrent and metastatic NPC after platinum-containing chemotherapy failed.

摘要

背景

在这项多机构前瞻性研究中,我们旨在评估奈达铂联合S-1(NS)化疗方案对含铂方案治疗失败的复发和转移性鼻咽癌(NPC)患者的安全性和疗效。

方法

共有52例复发和转移性NPC患者,此前接受过含铂化疗但治疗失败,接受口服S-1化疗(第1天至第14天,每日两次),每3周联合奈达铂(80mg/m²,第1天)。体表面积(BSA)决定S-1的剂量:BSA<1.25m²时,每日两次,每次40mg;1.25m²≤BSA<1.5m²时,每日两次,每次50mg;BSA≥1.5m²时,每日两次,每次60mg。

结果

治疗耐受性良好。主要血液学不良事件为中性粒细胞减少。5例患者(9.6%)出现3级中性粒细胞减少。3例患者出现3级贫血(5.8%)。1例患者出现3级血小板减少(1.9%)。未发现3级或4级非血液学毒性。完全缓解率、部分缓解率和总缓解率分别为3.8%、38.5%和42.3%。中位疾病进展时间为6.2个月,中位生存期为14.6个月。1年生存率和2年生存率分别为63%和27%。

结论

对于含铂化疗失败的复发和转移性NPC患者,NS化疗提供了令人满意且安全的临床疗效。

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