Peng PeiJian, Ou XueQing, Liao Hai, Liu YuMeng, Wang SiYang, Cheng ZhiBin, Lin Zhong
Department of Medical Oncology, The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, People's Republic of China.
Department of Radiation Oncology, The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong Province, People's Republic of China.
Ther Adv Med Oncol. 2016 May;8(3):153-9. doi: 10.1177/1758834016637592. Epub 2016 Mar 11.
No standard salvage regimen has been established for patients with recurrent and metastatic nasopharyngeal carcinoma (NPC) and disease progression after prior platinum-based chemotherapy. This phase II study was designed to evaluate the efficacy and safety of gemcitabine plus S-1 (GS) chemotherapy as a remedial regimen in this setting.
In this multicenter phase II study, 49 patients with recurrent and metastatic NPC who failed previous platinum-based chemotherapy received gemcitabine (1.0 g/m(2) on days 1 and 8) plus oral S-1 chemotherapy (twice daily from day 1 to 14). Each cycle was repeated every 3 weeks for two cycles at least. The dose of S-1 was determined according to the body surface area (BSA): 40 mg twice a day for BSA <1.25 m(2); 50 mg twice a day for 1.25 m(2) ⩽ BSA <1.5 m(2); and 60 mg twice a day for BSA ⩾1.5 m(2).
Treatment was generally well-tolerated. A total of seven patients (14.3%) had grade 3 toxicities and the main toxicity was myelosuppression, whereas the nonhematology adverse events were minimal. There were 3 complete responses (6.4%), 17 partial responses (36.2%), and the overall response rate was 42.6% (95% confidence interval: 27.3-61.2). Median time to progression was 5.8 months and median survival was 14.8 months. The 1- and 2-year survival rates were 64% and 30%, respectively.
Gemcitabine plus S-1 offers a satisfactory clinical activity and an acceptable safety profile for recurrent and metastatic NPC patients after failure of platinum-based chemotherapy.
对于复发和转移性鼻咽癌（NPC）患者以及先前铂类化疗后疾病进展的患者，尚未确立标准的挽救治疗方案。本II期研究旨在评估吉西他滨联合S-1（GS）化疗作为补救方案在此情况下的疗效和安全性。
在这项多中心II期研究中，49例先前铂类化疗失败的复发和转移性NPC患者接受吉西他滨（第1天和第8天，1.0 g/m²）联合口服S-1化疗（第1天至第14天，每日两次）。每个周期每3周重复一次，至少进行两个周期。S-1的剂量根据体表面积（BSA）确定：BSA<1.25 m²时，每天两次，每次40 mg；1.25 m²≤BSA<1.5 m²时，每天两次，每次50 mg；BSA≥1.5 m²时，每天两次，每次60 mg。
治疗耐受性总体良好。共有7例患者（14.3%）出现3级毒性，主要毒性为骨髓抑制，而非血液学不良事件极少。有3例完全缓解（6.4%），17例部分缓解（36.2%），总缓解率为42.6%（95%置信区间：27.3-61.2）。中位疾病进展时间为5.8个月，中位生存期为14.8个月。1年和2年生存率分别为64%和30%。
对于铂类化疗失败后的复发和转移性NPC患者，吉西他滨联合S-1具有令人满意的临床活性和可接受的安全性。
