PeiJian Peng1, XueQing Ou2, Hai Liao3, YuMeng Liu4, SiYang Wang2, ZhiBin Cheng2, Zhong Lin5. 1. Department of Medical Oncology, The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, People's Republic of China. 2. Department of Radiation Oncology, The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong Province, People's Republic of China. 3. Department of Medical Oncology, Cancer Center, Sun Yat-Sen University, Guangzhou, People's Republic of China. 4. Department of Oncology, the People's Hospital of Zhongshan City, Zhongshan, People's Republic of China. 5. Department of Medical Oncology, The Fifth Affiliated Hospital of Sun Yat-Sen University, 52 Mei Hua Road East, Zhuhai 519000, Guangdong Province, People's Republic of China.
Abstract
PURPOSE: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.
PURPOSE: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS:Gemcitabine plus S-1 offers a satisfactory clinical activity and an acceptable safety profile for recurrent and metastatic NPCpatients after failure of platinum-based chemotherapy.
Authors: K F Foo; E H Tan; S S Leong; J T S Wee; T Tan; K W Fong; L Koh; B C Tai; L G Lian; D Machin Journal: Ann Oncol Date: 2002-01 Impact factor: 32.976