Phase II study of gemcitabine plus S-1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma 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) chemo...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2016-05-01
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| Series: | Therapeutic Advances in Medical Oncology |
| Online Access: | https://doi.org/10.1177/1758834016637592 |
| _version_ | 1818246193645355008 |
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| author | PeiJian Peng XueQing Ou Hai Liao YuMeng Liu SiYang Wang ZhiBin Cheng Zhong Lin |
| author_facet | PeiJian Peng XueQing Ou Hai Liao YuMeng Liu SiYang Wang ZhiBin Cheng Zhong Lin |
| author_sort | PeiJian Peng |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T14:44:55Z |
| format | Article |
| id | doaj.art-b5c7758bf3a34f30b8437204ffd4ea0a |
| institution | Directory Open Access Journal |
| issn | 1758-8359 |
| language | English |
| last_indexed | 2024-12-12T14:44:55Z |
| publishDate | 2016-05-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Medical Oncology |
| spelling | doaj.art-b5c7758bf3a34f30b8437204ffd4ea0a2022-12-22T00:21:08ZengSAGE PublishingTherapeutic Advances in Medical Oncology1758-83592016-05-01810.1177/1758834016637592Phase II study of gemcitabine plus S-1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma patients after failure of platinum-based chemotherapyPeiJian PengXueQing OuHai LiaoYuMeng LiuSiYang WangZhiBin ChengZhong LinPurpose: 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.https://doi.org/10.1177/1758834016637592 |
| spellingShingle | PeiJian Peng XueQing Ou Hai Liao YuMeng Liu SiYang Wang ZhiBin Cheng Zhong Lin Phase II study of gemcitabine plus S-1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma patients after failure of platinum-based chemotherapy Therapeutic Advances in Medical Oncology |
| title | Phase II study of gemcitabine plus S-1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma patients after failure of platinum-based chemotherapy |
| title_full | Phase II study of gemcitabine plus S-1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma patients after failure of platinum-based chemotherapy |
| title_fullStr | Phase II study of gemcitabine plus S-1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma patients after failure of platinum-based chemotherapy |
| title_full_unstemmed | Phase II study of gemcitabine plus S-1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma patients after failure of platinum-based chemotherapy |
| title_short | Phase II study of gemcitabine plus S-1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma patients after failure of platinum-based chemotherapy |
| title_sort | phase ii study of gemcitabine plus s 1 chemotherapy in recurrent and metastatic nasopharyngeal carcinoma patients after failure of platinum based chemotherapy |
| url | https://doi.org/10.1177/1758834016637592 |
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