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CLINICAL TRIAL, PHASE II
JOURNAL ARTICLE
Phase II study of docetaxel, cisplatin, and 5-FU induction chemotherapy followed by chemoradiotherapy in locoregionally advanced nasopharyngeal cancer.
Cancer Chemotherapy and Pharmacology 2010 Februrary
PURPOSE: This study sought to determine the feasibility and safety of induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil (5-FU) triple combination chemotherapy (TPF) followed by concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal cancer (NPC).
METHODS: Patients with advanced NPC were treated with three cycles of induction chemotherapy. Docetaxel (70 mg/m2) and cisplatin (75 mg/m2) were given on day 1, followed by 5-FU (1,000 mg/m2) as a continuous infusion for 4 days. After induction chemotherapy, cisplatin was given at a dose of 100 mg/m2 every 3 weeks with radiotherapy.
RESULTS: Thirty-three patients were enrolled; all patients were stage III (n=4, 12.1%) or IV (n=29, 87.9%). Among the patients, 32 patients completed both induction TPF therapy and CCRT, with responses as follows: Wve patients (15.2%) achieved a complete response (CR), and 27 patients (81.8%) a partial response (PR). At 6 weeks after CCRT, 23 patients (69.7%) had a CR and 9 patients (27.3%) a PR. The 3-year progression-free survival was 75.6% and the 3-year overall survival was 86.1%. Neutropenia (72.7%), febrile neutropenia (9.1%), and nausea (9.1%) were the most severe toxicities (grade 3-4) during induction chemotherapy, and mucositis (39.4%), fatigue (15.2%), and nausea (9.1%) were the most common toxicities (grade 3-4) during CCRT.
CONCLUSIONS: Although most patients had stage IV NPC, the TPF induction chemotherapy followed by CCRT showed promising activity with manageable toxicity. These results demonstrated the possibility of effective treatment with the aim of not only a palliative, but also a curative, approach to the treatment of advanced NPC.
METHODS: Patients with advanced NPC were treated with three cycles of induction chemotherapy. Docetaxel (70 mg/m2) and cisplatin (75 mg/m2) were given on day 1, followed by 5-FU (1,000 mg/m2) as a continuous infusion for 4 days. After induction chemotherapy, cisplatin was given at a dose of 100 mg/m2 every 3 weeks with radiotherapy.
RESULTS: Thirty-three patients were enrolled; all patients were stage III (n=4, 12.1%) or IV (n=29, 87.9%). Among the patients, 32 patients completed both induction TPF therapy and CCRT, with responses as follows: Wve patients (15.2%) achieved a complete response (CR), and 27 patients (81.8%) a partial response (PR). At 6 weeks after CCRT, 23 patients (69.7%) had a CR and 9 patients (27.3%) a PR. The 3-year progression-free survival was 75.6% and the 3-year overall survival was 86.1%. Neutropenia (72.7%), febrile neutropenia (9.1%), and nausea (9.1%) were the most severe toxicities (grade 3-4) during induction chemotherapy, and mucositis (39.4%), fatigue (15.2%), and nausea (9.1%) were the most common toxicities (grade 3-4) during CCRT.
CONCLUSIONS: Although most patients had stage IV NPC, the TPF induction chemotherapy followed by CCRT showed promising activity with manageable toxicity. These results demonstrated the possibility of effective treatment with the aim of not only a palliative, but also a curative, approach to the treatment of advanced NPC.
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