Phase Ⅱ study of induction chemotherapy followed by concurrent chemoradiotherapy with raltitrexed an

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Objectivo: For locally advanced nasopharyngeal carcinoma (LA-NPC) patients,high incidences of distaat metastases and severe treaunent related toxicities are the main obstacles needed to be overcome.Raltitrexed,a spedfic thymidylate synthase inhibitor with a convenient administration schedule,has an acceptable and manageable toxicity,and possesses radio-sensitizing properties.To investigate the efficacy and safety of raltitrexed and cisplatin induction chemotherapy and concurrent chemoradiotherapy (IC+CCRT) in patients with LA-NPC,a phase Ⅱ clinical study was conducted.Methods: Sixty eligible patients with LA-NPC were enrolled into this study.A raltitrexed-cisplatin combination was used as part of an IC+CCRT regimen.Raltitrexed-cisplatin IC was given once every 3 weeks (q3w) for two cycles,followed by raltitrexed-cisplatin based CCRT q3w for two cycles.Intensity-modulated radiotherapy (IMRT)was given for all enrolled patients.Results: All patients were included in survival analysis according to the intent-to-treat principle.The objective response rate (ORR) 3 months after treatment was 98%.The 2-year overall survival (OS) rate was 92%.The median relapse-free survival (RFS) time was 30.5[95% confidence interval (95% CI),28.4-32.3]months.The 2-year RFS rate was 85%.The 2-year local failure-free survival (LFFS) rate was 97% and the 2-year distant metastasis-free survival (DMFS) rate was 88%.Acute toxicities were mostly grade 2 and 3 reactions in bone marrow suppression,gastrointestinal side effect and oropharyngeal mucositis.Only two patients occurred grade 4 acute toxicities,one was bone marrow suppression and the other was dermatitis radiation.Conclusions: The combination of raltitexed and cisplatin has a comparable efficacy to those in standard firstline therapy.
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