Satge I clinical study of dose escalation of capecitabine during intensity modulated radiotherapy concurrent chemotherapy for local regional advanced nasopharyngeal carcinoma / 中华放射医学与防护杂志

ABSTRACT

Objective To decrease radiation induced toxicities especially mucostis in patients with locally advanced nasopharyngeal carcinoma( NPC ) who underwent concurrent radiochemotherapy, the maximum tolerated dose and dose limited toxicities of capecitabine combination with cisplatin were observed. Methods From Aug 2006 to Oct 2007, 24 patients with intensity modulated radiotherapy(IMRT) and concurrent chemotherapy with capecitabine and cisplatin for nasopharyngeal carcinoma(stages Ⅲ-Ⅳ) were enrolled in this study. There were four dose-level groups of Capecitabine[625-1250 mg/(m2 ·d) , d1-14]and fixed cisplatin dose[20 mg/(m ·d) ,d1-5) ]MRI and CT scan were used for evaluation of tumor shrinkage. Treatment related toxicities were evaluated according to the common toxicity criteria( NCI-CTC Version 3.0). Results The acute side-effects include Grade 3 or Grade 4 mucosal toxicity(lasting for at least 5 d) and Grade 3 or Grade 4 non-mucosal toxicity were evaluated. Group 625 mg/m2 and Group 825 mg/m2 had none, Group 1000 mg/m2 had 6 patients and Group 1250 mg/m2 had 3 patients for mucosal toxicity, which were the main dose-limited toxicity and relevant to the dose of capecitabine apparently( P < 0. 05 ). There was also a trend of increase by the dose level of capecitabine for other toxicities. The median follow-up time for all patients was 28. 5 months. The locoregional recurrence occurred in 2 patients and distant metastasis in 2 patients. Two-year overall survival rate and locoregional control rate were 100% and 91.7%, respectively.Complete response and partialresponse were found on MRI or CT scan in patients of 29. 2% at the end of treatment and 83. 3% after three months, respectively. Conclusions The combination regimen of capecitabine and cisplatin is safe and effective according to the preliminary result. Toxicities related to radiochemotherapy for NPC were significantly associated with the dose level of chemotherapy.