[Concurrent chemotherapy with different dose regimens of cisplatin for nasopharyngeal carcinoma using intensity-modulated radiation therapy: a phase II prospective randomized controlled trial].

OBJECTIVE: To explore the acute toxic effects and early curative efficacy of concurrent chemotherapy with different doses of cisplatin for Chinese nasopharyngeal carcinoma (NPC) patients using intensity-modulated radiation therapy (IMRT). METHODS: Eighty-eight untreated stage II/III nasopharyngeal cancer patients receiving IMRT and concurrent cisplatin were randomized into two groups receiving different doses of cisplatin. The standard group (DDP 100 mg/m(2) q3w, n = 44) and the study group (DDP 80 mg/m(2) q3w, n = 44). The acute toxic effects and 3-month therapeutic efficacy (early curative efficacy) in patients of the two groups who completed treatment were compared and analyzed. RESULTS: During the treatment, grade III-IV acute toxic effects were observed in more patients of the standard group compared with that in the study group (72.7% vs. 59.1%), but the difference was statistically not significant (P = 0.18). Significant difference was only seen in upper gastrointestinal reaction (P = 0.01) and anemia (P = 0.03) among the non-hematological and hematological adverse events. No significant differences in other adverse events were found between the two groups (P < 0.05). Three months after the completion of radiotherapy, 80 cases of the whole group achieved complete remission (CR) in the nasopharynx and neck MRI. In both the standard group and study group, 40 patients had CR and 4 patients had residual disease, respectively, showing a non-significant difference (P = 0.51) between the two groups. CONCLUSIONS: During the IMRT course, patients received cisplatin 80 mg/m(2) q3w, experienced less grade III-IV acute toxic effects. Concurrent chemoradiotherapy with cisplatin 80 mg/m(2) q3w or 100 mg/m(2) q3w, demonstrate similar early curative efficacy in II/III stage NPC patients in endemic regions of China.