Chemotherapy adjunctive to definitive radiotherapy in locally advanced nasopharyngeal carcinoma (NPC):prospective randomized study / 中国癌症杂志

ABSTRACT

Purpose:To compare chemoradiotherapy against radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma.Methods:From September 1995 to July 1997,eighty-six patients with histologically proven NPC who were staged according to the Fuzhou stage classification to be N 2-3 were entered. Eighty-four patients were evaluable for tumor response and survival. The patients were randomized to receive two cycles of cisplatin (DDP) 20 mg/m 2 on Days 1-3,fluorouracil (5-Fu) 500 mg/m 2 on Days 1-3,before radical radiotherapy (RT),and three cycles of postradiotherapy chemotherapy (39 patients) or radiotherapy alone (45 patients). For chemoradiotherapy (CT-RT) group,the second cycle was given on Day 14 and the radiotherapy was given on Day 27. All patients received radical radiotherapy to the nasopharynx and neck. Radiation therapy consisted of delivering 65.1-70.3 Gy in 35-37 fractions of 1.85-1.9 Gy each over 7-7.5 weeks to the primary site with external beam 60 Co in both groups. The lymph nodes of the neck were given 56.6-65.5 Gy in 7-7.5 weeks. Boost radiotherapy was given to any residual disease. The rates of radiotherapy for boosting primary site or residual lymph nodes were not significantly different in the two arms. Results:The median follow up was 5.04 years. The 5-year actuarial survival rate (ASR) was 72.3% in CT-RT arm and 58.4% in RT arm ( P =0.154). The 5-year disease free survival rate (DFS) was 59.9% in CT-RT arm and 47.7% in RT arm ( P =0.207). The 5-year free from local failure rate (FLF) in nasopharynx was 89.5% in CT-RT arm and 81.4% in RT arm respectively ( P =0.151). The 5-year FLF in neck was 88.3% in CT-RT arm and 75.2% in RT arm respectively ( P =0.134). The 5-year free from distant metastasis rate (FDM) was 76.3% in CT-RT arm and 60.3% in RT arm ( P =0.181). The median time to first distant metastasis was 1.08 years in CT-RT arm and 0.88 year in RT arm. Although the differences did not reach statistical significance,there was some benefit from adjunctive chemotherapy to radiotherapy in the treatment of locoregionally advanced nasopharyngeal carcinoma. Toxicities in CT-RT arm were mainly myelosuppression and nausea and vomiting. There was no significant difference in the incidence and severity of acute mucositis between the two arms during radiotherapy. There was no treatment-related death. Conclusions:This prospective randomized trial demonstrated some benefit in DFS,FLF,FDM from adjunctive chemotherapy to radiotherapy in the treatment of locoregionally advanced nasopharyngeal carcinoma. But the differences were not significant. The chemoradiotherapy increased neither the incidence and severity of acute mucositis nor the late reaction.