Purpose: To investigate the efficacy and safety of selective radiotherapy after distant metastasis ofnasopharyngeal carcinoma (NPC) treated with dose-dense cisplatin plus fluorouracil. Materials and
Methods:Eligible patients were randomly assigned to a study group treated with dose-dense cisplatin plus fluorouracilfollowing selective radiotherapy and a control group receiving traditional cisplatin plus fluorouracil followingselective radiotherapy according to a 1:1 distribution using a digital random table method. The primary endpointwas overall survival (OS). Secondary endpoints were progression-free survival (PFS), objective response rate,relapse or progression rate in the radiation field and treatment toxicity.
Results: Of 52 patients in the study group,20 cases underwent radiotherapy., while in the control group of 51 patients, 16 underwent radiotherapy. Themedian PFS, median OS, survival rates in 1, 2 and 3 years in study and control group were 20.9 vs 12.7months,28.3 vs 18.8months, 85.2%vs 65.9%, 62.2% vs 18.3%, and 36.6%vs 5.2% (p values of 0.00, 0.00, 0.04, 0.00 and0.00, respectively). Subgroup analysis showed that the median OS and survival rates of 1, 2, 3 years for patientsundergoing radiotherapy in the study group better than that in control group( 43.2vs24.1 months, 94.1% vs86.7%, 82.4% vs 43.3%, 64.7% vs 17.3%, (p=0.00, 0.57, 0.04 and 0.01, respectively). The complete response rate,objective response rate after chemotherapy and three months after radiotherapy, relapse or progression rate inradiation field in study group and in control group were 19.2% vs 3.9%, 86.5% vs 56.9%, 85% vs 50%, 95% vs81.3% and 41.3% vs 66.7% (p =0.03, 0.00, 0.03,0.30, 0.01 respectively). The grade 3-4 acute adverse reactions inthe study group were significantly higher than in the control group (53.8% vs 9.8%, p=0.00).
Conclusions: Thesurvival of patients benefits from selective radiotherapy after distant metastasis of NPC treated with dose-densecisplatin plus fluorouracil.