The study was done to investigate the efficacy and safety of locoregional radiotherapy in de novo mNPC.
Patients with biopsy-proven mNPC, demonstrating response following 3 cycles of cisplatin and fluorouracil chemotherapy, were enrolled. Eligible patients were randomly assigned to receive either chemotherapy plus radiotherapy or chemotherapy alone. Overall, 126 were eligible according to the study inclusion criteria.
126 patients were enrolled that fulfilled the inclusion criteria. The 24-month OS was 76.4% in the chemotherapy plus radiotherapy group, compared with 54.5% in the chemotherapy alone group. The study met its primary endpoint of improved OS in favor of chemotherapy plus radiotherapy. Progression-free survival was also improved in the chemotherapy plus radiotherapy group compared with the chemotherapy-alone group. No significant differences in acute hematological or gastrointestinal toxic effects were observed between the treatment arms. The frequency of acute grade 3 or higher dermatitis, mucositis, and xerostomia was 8.1%, 33.9%, and 6.5%, respectively, in the chemotherapy plus radiotherapy group.
This study concluded that the radiotherapy added to chemotherapy significantly improved OS in chemotherapy-sensitive patients with mNPC.