Sequential induction chemotherapy plus intensity‐modulated radiotherapy versus concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: the three‐year report of a phase II, single center, randomized, non‐inferiority trial

Abstract To compare the efficacy and safety of induction chemotherapy (IC) followed by intensity‐modulated radiotherapy (IMRT) alone versus concurrent CCRT in locoregionally advanced nasopharyngeal carcinoma (LA‐NPC). Patients with newly diagnosed stage III to IVB nasopharyngeal carcinoma (NPC) were randomized to receive IC plus IMRT (IC+RT arm), or concurrent chemotherapy plus IMRT (CCRT arm), using a random number table. Both treatment arms received the same chemotherapy regimen. The primary endpoint was progression‐free survival (PFS). Secondary end points included overall survival (OS), locoregional recurrence‐free survival (LRRFS), distant metastasis‐free survival (DMFS), treatment response, and acute treatment toxicities. From June 2013 to September 2018, a total of 204 patients histologically diagnosed with LA‐NPC were enrolled in the study, with 102 patients randomly assigned to each arm. After a median follow‐up duration of 45 months (range 4 to 84 months), the 3‐year PFS, OS, LRRFS and DMFS were 72.2%, 87.8%, 92.3%, and 82.7% in the IC+RT arm, compared with 82.6%, 92.8%, 94.7%, and 88.2% in the CCRT arm. No statistical difference for PFS, OS, LRRFS, DMFS, or treatment response was observed between the two arms ( p > 0.05). The incidences of leukopenia ( p = 0.008) and anemia ( p = 0.015) were significantly higher in patients in the CCRT arm than those in the IC+RT arm. Compared to CCRT, IC plus IMRT alone provided similarly favorable treatment outcomes in terms of PFS, OS, LRRFS, and DMFS for patients with LA‐NPC, but resulted in fewer incidences of leukopenia and anemia.