Bevacizumab versus placebo in combination with paclitaxel and carboplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase II trial.

Background The value of anti-angiogenesis antibody therapy in recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) remains unknown. We carried out a phase II study to evaluate the addition of bevacizumab to paclitaxel plus carboplatin in R/M NPC. Materials and methods A total of 80 patients with previously untreated R/M NPC were randomly assigned (1 : 1) to CPB or CP groups to receive carboplatin (area under the curve 6) and paclitaxel (175 mg/m2) intravenously every 3 weeks for a maximum of six cycles in combination with or without bevacizumab (7.5 mg/kg), respectively. The primary endpoint was progression-free survival (PFS) as per investigators, and the secondary endpoints were PFS as per independent review committee (IRC), overall survival (OS), objective response rate (ORR), and safety. This study was registered with ClinicalTrials.gov ( NCT02250599 ). Results The median PFS as per investigators was 7.5 months [95% confidence interval (CI), 6.53-8.45 months] in the CPB group and 6.5 months (95% CI, 5.53-7.52 months) in the CP group (P = 0.148), which were similar to IRC-assessed PFS. The median OS was also alike between CPB and CP arms (21.0 versus 24.7 months; P = 0.326). ORRs were 87.2% and 72.5%, respectively (P = 0.105). However, the tumor-shrinking rate was higher in the CPB arm than in the CP arm (P = 0.035). No differences in grade 3 or higher adverse events between the groups were observed. Conclusions Addition of bevacizumab to paclitaxel plus carboplatin as first-line treatment did not prolong PFS and OS in patients with R/M NPC but improved tumor-shrinking rate. These results indicated that bevacizumab plus chemotherapy might be an optional choice for NPC with heavy tumor load or those pursuing short-term efficacy in neoadjuvant and concurrent chemotherapy.