| Objective: Patients with metastatic or locoregionally recurrent nasopharyngeal carcinoma(NPC)after platinum-based chemotherapy have limited treatment options.We investigated the efficacy and safety of apatinib alone as a late-line treatment in this patient population.Methods: A multicenter,single-arm,prospective phase II study was conducted on patients(aged 18 to 70 years)with metastatic or recurrent NPC who had failed of chemotherapy.We excluded patients with recurrent disease involved vascular structure invasion.Patients were treated with apatinib 500 mg daily in continuous 4-week cycles until progression or unacceptable toxicity.The primary endpoint of this study was objective response rate(ORR);the secondary endpoints were progression free survival(PFS),overall survival(OS),and toxicity.This study was registered with Clinical Trials.gov(No.NCT03130270).Results: Between January 2017 and June 2018,33 patients were enrolled.At end of data collection(May 20,2020),the 33 patients had completed a total of 261.2 cycles of apatinib.While 12 patients achieved a partial response,no patient achieved complete response;thus,the ORR was 36.4%(95% CI,19.0%to 53.7%).At end of the follow-up time(median,30 months,95% CI,24.87 to35.13),the median OS and median PFS were 16 months(95% CI,14.65 to17.35)and 5.0 months(95% CI,3.47 to 6.53),respectively.The most common adverse events(grade 1 to 2)were hypertension(42.4%),hand-foot syndrome(54.5%),proteinuria(12.1%),and oral ulcer(24.2%).Two patients(one with diabetes and the other with hypertension)developed cerebral infarction.Grade3/4 toxicities were uncommon.Conclusions: Apatinib shows promising activity,with manageable toxicities,in patients with metastatic or locoregionally recurrent NPC who have failed chemotherapy.Further evaluation of apatinib in large-scale studies is warranted. |
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