Apatinib in treating patients with recurrent or metastatic nasopharyngeal carcinoma who had failed prior platinum-based chemotherapy.

ABSTRACT

BACKGROUND: Platinum-based chemotherapy is the standard first-line treatment for recurrent/metastatic nasopharyngeal carcinoma (NPC); however, there is no standard regimen for those who failed first-line treatment. This study aimed to evaluate the efficacy and safety of apatinib in treating patients with recurrent/metastatic NPC who failed prior platinum-based chemotherapy. METHODS: Patients aged 18-65 years with recurrent/metastatic NPC were treated with apatinib at an initial dose of 500 mg once daily and continued until disease progression, patient withdrawal, or unacceptable toxic effects. The primary endpoints were clinical benefit rate (CBR) and toxicity. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). RESULTS: Nineteen patients were enrolled in this study. At the final follow-up, the CBR was 52.6% (95% CI 29.8-76.2%) in the intention-to-treat population. The median PFS and OS were 3.7 (95% CI 0.6-6.8) months and 12.9 (95% CI 9.3-16.5) months, respectively. The most common grade 3-4 adverse events (AEs) were hand-foot syndrome [3 (15.8%)], neutropenia [2 (10.5%)], proteinuria [2 (10.5%)], oral mucosal pain [2 (10.5%)], hypertension [1 (5.3%)], hyponatremia [1 (5.3%)], artery dissection [1 (5.3%)], and nasopharyngeal hemorrhage [1 (5.3%)]. A serious AEs was reported in one patient who died of nasopharyngeal hemorrhage. Treatment with apatinib did not significantly influence patient-reported quality-of-life, except for nausea/vomiting and pain (P<0.05). CONCLUSIONS: Apatinib achieved modest disease control with acceptable toxicity in recurrent/metastatic NPC patients pretreated with platinum-based chemotherapy.