An open, multicenter, exploratory study of apatinib mesylate maintenance therapy for recurrent/metastatic head and neck squamous cell carcinoma (ChiCTR1800019375)

Abstract Background This study evaluated the efficacy of apatinib in maintenance therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Methods Twenty‐six patients from three centers were enrolled from November 2018 to September 2021. These patients received 2 weeks apatinib, administered at 250 mg qd. Then apatinib dose may be administered to 500 mg qd continuous in 4 weeks cycle if no patients experienced adverse reaction. Enrolled patients can receive a combination of radiotherapy or chemotherapy. The primary endpoints were progression‐free survival (PFS), and secondary endpoints included overall survival (OS), disease control rate (DCR), objective response rate (ORR), quality of life (QOL) score, and adverse drug reactions. Results Median PFS of all patients was 3.2 months (95% CI: 2.06–4.33). Median OS of all patients was 7.3 months (95% CI: 2.14–12.46). The DCR was 92.3%. The ORR was 30.8%. In univariate analysis, the results showed that ECOG score 0–1 (HR = 0.31, p = 0.006) and treated with apatinib for more than 60 days (HR = 0.31, p = 0.003) were independent prognostic indicators affecting PFS, and ECOG score 0–1 (HR = 0.40, p = 0.027) and moderately differentiated or highly differentiated (HR = 0.38, p = 0.048) were independent prognostic indicators of OS. The most common adverse events among treated subjects included hypertension (46.1%), fatigue (42.3%), and hand‐foot syndrome (23.1%). There were only two cases (7.7%) of Grade III or above adverse reactions. Conclusions Maintenance therapy with apatinib is an effective and well‐tolerated regimen in patients with R/M HNSCC.