Safety and Feasibility of Low-Dose Apatinib Combined with S-1 as the Second-Line Therapy or Beyond in Chinese Patients with Pulmonary and Hepatic Metastasis of Nasopharyngeal Carcinoma.

INTRODUCTION

The purpose of this study was to analyze the safety and feasibility of low-dose apatinib combined with S-1 as a second-line therapy or beyond in Chinese patients with pulmonary and/or hepatic metastases of nasopharyngeal carcinoma (NPC).

METHODS

Forty-one Chinese NPC patients with pulmonary and hepatic metastases were treated with low-dose apatinib plus S-1. The S-1 dose was determined according to each patient's body surface area (BSA): 40 mg twice a day for BSA <1.25 m; 50 mg twice a day for 1.25 m≤BSA <1.5 m; and 60 mg twice a day for BSA ≥1.5 m. S-1 was received for 14 days, after stopping for 7 days, given 3 weeks apart. Apatinib, 125 mg was orally administered daily on days 1 through 28 of each 4-week cycle. If the toxicity was not tolerable, the dose of apatinib was reduced to 125 mg every other day.

RESULTS

Treatment efficacy was evaluated in all 41 patients after four courses of chemotherapy. The objective response rate was 34.1%, and the disease control rate was 80.4%. The median progression-free survival was 9.7 months (95% confidence interval, 6.2-13.8 months), and the median overall survival was 22.1 months (95% confidence interval, 15.1-28.9 months). The 2-year survival rate was 41.5%. The most common toxicities included loss of appetite in 39.0% of patients, dyslipidemia in 34.1%, hypertension in 31.7%, myelosuppression in 24.4%, fatigue in 21.9%, and hand-foot syndrome in 17.1%. Seven patients received dose adjustment of apatinib due to side effects.

CONCLUSION

In patients with pulmonary and/or hepatic metastases of NPC, low-dose apatinib plus S-1 yielded an excellent survival benefit, and the toxicities were mild and tolerable.