Department of Radiation Oncology, Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University, Haikou, Hainan Province 570311, People's Republic of China.
Drug Des Devel Ther. 2020 Mar 30;14:1257-1262. doi: 10.2147/DDDT.S244102. eCollection 2020.
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).
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.
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.
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.
本研究旨在分析低剂量阿帕替尼联合 S-1 作为二线或二线以上治疗方案在合并肺及/或肝转移的中国鼻咽癌（NPC）患者中的安全性和可行性。
41 例合并肺及肝转移的中国 NPC 患者接受低剂量阿帕替尼联合 S-1 治疗。S-1 的剂量根据每位患者的体表面积（BSA）确定：BSA＜1.25 m 者给予 S-1 40 mg，每日 2 次；1.25 m≤BSA＜1.5 m 者给予 S-1 50 mg，每日 2 次；BSA≥1.5 m 者给予 S-1 60 mg，每日 2 次。S-1 连续给药 14 天，停药 7 天，每 3 周重复 1 个周期。阿帕替尼，每日 125 mg，连续给药 28 天，每 4 周重复 1 个周期。如果毒性不可耐受，阿帕替尼剂量减为 125 mg 隔日 1 次。
41 例患者均完成了 4 个周期的化疗，评估治疗疗效。客观缓解率为 34.1%，疾病控制率为 80.4%。中位无进展生存期为 9.7 个月（95%置信区间，6.2-13.8 个月），中位总生存期为 22.1 个月（95%置信区间，15.1-28.9 个月）。2 年生存率为 41.5%。最常见的毒性反应包括 39.0%的患者出现食欲下降，34.1%的患者出现血脂异常，31.7%的患者出现高血压，24.4%的患者出现骨髓抑制，21.9%的患者出现乏力，17.1%的患者出现手足综合征。7 例患者因不良反应调整了阿帕替尼的剂量。
在合并肺及/或肝转移的 NPC 患者中，低剂量阿帕替尼联合 S-1 治疗可带来极好的生存获益，且毒性反应轻微，可耐受。
