Department of Medical Oncology, The Fifth Affiliated Hospital of Sun-Yat-Sen University, 52 Mei Hua Road East, Zhu Hai, Guangdong Province, People's Republic of China.
Cancer Chemother Pharmacol. 2013 Aug;72(2):323-8. doi: 10.1007/s00280-013-2203-0. Epub 2013 Jun 1.
There is no standard second-line regimen for recurrent and metastatic nasopharyngeal carcinoma patients after failure of cisplatin-based chemotherapy. A multicenter phase II study was conducted to evaluate the efficacy and toxicity of capecitabine combined with nedaplatin for these patients.
In the multicenter, open-label, single-arm phase II study, patients with recurrent and metastatic nasopharyngeal carcinoma who failed to previous cisplatin-based chemotherapy were enrolled. Patients received oral capecitabine (1,000 mg/m(2) twice daily from day 1 to 14) and intravenous nedaplatin (80 mg/m(2), day 1) every 3 weeks for two cycles at least.
A total of forty-eight patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events. Treatment was well tolerated. Grade 3/4 toxicities included neutropenia (8.4 %), anemia (2.1 %), diarrhea (4.2 %), stomatitis (6.3 %), and hand-foot syndrome (HFS) (4.2 %). There were two complete response (4.2 %), eighteen partial responses (37.5 %), giving an overall response rate of 41.7 % [95 % confidence interval (CI) 27.7-55.8]. With a median follow-up period of 12.1 months, the median time to progression was 5.8 months (95 % CI 3.9-7.8 months) and median overall survival was 12.4 months (95 % CI 9.6-16.8 months).
Capecitabine combined with nedaplatin offers a satisfactory clinical activity and an acceptable safety profile for recurrent and metastatic nasopharyngeal carcinoma patients after failure of cisplatin-based chemotherapy.
顺铂为基础的化疗失败后的复发性和转移性鼻咽癌患者尚无标准二线治疗方案。本多中心 II 期研究旨在评估卡培他滨联合奈达铂治疗此类患者的疗效和毒性。
在这项多中心、开放标签、单臂 II 期研究中，入组了先前顺铂为基础的化疗失败的复发性和转移性鼻咽癌患者。患者接受卡培他滨（1000mg/m2，每日 2 次，第 1 至 14 天）和奈达铂（80mg/m2，第 1 天）静脉滴注，每 3 周为一个周期，至少进行两个周期。
共有 48 例患者入组并纳入疗效和不良事件的意向治疗分析。治疗耐受性良好。3/4 级毒性包括中性粒细胞减少（8.4%）、贫血（2.1%）、腹泻（4.2%）、口腔炎（6.3%）和手足综合征（HFS）（4.2%）。完全缓解 2 例（4.2%），部分缓解 18 例（37.5%），总缓解率为 41.7%[95%可信区间（CI）为 27.7%至 55.8%]。中位随访 12.1 个月，中位无进展生存期为 5.8 个月（95%CI 3.9 至 7.8 个月），中位总生存期为 12.4 个月（95%CI 9.6 至 16.8 个月）。
卡培他滨联合奈达铂治疗顺铂为基础的化疗失败后的复发性和转移性鼻咽癌患者具有令人满意的临床活性和可接受的安全性。
