A Phase II Trial of Endostar Combined With Gemcitabine and Cisplatin Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma (NCT01612286)
A Phase II Trial of Endostar Combined With Gemcitabine and Cisplatin Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma (NCT01612286)
复制标题
恩度联合吉西他滨和顺铂化疗治疗转移性鼻咽癌的 II 期试验 (NCT01612286)
DOI：
10.3727/096504014x13983417587401
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发表时间：
2013-01-01
影响因子：
3.1
通讯作者：
Chen, Xiao-Zhong
中科院分区：
文献类型：
--
作者：
Jin, Ting;Li, Bin;Chen, Xiao-Zhong
尽管吉西他滨-顺铂（GC）方案的疗效，转移性鼻咽癌（M NPC）患者的结局较差。我们进行了一项II期试验，以确定血管生成的内源性抑制剂Endostar与GC化疗联合使用的安全性和有效性。共入组30例M NPC患者。治疗方案为吉西他滨（1，000 mg/m2，第1天和第8天）、顺铂（80 mg/m2，第1天）和Endostar（15 mg/天，第1天至第14天）联合治疗，21天为一个周期，最多4个周期。主要终点为无进展生存期（PFS）。中位随访时间为13.1个月（范围：2.9-20.7个月）。共对28例患者进行了评价。中位PFS为19.4个月（95% CI，13.6-25.1个月）。1年PFS率为69.8%。确认的客观缓解率为85.7%（95% CI，66.4-95.3%），包括14例患者（50%）的完全缓解。1年总生存率为90.2%。最常见的3/4级不良事件是中性粒细胞减少症（46.4%）和血小板减少症（14.3%）。我们的研究结果表明，恩度联合GC化疗可以导致有效的肿瘤消退，控制疾病进展，并改善预后的M NPC。因此，联合应用恩度和GC方案应被视为治疗M NPC患者的潜在方案。
Despite the efficacy of gemcitabine-cisplatin (GC) regimens, the outcome of patients with metastatic nasopharyngeal carcinoma (M NPC) is poor. We conducted a phase II trial to determine the safety and efficacy of Endostar, an endogenous inhibitor of angiogenesis, in combination with GC chemotherapy. A total of 30 patients with M NPC were enrolled. The treatment regimen was a combination of gemcitabine (1,000 mg/m(2)) on days 1 and 8, cisplatin (80 mg/m(2)) on day 1, and Endostar (15 mg/day) from day 1 to day 14 of a 21-day cycle for a maximum of four cycles. The primary endpoint was progression-free survival (PFS). The median follow-up was 13.1 months (range: 2.9-20.7 months). A total of 28 patients were evaluated. The median PFS was 19.4 months (95% CI, 13.6-25.1 months). The 1-year PFS rate was 69.8%. The confirmed objective response rate was 85.7% (95% CI, 66.4-95.3%), including complete response in 14 patients (50%). The 1-year overall survival rate was 90.2%. The most common grade 3/4 adverse events were neutropenia (46.4%) and thrombocytopenia (14.3%). Our results suggest that a combination of Endostar with GC chemotherapy can lead to effective tumor regression, control disease progression, and improve prognosis in M NPC. Therefore, a combined Endostar and GC regimen should be considered as a potential treatment for patients with M NPC.