一项多中心、开放标签、随机对照的 II 期临床试验，评估 rh-endostatin（恩度）联合化疗治疗未经治疗的广泛期小细胞肺癌。
A multicenter, open-label, randomized phase II controlled study of rh-endostatin (Endostar) in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer.
机构信息
*Department of Oncology, Shanghai Lung Cancer Center, Chest Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China; †Department of Thoracic Cancer, Cancer Center, West China Hospital, Sichuan University, Chengdu, China; ‡Department of Medical Oncology, Hunan Provincial Tumor Hospital, Changsha, Hunan, China; §Department of Medical Oncology, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, China; ‖The Cancer Center of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; ¶Department of Medical Oncology, Fujian Provincial Tumor Hospital, Fujian Medical University Educational Hospital, Fuzhou, China; #Department of Respiratory Medicine, The First Affiliated Hospital, Chongqing University of Medical Sciences, Chongqing, China; **Chemotherapy Center of Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China; ††Department of Chemotherapy, Affiliated Tumor Hospital, Guangxi Medical University, Guangxi, China; ‡‡Department of Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China; §§Cancer Center of the First University Hospital, Jilin University, Changchun, China; ‖‖Department of General, Beijing Chest Hospital, Beijing, China; ¶¶Department of Oncology, Second Xiangya Hospital of Central-South University, Changsha, China; and ##Department of Respiratory Disease, Xiang-ya Hospital, Central Southern University, Hunan, Changsha, China.
出版信息
J Thorac Oncol. 2015 Jan;10(1):206-11. doi: 10.1097/JTO.0000000000000343.
BACKGROUND
Based on promising efficacy in a single-arm study, a randomized phase II trial was designed to compare the efficacy and safety of adding rh-endostatin (Endostar) to first-line standard etoposide and carboplatin (EC) chemotherapy for treatment of extensive-stage small-cell lung cancer.
METHODS
One hundred forty Chinese patients with pathologically confirmed, extensive-stage small-cell lung cancer were randomly assigned to EC alone or rh-endostatin + EC for 4-6 cycles, followed by single-agent rh-endostatin until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival, Objective response rate (ORR), and quality of life.
RESULTS
Median PFS was 6.4 months with rh-endostatin + EC (n = 69) and 5.9 months with EC (n = 69) (hazard ratio 0.8 [95% confidence interval 0.6-1.1]). PFS was significantly higher with rh-endostatin + EC than with EC (hazard ratio 0.4 [0.2-0.9; p = 0.020]) in female. Median overall survival was similar in both groups (12.1 versus 12.4 months, respectively [p = 0.82]). ORR was higher in the rh-endostatin + EC group (75.4%) than in the EC group (66.7%) (p = 0.348). The efficacy of rh-endostatin + EC relative to that of EC was reflected by greater improvements in patient-assessed quality of life scores after 4 and 6 weeks of treatment. There was no difference between each regimen in the incidence of nonhematological or Grade III-IV hematological toxicities.
CONCLUSIONS
Addition of rh-endostatin to EC for the treatment of extensive-stage small-cell lung cancer had an acceptable toxicity profile, but did not improve overall survival, PFS, and ORR.
背景
基于单臂研究中疗效显著，设计了一项随机二期试验，旨在比较 rh-endostatin（恩度）联合一线标准依托泊苷和卡铂（EC）化疗治疗广泛期小细胞肺癌的疗效和安全性。
方法
140 例经病理证实的广泛期小细胞肺癌患者随机分为 EC 单药组或 rh-endostatin+EC 组，接受 4-6 个周期治疗，随后单药 rh-endostatin 治疗，直至疾病进展或出现不可耐受的毒性。主要终点是无进展生存期（PFS）。次要终点包括总生存期、客观缓解率（ORR）和生活质量。
结果
rh-endostatin+EC 组（n=69）和 EC 组（n=69）的中位 PFS 分别为 6.4 个月和 5.9 个月（风险比 0.8[95%置信区间 0.6-1.1]）。rh-endostatin+EC 组 PFS 显著高于 EC 组（风险比 0.4[0.2-0.9；p=0.020]），女性患者获益更明显。两组总生存期相似（分别为 12.1 个月和 12.4 个月，p=0.82）。rh-endostatin+EC 组的 ORR（75.4%）高于 EC 组（66.7%）（p=0.348）。rh-endostatin+EC 组的疗效优于 EC 组，治疗 4 周和 6 周后患者评估的生活质量评分均有显著改善。两组非血液学毒性或 3-4 级血液学毒性发生率无差异。
结论
rh-endostatin 联合 EC 治疗广泛期小细胞肺癌的毒性可接受，但未改善总生存期、PFS 和 ORR。
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