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A multicenter, open-label, randomized phase II controlled study of rh-endostatin (Endostar) in combination with
1*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.
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.
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