Phase II study of cisplatin/etoposide and endostar for extensive-stage small-cell lung cancer

被引:30
作者
Zhou, Zheng-tao [1 ,2 ,3 ]
Zhou, Fu-xiang [1 ]
Wei, Qing [3 ,4 ]
Zou, Li-yong [5 ]
Qin, Bin-fang [2 ,3 ]
Peng, Xu-shen [2 ,3 ]
机构
[1] Wuhan Univ, Zhongnan Hosp, Dept Med & Radiat Oncol, Wuhan 430071, Peoples R China
[2] China Three Gorges Univ, Dept Oncol, Coll Clin Med Sci 1, Yichang 443003, Peoples R China
[3] Yichang Cent Peoples Hosp, Yichang 443003, Peoples R China
[4] China Three Gorges Univ, Coll Clin Med Sci 1, Dept Pharm, Yichang 443003, Peoples R China
[5] Second Hosp Yichang, Dept Oncol, Yichang 443000, Peoples R China
关键词
Small-cell lung cancer; Endostar; Cisplatin; Etoposide; Chemotherapy; BEVACIZUMAB; ANGIOGENESIS; THERAPY; TRIAL; CARBOPLATIN; PACLITAXEL; IRINOTECAN; INHIBITOR;
D O I
10.1007/s00280-011-1576-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose To investigate the efficacy and safety of endostar, a novel recombinant human endostatin, plus cisplatin, and etoposide in patients with extensive-stage small-cell lung cancer (ED-SCLC). Patients and methods Chemotherapy-naive patients with histologically confirmed, measurable ED-SCLC were enrolled. Treatment consisted of cisplatin (25 mg/m(2)) administered intravenously (IV) on days 1-3; etoposide (120 mg/m(2)) administered intravenously (IV) on days 1-3; endostar (15 mg) administered intravenously (IV) on days 1-14 every 21 days for up to four cycles. The primary objective was to assess the progression-free survival (FPS). Secondary objectives were to assess the objective response rate, median overall survival (OS), and treatment-related toxicity. Results Thirty-three patients were enrolled, the median age of the patients was 53 years (range, 29-74), twenty-three patients (69.7%) were men and 10 patients were women. Eastern Cooperative Oncology Group performance status scores were 0, 1, and 2 in 30.3, 60.6, and 9.1% of the patients, respectively. The overall response rate was 69.7%, one patient (3%) had a complete response, and 22 patients (66.7%) had partial responses. Five patients (15.1%) had stable disease; the median PFS was 5.0 months (95% CI, 4.2-5.6 months), and the 6-month PFS was 33.3%. The median OS was 11.5 months (95% CI, 9.6-13.4 months), and the 1-year OS was 38.1% (95% CI, 26-50.1%). Sixteen patients (48.5%) had at least one grade 3/4 adverse events; the most common grade 3/4 hematologic toxicity included neutropenia in 57.6%, thrombocytopenia in 12.1% of patients. The most common grade 3/4 non-hematologic toxicities included fatigue in 15.2%, nausea/vomiting in 9.1%, diarrhea in 6.1%, anorexia in 6.1%, mucositis in 6.1% of patients. Conclusion The addition of rh-endostain to cisplatin and etoposide in patients with ED-SCLC results in slightly improved PFS and OS relative to historical controls who received this chemotherapy regimen alone. This regimen appears to be well tolerated; the promising results suggest the further randomized phase III trial to define endostar's impact on SCLC treatment.
引用
收藏
页码:1027 / 1032
页数:6
相关论文
共 26 条
[1]   Cloning, expression, and in vitro activity of human endostatin [J].
Dhanabal, M ;
Volk, R ;
Ramchandran, R ;
Simons, M ;
Sukhatme, VP .
BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS, 1999, 258 (02) :345-352
[2]   Endostatin induces endothelial cell apoptosis [J].
Dhanabal, M ;
Ramchandran, R ;
Waterman, MJF ;
Lu, H ;
Knebelmann, B ;
Segal, M ;
Sukhatme, VP .
JOURNAL OF BIOLOGICAL CHEMISTRY, 1999, 274 (17) :11721-11726
[3]  
FOLKMAN J, 1971, NEW ENGL J MED, V285, P1182
[4]   Phase II Study of Cisplatin Plus Etoposide and Bevacizumab for Previously Untreated, Extensive-Stage Small-Cell Lung Cancer: Eastern Cooperative Oncology Group Study E3501 [J].
Horn, Leora ;
Dahlberg, Suzanne E. ;
Sandler, Alan B. ;
Dowlati, Afshin ;
Moore, Dennis F. ;
Murren, John R. ;
Schiller, Joan H. .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (35) :6006-6011
[5]   Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer [J].
Hurwitz, H ;
Fehrenbacher, L ;
Novotny, W ;
Cartwright, T ;
Hainsworth, J ;
Heim, W ;
Berlin, J ;
Baron, A ;
Griffing, S ;
Holmgren, E ;
Ferrara, N ;
Fyfe, G ;
Rogers, B ;
Ross, R ;
Kabbinavar, F .
NEW ENGLAND JOURNAL OF MEDICINE, 2004, 350 (23) :2335-2342
[6]  
Iughetti P, 2001, CANCER RES, V61, P7375
[7]  
Jemal A, 2009, CA-CANCER J CLIN, V59, P225, DOI [10.3322/caac.20006, 10.3322/caac.21387]
[8]   Management of small cell lung cancer [J].
Johnson, BE .
CLINICS IN CHEST MEDICINE, 2002, 23 (01) :225-+
[9]  
Kisker O, 2001, CANCER RES, V61, P7669
[10]   Endostar, a novel recombinant human endostatin, exerts antiangiogenic effect via blocking VEGF-induced tyrosine phosphorylation of KDR/Flk-1 of endothelial cells [J].
Ling, Yun ;
Yang, Yong ;
Lu, Na ;
You, Qi-Dong ;
Wang, Sen ;
Gao, Ying ;
Chen, Yan ;
Guo, Qing-Long .
BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS, 2007, 361 (01) :79-84