Nimotuzumab combined with gemcitabine and cisplatin as second‐line chemotherapy for advanced non‐small‐cell lung cancer

Thoracic Cancer

Hua-qing Wang²  Yangang Ren¹  Zheng-zi Qian²  Kai Fu³  Hui-lai Zhang³  Wei Li³  Yun Hou³  Shi-yong Zhou³  Xi-shan Hao³ 

[1] Editorial Department of Chinese Journal of Practical Internal Medicine, China Medical University, ShenYang, China;Department of Radiation and Medical Oncology, Zhongnan Hospital, Hubei Cancer Clinical Study Center, Wuhan University, Wuhan, China;Department of Medical Oncology, Tianjin Medical University Cancer Hospital and Institute, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China

关键词: Advanced non‐small‐cell lung cancer;    combined therapy;    nimotuzumab;    second‐line chemotherapy;   

DOI  :  10.1111/j.1759-7714.2011.00083.x

来源: Wiley

【 摘 要 】

Abstract

Objective:  To evaluate the efficacy and safety of nimotuzumab combined with gemcitabine and cisplatin as second-line chemotherapy for advanced non-small-cell lung cancer (NSCLC) and to investigate the association of the status of KRAS gene mutation and epidermal growth factor receptor (EGFR) genotype with clinical outcome.

Methods:  Twenty-eight patients with advanced NSCLC were enrolled in this single center, uncontrolled pilot clinical study. All the patients developed drug resistance or disease progression after first-line chemotherapy of either a docetaxel + cisplatin regimen or a vinorelbine + cisplatin regimen and then received nimotuzumab combined with gemcitabine and cisplatin as second-line chemotherapy. Eight cases were stage IIIB and 20 were stage IV. An i.v. dosage regimen of 200 mg of nimotuzumab was given as a single dose, injected into the patient at days 1, 8 and 15; i.v. gemcitabine was injected at a dose of 1000 mg/m² at days 1 and 8 and cisplatin (25 mg/m² i.v.) at days 1, 2 and 3. Each patient received four or more therapeutic cycles. The efficacy and toxic reactions were evaluated, as well as time to progression and overall survival.

Results:  In total, 28 patients with advanced NSCLC received 101 therapeutic cycles. The mean cycle number was 3.6. Median time to progression was 4.9 (2.5–6.5) months; median overall survival and 1-year survival rate were 9.8 months and 48.5%, respectively. There was one case of complete response, six cases of partial response, 11 cases of stable disease and 10 cases of progressive disease. Response rate was 25%, and clinical benefit rate was 64.3%. Major toxic reactions were bone marrow suppression and gastrointestinal reaction. Only one patient developed grade I acneiform eruption.

Conclusion:  Nimotuzumab combined with gemcitabine and cisplatin as second-line chemotherapy for advanced NSCLC was active and well-tolerated in this setting. Patients with EGFR amplification and KRAS gene wild type had a better prognosis. Prospective, randomized, controlled, large-scale clinical studies are needed to confirm the results.

【 授权许可】

Unknown   
© 2011 Tianjin Lung Cancer Institute and Blackwell Publishing Asia Pty. Ltd