1341 - Docetaxel regimen as second-line treatment for pretreated advanced NSCLC patients - a large-scale, multicenter, uncontrolled, registry study in china

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Shun Lu
Authors S. Lu1, Y. Wu2, Y.Z. Wang3, X. Song4, L.Q. Jia5, G.Y. Chen6, T. Sun7, K.H. Lu8, M. Ouyang9, H. Zhao10
  • 1Shanghai Lung Tumor Clinical Center, Shanghai Chest Hospital, 20030 - Shanghai/CN
  • 2Department Of Clinical Oncology, Guangdong General Hospital (GGH) & Guangdong Academy of Medical Sciences, guangzhou/CN
  • 3Department Of Medical Oncology, Peking union medical college hospital, beijing/CN
  • 42nd Department Of Respiratory Diseases, Shanxi Cancer Hospital, Taiyuan/CN
  • 5Oncology Department Of Integrative Medicine, China Janpan Friendship Hospital, beijing/CN
  • 6Department Of Medical Oncology, Heilongjiang Cancer Hospital, harbin/CN
  • 7Department Of Medical Oncology, Liaoning Cancer Hospital, Shenyang/CN
  • 8Department Of Medical Oncology, Jiangsu Province Hospital, Nanjing/CN
  • 9Department Of Thoracic Surgery, The first affiliated hospital of Guangzhou medical university, guangzhou/CN
  • 10Department Of Medical Oncology, The 301 Military Hospital, Beijing/CN



Docetaxel has been approved as a second-line therapy for advanced non-small cell lung cancer (NSCLC) patients. The objective of this study is to provide real-world data of docetaxel regimen as second-line treatment in Chinese NSCLC patients through comparing the efficacy, toxicities and therapeutic schema.


1220 advanced NSCLC patients who had received docetaxel regimen as second-line treatment from nationwide 47 clinical centers in China from April 2009 to October 2010 were analyzed. The primary end point was overall survival (OS). Progression-free survival (PFS), response, toxicities and therapeutic models of docetaxel were assessed as secondary end points. Survival analysis was evaluated by Kaplan-Meier method. Single factor analysis and the COX regression model were performed to analyze the relationship between the influential factors and the prognosis of disease.


Docetaxel as second-line treatment for NSCLC associated with high response rate (RR) of 29.7%, median PFS of 8.2 months, median OS of 16.1 months. TNM staging (IV vs non-IV, P = 0.0270) and docetaxel regimen (docetaxel-based combinations vs docetaxel alone, P < 0.0001) were the prognostic factors for the studied group. The hematologic toxicity was the main adverse effect for docetaxel regimen. The most common grade III/IV adverse events were febrile neutropenia (4.3%), leucopenia (9.3%), neutropenia (11.6%), thrombocytopenia (0.6%), anemia (0.3%), nausea (1.6%), vomiting (1.6%), and alopecia (5.2%) in the total group. 608 (608/1220, 49.8%) patients were treated with docetaxel alone, and 612 (612/1220, 50.2%) with docetaxel-based combinations. Compared with docetaxel alone regimen, docetaxel-based combinations better prolonged the PFS (9.0m vs 7.1m, P < 0.0001) and OS (20.6m vs 14.3m, P < 0.0001) for advanced NSCLC. The toxicity of combination therapy was significantly higher in terms of hematologic (P = 0.0197) and non-hematologic adverse events (P = 0.0322) compared with docetaxel alone.


Docetaxel as a second-line treatment provides better PFS and OS for Chinese NSCLC patients. The hematologic toxicity is the main adverse effect for docetaxel regimen. Owing to the limitation of registry study, further studies are warranted to confirm these findings.


All authors have declared no conflicts of interest.