101PD - A prospective randomized open label phase III study of geftinib versus docetaxel as second or third line therapy in patients with advanced non small...

Date 16 April 2015
Event ELCC 2015
Session Medical and radiation oncology
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Akhil Kapoor
Citation Annals of Oncology (2015) 26 (suppl_1): 29-44. 10.1093/annonc/mdv050
Authors A. Kapoor1, N. Kumar2, S. Narayan1, R.K. Nirban1, S. Maharia1, S.K. Beniwal3, S.L. Jakhar1, H.S. Kumar1
  • 1Radiation Oncology, Acharya Tulsi Regional Cancer Treatment & Research Institute, 334003 - Bikaner/IN
  • 2Mbbs - Student, Sardar Patel Medical College, 334003 - Bikaner/IN
  • 3Medical Oncology, Acharya Tulsi Regional Cancer Treatment & Research Institute, 334003 - Bikaner/IN



Selected patients with good responses to first-line chemotherapy, good performance status, and a long disease-free period between initial chemotherapy and relapse are the candidates for second-line chemotherapy with docetaxel or pemetrexed. The aim of this study is to evaluate the efficacy of geftinib versus docetaxel in previously treated patients of advanced non small cell lung cancer (NSCLC) in an epidermal growth factor receptor (EGFR)-unselected Asian Indian patient population.


Between October 2011 and December 2012, previously platinum based chemotherapy treated patients with stage IIIB/IV NSCLC were randomized 1:1 to geftinib (150 mg daily) or docetaxel (75 mg/m2) every 3 weeks. The primary endpoint was the comparison of progression free survival (PFS) between the two arms and the secondary endpoints included overall survival (OS), toxicity and analyses on EGFR wild-type tumors. All statistical analyses were performed by using SPSS version 20.0.


107 patients were enrolled in this study (median age: 56 years, males 80.4%, stage IV disease 73.8%, ECOG performance status 0/1: 68.5%). EGFR wild-type NSCLC was identified in 37% and 32.1% patients in the geftinib (n = 54) and docetaxel (n = 53) arms, respectively. Median PFS for geftinib versus docetaxel was 2.3 vs. 3.1 months (hazard ratio [HR], 1.12; 95% CI, 0.77-1.45; P = 0.06), and median OS was 12.8 vs. 11.3 months (HR, 0.89; 95% CI, 0.49 to 1.29; P = 0.47), respectively. In a subset analysis of EGFR wild-type tumors, PFS for geftinib versus docetaxel was 1.7 vs. 3.3 months (HR, 1.36; 95% CI, 1.05 to 1.67; P = 0.03), and OS was 9.7 vs. 10.6 months (HR, 0.96; 95% CI, 0.49 to 1.43; P = 0.88), respectively. Geftinib was well tolerated with grade 3-4 neutropenia (5.5% vs. 22.6%, P < 0.001) and grade 3-4 diarrhea (5.5% vs. 3.8%, P = 0.78).


Geftinib showed similar PFS and OS as docetaxel in an EGFR-unselected Asian Indian patient population. Also, the hematological Grade 3/4 toxicities were significantly lesser with Geftinib. Thus, Geftinib may be used as second or third line chemotherapy in Asian Indian patients of advanced NSCLC.


All authors have declared no conflicts of interest.