The aim of this study is to evaluate the efficacy of geftinib in previously treated patients of advanced squamous cell carcinoma of lung (SCCL) in an epidermal growth factor receptor (EGFR)-unselected Asian Indian patients. Histologically confirmed patients with SCCL were enrolled and randomized in this study. 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 geftinib and best supportive care or best supportive care alone.
Between October 2012 and December 2013, newly diagnosed or previously platinum based chemotherapy treated patients having ECOG performance status 2/3, age >65 years with stage IIIB/IV SCCL were randomized 1:1 to geftinib (150 mg daily) (till progression or intolerable toxicity) and best supportive care (BSC) or BSC alone. 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.
73 patients were enrolled in this study (median age: 70.3 years, males 80.8%. EGFR wild-type SCCL patients was identified in 89% patients in the geftinib (n = 36) and BSC alone (n = 37) arms, respectively. In patients receiving geftinib and BSC, the median PFS and OS were 2.3 months (95% confidence interval, 1.5-2.5 months) and 12.2 months (95% CI, 0.6-20.2 months), in patients receiving BSC alone, the median PFS and OS were 2.0 months (95% CI, 1.0-2.5 months) and 10.3 months (95% CI, 0.56-18.4 months). Patients who never smoked seemed to have better clinical response and longer survival than those who had smoking history (P = 0.08 and 0.09, respectively). Geftinib was well tolerated with grade 3-4 neutropenia (11.1%) and grade 3-4 diarrhea (11.1%).
Geftinib with best supportive care showed better PFS and OS as best supportive care alone in an EGFR-unselected Asian Indian patient population. Geftinib may be used as second or third line chemotherapy in Asian Indian patients of advanced squamous cell carcinoma of lung.
Clinical trial identification
All authors have declared no conflicts of interest.