James Chih-Hsin Yang1, Vichien Srimuninnimit2, Myung-Ju Ahn3, Chia-Chi Lin4, Sang-We Kim5, Chun-Ming Tsai6, Tony Mok7, Mauro Orlando8, Tarun Puri9, Xin Wang10, Keunchil Park3. 1. National Taiwan University Hospital, Taipei, Taiwan. Electronic address: chihyang@ntu.edu.tw. 2. Siriraj Hospital, Mahidol University, Bangkok, Thailand. 3. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 4. National Taiwan University Hospital, Taipei, Taiwan. 5. Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 6. Taipei Veterans General Hospital and National Yang-Ming University, Shi-Pai, Taipei, Taiwan. 7. Prince of Wales Hospital, Sha Tin, Hong Kong. 8. Eli Lilly Interamerica Inc., Buenos Aires, Argentina. 9. Eli Lilly and Company, Gurgaon, Haryana, India. 10. Eli Lilly and Company, Shanghai, China.
Abstract
INTRODUCTION: The primary analysis of this open-label, randomized, multicenter phase 3 study revealed no significant difference in progression-free survival between pemetrexed plus cisplatin followed by maintenance gefitinib (PC/G) and gefitinib monotherapy (G) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) and unknown epidermal growth factor receptor gene (EGFR) mutation status; however, the hazard ratio favored PC/G. This report describes the final overall survival (OS) results. METHODS:Chemonaive, East Asian light ex-smokers/never-smokers with advanced nonsquamous NSCLC and unknown EGFR mutation status were randomized (1:1) to PC/G (n = 118) or G (n = 118). EGFR mutation status was retrospectively determined for 76 patients, 52 (68.4%) of whom had EGFR-mutated tumors (exon 19 deletions in 26 and L858R point mutation in 24). OS was analyzed by the Kaplan-Meier method. The study was registered at ClinicalTrials.gov (NCT01017874). RESULTS:Median OS was similar in the PC/G (26.9 months) and G (27.9 months) groups (hazard ratio = 0.94, 95% confidence interval: 0.68-1.31, p = 0.717). Median OS was longer with PC/G than with G in patients with EGFR wild-type tumors (28.4 versus 8.9 months) and longer with G than with PC/G in patients with EGFR-mutated tumors (45.7 versus 32.4 months), especially those with exon 19 deletions. Second-line postdiscontinuation therapy was common and included chemotherapy (PC/G, 41 of 118 [34.7%]; G, 73 of 118 [61.9%]) and rechallenge with an EGFR tyrosine kinase inhibitor (PC/G, 27 of 118 [22.9%]; G, 9 of 118 [7.6%]). CONCLUSIONS: The progression-free survival and OS results from this study further demonstrate the importance of determining EGFR mutation status to select the most appropriate first-line treatment for patients with advanced NSCLC.
RCT Entities:
INTRODUCTION: The primary analysis of this open-label, randomized, multicenter phase 3 study revealed no significant difference in progression-free survival between pemetrexed plus cisplatin followed by maintenance gefitinib (PC/G) and gefitinib monotherapy (G) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) and unknown epidermal growth factor receptor gene (EGFR) mutation status; however, the hazard ratio favored PC/G. This report describes the final overall survival (OS) results. METHODS: Chemonaive, East Asian light ex-smokers/never-smokers with advanced nonsquamous NSCLC and unknown EGFR mutation status were randomized (1:1) to PC/G (n = 118) or G (n = 118). EGFR mutation status was retrospectively determined for 76 patients, 52 (68.4%) of whom had EGFR-mutated tumors (exon 19 deletions in 26 and L858R point mutation in 24). OS was analyzed by the Kaplan-Meier method. The study was registered at ClinicalTrials.gov (NCT01017874). RESULTS: Median OS was similar in the PC/G (26.9 months) and G (27.9 months) groups (hazard ratio = 0.94, 95% confidence interval: 0.68-1.31, p = 0.717). Median OS was longer with PC/G than with G in patients with EGFR wild-type tumors (28.4 versus 8.9 months) and longer with G than with PC/G in patients with EGFR-mutated tumors (45.7 versus 32.4 months), especially those with exon 19 deletions. Second-line postdiscontinuation therapy was common and included chemotherapy (PC/G, 41 of 118 [34.7%]; G, 73 of 118 [61.9%]) and rechallenge with an EGFR tyrosine kinase inhibitor (PC/G, 27 of 118 [22.9%]; G, 9 of 118 [7.6%]). CONCLUSIONS: The progression-free survival and OS results from this study further demonstrate the importance of determining EGFR mutation status to select the most appropriate first-line treatment for patients with advanced NSCLC.
Authors: Nikhil Suresh Ghadyalpatil; Avinash Pandey; Iyer Krishnamani; Chilukuri Srinivas; Shabnam J Rafiq; Sachin S Hingmire; Nagarjuna Maturu; Ragotham Reddy; Kiran K Kumar; K Sreekanth; Bharath Chandra Gurram; P M Parikh Journal: South Asian J Cancer Date: 2019 Apr-Jun