1283P - Gefitinib and pemetrexed as a first line treatment in patients with EGFR mutant advanced NSCLC: A Phase II study

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Pathology/Molecular Biology
Personalised/Precision Medicine
Non-Small Cell Lung Cancer
Basic Scientific Principles
Basic Principles in the Management and Treatment (of cancer)
Biological Therapy
Presenter Naruo Yoshimura
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors N. Yoshimura1, S. Mitsuoka1, N. Yoshimoto2, T. Nakai2, T. Oka2, K. Matsuura3, T. Kimura2, S. Kudoh1, T. Kawaguchi2, K. Hirata3
  • 1Department Of Clinical Oncology, Graduate School of Medicine, Osaka City University, 545-8585 - Osaka/JP
  • 2Department Of Respiratory Medicine, Graduate School of Medicine, Osaka City University, 545-8585 - Osaka/JP
  • 3Department Of Respiratory Medicine, Osaka City University Medical School, 545-8585 - Osaka/JP



Gefitinib (G) is the key drug for patients (pts) with Non-Small Cell Lung Cancer (NSCLC) harboring mutations of EGFR as a first line treatment. However, they have disease progression in most cases. Pemetrexed (PEM) and G are reported to have a schedule-depended cytotoxic synergism. We evaluated the efficacy and safety of G and PEM as a first line chemotherapy in pts with NSCLC harboring mutations of EGFR.


Eligibilities were histological or cytologically proven non-squamous NSCLC with EGFR active mutation, chemotherapy naive, measurable lesion, ECOG PS 0-1, adequate organ function, life expectancy longer than 12 weeks and written informed consent. G (250mg/body) was administered on day 2-16 and PEM (500mg/m2) was administered on day1. The combination was repeated every 3 weeks until progressive disease (PD). Primary endpoint was overall response rate (ORR) and secondary endpoints were toxicities, disease control rate (DCR), progression free survival (PFS), and overall survival (OS). The planed sample size was 26 pts.


From March 2010 to January 2013, 26 pts were enrolled and eligible: males/females 13/13; median age 66 (range 58-84); PS 0/1 3/23; stage III/IV 1/25; Adeno/Others 26/0. All pts were eligible for efficacy and toxicity; a total 398 cycles (median 16 cycles, range 1-35) were given. Major grade 3/4 toxicities were neutropenia, infection, and liver dysfunction. There was no treatment-related death. ORR was 84.6%, and DCR was 96.2%. Median PFS was18.0 months, and median OS was 32.0 months.


This combination showed high ORR, long median PFS, and acceptable toxicity. Randomized trial of PEM + G compare with G alone is warranted.


All authors have declared no conflicts of interest.