1286P - A phase II study of pemetrexed in chemotherapy-naïve elderly patients with advanced non-squamous non-small-cell lung cancer: HANSHIN oncology group...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Geriatric Oncology
Non-Small-Cell Lung Cancer, Metastatic
Presenter Masahiro Iwasaku
Authors M. Iwasaku1, Y. Hattori2, S. Morita3, H. Yoshioka1, K. Otsuka4, N. Katakami5, S. Fujita6, S. Yokota7, F. Imamura8, S. Negoro9
  • 1Respiratory Medicine Dept., Kurashiki central hospital, 710-8602 - Kurashiki/JP
  • 2Department Of Thoracic Oncology, Hyogo Cancer Center, 673-8558 - Akashi/JP
  • 3Biostatistics And Epidemiology, Yokohama City University Medical Center, Yokohama/JP
  • 4Division Of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe/JP
  • 5Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe/JP
  • 6Department Of Translational Research, Institute of Biomedical Research and Innovation Hospital, Kobe/JP
  • 7Department Of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, Toyonaka/JP
  • 8Department Of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka/JP
  • 9Medical Oncology, Hyogo Cancer Center, JP-673-8558 - Akashi/JP



Single-agent chemotherapy (ie, doxetaxel, gemcitabine or vinorelbine) is one of the standard treatments for elderly patients with advanced NSCLC. Pemetrexed has clinically equivalent efficacy, but with less toxicity compared to doxetaxel in the second line setting of patients with advanced NSCLC. We conducted a phase II trial to evaluate the efficacy and safety of frontline pemetrexed in elderly patients with advanced non-squamous (non-Sq) NSCLC.


In this multicenter phase II trial, we recruited elderly patients with non-Sq NSCLC. Eligibility criteria were as follows: chemonaïve; locally advanced or metastatic non-Sq NSCLC; age 75 or older; ECOG performance status 0-1; adequate organ function. Patients received pemetrexed (500 mg/m2) intravenously on day 1 every 3 weeks until disease progression had been confirmed. The primary endpoint was response rate (RR). The secondary endpoints included progression free survival (PFS), overall survival (OS), disease control rate (DCR) and safety. The planned sample size was 45 patients.


Between August 2009 and July 2011, 47 patients were enrolled. Median age was 79 years (range: 75-91), 57% (20/47) were male, 36% (17/47) had never smoked, 85% (40/47) had adenocarcinoma, 72% (34/47) had stage IV and 41% (16/39) had EGFR tyrosine kinase activating mutation. Median number of cycles was 4 (1 to 15). RR was 13.3% (95%CI: 5.1, 26.8), DCR was 66.7% (95%CI: 51.0, 80.0), PFS was 4.9 months (95%CI: 3.0, 6.2 months), median OS was not reached. The most frequent treatment-related AEs were anemia, fatigue, hypocalcemia, mostly grade1/2. Treatment-related Grade 3/4 AEs were reported in 17.8% of patients (mostly neutropenia and fatigue). No treatment-related death occurred.


The efficacy and limited side effects of pemetrexed are promising in elderly patients with non-Sq NSCLC.


S. Negoro: HONORARIA: Lily.

All other authors have declared no conflicts of interest.