1356 - Phase II study of pemetrexed in elderly (≥75) non-squamous non-small-cell lung cancer: Kyoto Thoracic Oncology Research Group trial 0901

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Geriatric Oncology
Non-small-cell lung cancer
Biological therapy
Presenter Young Hak Kim
Authors Y.H. Kim1, M. Hirabayashi2, S. Kosaka3, J. Nikaidoh2, Y. Yamamoto3, M. Shimada2, T. Toyazaki3, H. Nagai4, M. Mishima4
  • 1Kyoto University-Graduate school of medicine, 606-8507 - Kyoto/JP
  • 2Respiratory Medicine, Hyogo Prefectural Amagasaki Hospital, 660-0828 - Amagasaki/JP
  • 3Thoracic Surgery, Shimane Prefectural Central Hospital, 693-8555 - Izumo/JP
  • 4Respiratory Medicine, Kyoto University-Graduate school of medicine, 606-8507 - Kyoto/JP



Single-agent chemotherapy with non-platinum agents, such as vinorelbine, gemcitabine, and docetaxel (DOC), is considered to be a standard therapeutic option for elderly non-small-cell lung cancer (NSCLC). Previous randomized trials have reproducibly demonstrated that pemetrexed (PEM) is more effective for non-squamous NSCLC, in contrast to be less effective for squamous cell lung cancer. In addition, although in second-line setting, subgroup analysis of the phase III study comparing PEM with DOC suggested that PEM was superior to DOC in the elderly population (≥70) in terms of both efficacy and toxicity.

Patients and methods

This was a single-arm phase II study of PEM in elderly (≥75) Japanese patients with chemo-naive advanced non-squamous NSCLC. Patients received four cycles of PEM (500 mg/m2) every 3 weeks. The primary endpoint was the response rate, and secondary endpoints were safety and survival.


Twenty-eight patients were enrolled between January 2010 and April 2012. Patient characteristics were as follows: male/female: 14/14; median age: 77 yr (75-88); histology, Ad/La: 27/1; disease stage, IIIB/IV: 6/22; PS, 0/1: 7/21. Five patients were still under protocol treatment, and 23 patients were evaluable for both safety and efficacy. There were 0 CR, 7 PR, 10 SD, 5 PD, and 1 NE. Response rate and disease control rate were 30.4% and 73.9%, respectively. Median treatment cycles were four. Grade 3/4 toxicity rates were 21.7% for leukocytopenia, 26.1% for neutropenia, 4.3% for anemia, 8.7% for thrombocytopenia, and 8.7% for nausea/vomiting, respectively. Four patients required G-CSF treatment, but no patients required blood transfusion. There were no treatment-related deaths.


PEM was safe and effective in elderly (≥75) Japanese patients with non-squamous NSCLC. Final results, including survival data, will be presented at the meeting.


All authors have declared no conflicts of interest.