1325 - First-line gefitinib treatment for elderly patients with non-small cell lung cancer harboring EGFR mutation: multicenter phase II trial CJLSG0901

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Geriatric Oncology
Non-small-cell lung cancer
Biological therapy
Presenter Kosuke Takahashi
Authors K. Takahashi1, H. Saito2, M. Yamamoto3, E. Kojima4, T. Yokoyama5, Y. Sugino6, T. Kimura7, T. Ogasawara8, R. Suzuki9, Y. Hasegawa10
  • 1Internal Medicine Dept., Aichi Cancer Center Aichi Hospital, 444-0011 - Okazaki/JP
  • 2Respiratory Medicine, Aichi Cancer Center Aichi Hospital, 444-0011 - Okazaki/JP
  • 3Respiratory Medicine, Nagoya Ekisaikai Hospital, Nagoya/JP
  • 4Respiratory Medicine, Komaki Municipal Hospital, Komaki/JP
  • 5Respiratory Medicine, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya/JP
  • 6Respiratory Medicine, Toyota Memorial Hospital, Toyota/JP
  • 7Respiratory Medicine And Allergy, Tosei General Hospital, Seto/JP
  • 8Respiratory Medicine, NagoyaDaini Red Cross Hospital, Nagoya/JP
  • 9Respiratory Medicine, Toyohashi Municipal Hospital, Toyohashi/JP
  • 10Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya/JP



Recently, the elderly population of lung cancer patients is increasing worldwide. Although first-line Gefitinib is one of the standard treatments for advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation, few data have been reported on elderly patients. Thus, we conducted a phase II trial to evaluate the efficacy and safety of first-line gefitinib therapy for this specific population.


Chemotherapy-naïve patients aged 70 years or older and diagnosed with stage IIIB or IV (including recurrent non-small cell lung cancer) harboring either exon 19 deletion or L858R point mutation were enrolled and treated with oral gefitinib 250 mg daily until disease progression or unacceptable toxicity occurred. The primary endpoint was response rate. Quality of life was also assessed prospectively.


Twenty patients were enrolled between June 2009 and March 2011. The median age was 79.5 years (range: 72-90). All the patients had adenocarcinoma, 12 patients had exon 19 deletion, and 8 had L858R mutation. Overall response rate was 70% (95% CI, 46 - 88%), and the disease control rate was 90% (95% CI, 68 - 99%). The median progression-free survival was 10.8 months. The median overall survival time has not been reached. The most common adverse events were rash and liver dysfunction, and grade 1 interstitial lung disease developed in one patient. No treatment-related death was observed. The scores of the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) improved significantly four weeks after the initiation of gefitinib and maintained a favorable tendency during the 12 weeks of treatment.


First-line gefitinib therapy for elderly patients with NSCLC harboring EGFR mutation demonstrated a good response rate, quality of life, and tolerance.


All authors have declared no conflicts of interest.