Email updates

Keep up to date with the latest news and content from BMC Cancer and BioMed Central.

Open Access Highly Accessed Research article

Customized chemotherapy based on epidermal growth factor receptor mutation status for elderly patients with advanced non-small-cell lung cancer: a phase II trial

Shiro Fujita1*, Nobuyuki Katakami1, Katsuhiro Masago2, Hiroshige Yoshioka3, Keisuke Tomii4, Toshihiko Kaneda5, Masataka Hirabayashi6, Kei Kunimasa3, Toshio Morizane7 and Tadashi Mio2

Author Affiliations

1 Institute of Biomedical Research and Innovation Hospital, 2-2 Minatojima Minami-machi, Chuo-ku, Kobe, 650-0047, Japan

2 Kyoto University Hospital, 54 Shogoin Kawaracho, Sakyo-ku, Kyoto, 606-8507, Japan

3 Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki-shi, Okayama, 710-8602, Japan

4 Kobe City Medical Center General Hospital, 2-1-1 Minatojima Minami-machi, Chuo-ku, Kobe, 650-0047, Japan

5 Kobe City Medical Center West Hospital, 2-4 Ichibancho, Nagata-ku, Kobe, 653-0013, Japan

6 Hyogo Prefectural Amagasaki Hospital, Higashidaimotsu-cho, Amagasaki, Hyogo, 660-0828, Japan

7 Kanagawa Dental College, 82 Inaokacho, Yokosuka-ku, Kanagawa, 238-8580, Japan

For all author emails, please log on.

BMC Cancer 2012, 12:185  doi:10.1186/1471-2407-12-185

Published: 21 May 2012



Elderly patients are more vulnerable to toxicity from chemotherapy. Activating epidermal growth factor receptor (EGFR) mutations in non-small-cell lung cancer (NSCLC) are associated with enhanced response to EGFR tyrosine-kinase inhibitors. We studied patients with advanced NSCLC for whom treatment was customized based on EGFR mutation status.


We screened 57 chemotherapy-naïve patients with histologically or cytologically confirmed NSCLC, stage IIIB or IV, aged 70 years or older, and with an Eastern Cooperative Oncology Group performance status 0 or 1, for EGFR exon 19 codon 746–750 deletion and exon 21 L858R mutation. Twenty-two patients with EGFR mutations received gefitinib; 32 patients without mutations received vinorelbine or gemcitabine. The primary endpoint was the response rate.


The response rate was 45.5% (95% confidence interval [CI]: 24.4%, 67.8%) in patients with EGFR mutations and 18.8% (95% CI: 7.2%, 36.4%) in patients without EGFR mutations. The median overall survival was 27.9 months (95%CI: 24.4 months, undeterminable months) in patients with EGFR mutations and 14.9 months (95%CI: 11.0 months, 22.4 months) in patients without EGFR mutations. In the gefitinib group, grade 3/4 hepatic dysfunction and dermatitis occurred in 23% and 5% of patients, respectively. In patients treated with vinorelbine or gemcitabine, the most common grade 3 or 4 adverse events were neutropenia (47%; four had febrile neutropenia), anemia (13%), and anorexia (9%). No treatment-related deaths occurred.


Treatment customization based on EGFR mutation status deserves consideration, particularly for elderly patients who often cannot receive second-line chemotherapy due to poor organ function or comorbidities.

Trial registration

This trial is registered at University hospital Medical Information Network-clinical trial registration ( webcite) with the registration identification number C000000436.