Phase II Trial of Erlotinib in Elderly Patients with Previously Treated Non-small Cell Lung Cancer: Results of the Lung Oncology Group in Kyushu (LOGiK-0802).
BACKGROUND
As the incidence of lung cancer in the elderly is increasing worldwide, there exists a need to develop a clinically effective, less toxic therapy for this patient population. Although erlotinib has shown proven effectiveness against non-small cell lung cancer (NSCLC), few studies have prospectively investigated its application to elderly patients.


METHODS
Patients aged ≥75 years with advanced or recurrent NSCLC including wild-type EGFR who had previously received one or two chemotherapy regimens were enrolled in this trial. Erlotinib was initially administered at a dose of 150 mg/day orally until disease progression or unacceptable toxicities occurred. The primary endpoint was the objective response rate.


RESULTS
Forty patients were enrolled between May 2009 and January 2014. An objective response was observed in 8 patients (20%, 95%CI=9.1-35.7%), and the disease control rate reached 62.5% (95%CI=45.8-77.3%). After a median follow-up period of 12.2 months (range=1.4-47.2 months), the median progression-free survival period was 5.0 months (95%CI=2.3-7.6 months), and the median survival period was 12.2 months (95%CI=6.1-24.7 months). Major toxicities were skin disorders, fatigue, and anorexia. Most adverse events were grade 2 or less, but 13 patients (32.5%) required a dose reduction. Two patients developed interstitial lung disease, that was nevertheless reversible, and there were no treatment-related deaths.


CONCLUSIONS
Although the percentage of patients requiring dose reduction seemed relatively higher than that in previous studies, erlotinib is a potentially useful therapeutic option for unselected elderly patients with previously treated advanced or recurrent NSCLC, as has been also shown for younger patients.
Division of Respirology, Neurology and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan kayamada@med.kurume-u.ac.jp.
Kazuhiko
K
Yamada
Division of Respirology, Neurology and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.
Koichi
K
Azuma
Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Fukuoka, Japan.
Masafumi
M
Takeshita
Department of Respiratory Medicine, Fukuoka University School of Medicine, Fukuoka, Japan.
Junji
J
Uchino
Department of Respiratory Medicine, University of Occupational and Environmental Health, Fukuoka, Japan.
Chinatsu
C
Nishida
Department of Respiratory Medicine, Sendai Medical Association Hospital, Kagoshima, Japan.
Takayuki
T
Suetsugu
Department of Respiratory Medicine, Japan Community Health care Organization Isahaya General Hospital, Nagasaki, Japan.
Akira
A
Kondo
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Taishi
T
Harada
Department of Respiratory Medicine, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.
Hirofumi
H
Eida
Department of Research and Development of Next Generation Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
Junji
J
Kishimoto
Department of Clinical Research Promotion, Kyushu University Hospital, Fukuoka, Japan.
Goki
G
Eriguchi
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Koichi
K
Takayama
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yoichi
Y
Nakanishi
Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.
Kenji
K
Sugio
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D066246:ErbB Receptors / Q000235:genetics; D000069347:Erlotinib Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D009154:Mutation; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors
EGFR; Erlotinib; non-small cell lung cancer; unselected