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- Title
Erlotinib as second- or third-line treatment in elderly patients with advanced non-small cell lung cancer: Keio Lung Oncology Group Study 001 (KLOG001).
- Authors
MASAYOSHI MIYAWAKI; KATSUHIKO NAOKI; SATOSHI YODA; SOHEI NAKAYAMA; RYOSUKE SATOMI; TAKASHI SATO; SHINNOSUKE IKEMURA; KEIKO OHGINO; KOTA ISHIOKA; DAISUKE ARAI; HO NAMKOONG; KENGO OTSUKA; MASAKI MIYAZAKI; TETSUO TANI; AOI KURODA; MAKOTO NISHINO; HIROYUKI YASUDA; ICHIRO KAWADA; HIDEFUMI KOH; MORIO NAKAMURA
- Abstract
The aim of this study was to assess the efficacy and safety of erlotinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), as second- or third-line treatment for elderly Japanese patients with non-small-cell lung cancer (NSCLC). The patients eligible for this phase II trial were aged ≥70 years, had stage III/IV or recurrent NSCLC, and had previously received 1 or 2 chemotherapy regimens that did not include EGFR-TKIs. The patients received erlotinib at a dose of 150 mg/day. The primary endpoint was overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS) and toxicity. A total of 38 patients with a median age of 76 years were enrolled. The majority of the patients were men (66%), had an Eastern Cooperative Oncology Group performance status of 1 (58%), stage IV disease (66%) and adenocarcinoma (74%). Of the 35 patients, 13 (34%) had tumors with EGFR mutations. The ORR was 26.3% (95% confidence interval: 12.1-40.5%) and the disease control rate was 47.4%. The median PFS was 3.7 months and the median OS was 17.3 months. The grade 3 adverse events observed included rash (13%), diarrhea (5%), interstitial pneumonitis (5%), anorexia (3%) and gastrointestinal bleeding (3%). Grade 4 or 5 adverse events were not observed. The median OS did not differ significantly between patients aged <75 years (14.9 months) and those aged ≥75 years (19.0 months; P=0.226). Therefore, erlotinib was found to be effective and well-tolerated in elderly patients with previously treated NSCLC.
- Subjects
CANCER treatment; ERLOTINIB; NON-small-cell lung carcinoma; EPIDERMAL growth factor receptors regulation; PROTEIN-tyrosine kinase inhibitors; DRUG efficacy; PATIENTS; THERAPEUTICS
- Publication
Molecular & Clinical Oncology, 2017, Vol 6, Issue 3, p409
- ISSN
2049-9450
- Publication type
Article
- DOI
10.3892/mco.2017.1154