Erlotinib as second‑ or third‑line treatment in elderly patients with advanced non‑small cell lung cancer: Keio Lung Oncology Group Study 001 (KLOG001)

Miyawaki,Masayoshi; Naoki,Katsuhiko; Yoda,Satoshi; Nakayama,Sohei; Satomi,Ryosuke; Sato,Takashi; Ikemura,Shinnosuke; Ohgino,Keiko; Ishioka,Kota; Arai,Daisuke; Namkoong,Ho; Otsuka,Kengo; Miyazaki,Masaki; Tani,Tetsuo; Kuroda,Aoi; Nishino,Makoto; Yasuda,Hiroyuki; Kawada,Ichiro; Koh,Hidefumi; Nakamura,Morio; Terashima,Takeshi; Sakamaki,Fumio; Sayama,Koichi; Betsuyaku,Tomoko; Soejima,Kenzo

doi:10.3892/mco.2017.1154

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
- Takeshi Terashima
- Fumio Sakamaki
- Koichi Sayama
- Tomoko Betsuyaku
- Kenzo Soejima
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Affiliations: Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine, Tokyo 160‑8582, Japan, Keio Lung Oncology Group, Keio University School of Medicine, Tokyo 160‑8582, Japan
Published online on: February 6, 2017 https://doi.org/10.3892/mco.2017.1154
Pages: 409-414

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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.

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