Meeting
2018 ASCO Annual Meeting
A multicenter phase II study of low-dose erlotinib in frail patients with EGFR mutation-positive, non-small cell lung cancer: Thoracic oncology research group (TORG) trial 1425.
Authors
Kazuhiko Yamada
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan
Kazuhiko Yamada , Shingo Miyamoto , Koichi Azuma , Hidenobu Ishii , Akihiro Bessho , Nobuaki Fukamatsu , Hideo Kunitoh , Mari Ishii , Hiroshi Tanaka , Hiromi Aono , Yoshiro Nakahara , Kei Kusaka , Yukio Hosomi , Norihiro Kikuchi , Yoshiaki Mori , Hidetoshi Itani , Takashi Kasai , Masao Ichiki , Nobuhiko Seki , Hiroaki Okamoto
Organizations
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan, Japanese Red Cross Medical Center, Tokyo, Japan, Japanese Red Cross Okayama Hospital, Okayama, Japan, Yokohama Municipal Citizen's Hospital, Yokohama, Japan, Department of Respiratory Medicine, Niigata Cancer Center Hospital, Niigata, Japan, Mitsui Memorial Hospital, Tokyo, Japan, Kitasato University School of Medicine, Sagamihara, Japan, National Hospital Organization Tokyo National Hospital, Tokyo, Japan, Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan, Kasumigaura Medical Center, Tsuchiura, Japan, Iwate Prefectural Central Hospital, Morioka, Japan, Japanese Red Cross Ise Hospital, Ise, Japan, Department of Respiratory Medicine, Tochigi Cancer Center, Utsunomiya, Japan, Kyushu Medical Center, Fukuoka, Japan, Teikyo University School of Medicine, Tokyo, Japan, Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan
Research Funding
Other
Background: We previously reported that low-dose erlotinib has a certain degree of efficacy with lower toxicity in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations (Eur J Cancer 2015). This multicenter phase II study was undertaken to investigate the efficacy and safety of low-dose erlotinib for those patients with frailty. Methods: Chemotherapy-naïve NSCLC patients with EGFR mutations who had frailty were enrolled and received erlotinib 50 mg/d. Dose escalation was allowed to those with stable disease after 4 weeks. Patient’s frailty was defined as follows: (Group 1) 20 to 74 years of age with Eastern Cooperative Oncology Group performance status (PS) ≥2 or Charlson Comorbidity Index (CCI) ≥6 points; (Group 2) 75 to 80 years of age with PS ≥1 or CCI ≥6 points; (Group 3) ≥81 years of age with any PS and CCI. The primary endpoint was independent review committee (IRC)-confirmed objective response rate (ORR) to the low-dose erlotinib, with target ORR of 65% and threshold of 50% (SWOG two-stage design). Results: Eighty patients were enrolled between December 2014 and April 2017: males/females 26/54; median age 80 (range 49-90); Group 1/2/3 15/28/37; Ad/Sq/Others 76/1/3. EGFR mutation types were: exon 19/21 42/38. All 80 patients were included in efficacy and safety analysis. The IRC-confirmed ORR was 60.0% (90%CI: 50.2-69.2%), and the primary endpoint was met. The disease control rate was 86.3% (90%CI: 78.3-92.1%). Median progression-free survival was 9.2 months. Although overall survival data are immature, median survival time and 1-year survival rate were 26.3 months and 68.9%, respectively. Toxicities were generally mild, with a few grade 3 or more toxicities. There was no case of interstitial lung disease or treatment-related death. Conclusions: This is the first prospective study evaluating low-dose erlotinib for frail patients with EGFR mutation-positive NSCLC. Low-dose erlotinib is active and could be a treatment option for those patients. Clinical trial information: UMIN 000015949.
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Abstract Details
Session Type
Poster Session
Session Title
Lung Cancer—Non-Small Cell Metastatic
Track
Lung Cancer
Sub Track
Metastatic Non–Small Cell Lung Cancer
Clinical Trial Registration Number
UMIN 000015949
Citation
J Clin Oncol 36, 2018 (suppl; abstr 9063)
DOI
10.1200/JCO.2018.36.15_suppl.9063
Abstract #
9063
Poster Bd #
386
Abstract Disclosures
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