Osimertinib for patients with poor performance status and EGFR T790M mutation-positive advanced non-small cell lung canc
- PDF / 325,788 Bytes
- 8 Pages / 595.276 x 790.866 pts Page_size
- 69 Downloads / 187 Views
PHASE II STUDIES
Osimertinib for patients with poor performance status and EGFR T790M mutation-positive advanced non-small cell lung cancer: a phase II clinical trial Kazuhisa Nakashima 1,2 & Yuichi Ozawa 3 & Haruko Daga 4 & Hisao Imai 5 & Motohiro Tamiya 6 & Takaaki Tokito 7 & Takahisa Kawamura 1 & Hiroaki Akamatsu 3 & Yuko Tsuboguchi 4 & Toshiaki Takahashi 1 & Nobuyuki Yamamoto 3 & Keita Mori 8 & Haruyasu Murakami 1 Received: 26 March 2020 / Accepted: 29 April 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
Summary Osimertinib is a molecularly targeted agent used to treat non-small cell lung cancer (NSCLC) patients with an epidermal growth factor receptor (EGFR) T790M mutation. However, its efficacy and safety profile when patients have poor performance status (PS) is unknown. Therefore, we conducted an open-label, multi-center, single-arm phase II study to evaluate its efficacy and safety in EGFR T790M mutation-positive NSCLC patients with Eastern Cooperative Oncology Group PS scores of between 2 and 4. Patients received 80 mg of osimertinib once daily. Our primary endpoint was progression-free survival. Eighteen patients were enrolled between June 2017 and November 2018. The median age was 77 years (range: 55–85 years). Ten, six, and two patients had PS scores of 2, 3, and 4, respectively. All patients had adenocarcinoma with common EGFR mutations and had been treated with first- or second-generation EGFR- tyrosine kinase inhibitors previously. The overall median progression-free survival was 7.0 months (90% confidence interval: 5.5–8.9 months). The overall response rate and median overall survival were 53% and 12.7 months, respectively. Moreover, improved PS scores were observed in 72% of the patients. Although the incidence of grade 3 adverse events was low, with no grade 4 or 5 events observed, three patients required treatment cessation due to the development of interstitial lung disease. Osimertinib therapy could be beneficial for EGFR T790M mutation-positive advanced NSCLC patients with poor PS. This trial was registered with the Japan Registry of Clinical Trials on March 12, 2019 (trial no. jRCT1041180081). Keywords EGFR T790M mutation-positive . Non-small-cell lung cancer . Osimertinib . Poor performance status
Introduction Lung cancer is the most common type of cancer worldwide, with approximately 85% of diagnosed lung cancers being non-small cell lung cancer (NSCLC). About 70% of
* Kazuhisa Nakashima [email protected] 1
2
3
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, 89-1 Enya-cho, Izumo, Shimane, Japan Internal Medicine III, Wakayama Medical University, Wakayama, Japan
NSCLC patients are diagnosed at advanced stages, and the disease is a common cause of cancer-related mortality [1, 2]. Epidermal growth factor receptor (EGFR) gene mutations are detected in roughly 30% of East Asian NSCLCs patients [3, 4]. Fi
Data Loading...
