التفاصيل البيبلوغرافية
| العنوان: |
Prospective exosome-focused translational research for afatinib (EXTRA) study of patients with nonsmall cell lung cancer harboring EGFR mutation: an observational clinical study |
| المؤلفون: |
Takata, Saori, Morikawa, Kei, Tanaka, Hisashi, Itani, Hidetoshi, Ishihara, Masashi, Horiuchi, Kazuya, Kato, Yasuhiro, Ikemura, Shinnosuke, Nakagawa, Hideyuki, Nakahara, Yoshiro, Seki, Yoshitaka, Bessho, Akihiro, Takahashi, Nobumasa, Hayashi, Kentaro, Endo, Takeo, Takeyama, Kiyoshi, Maekura, Toshiya, Takigawa, Nagio, Kawase, Akikazu, Endoh, Makoto, Nemoto, Kenji, Kishi, Kazuma, Soejima, Kenzo, Okuma, Yusuke, Yoshimura, Kenichi, Saigusa, Daisuke, Kanai, Yae, Ueda, Koji, Togashi, Akira, Matsutani, Noriyuki, Seki, Nobuhiko |
| المساهمون: |
Boehringer Ingelheim |
| المصدر: |
Therapeutic Advances in Medical Oncology ; volume 15, page 175883592311770 ; ISSN 1758-8359 1758-8359 |
| بيانات النشر: |
SAGE Publications |
| سنة النشر: |
2023 |
| مصطلحات موضوعية: |
Oncology |
| الوصف: |
Background: The exosome-focused translational research for afatinib (EXTRA) study is the first trial to identify novel predictive biomarkers for longer treatment efficacy of afatinib in patients with epidermal growth factor receptor ( EGFR) mutation-positive nonsmall cell lung cancer (NSCLC) via a comprehensive association study using genomic, proteomic, epigenomic, and metabolomic analyses. Objectives: We report details of the clinical portion prior to omics analyses. Design: A prospective, single-arm, observational study was conducted using afatinib 40 mg/day as an initial dose in untreated patients with EGFR mutation-positive NSCLC. Dose reduction to 20 mg every other day was allowed. Methods: Progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated. Results: A total of 103 patients (median age 70 years, range 42–88 years) were enrolled from 21 institutions in Japan between February 2017 and March 2018. After a median follow-up of 35.0 months, 21% remained on afatinib treatment, whereas 9% had discontinued treatment because of AEs. The median PFS was 18.4 months, with a 3-year PFS rate of 23.3%. The median afatinib treatment duration in patients with final doses of 40 ( n = 27), 30 ( n = 23), and 20 mg/day ( n = 35), and 20 mg every other day ( n = 18) were 13.4, 15.4, 18.8, and 18.3 months, respectively. The median OS was not reached, with a 3-year OS rate of 58.5%. The median OS in patients who did ( n = 25) and did not ( n = 78) receive osimertinib during the entire course of treatment were 42.4 months and not reached, respectively ( p = 0.654). Conclusions: As the largest prospective study in Japan, this study confirmed favorable OS following first-line afatinib in patients with EGFR mutation-positive NSCLC in a real-world setting. Further analysis of the EXTRA study is expected to identify novel predictive biomarkers for afatinib. Trial registration: UMIN-CTR identifier (UMIN000024935, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000028688Test |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1177/17588359231177021 |
| الإتاحة: |
https://doi.org/10.1177/17588359231177021Test |
| حقوق: |
https://creativecommons.org/licenses/by-nc/4.0Test/ |
| رقم الانضمام: |
edsbas.CB82B2E |
| قاعدة البيانات: |
BASE |
