First-line osimertinib for poor performance status patients with EGFR mutation-positive non-small cell lung cancer: A prospective observational study.

Satoshi Igawa,Seiichiro Kusuhara,Jiichiro Sasaki,Takashi Sato,Masashi Kasajima,Tomoya Fukui,Yoshiro Nakahara,Mikiko Kakegawa,Taihei Ono,Mitsufuji Hisashi,Katsuhiko Naoki,Takahiro Ozawa

doi:10.1007/s10637-021-01195-2

Satoshi Igawa, Seiichiro Kusuhara + Show 10 more

Open Access

https://doi.org/10.1007/s10637-021-01195-2

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Journal: Investigational new drugs	Publication Date: Nov 22, 2021
Citations: 10	License type: cc-by

Affiliation: Kitasato University

Abstract

The clinical outcomes of poor performance status (PS) patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who are treated with osimertinib as a first-line treatment have not been sufficiently evaluated. This study aimed to assess the efficacy and safety of osimertinib in chemotherapy-naive and poor PS (2 or more) patients with NSCLC harboring sensitive EGFR mutations. We assessed the clinical effects of osimertinib as a first-line treatment for patients with poor PS NSCLC with an exon 19 deletion or exon 21 L858R mutation in EGFR. All patients were administered osimertinib (80mg/day) as the initial treatment. Sixteen patients (nine women and seven men) who were treated between August 2018 and July 2021 were included in this study; their median age was 78years. The overall objective response rate was 56.3%. The median progression-free survival (PFS) of the entire patient population was 10.5months and the PS score improved in 8 of 16 patients (50%). The most common adverse event was acneiform rash (42%), followed by diarrhea (36%) and paronychia (36%); none of these were of grade ≥ 3. Interstitial lung disease occurred in 2 patients (12.5%); however, no treatment-related deaths occurred. Considering the findings of this study, osimertinib appears to be an effective and safe treatment option for patients with poor PS and advanced NSCLC harboring sensitive EGFR mutations. To obtain conclusive results, further studies with larger cohorts are warranted.

Highlights

Lung cancer is one of the main causes of cancer-related deaths, and non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases [1]
Based on the positive results from phase III trials [5,6,7,8,9,10,11,12], epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) have been administered to such patients, and several EGFR-TKIs are currently approved as first-line treatments for EGFR mutation-positive NSCLC in Japan
We have previously reported real-world data, indicating the efficacy of first- and secondgeneration TKIs for patients with EGFR mutation-positive NSCLC [13,14,15]

Summary

Introduction

Lung cancer is one of the main causes of cancer-related deaths, and non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases [1]. Based on the positive results from phase III trials [5,6,7,8,9,10,11,12], EGFR-TKIs have been administered to such patients, and several EGFR-TKIs are currently approved as first-line treatments for EGFR mutation-positive NSCLC in Japan These include the first-, second-, and third-generation TKIs: erlotinib and gefitinib, afatinib and dacomitinib, and osimertinib, respectively. It was reported that osimertinib had survival benefits compared to first-generation EGFR-TKIs, with a significantly superior survival time, and a less toxic profile in the FLAURA trial [12] This resulted in its approval as a standard first-line treatment for EGFR-mutated NSCLC, indicating that its administration may be a feasible intervention for patients with poor performance status (PS).

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