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Observational Study
. 2022 Apr;40(2):430-437.
doi: 10.1007/s10637-021-01195-2. Epub 2021 Nov 22.

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

Satoshi Igawa  1 , Tomoya Fukui  2 , Masashi Kasajima  2 , Taihei Ono  2 , Takahiro Ozawa  2 , Mikiko Kakegawa  2 , Seiichiro Kusuhara  2 , Takashi Sato  2 , Yoshiro Nakahara  2 , Mitsufuji Hisashi  3 , Jiichiro Sasaki  4 , Katsuhiko Naoki  2
Affiliations
Observational Study

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

Satoshi Igawa et al. Invest New Drugs. 2022 Apr.

Abstract

Objective: 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.

Materials and methods: 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 (80 mg/day) as the initial treatment.

Results: 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 78 years. The overall objective response rate was 56.3%. The median progression-free survival (PFS) of the entire patient population was 10.5 months 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.

Conclusion: 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.

Keywords: Efficacy; Non-small cell lung carcinoma; Osimertinib; Poor performance status.

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