A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer

Abstract

Background

The clinical outcomes of elderly patients with EGFR-mutated non-small cell lung cancer (NSCLC) who are treated with osimertinib have not been sufficiently evaluated. This study aimed to assess the efficacy and safety of osimertinib in elderly chemotherapy-naive patients with NSCLC harboring sensitive EGFR mutations.

Patients and Methods

We assessed the clinical effects of osimertinib as a first-line treatment for elderly NSCLC patients (≥75 years of age) with an exon 19 deletion or exon 21 L858R mutation in EGFR. All patients were administered 80 mg/day osimertinib as initial treatment.

Results

Forty-three patients (24 women and 19 men) with adenocarcinoma who were treated between August 2018 and July 2021 were included in this study; their median age was 79 years (range, 75–90 years). The overall objective response rate was 60.5%. The median progression-free survival (PFS) and time to treatment failure (TTF) of the entire patient population were 22.1 months and 14.6 months, respectively. The most common adverse event was rash acneiform (42%), followed by diarrhea (33%) and paronychia (28%); none of these were grades ≥3. Interstitial lung disease developed in 8 patients (18.6%); however, no treatment-related deaths occurred. Multivariate analysis identified performance status and disease stage as predictors of PFS and TTF.

Conclusion

Considering the findings of this study and despite an observed discordance between PFS and TTF, osimertinib appears to be an effective and safe treatment option in elderly patients with advanced NSCLC harboring sensitive EGFR mutations. To obtain conclusive results, further studies in a larger elderly population are warranted.

Keywords:

• non-small cell lung carcinoma
• chemotherapy-naïve patients
• efficacy

Acknowledgments

We gratefully thank the staff members of the Department of Respiratory Medicine, Kitasato University School of Medicine, for their suggestions and assistance.

Research Involving Human Participants and/or Animals

This study does not include human participants and animals.

Data Sharing Statement

The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Ethics Approval and Consent to Participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was approved by the Institutional Ethics Review Board of Kitasato University Hospital. All patients gave informed consent for study participation.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Consent for Publication

All authors the study gave consent to publication of this study.

Author Contributions

All authors contributed to data analysis, drafting or revising the article, have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

Dr Takashi Sato reports personal fees from Chugai Pharmaceutical, Bristol Myers Squibb, Ono Pharmaceutical, and AstraZeneca, outside the submitted work. Dr Yoshiro Nakahara reports personal fees from BMS, Ono, Boehringer, AstraZeneca, Lilly, and Chugai; grants from Takeda and BMS, outside the submitted work. Prof. Dr. Jiichiro Sasaki reports personal fees from AstraZeneca, outside the submitted work. The authors report no other conflicts of interest in this work.