Safety and efficacy of afatinib for the treatment of non-small-cell lung cancer following osimertinib-induced interstitial lung disease: A retrospective study


Background Osimertinib is one of the first-line treatments for advanced non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. However, the occurrence rate of osimertinib-induced interstitial lung disease (ILD) is particularly high in Japanese patients and little information on subsequent cancer treatment options after recovery from osimertinib-induced ILD is currently available. Thus, this study aims to determine the safety and efficacy of afatinib for the treatment of NSCLC following osimertinib-induced ILD. Methods We retrospectively investigated the clinical courses of all NSCLC patients with EGFR mutations at our facility between August 2018 and September 2019, who received osimertinib as first-line treatment and were subsequently treated with afatinib after developing osimertinib-induced ILD. Results Forty-two patients received osimertinib treatment at our facility during the study period, and four patients received afatinib after developing osimertinib-induced ILD. All events of ILD improved either spontaneously or with steroid therapy before the initiation of afatinib. For the four patients who were retrospectively reviewed, the overall response rate to afatinib therapy was 75%, and the disease control rate was 100%. During the study period, no ILD recurrence was observed in any of the four patients. Conclusions According to our study findings, afatinib treatment after osimertinib-induced ILD is considered safe and effective and it can be used as one of the treatment options for NSCLC following osimertinib-induced ILD.

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Author information




Shingo Nasu designed the study and wrote the initial draft of the manuscript. Shingo Nasu, Hidekazu Suzuki contributed to analysis and interpretation of our data and assisted in the preparation of the manuscript. All other authors have contributed to the data collection and interpretation and reviewed the manuscript. All authors approved the version of the manuscript finally and agree to be accountable for all aspects of the work.

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Correspondence to Shingo Nasu.

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The authors declare that they have no conflict of interest.

Ethical approval

Institutional review board (IRB) approval for this study was obtained from the Medical Research Ethics Committee of Osaka Habikino Medical Center. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was waived by the IRB because of the retrospective nature of this study.

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Nasu, S., Suzuki, H., Shiroyama, T. et al. Safety and efficacy of afatinib for the treatment of non-small-cell lung cancer following osimertinib-induced interstitial lung disease: A retrospective study. Invest New Drugs (2020).

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  • Afatinib
  • Drug-induced interstitial lung disease
  • Osimertinib
  • Epidermal growth factor receptor mutation