Abstract
Background
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are now key agents in treating EGFR-mutant non-small cell lung cancer (NSCLC). The efficacy of gefitinib or erlotinib monotherapy can be predicted by the development of a skin rash. However, it has not been fully evaluated if this is the case with afatinib monotherapy.
Methods
We retrospectively studied 49 consecutive patients with EGFR-mutant NSCLC who received afatinib therapy between 2009 and 2015. The relationship of several toxicities with tumor response was examined.
Results
Grade 2, or more severe, common adverse events (AEs) included skin rash in 17 patients (35 %), diarrhea in 19 (39 %) and mucositis in 15 (31 %). Of these, the number of patients who developed ≥Grade 2 AEs during the first week after the initiation of afatinib therapy was: five patients had skin rash (10 %), 12 patients had diarrhea (25 %) and four patients had mucositis (8 %). As for an objective response, 21 (43 %) of the 49 had a partial response. Associating the AEs with the antitumor effect, those who had a ≥Grade 2 skin rash within the first week tended to have a greater tumor response compared with those without a rash (80 vs. 39 %; p = 0.077).
Conclusion
Our small study demonstrated that the early development of a skin rash might be associated with the response to afatinib monotherapy.
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Acknowledgments
The authors acknowledge the following people for assistance and input in this trial: Kiichiro Ninomiya, Hisao Higo, Go Makimoto and Shinobu Hosokawa. The authors are also deeply grateful for all the participants who made this study possible.
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KH has received honoraria from Eli Lilly Japan, Taiho Pharmaceutical, Chugai Pharmaceutical and Sanofi-Aventis. NT has received honoraria from Eli Lilly Japan, Nihon Kayaku, AstraZeneca, Daiichi-Sankyo Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical, Pfizer Inc. Japan, Boehringer-Ingelheim in Japan, and Sanofi-Aventis. NT also received research donated funds from Eli Lilly Japan, Nihon Kayaku, AstraZeneca, Chugai Pharmaceutical, Taiho Pharmaceutical, Pfizer Inc. Japan, Boehringer-Ingelheim in Japan. KK has received honoraria from Eli Lilly Japan, Nihon Kayaku, AstraZeneca, Daiichi-Sankyo Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical and Sanofi-Aventis. All other authors declare that they have no conflicts of interest relating to this study.
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Kudo, K., Hotta, K., Bessho, A. et al. Development of a skin rash within the first week and the therapeutic effect in afatinib monotherapy for EGFR-mutant non-small cell lung cancer (NSCLC): Okayama Lung Cancer Study Group experience. Cancer Chemother Pharmacol 77, 1005–1009 (2016). https://doi.org/10.1007/s00280-015-2910-9
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DOI: https://doi.org/10.1007/s00280-015-2910-9