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Rationale and design of a phase II study to evaluate prophylactic treatment of dacomitinib-induced dermatologic adverse events in epidermal growth factor receptor-mutated advanced non-small cell lung cancer (SPIRAL-Daco study)

   
@article{TLCR31057,
	author = {Masahiro Iwasaku and Junji Uchino and Tadaaki Yamada and Yusuke Chihara and Takayuki Shimamoto and Nobuyo Tamiya and Yoshiko Kaneko and Fumiaki Kiyomi and Koichi Takayama},
	title = {Rationale and design of a phase II study to evaluate prophylactic treatment of dacomitinib-induced dermatologic adverse events in epidermal growth factor receptor-mutated advanced non-small cell lung cancer (SPIRAL-Daco study)},
	journal = {Translational Lung Cancer Research},
	volume = {8},
	number = {4},
	year = {2019},
	keywords = {},
	abstract = {Background: Dacomitinib is the first second-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) to significantly improve overall survival in the patients of EGFR mutation-positive inoperable or postoperative recurrent non-small cell lung cancer (NSCLC). However, dermatologic adverse events (AEs) increase with dacomitinib treatment, and the management strategy for dermatologic AEs is crucial. In particular, a proactive strategy has become desirable in clinical practice settings. We designed a trial to assess a proactive strategy for dermatologic AEs associated with dacomitinib treatment.
Methods: This is a single-arm, prospective, open-label, multicenter, phase II trial. Patients with advanced NSCLC harboring EGFR-activating mutations will receive dacomitinib and prophylactic treatment as follows: minocycline, skin moisturizer, topical steroid, and sunscreen. Treatment will be continued until progressive disease or any of the discontinuation criteria are met. The primary endpoint is the incidence of dermatologic AEs (≥ grade 2) in the first 8 weeks of dacomitinib treatment. Secondary endpoints are the proportion of dose reduction of dacomitinib, progression-free survival, and safety.
Discussion: We are conducting a phase II study to explore the preventive efficacy of prophylactic medication against dacomitinib-induced dermatologic AEs.
Trial registration: jRCTs071190015.},
	issn = {2226-4477},	url = {https://tlcr.amegroups.org/article/view/31057}
}