Real-world experience of first-line afatinib in patients with EGFR-mutant advanced NSCLC: a multicenter observational study

Ho, Gwo Fuang and Chai, Chee Shee and Alip, Adlinda and A. Wahid, Mohd Ibrahim and Abdullah, Matin Mellor and Foo, Yoke Ching and How, Soon Hin and Zaatar, Adel and Lam, Kai Seng and Leong, Kin Wah and Low, John Seng Hooi and Md Yusof, Mastura and Lee, Erica Chai Yong and Toh, Yok Yong and Liam, Chong Kin (2019) Real-world experience of first-line afatinib in patients with EGFR-mutant advanced NSCLC: a multicenter observational study. BMC Cancer, 19 (1). pp. 1-11. ISSN 14712407

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Abstract

Abstract Background: This study aimed to evaluate the efficacy, side effects and resistance mechanisms of first-line afatinib in a real-world setting. Methods: This is a multicenter observational study of first-line afatinib in Malaysian patients with epidermal growth factor receptor (EGFR)-mutant advanced non-small cell lung cancer (NSCLC). Patients’ demographic, clinical and treatment data, as well as resistance mechanisms to afatinib were retrospectively captured. The statistical methods included Chi-squared test and independent t-test for variables, Kaplan-Meier curve and log-rank test for survival, and Cox regression model for multivariate analysis. Results: Eighty-five patients on first-line afatinib from 1st October 2014 to 30th April 2018 were eligible for the study. EGFR mutations detected in tumors included exon 19 deletion in 80.0%, exon 21 L858R point mutation in 12.9%, and rare or complex EGFR mutations in 7.1% of patients. Among these patients, 18.8% had Eastern Cooperative Oncology Group performance status of 2–4, 29.4% had symptomatic brain metastases and 17.6% had abnormal organ function. Afatinib 40 mg or 30 mg once daily were the most common starting and maintenance doses. Only one-tenth of patients experienced severe side-effects with none having grade 4 toxicities. The objective response rate was 76.5% while the disease control rate was 95.3%. At the time of analysis, 56 (65.9%) patients had progression of disease (PD) with a median progression-free survival (mPFS) of 14.2 months (95% CI, 11.85–16.55 months). Only 12.5% of the progressed patients developed new symptomatic brain metastases. The overall survival (OS) data was not mature. Thirty-three (38.8%) patients had died with a median OS of 28.9 months (95% CI, 19.82–37.99 months). The median follow-up period for the survivors was 20.0 months (95% CI, 17.49–22.51 months). Of patients with PD while on afatinib, 55.3% were investigated for resistance mechanisms with exon 20 T790 M mutation detected in 42.0% of them. Conclusions: Afatinib is an effective first-line treatment for patients with EGFR-mutant advanced NSCLC with a good response rate and long survival, even in patients with unfavorable clinical characteristics. The side-effects of afatinib were manageable and T790 M mutation was the most common resistance mechanism causing treatment failure.

Item Type:	Article (Journal)
Additional Information:	2987/86185
Uncontrolled Keywords:	Afatinib, Dose adjustment, Epidermal growth factor receptor (EGFR), Real-world, Tyrosine kinase inhibitor
Subjects:	L Education > L Education (General) R Medicine > RC Internal medicine R Medicine > RC Internal medicine > RC731 Specialties of Internal Medicine-Diseases of The Respiratory System
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button):	Kulliyyah of Medicine Kulliyyah of Medicine > Department of Internal Medicine
Depositing User:	Miss Noor Shafiruz Ahmad
Date Deposited:	14 Dec 2020 12:28
Last Modified:	14 Dec 2020 12:28
URI:	http://irep.iium.edu.my/id/eprint/86185

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