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Phase II Study of Afatinib as Third-Line Treatment for Patients in Korea With Stage IIIB/IV Non-Small Cell Lung Cancer Harboring Wild-Type EGFR

Authors
 Myung-Ju Ahn  ;  Sang-We Kim  ;  Byoung-Chul Cho  ;  Jin Seok Ahn  ;  Dae Ho Lee  ;  Jong-Mu Sun  ;  Dan Massey  ;  Miyoung Kim  ;  Yang Shif  ;  Keunchil Park 
Citation
 ONCOLOGIST, Vol.19(7) : 702-703, 2014 
Journal Title
ONCOLOGIST
ISSN
 1083-7159 
Issue Date
2014
MeSH
Carcinoma, Non-Small-Cell Lung/drug therapy* ; Carcinoma, Non-Small-Cell Lung/enzymology ; Carcinoma, Non-Small-Cell Lung/genetics ; Disease-Free Survival ; Female ; Humans ; Lung Neoplasms/drug therapy* ; Lung Neoplasms/enzymology ; Lung Neoplasms/genetics ; Male ; Neoplasm Staging ; Quinazolines/adverse effects ; Quinazolines/therapeutic use* ; Receptor, Epidermal Growth Factor/antagonists & inhibitors ; Receptor, Epidermal Growth Factor/genetics ; Receptor, Epidermal Growth Factor/metabolism* ; Republic of Korea
Abstract
BACKGROUND:
This phase II single-arm trial evaluated afatinib, an irreversible inhibitor of the ErbB receptor family as third-line treatment of Korean patients with advanced non-small cell lung cancer (NSCLC) and tumors with wild-type EGFR. Currently, no standard therapy exists for these patients.
METHODS:
Eligible patients had stage IIIB/IV wild-type EGFR lung adenocarcinoma and had failed to benefit from two previous lines of chemotherapy but had not received anti-EGFR treatment. Patients received oral afatinib at 40 mg per day until disease progression or occurrence of intolerable adverse events (AEs). The primary endpoint was confirmed objective tumor response (OR) rate (confirmed complete response [CR] or partial response [PR]). Secondary endpoints included disease control rate (DCR; OR or stable disease for ≥6 weeks), progression-free survival (PFS), and safety.
RESULTS:
Forty-two patients received afatinib treatment, and 38 of those were included in efficacy analyses. No confirmed CRs or PRs were reported. DCR was 24% (9 of 38 patients), with a median disease control duration of 19.3 weeks. Median PFS was 4.1 weeks (95% confidence interval: 3.9-8.0). Frequently reported AEs (mainly grades 1 and 2) were rash/acne (88%), diarrhea (62%), and stomatitis (57%).
CONCLUSION:
Heavily pretreated patients with wild-type EGFR NSCLC treated with afatinib monotherapy did not experience an objective response and only 24% had disease stabilization lasting more than 6 weeks. AEs were manageable and consistent with the expected safety profile.
Full Text
http://theoncologist.alphamedpress.org/content/19/7/702.long
DOI
10.1634/theoncologist.2013-0419
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/99581
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