A real-world cohort study of first-line afatinib in patients with EGFR-mutant advanced non-small cell lung cancer in Vietnam

Abstract Background This study aimed to evaluate the efficacy and side effects of first-line afatinib treatment in a real-world setting in Vietnam. Methods This retrospective study was conducted across nine hospitals in Vietnam. Advanced epidermal growth factor receptor (EGFR)-mutant non-small cell...

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Main Authors: Cam Phuong Pham, Thi Thai Hoa Nguyen, Anh Tu Do, Tuan Khoi Nguyen, Thi Anh Thu Hoang, Tuan Anh Le, Dinh Thy Hao Vuong, Dac Nhan Tam Nguyen, Van Khiem Dang, Thi Oanh Nguyen, Van Luan Pham, Minh Hai Nguyen, Thi Huyen Trang Vo, Hung Kien Do, Ha Thanh Vu, Thi Thuy Hang Nguyen, Van Thai Pham, Le Huy Trinh, Khac Dung Nguyen, Hoang Gia Nguyen, Cong Minh Truong, Tran Minh Chau Pham, Thi Bich Phuong Nguyen
Format: Article
Language:English
Published: BMC 2024-02-01
Series:BMC Cancer
Subjects:
Online Access:https://doi.org/10.1186/s12885-024-11891-w
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author Cam Phuong Pham
Thi Thai Hoa Nguyen
Anh Tu Do
Tuan Khoi Nguyen
Thi Anh Thu Hoang
Tuan Anh Le
Dinh Thy Hao Vuong
Dac Nhan Tam Nguyen
Van Khiem Dang
Thi Oanh Nguyen
Van Luan Pham
Minh Hai Nguyen
Thi Huyen Trang Vo
Hung Kien Do
Ha Thanh Vu
Thi Thuy Hang Nguyen
Van Thai Pham
Le Huy Trinh
Khac Dung Nguyen
Hoang Gia Nguyen
Cong Minh Truong
Tran Minh Chau Pham
Thi Bich Phuong Nguyen
author_facet Cam Phuong Pham
Thi Thai Hoa Nguyen
Anh Tu Do
Tuan Khoi Nguyen
Thi Anh Thu Hoang
Tuan Anh Le
Dinh Thy Hao Vuong
Dac Nhan Tam Nguyen
Van Khiem Dang
Thi Oanh Nguyen
Van Luan Pham
Minh Hai Nguyen
Thi Huyen Trang Vo
Hung Kien Do
Ha Thanh Vu
Thi Thuy Hang Nguyen
Van Thai Pham
Le Huy Trinh
Khac Dung Nguyen
Hoang Gia Nguyen
Cong Minh Truong
Tran Minh Chau Pham
Thi Bich Phuong Nguyen
author_sort Cam Phuong Pham
collection DOAJ
description Abstract Background This study aimed to evaluate the efficacy and side effects of first-line afatinib treatment in a real-world setting in Vietnam. Methods This retrospective study was conducted across nine hospitals in Vietnam. Advanced epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) patients who received afatinib as first-line therapy between April 2018 and June 2022 were included, and patient medical records were reviewed. Key outcomes were overall response rate (ORR), time-to-treatment failure (TTF), and tolerability. Results A total of 343 patients on first-line afatinib were eligible for the study. EGFR exon 19 deletion (Del19) alone was detected in 46.9% of patients, L858R mutation alone in 26.3%, and other uncommon EGFR mutations, including compound mutations, in 26.8%. Patients with brain metastases at baseline were 25.4%. Patients who received 40 mg, 30 mg, and 20 mg as starting doses of afatinib were 58.6%, 39.9%, and 1.5%, respectively. The ORR was 78.1% in the overall population, 82.6% in the Del19 mutation subgroup, 73.3% in the L858R mutation subgroup, and 75.0% in the uncommon mutation subgroup (p > 0.05). The univariate and multivariate analyses indicate that the ORR increased when the starting dose was 40 mg compared to starting doses below 40 mg (83.9% vs. 74.3%, p = 0.034). The median TTF (mTTF) was 16.7 months (CI 95%: 14.8–18.5) in all patients, with a median follow-up time of 26.2 months. The mTTF was longer in patients in the common EGFR mutation subgroup (Del19/L858R) than in those in the uncommon mutation subgroup (17.5 vs. 13.8 months, p = 0.045) and in those without versus with brain metastases at baseline (17.5 vs. 15.1 months, p = 0.049). There were no significant differences in the mTTF between subgroups based on the starting dose of 40 mg and < 40 mg (16.7 vs. 16.9 months, p > 0.05). The most common treatment-related adverse events (any grade/grade ≥ 3) were diarrhea (55.4%/3.5%), rash (51.9%/3.2%), paronychia (35.3%/5.0%), and stomatitis (22.2%/1.2%). Conclusions Afatinib demonstrated clinical effectiveness and good tolerability in Vietnamese EGFR-mutant NSCLC patients. In our real-world setting, administering a starting dose below 40 mg might result in a reduction in ORR; however, it might not have a significant impact on TTF.
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spelling doaj.art-36865a07e0674f89ab90acac425e34cb2024-03-05T19:22:42ZengBMCBMC Cancer1471-24072024-02-0124111010.1186/s12885-024-11891-wA real-world cohort study of first-line afatinib in patients with EGFR-mutant advanced non-small cell lung cancer in VietnamCam Phuong Pham0Thi Thai Hoa Nguyen1Anh Tu Do2Tuan Khoi Nguyen3Thi Anh Thu Hoang4Tuan Anh Le5Dinh Thy Hao Vuong6Dac Nhan Tam Nguyen7Van Khiem Dang8Thi Oanh Nguyen9Van Luan Pham10Minh Hai Nguyen11Thi Huyen Trang Vo12Hung Kien Do13Ha Thanh Vu14Thi Thuy Hang Nguyen15Van Thai Pham16Le Huy Trinh17Khac Dung Nguyen18Hoang Gia Nguyen19Cong Minh Truong20Tran Minh Chau Pham21Thi Bich Phuong Nguyen22Bach Mai HospitalVietnam National Cancer HospitalVietnam National Cancer HospitalHo Chi Minh City Oncology HospitalHo Chi Minh City Oncology HospitalCho Ray HospitalCho Ray HospitalThong Nhat HospitalNational Lung HospitalNational Lung Hospital108 Military Central Hospital108 Military Central HospitalBach Mai HospitalVietnam National Cancer HospitalHanoi Medical UniversityVietnam National Cancer HospitalHanoi Medical UniversityHanoi Medical UniversityVietnam National Cancer HospitalHanoi Oncology HospitalVietnam National Cancer HospitalHo Chi Minh City Oncology HospitalVietnam National Cancer HospitalAbstract Background This study aimed to evaluate the efficacy and side effects of first-line afatinib treatment in a real-world setting in Vietnam. Methods This retrospective study was conducted across nine hospitals in Vietnam. Advanced epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) patients who received afatinib as first-line therapy between April 2018 and June 2022 were included, and patient medical records were reviewed. Key outcomes were overall response rate (ORR), time-to-treatment failure (TTF), and tolerability. Results A total of 343 patients on first-line afatinib were eligible for the study. EGFR exon 19 deletion (Del19) alone was detected in 46.9% of patients, L858R mutation alone in 26.3%, and other uncommon EGFR mutations, including compound mutations, in 26.8%. Patients with brain metastases at baseline were 25.4%. Patients who received 40 mg, 30 mg, and 20 mg as starting doses of afatinib were 58.6%, 39.9%, and 1.5%, respectively. The ORR was 78.1% in the overall population, 82.6% in the Del19 mutation subgroup, 73.3% in the L858R mutation subgroup, and 75.0% in the uncommon mutation subgroup (p > 0.05). The univariate and multivariate analyses indicate that the ORR increased when the starting dose was 40 mg compared to starting doses below 40 mg (83.9% vs. 74.3%, p = 0.034). The median TTF (mTTF) was 16.7 months (CI 95%: 14.8–18.5) in all patients, with a median follow-up time of 26.2 months. The mTTF was longer in patients in the common EGFR mutation subgroup (Del19/L858R) than in those in the uncommon mutation subgroup (17.5 vs. 13.8 months, p = 0.045) and in those without versus with brain metastases at baseline (17.5 vs. 15.1 months, p = 0.049). There were no significant differences in the mTTF between subgroups based on the starting dose of 40 mg and < 40 mg (16.7 vs. 16.9 months, p > 0.05). The most common treatment-related adverse events (any grade/grade ≥ 3) were diarrhea (55.4%/3.5%), rash (51.9%/3.2%), paronychia (35.3%/5.0%), and stomatitis (22.2%/1.2%). Conclusions Afatinib demonstrated clinical effectiveness and good tolerability in Vietnamese EGFR-mutant NSCLC patients. In our real-world setting, administering a starting dose below 40 mg might result in a reduction in ORR; however, it might not have a significant impact on TTF.https://doi.org/10.1186/s12885-024-11891-wAdvanced non-small cell lung cancerEGFR mutationsAfatinibFirst-lineVietnam
spellingShingle Cam Phuong Pham
Thi Thai Hoa Nguyen
Anh Tu Do
Tuan Khoi Nguyen
Thi Anh Thu Hoang
Tuan Anh Le
Dinh Thy Hao Vuong
Dac Nhan Tam Nguyen
Van Khiem Dang
Thi Oanh Nguyen
Van Luan Pham
Minh Hai Nguyen
Thi Huyen Trang Vo
Hung Kien Do
Ha Thanh Vu
Thi Thuy Hang Nguyen
Van Thai Pham
Le Huy Trinh
Khac Dung Nguyen
Hoang Gia Nguyen
Cong Minh Truong
Tran Minh Chau Pham
Thi Bich Phuong Nguyen
A real-world cohort study of first-line afatinib in patients with EGFR-mutant advanced non-small cell lung cancer in Vietnam
BMC Cancer
Advanced non-small cell lung cancer
EGFR mutations
Afatinib
First-line
Vietnam
title A real-world cohort study of first-line afatinib in patients with EGFR-mutant advanced non-small cell lung cancer in Vietnam
title_full A real-world cohort study of first-line afatinib in patients with EGFR-mutant advanced non-small cell lung cancer in Vietnam
title_fullStr A real-world cohort study of first-line afatinib in patients with EGFR-mutant advanced non-small cell lung cancer in Vietnam
title_full_unstemmed A real-world cohort study of first-line afatinib in patients with EGFR-mutant advanced non-small cell lung cancer in Vietnam
title_short A real-world cohort study of first-line afatinib in patients with EGFR-mutant advanced non-small cell lung cancer in Vietnam
title_sort real world cohort study of first line afatinib in patients with egfr mutant advanced non small cell lung cancer in vietnam
topic Advanced non-small cell lung cancer
EGFR mutations
Afatinib
First-line
Vietnam
url https://doi.org/10.1186/s12885-024-11891-w
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