Please use this identifier to cite or link to this item: https://doi.org/10.1007/s10147-021-01869-0
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dc.titleExperience from Asian centers in a named-patient-use program for afatinib in patients with advanced non-small-cell lung cancer who had progressed following prior therapies, including patients with uncommon EGFR mutations
dc.contributor.authorChang, Gee-Chen
dc.contributor.authorLam, David Chi-Leung
dc.contributor.authorTsai, Chun-Ming
dc.contributor.authorChen, Yuh-Min
dc.contributor.authorShih, Jin-Yuan
dc.contributor.authorAggarwal, Shyam
dc.contributor.authorWang, Shuhang
dc.contributor.authorKim, Sang-We
dc.contributor.authorKim, Young-Chul
dc.contributor.authorWahid, Ibrahim
dc.contributor.authorLi, Rubi
dc.contributor.authorLim, Darren Wan-Teck
dc.contributor.authorSriuranpong, Virote
dc.contributor.authorChan, Raymond Tsz-Tong
dc.contributor.authorLorence, Robert M
dc.contributor.authorCarriere, Philippe
dc.contributor.authorRaabe, Christina
dc.contributor.authorCseh, Agnieszka
dc.contributor.authorPark, Keunchil
dc.date.accessioned2022-04-07T03:54:00Z
dc.date.available2022-04-07T03:54:00Z
dc.date.issued2021-03-30
dc.identifier.citationChang, Gee-Chen, Lam, David Chi-Leung, Tsai, Chun-Ming, Chen, Yuh-Min, Shih, Jin-Yuan, Aggarwal, Shyam, Wang, Shuhang, Kim, Sang-We, Kim, Young-Chul, Wahid, Ibrahim, Li, Rubi, Lim, Darren Wan-Teck, Sriuranpong, Virote, Chan, Raymond Tsz-Tong, Lorence, Robert M, Carriere, Philippe, Raabe, Christina, Cseh, Agnieszka, Park, Keunchil (2021-03-30). Experience from Asian centers in a named-patient-use program for afatinib in patients with advanced non-small-cell lung cancer who had progressed following prior therapies, including patients with uncommon EGFR mutations. INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY 26 (5) : 841-850. ScholarBank@NUS Repository. https://doi.org/10.1007/s10147-021-01869-0
dc.identifier.issn13419625
dc.identifier.issn14377772
dc.identifier.urihttps://scholarbank.nus.edu.sg/handle/10635/218517
dc.description.abstractBackground: This study evaluated outcomes among patients with advanced/metastatic non-small-cell lung cancer (NSCLC) treated at Asian centers participating in the global named-patient-use (NPU) program for afatinib. Methods: Patients had progressed after initial benefit with erlotinib or gefitinib, and/or had an EGFR or HER2 mutation, had no other treatment options, and were ineligible for afatinib trials. The recommended starting dose of afatinib was 50 mg/day. Dose modifications were allowed, and afatinib was continued as long as deemed beneficial. Response and survival information was provided voluntarily. Safety reporting was mandatory. Results: 2242 patients (26% aged ≥ 70 years, 96% with adenocarcinoma) received afatinib at centers in 10 Asian countries. Most were heavily pre-treated, including prior treatment with erlotinib or gefitinib. Of 1281 patients tested, 1240 had EGFR mutations (common: 1034/1101; uncommon: 117/1101). There were no new safety signals, the most common adverse events being rash and diarrhea. Objective response rate (ORR) was 24% overall (n = 431 with data available), 27% for patients with common EGFR mutations (n = 230) and 28% for those with uncommon mutations (n = 32); median time to treatment failure (TTF) in these groups was 7.6 months (n = 1550), 6.4 months (n = 692) and 8.4 months (n = 83), respectively. In patients with EGFR exon 20 insertions (n = 23) and HER2 mutations (n = 12), median TTF exceeded 12 months. Conclusions: Patient outcomes in this study were similar to those reported in the analysis of the global NPU. Afatinib achieved clinical benefits in patients with refractory NSCLC. ORR and TTF were similar between patients with tumors harboring uncommon and common EGFR mutations.
dc.language.isoen
dc.publisherSPRINGER JAPAN KK
dc.sourceElements
dc.subjectScience & Technology
dc.subjectLife Sciences & Biomedicine
dc.subjectOncology
dc.subjectAfatinib
dc.subjectHER2 mutations
dc.subjectLung cancer
dc.subjectNamed patient use
dc.subjectNSCLC
dc.subjectUncommon EGFR mutations
dc.typeArticle
dc.date.updated2022-04-07T02:15:30Z
dc.contributor.departmentDUKE-NUS MEDICAL SCHOOL
dc.description.doi10.1007/s10147-021-01869-0
dc.description.sourcetitleINTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY
dc.description.volume26
dc.description.issue5
dc.description.page841-850
dc.published.statePublished
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