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Article: 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

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
Authors
KeywordsAfatinib
HER2 mutations
Lung cancer
Named patient use
NSCLC
Uncommon EGFR mutations
Issue Date2021
PublisherSpringer Japan. The Journal's web site is located at http://link.springer-ny.com/link/service/journals/10147/
Citation
International Journal of Clinical Oncology, 2021, v. 26 n. 5, p. 841-850 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/306501
ISSN
2020 Impact Factor: 3.402
2020 SCImago Journal Rankings: 1.060
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorChang, GC-
dc.contributor.authorLam, DCL-
dc.contributor.authorTsai, CM-
dc.contributor.authorChen, YM-
dc.contributor.authorShih, JY-
dc.contributor.authorAggarwal, S-
dc.contributor.authorWang, S-
dc.contributor.authorKim, SW-
dc.contributor.authorKim, YC-
dc.contributor.authorWahid, I-
dc.contributor.authorLi, R-
dc.contributor.authorLim, DWT-
dc.contributor.authorSriuranpong, V-
dc.contributor.authorChan, RTT-
dc.contributor.authorLorence, RM-
dc.contributor.authorCarriere, P-
dc.contributor.authorRaabe, C-
dc.contributor.authorCseh, A-
dc.contributor.authorPark, K-
dc.date.accessioned2021-10-22T07:35:31Z-
dc.date.available2021-10-22T07:35:31Z-
dc.date.issued2021-
dc.identifier.citationInternational Journal of Clinical Oncology, 2021, v. 26 n. 5, p. 841-850-
dc.identifier.issn1341-9625-
dc.identifier.urihttp://hdl.handle.net/10722/306501-
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.languageeng-
dc.publisherSpringer Japan. The Journal's web site is located at http://link.springer-ny.com/link/service/journals/10147/-
dc.relation.ispartofInternational Journal of Clinical Oncology-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectAfatinib-
dc.subjectHER2 mutations-
dc.subjectLung cancer-
dc.subjectNamed patient use-
dc.subjectNSCLC-
dc.subjectUncommon EGFR mutations-
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.typeArticle-
dc.identifier.emailLam, DCL: dcllam@hku.hk-
dc.identifier.authorityLam, DCL=rp01345-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1007/s10147-021-01869-0-
dc.identifier.pmid33783657-
dc.identifier.pmcidPMC8055616-
dc.identifier.scopuseid_2-s2.0-85103394339-
dc.identifier.hkuros328558-
dc.identifier.volume26-
dc.identifier.issue5-
dc.identifier.spage841-
dc.identifier.epage850-
dc.identifier.isiWOS:000635070000002-
dc.publisher.placeJapan-

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