Matches in SemOpenAlex for { <https://semopenalex.org/work/W4243733684> ?p ?o ?g. }
Showing items 1 to 87 of
87
with 100 items per page.
- W4243733684 abstract "Abstract Background: We investigated afatinib in elderly patients with epidermal growth factor receptor ( EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC). Patients and Methods: This was a single-arm, open-label, phase II study, performed in multiple centres in Japan. Previously untreated patients, aged ≥ 75 years, with EGFR mutation-positive (Del19 or L858R) advanced NSCLC were treated with afatinib 40 mg until disease progression or unacceptable toxicity. Adverse events (AEs) were managed with protocol defined dose adjustments. The primary endpoint was objective response rate (ORR) by central review. Results: In total, 38 patients received at least one dose of afatinib, and 37 were evaluable for response. Median age was 77.5 years (range 75–91), all patients had an Eastern Cooperative Oncology group performance status of 0 or 1, and 60.5% had Del19-positive disease. ORR was 75.7% (2 complete responses and 26 partial responses). Median progression-free survival was 14.2 months (95% confidence interval [CI], 9.5–19.0). Median overall survival (OS) was 35.2 months (95% CI, 35.2–not reached); the 2-year OS rate was 78.3%. The most common grade III/IV treatment-related AEs (TRAEs) were diarrhoea (28.9%), paronychia (23.7%), and rash/acne (15.8%). Dose reductions due to TRAEs were reported in 78.9% of patients, and 8 (21.1%) patients discontinued afatinib due to TRAEs. No treatment-related deaths were reported. Conclusion: First-line afatinib administered at a starting dose of 40 mg was well tolerated with dose adjustments and was associated with encouraging activity in Japanese patients aged ≥ 75 years with EGFR mutation-positive NSCLC. Trial Registration: The trial is registered with Japan Registry of Clinical Trials (JRCT) as trial number 031180136 (date of initial registration: 19 February 2019), and the University Hospital Network (UMIN) as trial number 000017877 (date of initial registration: 11 June 2015)." @default.
- W4243733684 created "2022-05-12" @default.
- W4243733684 creator A5006885419 @default.
- W4243733684 creator A5011533142 @default.
- W4243733684 creator A5029655825 @default.
- W4243733684 creator A5037600318 @default.
- W4243733684 creator A5039962714 @default.
- W4243733684 creator A5041720877 @default.
- W4243733684 creator A5054938771 @default.
- W4243733684 creator A5060437485 @default.
- W4243733684 creator A5070015883 @default.
- W4243733684 creator A5071117344 @default.
- W4243733684 creator A5080846994 @default.
- W4243733684 creator A5085358387 @default.
- W4243733684 date "2020-06-29" @default.
- W4243733684 modified "2023-09-27" @default.
- W4243733684 title "A Phase II Study of First-line Afatinib For Patients Aged ≥ 75 Years With EGFR Mutation-positive Advanced Non-small Cell Lung Cancer: North East Japan Study Group Trial NEJ027" @default.
- W4243733684 doi "https://doi.org/10.21203/rs.3.rs-38049/v1" @default.
- W4243733684 hasPublicationYear "2020" @default.
- W4243733684 type Work @default.
- W4243733684 citedByCount "0" @default.
- W4243733684 crossrefType "posted-content" @default.
- W4243733684 hasAuthorship W4243733684A5006885419 @default.
- W4243733684 hasAuthorship W4243733684A5011533142 @default.
- W4243733684 hasAuthorship W4243733684A5029655825 @default.
- W4243733684 hasAuthorship W4243733684A5037600318 @default.
- W4243733684 hasAuthorship W4243733684A5039962714 @default.
- W4243733684 hasAuthorship W4243733684A5041720877 @default.
- W4243733684 hasAuthorship W4243733684A5054938771 @default.
- W4243733684 hasAuthorship W4243733684A5060437485 @default.
- W4243733684 hasAuthorship W4243733684A5070015883 @default.
- W4243733684 hasAuthorship W4243733684A5071117344 @default.
- W4243733684 hasAuthorship W4243733684A5080846994 @default.
- W4243733684 hasAuthorship W4243733684A5085358387 @default.
- W4243733684 hasBestOaLocation W42437336841 @default.
- W4243733684 hasConcept C121608353 @default.
- W4243733684 hasConcept C126322002 @default.
- W4243733684 hasConcept C141071460 @default.
- W4243733684 hasConcept C143998085 @default.
- W4243733684 hasConcept C197934379 @default.
- W4243733684 hasConcept C203092338 @default.
- W4243733684 hasConcept C2776256026 @default.
- W4243733684 hasConcept C2778087573 @default.
- W4243733684 hasConcept C2778570526 @default.
- W4243733684 hasConcept C2778822529 @default.
- W4243733684 hasConcept C2779134260 @default.
- W4243733684 hasConcept C2779438470 @default.
- W4243733684 hasConcept C2780586478 @default.
- W4243733684 hasConcept C44249647 @default.
- W4243733684 hasConcept C535046627 @default.
- W4243733684 hasConcept C71924100 @default.
- W4243733684 hasConcept C90924648 @default.
- W4243733684 hasConceptScore W4243733684C121608353 @default.
- W4243733684 hasConceptScore W4243733684C126322002 @default.
- W4243733684 hasConceptScore W4243733684C141071460 @default.
- W4243733684 hasConceptScore W4243733684C143998085 @default.
- W4243733684 hasConceptScore W4243733684C197934379 @default.
- W4243733684 hasConceptScore W4243733684C203092338 @default.
- W4243733684 hasConceptScore W4243733684C2776256026 @default.
- W4243733684 hasConceptScore W4243733684C2778087573 @default.
- W4243733684 hasConceptScore W4243733684C2778570526 @default.
- W4243733684 hasConceptScore W4243733684C2778822529 @default.
- W4243733684 hasConceptScore W4243733684C2779134260 @default.
- W4243733684 hasConceptScore W4243733684C2779438470 @default.
- W4243733684 hasConceptScore W4243733684C2780586478 @default.
- W4243733684 hasConceptScore W4243733684C44249647 @default.
- W4243733684 hasConceptScore W4243733684C535046627 @default.
- W4243733684 hasConceptScore W4243733684C71924100 @default.
- W4243733684 hasConceptScore W4243733684C90924648 @default.
- W4243733684 hasLocation W42437336841 @default.
- W4243733684 hasLocation W42437336842 @default.
- W4243733684 hasLocation W42437336843 @default.
- W4243733684 hasOpenAccess W4243733684 @default.
- W4243733684 hasPrimaryLocation W42437336841 @default.
- W4243733684 hasRelatedWork W1973291625 @default.
- W4243733684 hasRelatedWork W2026011297 @default.
- W4243733684 hasRelatedWork W2186047679 @default.
- W4243733684 hasRelatedWork W2330761849 @default.
- W4243733684 hasRelatedWork W2810945895 @default.
- W4243733684 hasRelatedWork W2888534976 @default.
- W4243733684 hasRelatedWork W2906574801 @default.
- W4243733684 hasRelatedWork W3000574396 @default.
- W4243733684 hasRelatedWork W3042289395 @default.
- W4243733684 hasRelatedWork W4324344390 @default.
- W4243733684 isParatext "false" @default.
- W4243733684 isRetracted "false" @default.
- W4243733684 workType "article" @default.