FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4379285768> ?p ?o ?g. }

• W4379285768 endingPage "e13061" @default.
• W4379285768 startingPage "e13061" @default.
• W4379285768 abstract "e13061 Background: Fulvestrant, a selective estrogen receptor (ER) down-regulator, is a standard of care for first-line treatment in hormone receptor-positive (HR+) advanced breast cancer. This study is to assess the safety profile and effectiveness of fulvestrant 500mg as the first-line endocrine therapy of post-menopausal women with HR+ locally advanced or metastatic breast cancer. Methods: The study is an open-label, multicentre, prospective, observational study in China. Chinese patients receiving fulvestrant 500mg as the first endocrine agent after relapse according to investigator’s clinical practice were enrolled. Primary variable is the frequency and severity of adverse events (AEs). Secondary variables were objective response rate (ORR), clinical benefit rate (CBR), progress free survival (PFS) and overall survival (OS). Predictive effects of endocrine resistance, chemotherapy for advanced disease and adjuvant endocrine therapy on the effectiveness were prespecified as exploratory variables. Results: From November 2017 to December 2020, 461 patients were enrolled by 29 Chinese centers. Median age was 56 years and the ECOG score was: 0, 165 (35.8%); 1, 281 (60.9%); 2, 12 (2.6%); and 3, 3 (0.7%). 20 (4.3%) patients had the Kaplan-Feinstein index ≥2. Majority (77.0%) of the patients were ER+ and PgR+, and 190 (41.2%) had visceral metastasis. In total, 91 (19.7%) patients were primary endocrine resistant, 202 (43.8%) were secondary endocrine resistant and 123 (26.7%) were endocrine-therapy naïve. 147 (31.9%) patients received previous chemotherapy for advanced disease, while 101 (21.9%) patients had anti-estrogen drugs as adjuvant therapy. 54 (11.7%) patients had concurrent CDK4/6 inhibitors. After a median follow-up of 26.8 months (IQR 18.7-38.2), median PFS was 13.0 months (95% CI 9.8-16.4) and median OS was 41.2 months (95% CI 37.3-NE). ORR was 11.3% (95% CI 8.2-15.1) and CBR was 60.6% (95%CI 55.2-65.8). Patients with endocrine-therapy naïve tumor, no previous chemotherapy for advanced disease and adjuvant anti-estrogen treatment had a longer PFS of first-line fulvestrant 500mg. 67 (14.5%) patients had at least one AE, with 1 (0.2%) patient withdrawing because of AEs. Drug-related serious AEs (SAEs) were rare, occurring in 2 (0.4%) patients. No patient died as a result of a drug-related AE. Neutropenia, increased ALT/AST, and anemia were the most commonly reported AEs in this study. Conclusions: This is the first prospective real-world study confirming that fulvestrant 500mg is a well-tolerated treatment option in unselected ABC in China. In the real clinical practice, fulvestrant 500mg can achieve the consistent anti-tumor activity as in clinical trials. Patients with endocrine-therapy naïve status and no prior chemotherapy tend to have a longer control time. Clinical trial information: NCT02909361 ." @default.
• W4379285768 created "2023-06-05" @default.
• W4379285768 creator A5014330629 @default.
• W4379285768 creator A5015204683 @default.
• W4379285768 creator A5020219997 @default.
• W4379285768 creator A5026804113 @default.
• W4379285768 creator A5036761448 @default.
• W4379285768 creator A5042218625 @default.
• W4379285768 creator A5049464184 @default.
• W4379285768 creator A5054603016 @default.
• W4379285768 creator A5055519498 @default.
• W4379285768 creator A5062017281 @default.
• W4379285768 creator A5062969947 @default.
• W4379285768 creator A5072667148 @default.
• W4379285768 creator A5076246857 @default.
• W4379285768 creator A5076833306 @default.
• W4379285768 creator A5077068949 @default.
• W4379285768 creator A5078084988 @default.
• W4379285768 creator A5078674610 @default.
• W4379285768 creator A5079494402 @default.
• W4379285768 creator A5087722578 @default.
• W4379285768 creator A5087739105 @default.
• W4379285768 date "2023-06-01" @default.
• W4379285768 modified "2023-09-23" @default.
• W4379285768 title "Tolerability and effectiveness of fulvestrant as first-line endocrine therapy in unselected patients with advanced breast cancer (ABC): Results of a multicenter, single arm, non-interventional study." @default.
• W4379285768 doi "https://doi.org/10.1200/jco.2023.41.16_suppl.e13061" @default.
• W4379285768 hasPublicationYear "2023" @default.
• W4379285768 type Work @default.
• W4379285768 citedByCount "0" @default.
• W4379285768 crossrefType "journal-article" @default.
• W4379285768 hasAuthorship W4379285768A5014330629 @default.
• W4379285768 hasAuthorship W4379285768A5015204683 @default.
• W4379285768 hasAuthorship W4379285768A5020219997 @default.
• W4379285768 hasAuthorship W4379285768A5026804113 @default.
• W4379285768 hasAuthorship W4379285768A5036761448 @default.
• W4379285768 hasAuthorship W4379285768A5042218625 @default.
• W4379285768 hasAuthorship W4379285768A5049464184 @default.
• W4379285768 hasAuthorship W4379285768A5054603016 @default.
• W4379285768 hasAuthorship W4379285768A5055519498 @default.
• W4379285768 hasAuthorship W4379285768A5062017281 @default.
• W4379285768 hasAuthorship W4379285768A5062969947 @default.
• W4379285768 hasAuthorship W4379285768A5072667148 @default.
• W4379285768 hasAuthorship W4379285768A5076246857 @default.
• W4379285768 hasAuthorship W4379285768A5076833306 @default.
• W4379285768 hasAuthorship W4379285768A5077068949 @default.
• W4379285768 hasAuthorship W4379285768A5078084988 @default.
• W4379285768 hasAuthorship W4379285768A5078674610 @default.
• W4379285768 hasAuthorship W4379285768A5079494402 @default.
• W4379285768 hasAuthorship W4379285768A5087722578 @default.
• W4379285768 hasAuthorship W4379285768A5087739105 @default.
• W4379285768 hasConcept C121608353 @default.
• W4379285768 hasConcept C126322002 @default.
• W4379285768 hasConcept C143998085 @default.
• W4379285768 hasConcept C197934379 @default.
• W4379285768 hasConcept C2775930923 @default.
• W4379285768 hasConcept C2778375690 @default.
• W4379285768 hasConcept C2780482068 @default.
• W4379285768 hasConcept C29456083 @default.
• W4379285768 hasConcept C530470458 @default.
• W4379285768 hasConcept C71924100 @default.
• W4379285768 hasConcept C84606932 @default.
• W4379285768 hasConceptScore W4379285768C121608353 @default.
• W4379285768 hasConceptScore W4379285768C126322002 @default.
• W4379285768 hasConceptScore W4379285768C143998085 @default.
• W4379285768 hasConceptScore W4379285768C197934379 @default.
• W4379285768 hasConceptScore W4379285768C2775930923 @default.
• W4379285768 hasConceptScore W4379285768C2778375690 @default.
• W4379285768 hasConceptScore W4379285768C2780482068 @default.
• W4379285768 hasConceptScore W4379285768C29456083 @default.
• W4379285768 hasConceptScore W4379285768C530470458 @default.
• W4379285768 hasConceptScore W4379285768C71924100 @default.
• W4379285768 hasConceptScore W4379285768C84606932 @default.
• W4379285768 hasIssue "16_suppl" @default.
• W4379285768 hasLocation W43792857681 @default.
• W4379285768 hasOpenAccess W4379285768 @default.
• W4379285768 hasPrimaryLocation W43792857681 @default.
• W4379285768 hasRelatedWork W1871851646 @default.
• W4379285768 hasRelatedWork W1984009715 @default.
• W4379285768 hasRelatedWork W2134047754 @default.
• W4379285768 hasRelatedWork W2598428456 @default.
• W4379285768 hasRelatedWork W2913370005 @default.
• W4379285768 hasRelatedWork W2941264805 @default.
• W4379285768 hasRelatedWork W2970181139 @default.
• W4379285768 hasRelatedWork W4206711305 @default.
• W4379285768 hasRelatedWork W4283528480 @default.
• W4379285768 hasRelatedWork W4378570500 @default.
• W4379285768 hasVolume "41" @default.
• W4379285768 isParatext "false" @default.
• W4379285768 isRetracted "false" @default.
• W4379285768 workType "article" @default.