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Conference Paper: Phase Ib study of ribociclib plus letrozole in a subset of Asian patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer

TitlePhase Ib study of ribociclib plus letrozole in a subset of Asian patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer
Authors
Issue Date2017
PublisherOxford University Press. The Journal's web site is located at http://annonc.oxfordjournals.org/
Citation
European Society for Medical Oncology Asia 2017 Conference, Singapore, 17-19 November 2017. In Annals of Oncology, 2017, v. 28 n. suppl_10, p. x26-x34 How to Cite?
AbstractBackground: MONALEESASIA is an ongoing Phase Ib dose-escalation/-expansion study evaluating RIB + LET in a subset of Asian pts from Hong Kong and Singapore with HR+, HER2–ABC. Methods: Postmenopausal pts from Hong Kong and Singapore with HR+, HER2– ABC and no prior systemic therapy for ABC received RIB (400 or 600 mg/day; 3-weeks-on/1-week-off) + LET (2.5 mg/day; continuous). Dose escalation used a Bayesian Logistic Regression Model with overdose control. The primary endpoint was to determine the maximum tolerated dose (MTD)/recommended Phase II dose (RP2D); secondary endpoints included safety and pharmacokinetic (PK) profile. Blood samples for PK non-compartmental analysis were collected on Days 1 and 21 of Cycle 1 from pre-dose to 24 h post-dose. Results: At data cut-off (Jan 16, 2017), 26 pts were enrolled (RIB 400 mg: n = 6; 600 mg: n = 20). One dose-limiting toxicity was observed at 600 mg (Grade 3 increased alanine transaminase [ALT]); the MTD/RP2D was RIB 600 mg/day (3-weeks-on/1-week-off) + LET 2.5 mg/day (continuous). Grade 3/4 treatment-related adverse events (TRAEs) occurred in 4/6 pts at 400 mg and 17/20 pts at 600 mg during the dose-escalation and -expansion parts. The most common Grade 3/4 TRAEs (≥20% in either cohort; 400 mg vs 600 mg) were decreased neutrophil count (n = 3 vs n = 7), neutropenia (n = 1 vs n = 6), increased ALT (n = 1 vs n = 4), and increased aspartate transaminase (n = 0 vs n = 4). After a single dose (Cycle 1 Day 1) and at steady state (Cycle 1 Day 21), absorption of both RIB and LET was rapid (Table); increases in RIB exposure were dose dependent. Conclusions: The MTD/RP2D was declared as RIB 600 mg/day (3-weeks-on/1-week-off) + LET 2.5 mg/day (continuous) in Asian pts from Hong Kong and Singapore with HR+, HER2– ABC. Preliminary safety and PK data are consistent with prior observations in non-Asian pts.
Persistent Identifierhttp://hdl.handle.net/10722/249352
ISSN
2023 Impact Factor: 56.7
2023 SCImago Journal Rankings: 13.942

 

DC FieldValueLanguage
dc.contributor.authorYap, YS-
dc.contributor.authorIto, Y-
dc.contributor.authorBornstein, O-
dc.contributor.authorHan, Y-
dc.contributor.authorSamant, TS-
dc.contributor.authorLiu, X-
dc.contributor.authorChiu, WYJ-
dc.date.accessioned2017-11-21T03:00:57Z-
dc.date.available2017-11-21T03:00:57Z-
dc.date.issued2017-
dc.identifier.citationEuropean Society for Medical Oncology Asia 2017 Conference, Singapore, 17-19 November 2017. In Annals of Oncology, 2017, v. 28 n. suppl_10, p. x26-x34-
dc.identifier.issn0923-7534-
dc.identifier.urihttp://hdl.handle.net/10722/249352-
dc.description.abstractBackground: MONALEESASIA is an ongoing Phase Ib dose-escalation/-expansion study evaluating RIB + LET in a subset of Asian pts from Hong Kong and Singapore with HR+, HER2–ABC. Methods: Postmenopausal pts from Hong Kong and Singapore with HR+, HER2– ABC and no prior systemic therapy for ABC received RIB (400 or 600 mg/day; 3-weeks-on/1-week-off) + LET (2.5 mg/day; continuous). Dose escalation used a Bayesian Logistic Regression Model with overdose control. The primary endpoint was to determine the maximum tolerated dose (MTD)/recommended Phase II dose (RP2D); secondary endpoints included safety and pharmacokinetic (PK) profile. Blood samples for PK non-compartmental analysis were collected on Days 1 and 21 of Cycle 1 from pre-dose to 24 h post-dose. Results: At data cut-off (Jan 16, 2017), 26 pts were enrolled (RIB 400 mg: n = 6; 600 mg: n = 20). One dose-limiting toxicity was observed at 600 mg (Grade 3 increased alanine transaminase [ALT]); the MTD/RP2D was RIB 600 mg/day (3-weeks-on/1-week-off) + LET 2.5 mg/day (continuous). Grade 3/4 treatment-related adverse events (TRAEs) occurred in 4/6 pts at 400 mg and 17/20 pts at 600 mg during the dose-escalation and -expansion parts. The most common Grade 3/4 TRAEs (≥20% in either cohort; 400 mg vs 600 mg) were decreased neutrophil count (n = 3 vs n = 7), neutropenia (n = 1 vs n = 6), increased ALT (n = 1 vs n = 4), and increased aspartate transaminase (n = 0 vs n = 4). After a single dose (Cycle 1 Day 1) and at steady state (Cycle 1 Day 21), absorption of both RIB and LET was rapid (Table); increases in RIB exposure were dose dependent. Conclusions: The MTD/RP2D was declared as RIB 600 mg/day (3-weeks-on/1-week-off) + LET 2.5 mg/day (continuous) in Asian pts from Hong Kong and Singapore with HR+, HER2– ABC. Preliminary safety and PK data are consistent with prior observations in non-Asian pts.-
dc.languageeng-
dc.publisherOxford University Press. The Journal's web site is located at http://annonc.oxfordjournals.org/-
dc.relation.ispartofAnnals of Oncology-
dc.rightsPre-print: Journal Title] ©: [year] [owner as specified on the article] Published by Oxford University Press [on behalf of xxxxxx]. All rights reserved. Pre-print (Once an article is published, preprint notice should be amended to): This is an electronic version of an article published in [include the complete citation information for the final version of the Article as published in the print edition of the Journal.] Post-print: This is a pre-copy-editing, author-produced PDF of an article accepted for publication in [insert journal title] following peer review. The definitive publisher-authenticated version [insert complete citation information here] is available online at: xxxxxxx [insert URL that the author will receive upon publication here].-
dc.titlePhase Ib study of ribociclib plus letrozole in a subset of Asian patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer-
dc.typeConference_Paper-
dc.identifier.emailChiu, WYJ: jwychiu@hku.hk-
dc.identifier.authorityChiu, WYJ=rp01917-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1093/annonc/mdx654-
dc.identifier.hkuros283145-
dc.identifier.volume28-
dc.identifier.issuesuppl_10-
dc.identifier.spagex26-
dc.identifier.epagex34-
dc.publisher.placeUnited Kingdom-
dc.identifier.issnl0923-7534-

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