FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W1775596629> ?p ?o ?g. }

• W1775596629 endingPage "606" @default.
• W1775596629 startingPage "606" @default.
• W1775596629 abstract "Abstract Abstract 606FN2 Background: Recent studies have demonstrated that about 40% of very highly selected CML-CP pts treated with imatinib achieve durable CMR and may be able to cease therapy without disease recurrence. However, most CML pts don't achieve CMR on imatinib even with long-term therapy. Results from ENESTnd demonstrated that significantly more patients achieved MMR (≤ 0.1%IS), CMR4 (≤ 0.01%IS), and CMR4.5 (≤ 0.0032%IS) with nilotinib vs imatinib by 12, 18, and 24 months (mo). No pt in ENESTnd who achieved CMR4.5 has progressed to AP/BC. In this study we asked whether pts on long-term imatinib would be more likely to achieve undetectable BCR-ABL levels if they switched to nilotinib, allowing for participation in potential cessation studies in the future. Methods: This open label, 1:1 randomized, prospective, multi-center, phase 3 study enrolled 207 pts with CML-CP who had achieved a complete cytogenetic response (CCyR) but were still BCR-ABL positive by RQ-PCR after ≥ 24 mo on imatinib. CMR (primary endpoint) was defined as undetectable BCR-ABL by RQ-PCR where there was no detectable BCR-ABL with a sample sensitivity of ≥ 4.5-logs. CMR4 and CMR4.5 were defined as BCR-ABL levels of ≤ 0.01% and ≤ 0.0032% expressed on the International Scale (IS), respectively and included patients with undetectable BCR-ABL levels with high sample sensitivity (4 or 4.5 logs). Patients were randomized to nilotinib 400 mg BID vs continuing imatinib 400 or 600 mg daily (same dose as at study entry.) The randomization was stratified by prior use of IFN (none, ≤ 12 mo, > 12 mo) and prior duration of imatinib therapy (> 36 mo or ≤ 36 mo). The primary endpoint was the rate of confirmed best cumulative CMR by 12 mo of study therapy with nilotinib or imatinib. Secondary objectives included the kinetics of CMR at different timepoints, duration of CMR, progression-free survival, and overall survival in both arms. During the study, RQ-PCR for BCR-ABL was performed at baseline (BL) and every 3 mo and expressed on the IS in national reference laboratories in Australia, Brazil, and Canada. For this report: BL, 6 mo, and 12 mo results were analyzed in a central laboratory in Australia. Assessment of the primary efficacy endpoint has not been completed for 2% of the randomized pts; unblinded data will be available for all pts and will be presented by treatment arm. Results: BL results were available for 205/207 randomized pts. Overall, 56% of pts had no prior IFN exposure, while 21% and 23% had IFN exposure of ≤ 12 mo or > 12 mo, respectively; 81% of pts had been on imatinib > 36 mos. At BL, 153 pts (74%) were known to be in MMR and 54 pts (26%) had < MMR (including 2 pts with missing PCR samples); 53 pts (26%), and 20 pts (10%) had CMR4 or CMR4.5 (with detectable BCR-ABL) at BL, respectively. Overall, 67 pts (32%) had at least a half-log reduction in BCR-ABL levels from BL by 12 mo. Of the 52 pts (25%) known not to have MMR at BL, 24 pts (46%) achieved MMR or better by 12 mo in the study. To date, no pt experienced a loss of MMR or CCyR on study. By 12 mo, 50% of pts with a molecular assessment had CMR4 and 27% had CMR4.5. Of the 152 pts who did not have CMR4 at baseline, 30% had achieved CMR4 (unconfirmed) by 12 mo. Of the 185 pts who did not have CMR4.5 at baseline, 21% had achieved CMR4.5 (unconfirmed) by 12 mo. Undetectable levels of BCR-ABL transcripts (with a test sensitivity of ≥ 4.5 log), were achieved by 12 mo by 12% of pts who did not have undetectable BCR-ABL transcript levels at BL. By 12 mo, 20 (10%) pts discontinued study (none due to progression, 1 due to death). Grade 3/4 adverse events were uncommon. Conclusions: ENESTcmr is the first phase 3 randomized study in CML-CP pts to assess the achievement of CMR as the primary endpoint. Unblinded results from this ongoing study will be presented and will provide information on the ability of pts to achieve confirmed CMR on nilotinib vs imatinib following extended treatment with imatinib. These aggregate data demonstrate that 12% of pts achieved undetectable BCR-ABL levels by 12 months after study entry. This is in contrast to observations in previous trials where the increase in the proportion of pts with undetectable BCR-ABL levels over time is more gradual. Further follow-up will identify pts with sustained CMR over time, which may offer these pts an opportunity to discontinue therapy. Disclosures: Hughes: Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Ariad: Honoraria, Membership on an entity's Board of Directors or advisory committees. Lipton:Novartis Pharmaceuticals Canada Inc: Honoraria, Membership on an entity's Board of Directors or advisory committees. Leber:Novartis Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Spector:Novartis: Membership on an entity's Board of Directors or advisory committees. Cervantes:Novartis: Speakers Bureau; BMS: Speakers Bureau. Pasquini:Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Bristol Myers Squibb: Speakers Bureau. Schwarer:Novartis: Honoraria; BMS: Honoraria. Mahon:Novartis: Honoraria, Research Funding. Rea:BMS: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Yeung:Novartis Pharmaceuticals: Research Funding; BMS Oncology: Research Funding. Kamel-Reid:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Reynolds:Novartis: Employment, Equity Ownership. Williams:Novartis: Employment. Szczudlo:Novartis: Employment, Equity Ownership. Branford:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Honoraria, Research Funding; Ariad: Research Funding." @default.
• W1775596629 created "2016-06-24" @default.
• W1775596629 creator A5004871362 @default.
• W1775596629 creator A5005392796 @default.
• W1775596629 creator A5010623907 @default.
• W1775596629 creator A5011454613 @default.
• W1775596629 creator A5013683304 @default.
• W1775596629 creator A5014346242 @default.
• W1775596629 creator A5018111458 @default.
• W1775596629 creator A5023965566 @default.
• W1775596629 creator A5049971021 @default.
• W1775596629 creator A5050862386 @default.
• W1775596629 creator A5055797334 @default.
• W1775596629 creator A5069987563 @default.
• W1775596629 creator A5075844368 @default.
• W1775596629 creator A5079701102 @default.
• W1775596629 creator A5086474233 @default.
• W1775596629 creator A5086618764 @default.
• W1775596629 creator A5086730784 @default.
• W1775596629 date "2011-11-18" @default.
• W1775596629 modified "2023-09-30" @default.
• W1775596629 title "Complete Molecular Response (CMR) Rate with Nilotinib in Patients (pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) without CMR After ≥ 2 Years on Imatinib: Preliminary Results From the Randomized ENESTcmr Trial of Nilotinib 400 Mg Twice Daily (BID) Vs Imatinib" @default.
• W1775596629 doi "https://doi.org/10.1182/blood.v118.21.606.606" @default.
• W1775596629 hasPublicationYear "2011" @default.
• W1775596629 type Work @default.
• W1775596629 sameAs 1775596629 @default.
• W1775596629 citedByCount "3" @default.
• W1775596629 countsByYear W17755966292012 @default.
• W1775596629 countsByYear W17755966292023 @default.
• W1775596629 crossrefType "journal-article" @default.
• W1775596629 hasAuthorship W1775596629A5004871362 @default.
• W1775596629 hasAuthorship W1775596629A5005392796 @default.
• W1775596629 hasAuthorship W1775596629A5010623907 @default.
• W1775596629 hasAuthorship W1775596629A5011454613 @default.
• W1775596629 hasAuthorship W1775596629A5013683304 @default.
• W1775596629 hasAuthorship W1775596629A5014346242 @default.
• W1775596629 hasAuthorship W1775596629A5018111458 @default.
• W1775596629 hasAuthorship W1775596629A5023965566 @default.
• W1775596629 hasAuthorship W1775596629A5049971021 @default.
• W1775596629 hasAuthorship W1775596629A5050862386 @default.
• W1775596629 hasAuthorship W1775596629A5055797334 @default.
• W1775596629 hasAuthorship W1775596629A5069987563 @default.
• W1775596629 hasAuthorship W1775596629A5075844368 @default.
• W1775596629 hasAuthorship W1775596629A5079701102 @default.
• W1775596629 hasAuthorship W1775596629A5086474233 @default.
• W1775596629 hasAuthorship W1775596629A5086618764 @default.
• W1775596629 hasAuthorship W1775596629A5086730784 @default.
• W1775596629 hasConcept C126322002 @default.
• W1775596629 hasConcept C143998085 @default.
• W1775596629 hasConcept C168563851 @default.
• W1775596629 hasConcept C203092338 @default.
• W1775596629 hasConcept C2777413986 @default.
• W1775596629 hasConcept C2777583451 @default.
• W1775596629 hasConcept C2778729363 @default.
• W1775596629 hasConcept C3019892230 @default.
• W1775596629 hasConcept C71924100 @default.
• W1775596629 hasConcept C90924648 @default.
• W1775596629 hasConceptScore W1775596629C126322002 @default.
• W1775596629 hasConceptScore W1775596629C143998085 @default.
• W1775596629 hasConceptScore W1775596629C168563851 @default.
• W1775596629 hasConceptScore W1775596629C203092338 @default.
• W1775596629 hasConceptScore W1775596629C2777413986 @default.
• W1775596629 hasConceptScore W1775596629C2777583451 @default.
• W1775596629 hasConceptScore W1775596629C2778729363 @default.
• W1775596629 hasConceptScore W1775596629C3019892230 @default.
• W1775596629 hasConceptScore W1775596629C71924100 @default.
• W1775596629 hasConceptScore W1775596629C90924648 @default.
• W1775596629 hasIssue "21" @default.
• W1775596629 hasLocation W17755966291 @default.
• W1775596629 hasOpenAccess W1775596629 @default.
• W1775596629 hasPrimaryLocation W17755966291 @default.
• W1775596629 hasRelatedWork W1510497893 @default.
• W1775596629 hasRelatedWork W2001289393 @default.
• W1775596629 hasRelatedWork W2051726599 @default.
• W1775596629 hasRelatedWork W2073935113 @default.
• W1775596629 hasRelatedWork W2120868842 @default.
• W1775596629 hasRelatedWork W2134832378 @default.
• W1775596629 hasRelatedWork W2488200262 @default.
• W1775596629 hasRelatedWork W4230849756 @default.
• W1775596629 hasRelatedWork W4245675997 @default.
• W1775596629 hasRelatedWork W54919303 @default.
• W1775596629 hasVolume "118" @default.
• W1775596629 isParatext "false" @default.
• W1775596629 isRetracted "false" @default.
• W1775596629 magId "1775596629" @default.
• W1775596629 workType "article" @default.