Matches in SemOpenAlex for { <https://semopenalex.org/work/W2904999717> ?p ?o ?g. }
Showing items 1 to 67 of
67
with 100 items per page.
- W2904999717 endingPage "1742" @default.
- W2904999717 startingPage "1742" @default.
- W2904999717 abstract "Abstract Introduction Several randomized controlled trials (RCTs) compare second generation tyrosine kinase inhibitors (TKIs) with imatinib (IM) for the first-line (1L) treatment of chronic phase chronic myeloid leukemia (CP-CML). However, an examination indicated cross-trial heterogeneity in terms of disease and patient characteristics (baseline risk score, age, trial region, and post-baseline IM dose escalation) and outcomes reported (type and time of evaluation). For this reason, a matching adjusted indirect treatment comparison (MAIC) can be used to assess comparative efficacy. The objective of this study was to compare the efficacy of bosutinib (BOS) with nilotinib (NIL) and dasatinib (DAS) in 1L CP-CML via unanchored MAICs. Methods As well as heterogeneity in baseline characteristics, differences in the amount of IM dose escalations in earlier clinical pivotal trials (ENESTnd: 15.9% at 12 months; DASISION 20% at 24 months) relative to more recent ones (BFORE: 27.5% and 30.9% at 12 and 24 months, respectively) were observed. Because differences in IM dose-escalation regimens are trial design matters, they cannot be adjusted for using anchored MAICs. Therefore, an unanchored MAIC (which dismisses the common comparator arm, in this case IM) was used. Unanchored MAICs comparing BOS with NIL and DAS were performed to match the summary statistics in the BFORE trial to the reported summary statistics in the ENESTnd (NIL) and the DASISION (DAS) trials. Outcomes assessed included major molecular response (MMR) at 12 months and at any time after 12 months, complete cytogenetic response (CCyR) by 12 months, and deep molecular response (MR4) at 12 months. Statistical significance was assessed based on confidence intervals (CI; significant when CI excludes 1). The sample size of the matching-adjusted BOS population was estimated using the effective sample size (ESS). No adjustments for multiple comparisons were made. Results The MAICs showed an MMR at 12 months of 49.32% (vs 47.13% before the MAIC, N=244, ESS=186) for BOS vs 44% for NIL (OR 1.24, 95% CI [0.87-1.77], N=282) and an MMR at any time of 58.09% (vs 57.79% before MAIC, N=244, ESS=142) for BOS vs 57% for NIL (OR 1.05, 95% CI [0.72-1.5], N=282), and 58.52% (vs 58.16% before MAIC, N=239, ESS=192) for BOS vs 52% for DAS (OR 1.3, 95% CI [0.9-1.88], N=259). BOS had a CCyR by 12 months of 82.59% (vs 82.38% before MAIC, N=244) vs 80% for NIL (OR 1.19, 95% CI [0.75-1.87], N=282, ESS=195) and 80.47% (vs 82.01% before MAIC, N=239, ESS=185) vs 83% for DAS (OR 0.84, 95% CI [0.53-1.35], N=259). MR4 at 12 months was 20.34% (vs 20.49% before MAIC, N=244, ESS=185) for BOS vs 12% for NIL (OR 1.87, 95% CI [1.15-3.05], N=282). MMR and MR4 at month 12 were not reported for DAS. Discussion The general MAIC limitations (impact of having access to only marginal covariate distribution, choice of scale for indirect comparisons, choice of target population and sampling variation in the target population) apply to our analyses as well. Nevertheless, indirect comparisons using unanchored MAICs were conducted because cross-trial heterogeneity in patient baseline characteristics could bias the results of a naïve comparison and increases in IM dose escalation over time could bias the results of an anchored MAIC. The unanchored MAICs indicated that BOS was numerically higher than NIL for all response rates examined, however, except for MR4, none were statistically significant. BOS had a numerically higher MMR at any time and a numerically lower CCyR by 12 months compared with DAS, however, neither were statistically significant. BOS therefore seems to be an equally effective TKI as NIL and DAS in the 1L CP-CML setting. These findings, based on statistical methods, should be confirmed by clinical research. Disclosures Muresan: Ingress-health Nederland BV: Employment. Mamolo:Pfizer: Employment, Equity Ownership. Cappelleri:Pfizer: Employment, Equity Ownership. Crescenzo:Pfizer: Employment. Leip:Pfizer: Employment, Equity Ownership. Viqueira:Pfizer: Employment, Equity Ownership. Heeg:Ingress-health Nederland BV: Employment, Equity Ownership, Research Funding." @default.
- W2904999717 created "2018-12-22" @default.
- W2904999717 creator A5005182505 @default.
- W2904999717 creator A5039926945 @default.
- W2904999717 creator A5067366211 @default.
- W2904999717 creator A5068877757 @default.
- W2904999717 creator A5087641723 @default.
- W2904999717 creator A5090399884 @default.
- W2904999717 creator A5091669022 @default.
- W2904999717 date "2018-11-29" @default.
- W2904999717 modified "2023-10-17" @default.
- W2904999717 title "An Indirect Comparison between Bosutinib, Nilotinib and Dasatinib in First-Line Chronic Phase Chronic Myeloid Leukemia" @default.
- W2904999717 doi "https://doi.org/10.1182/blood-2018-99-114827" @default.
- W2904999717 hasPublicationYear "2018" @default.
- W2904999717 type Work @default.
- W2904999717 sameAs 2904999717 @default.
- W2904999717 citedByCount "0" @default.
- W2904999717 crossrefType "journal-article" @default.
- W2904999717 hasAuthorship W2904999717A5005182505 @default.
- W2904999717 hasAuthorship W2904999717A5039926945 @default.
- W2904999717 hasAuthorship W2904999717A5067366211 @default.
- W2904999717 hasAuthorship W2904999717A5068877757 @default.
- W2904999717 hasAuthorship W2904999717A5087641723 @default.
- W2904999717 hasAuthorship W2904999717A5090399884 @default.
- W2904999717 hasAuthorship W2904999717A5091669022 @default.
- W2904999717 hasBestOaLocation W29049997171 @default.
- W2904999717 hasConcept C126322002 @default.
- W2904999717 hasConcept C143998085 @default.
- W2904999717 hasConcept C168563851 @default.
- W2904999717 hasConcept C2777413986 @default.
- W2904999717 hasConcept C2777583451 @default.
- W2904999717 hasConcept C2778208673 @default.
- W2904999717 hasConcept C2778729363 @default.
- W2904999717 hasConcept C2779536868 @default.
- W2904999717 hasConcept C535046627 @default.
- W2904999717 hasConcept C71924100 @default.
- W2904999717 hasConceptScore W2904999717C126322002 @default.
- W2904999717 hasConceptScore W2904999717C143998085 @default.
- W2904999717 hasConceptScore W2904999717C168563851 @default.
- W2904999717 hasConceptScore W2904999717C2777413986 @default.
- W2904999717 hasConceptScore W2904999717C2777583451 @default.
- W2904999717 hasConceptScore W2904999717C2778208673 @default.
- W2904999717 hasConceptScore W2904999717C2778729363 @default.
- W2904999717 hasConceptScore W2904999717C2779536868 @default.
- W2904999717 hasConceptScore W2904999717C535046627 @default.
- W2904999717 hasConceptScore W2904999717C71924100 @default.
- W2904999717 hasIssue "Supplement 1" @default.
- W2904999717 hasLocation W29049997171 @default.
- W2904999717 hasOpenAccess W2904999717 @default.
- W2904999717 hasPrimaryLocation W29049997171 @default.
- W2904999717 hasRelatedWork W1554937972 @default.
- W2904999717 hasRelatedWork W1976491322 @default.
- W2904999717 hasRelatedWork W1982938623 @default.
- W2904999717 hasRelatedWork W2012383978 @default.
- W2904999717 hasRelatedWork W2074762197 @default.
- W2904999717 hasRelatedWork W2114348747 @default.
- W2904999717 hasRelatedWork W2146006566 @default.
- W2904999717 hasRelatedWork W2149166282 @default.
- W2904999717 hasRelatedWork W2401908067 @default.
- W2904999717 hasRelatedWork W2952141298 @default.
- W2904999717 hasVolume "132" @default.
- W2904999717 isParatext "false" @default.
- W2904999717 isRetracted "false" @default.
- W2904999717 magId "2904999717" @default.
- W2904999717 workType "article" @default.