One-year and long-term molecular response to nilotinib and dasatinib for newly diagnosed chronic myeloid leukemia: a matching-adjusted indirect comparison

Signorovitch, James; Betts, Keith A.; Reichmann, William M.; Thomason, Darren; Galebach, Phil; Wu, Eric Q.; Chen, Lei; DeAngelo, Daniel J.

doi:10.1185/03007995.2014.977992

Cited by 15 publications

(17 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The method corrects for potential biases caused by imbalances in patient characteristics that may have an impact on the relative treatment effect, allowing for indirect comparison with limited bias [16]. MAIC modeling has provided strong comparative evidence in the absence of head-to-head studies in various disease settings [17][18][19]. When studies use the same comparator, such as placebo plus ADT in the case of SPARTAN and PROSPER, MAIC is considered an appropriate methodology to examine comparative effectiveness [16].…”

Section: Introductionmentioning

confidence: 99%

Matching-Adjusted Indirect Comparison of the Efficacy of Apalutamide and Enzalutamide with ADT in the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer

Oudard

Uemura

Joniau³

et al. 2019

Adv Ther

View full text Add to dashboard Cite

Introduction: Apalutamide and enzalutamide are next-generation androgen receptor inhibitors that demonstrated efficacy in placebo-controlled studies (SPARTAN for apalutamide; PROSPER for enzalutamide) when used in combination with androgen deprivation therapy (ADT) for treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). In the absence of comparative studies between these agents, the present study sought to indirectly compare metastasis-free survival (MFS) and overall survival (OS) in patients with nmCRPC who received these therapies. Methods: Individual patient-level data from SPARTAN (apalutamide plus ADT) and published data from PROSPER (enzalutamide plus ADT) were utilized. An anchored matching-adjusted indirect comparison (MAIC) was conducted by weighting the patients from the SPARTAN study to match baseline characteristics reported for PROSPER. Hazard ratios (HRs) for MFS and OS were re-estimated for SPARTAN using weighted Cox proportional hazards models and indirectly compared with those of PROSPER using a Bayesian network metaanalysis. Results: From the SPARTAN population (N = 1207), a total of 1171 patients were matched to the PROSPER population (N = 1401). The recalculated HRs (95% confidence interval) Martin Ladouceur was an employee of Analysis Group, Inc. during the development of this manuscript. Ajay S. Behl was an employee of Janssen Scientific Affairs during the development of this manuscript.

show abstract

Section: Introductionmentioning

confidence: 99%

Matching-Adjusted Indirect Comparison of the Efficacy of Apalutamide and Enzalutamide with ADT in the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer

Oudard

Uemura

Joniau³

et al. 2019

Adv Ther

View full text Add to dashboard Cite

show abstract

“…Signorovitch et al previously conducted matching-adjusted, indirect comparisons of dasatinib and nilotinib using published data from the DASISION and ENESTnd trials. [19][20][21] Those authors reported that nilotinib was associated with significantly higher rates of MMR, MR 4.0 , and MR 4.5 at 12 months and produced superior overall survival compared with dasatinib. However, their analysis included several limitations: 1) individual patient data were not available from the DASISION trial, and the study used published data for comparison; 2) the study did not adjust for risk scores in the matching process, because the ENESTnd and DASISION studies used different prognostic scores; and 3) different ethnic groups of patients were treated in the 2 trials, because the ENESTnd trial accrued patients mostly from United States and the United Kingdom; whereas the DASISION study Although there is no substitute for a head-to-head randomized trial, our study provides the "next best" comparative analysis of the available evidence for dasatinib and nilotinib as the initial treatment for patients with newly diagnosed CML-CP.…”

Section: Discussionmentioning

confidence: 99%

A propensity score matching analysis of dasatinib and nilotinib as a frontline therapy for patients with chronic myeloid leukemia in chronic phase

Takahashi

Kantarjian

Yang

et al. 2016

Cancer

View full text Add to dashboard Cite

Background Both dasatinib and nilotinib are approved frontline therapy for chronic myeloid leukemia, chronic phase (CML-CP) based on randomized trials compared to imatinib. However, no head to head comparison of dasatinib and nilotinib has been conducted in newly diagnosed CML-CP patients. Method We conducted a propensity score (PS) matched comparison of patients with CML-CP, who received front-line therapy by either dasatinib (N = 102) or nilotinib (N = 104) under the respective phase II trials conducted in parallel. Result PS matching resulted in 87 patients from each trial to be matched for pre-treatment characteristics. The 3-month BCR-ABL1/ABL1 <10% rate was 93% with dasatinib and 94% with nilotinib (p=0.25), respectively. Rates of major molecular response (MMR) at 12 months were 77% and 85% (p=0.13), respectively, and MR4.5 at 36 months are 66% and 64% (p=0.96), respectively. All other clinically relevant response were similar between the two treatment cohorts. The 3-year probability of event-free survival was 89% in the dasatinib-treated patients and 87% for those treated with nilotinib (p=0.99). Corresponding 3-year overall survival probabilities were 99% and 93%, respectively (p=0.95). No statistical difference was observed between dasatinib and nilotinib treated groups in any of the other survival endpoints. Treatment discontinuation rate was also similar between the two cohorts (18% in dasatinib and 19% in nilotinib, P = 0.82). Conclusion In PS matched cohort of newly diagnosed CML-CP patients, dasatinib and nilotinib offer similar response and survival outcomes. Both drugs can be considered as reasonable standard of care options as a first line therapy in CML-CP patients.

show abstract

“…Five articles were excluded because they were one of the 11 used in the citation searching process. Of the remaining 36 articles, full text articles were reviewed during which a further 8 articles were excluded because they discussed the general issue of comparative effectiveness or were about specific clinical aspects, leaving 28 articles …”

Section: Systematic Review Of Evidence Synthesis Methods For Comparinmentioning

confidence: 99%

A review of methods for comparing treatments evaluated in studies that form disconnected networks of evidence

Stevens

Fletcher

Downey

et al. 2017

Research Synthesis Methods

View full text Add to dashboard Cite

A network meta-analysis allows a simultaneous comparison between treatments evaluated in randomised controlled trials that share at least one treatment with at least one other study. Estimates of treatment effects may be required for treatments across disconnected networks of evidence, which requires a different statistical approach and modelling assumptions to account for imbalances in prognostic variables and treatment effect modifiers between studies. In this paper, we review and discuss methods for comparing treatments evaluated in studies that form disconnected networks of evidence. Several methods have been proposed but assessing which are appropriate often depends on the clinical context as well as the availability of data. Most methods account for sampling variation but do not always account for others sources of uncertainty. We suggest that further research is required to assess the properties of methods and the use of approaches that allow the incorporation of external information to reflect parameter and structural uncertainty.

show abstract

One-year and long-term molecular response to nilotinib and dasatinib for newly diagnosed chronic myeloid leukemia: a matching-adjusted indirect comparison

Cited by 15 publications

References 23 publications

Matching-Adjusted Indirect Comparison of the Efficacy of Apalutamide and Enzalutamide with ADT in the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer

Matching-Adjusted Indirect Comparison of the Efficacy of Apalutamide and Enzalutamide with ADT in the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer

A propensity score matching analysis of dasatinib and nilotinib as a frontline therapy for patients with chronic myeloid leukemia in chronic phase

A review of methods for comparing treatments evaluated in studies that form disconnected networks of evidence

Contact Info

Product

Resources

About