Idasanutlin, an MDM2 antagonist, showed clinical activity and a rapid reduction in JAK2 V617F allele burden in patients with polycythemia vera (PV) in a phase 1 study. This open-label phase 2 study evaluated idasanutlin in patients with hydroxyurea (HU)-resistant/-intolerant PV, per the European LeukemiaNet criteria, and phlebotomy dependence; prior ruxolitinib exposure was permitted. Idasanutlin was administered once daily on days 1 through 5 of each 28-day cycle.
View Article and Find Full Text PDFPurpose: PI3K/AKT pathway alterations are frequent in hormone receptor-positive (HR+) breast cancers. IPATunity130 Cohort B investigated ipatasertib-paclitaxel in PI3K pathway-mutant HR+ unresectable locally advanced/metastatic breast cancer (aBC).
Methods: Cohort B of the randomized, double-blind, placebo-controlled, phase 3 IPATunity130 trial enrolled patients with HR+ HER2-negative PIK3CA/AKT1/PTEN-altered measurable aBC who were considered inappropriate for endocrine-based therapy (demonstrated insensitivity to endocrine therapy or visceral crisis) and were candidates for taxane monotherapy.
Importance: Progression-free survival (PFS) has become a commonly used outcome to assess the efficacy of new cancer drugs. However, it is not clear if delay in progression leads to improved quality of life with or without overall survival benefit.
Objective: To evaluate the association between PFS and health-related quality of life (HRQoL) in oncology through a systematic review and quantitative analysis of published randomized clinical trials.
Objective: The objectives of this study were to evaluate the current state of reporting and handling of effect modification in network meta-analyses (NMAs) and perform exploratory analyses to identify variables that are potentially associated with incomplete reporting of effect modifiers in NMAs.
Study Design And Setting: We conducted a meta-epidemiological survey using a systematic review of NMAs published in 2013 and identified through MEDLINE and Embase databases.
Results: The review identified 77 NMAs.
Background: Osteoarthritis (OA) consumes a significant amount of healthcare resources, and impairs the health-related quality of life (HRQoL) of patients. Previous reviews have consistently found substantial variations in the costs of OA across studies and countries. The comparability between studies was poor and limited the detection of the true differences between these studies.
View Article and Find Full Text PDFIntroduction: There is an increasing number of new oncology drugs being studied, approved and put into clinical practice based on improvement in progression-free survival, when no overall survival benefits exist. In oncology, the association between progression-free survival and health-related quality of life is currently unknown, despite its importance for patients with cancer, and the unverified assumption that longer progression-free survival indicates improved health-related quality of life. Thus far, only 1 study has investigated this association, providing insufficient evidence and inconclusive results.
View Article and Find Full Text PDFPurpose: The Avastin in Glioblastoma trial has shown that patients newly diagnosed with glioblastoma multiforme (GBM) treated with bevacizumab plus radiotherapy and temozolomide versus radiotherapy and temozolomide alone showed improvement in progression-free survival, possibly leading to a new indication for first-line use of bevacizumab in GBM. The cost-utility of this new intervention remains unknown; therefore, we developed a Markov model estimating the incremental cost-utility ratio (ICUR) from a Canadian public payer perspective.
Methods: We incorporated trial data for state transitions and treatment effects from the Avastin in Glioblastoma trial, costs and resource use data from Canadian published studies and databases, and utility parameters from published literature.