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Title: A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis.
Author: Vannucchi, Alessandro M.
Kantarjian, Hagop M.
Kiladjian, Jean-Jacques
Gotlib, Jason
Cervantes Requena, F.
Mesa, Ruben A.
Sarlis, Nicholas J.
Peng, Wei
Sandor, Victor
Gopalakrishna, Prashanth
Hmissi, Abdel
Stalbovskaya, Viktoriya
Gupta, Vikas
Harrison, Claire
Verstovsek, Srdan
García Pagán, Juan Carlos
Keywords: Càncer
Assaigs clínics de medicaments
Factors de risc en les malalties
Drug testing
Risk factors in diseases
Issue Date: 11-Jun-2015
Publisher: Ferrata Storti Foundation
Abstract: Ruxolitinib, a potent Janus kinase 1/2 inhibitor, resulted in rapid and durable improvements in splenomegaly and disease-related symptoms in the 2 phase III COMFORT studies. In addition, ruxolitinib was associated with prolonged survival compared with placebo (COMFORT-I) and best available therapy (COMFORT-II). We present a pooled analysis of overall survival in the COMFORT studies using an intent-to-treat analysis and an analysis correcting for crossover in the control arms. Overall, 301 patients received ruxolitinib (COMFORT-I, n=155; COMFORT-II, n=146) and 227 patients received placebo (n=154) or best available therapy (n=73). After a median three years of follow up, intent-to-treat analysis showed that patients who received ruxolitinib had prolonged survival compared with patients who received placebo or best available therapy [hazard ratio=0.65; 95% confidence interval (95%CI): 0.46-0.90; P=0.01]; the crossover-corrected hazard ratio was 0.29 (95%CI: 0.13-0.63). Both patients with intermediate-2- or high-risk disease showed prolonged survival, and patients with high-risk disease in the ruxolitinib group had survival similar to that of patients with intermediate-2-risk disease in the control group. The Kaplan-Meier estimate of overall survival at week 144 was 78% in the ruxolitinib arm, 61% in the intent-to-treat control arm, and 31% in the crossover-adjusted control arm. While larger spleen size at baseline was prognostic for shortened survival, reductions in spleen size with ruxolitinib treatment correlated with longer survival. These findings are consistent with previous reports and support that ruxolitinib offers a survival benefit for patients with myelofibrosis compared with conventional therapies. ( identifiers: COMFORT-I, NCT00952289; COMFORT-II, NCT00934544).
Note: Reproducció del document publicat a:
It is part of: Haematologica, 2015, vol. 100, num. 9, p. 1139-1145
Related resource:
ISSN: 0390-6078
Appears in Collections:Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

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