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      A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis.

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          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. (clinicaltrials.gov identifiers: COMFORT-I, NCT00952289; COMFORT-II, NCT00934544).

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          Author and article information

          Journal
          Haematologica
          Haematologica
          1592-8721
          0390-6078
          Sep 2015
          : 100
          : 9
          Affiliations
          [1 ] University of Florence, Italy amvannucchi@unifi.it.
          [2 ] The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
          [3 ] Hôpital Saint-Louis et Université Paris Diderot, Paris, France.
          [4 ] Stanford Cancer Institute, CA, USA.
          [5 ] Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
          [6 ] Mayo Clinic, Scottsdale, AZ, USA.
          [7 ] Incyte Corporation, Wilmington, DE, USA.
          [8 ] Novartis Pharma AG, Basel, Switzerland.
          [9 ] Princess Margaret Cancer Center, University of Toronto, Ontario, Canada.
          [10 ] Guy's and St. Thomas' NHS Foundation Trust, Guy's Hospital, London, UK.
          Article
          haematol.2014.119545
          10.3324/haematol.2014.119545
          4800694
          26069290
          Copyright© Ferrata Storti Foundation.

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