TY - JOUR
T1 - Impact of ruxolitinib on the natural history of primary myelofibrosis
T2 - A comparison of the DIPSS and the COMFORT-2 cohorts
AU - Passamonti, Francesco
AU - Maffioli, Margherita
AU - Cervantes, Francisco
AU - Vannucchi, Alessandro Maria
AU - Morra, Enrica
AU - Barbui, Tiziano
AU - Caramazza, Domenica
AU - Pieri, Lisa
AU - Rumi, Elisa
AU - Gisslinger, Heinz
AU - Knoops, Laurent
AU - Kiladjian, Jean Jaques
AU - Mora, Barbara
AU - Hollaender, Norbert
AU - Pascutto, Cristiana
AU - Harrison, Claire
AU - Cazzola, Mario
PY - 2014/3/20
Y1 - 2014/3/20
N2 - The international prognostic scoring system (IPSS) provides reliable risk assessment in patients with primary myelofibrosis (PMF). Recent clinical trials in PMF patients with intermediate-2 or high IPSS risk have shown a survival advantage of ruxolitinib over placebo (COMFORT-1) or best available therapy (COMFORT-2). Because crossover was allowed in these studies, we analyzed the cohort of ruxolitinib-naive patients used for developing the dynamic IPSS (DIPSS). By adopting ad hoc statistical analyses, we compared survival from diagnosis of 100 PMF patients receiving ruxolitinib within COMFORT-2 with that of 350 patients of the DIPSS study. Subjects were properly matched, and both left-truncation and right-censoring were accounted in order to compare higher IPSS risks exclusively. Patients receiving ruxolitinib had longer survival (5 years, 95% confidence interval [CI]: 2.9-7.8 vs 3.5 years, 95% CI: 3.0-3.9) with a hazard ratio of 0.61 (95% CI: 0.41-0.91; P = .0148). This observation suggests that ruxolitinib may modify the natural history of PMF.
AB - The international prognostic scoring system (IPSS) provides reliable risk assessment in patients with primary myelofibrosis (PMF). Recent clinical trials in PMF patients with intermediate-2 or high IPSS risk have shown a survival advantage of ruxolitinib over placebo (COMFORT-1) or best available therapy (COMFORT-2). Because crossover was allowed in these studies, we analyzed the cohort of ruxolitinib-naive patients used for developing the dynamic IPSS (DIPSS). By adopting ad hoc statistical analyses, we compared survival from diagnosis of 100 PMF patients receiving ruxolitinib within COMFORT-2 with that of 350 patients of the DIPSS study. Subjects were properly matched, and both left-truncation and right-censoring were accounted in order to compare higher IPSS risks exclusively. Patients receiving ruxolitinib had longer survival (5 years, 95% confidence interval [CI]: 2.9-7.8 vs 3.5 years, 95% CI: 3.0-3.9) with a hazard ratio of 0.61 (95% CI: 0.41-0.91; P = .0148). This observation suggests that ruxolitinib may modify the natural history of PMF.
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U2 - 10.1182/blood-2013-12-544411
DO - 10.1182/blood-2013-12-544411
M3 - Article
C2 - 24443442
AN - SCOPUS:84897528714
VL - 123
SP - 1833
EP - 1835
JO - Blood
JF - Blood
SN - 0006-4971
IS - 12
ER -