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Blood, 15 October 2008, Vol. 112, No. 8, pp. 3065-3072. Prepublished online as a Blood First Edition Paper on July 23, 2008; DOI 10.1182/blood-2008-03-143537. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2008-03-143537v1 112/8/3065    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via CrossRef Google Scholar Articles by Kiladjian, J.-J. Articles by Fenaux, P. PubMed PubMed Citation Articles by Kiladjian, J.-J. Articles by Fenaux, P. Related Collections Neoplasia Red Cells Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Pegylated interferon-alfa-2a induces complete hematologic and molecular responses with low toxicity in polycythemia vera Jean-Jacques Kiladjian1,*, Bruno Cassinat2,*, Sylvie Chevret3, Pascal Turlure4, Nathalie Cambier5, Murielle Roussel6, Sylvia Bellucci7, Bernard Grandchamp8, Christine Chomienne2, and Pierre Fenaux1 1 Assistance Publique-Hôpitaux de Paris, Hôpital Avicenne, Service d'Hématologie Clinique and Paris 13 University, Bobigny; 2 Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Unité de Biologie Cellulaire, Paris; 3 Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, DBIM, Paris; 4 CHU Dupuytren, Service d'Hematologie, Limoges; 5 CHRU de Lille, Hopital Huriez, Service des Maladies du Sang, Lille; 6 Service d'Hématologie, CHU Purpan, Toulouse; 7 Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisiere, Service d'Hématologie, Paris; and 8 Inserm U656 and Assistance Publique-Hôpitaux de Paris, Service de Biochimie Hormonale et Génétique, Hôpital Bichat and Paris 7 University, Paris, France Interferon- (IFN-) is a nonleukemogenic treatment of polycythemia vera (PV) able to induce cytogenetic remissions. Its use is limited by toxicity, leading to treatment discontinuation in approximately 20% of patients. We completed a phase 2 multicenter study of pegylated IFN--2a in 40 PV patients. Objectives included evaluation of efficacy, safety, and monitoring of residual disease using JAK2V617F quantification (%V617F). Median follow-up was 31.4 months. At 12 months, all 37 evaluable patients had hematologic response, including 94.6% complete responses (CRs). Only 3 patients (8%) had stopped treatment. After the first year, 35 patients remained in hematologic CR, including 5 who had stopped pegylated IFN--2a. Sequential samples for %V617F monitoring, available in 29 patients, showed %V617F decrease in 26 (89.6%). Median %V617F decreased from 45% before pegylated IFN--2a to 22.5%, 17.5%, 5%, and 3% after 12, 18, 24, and 36 months, respectively. Molecular CR (JAK2V617F undetectable) was achieved in 7 patients, lasting from 6+ to 18+ months, and persisted after pegylated IFN--2a discontinuation in 5. No vascular event was recorded. These results show that pegylated IFN--2a yields high rates of hematologic and molecular response in PV with limited toxicity, and could even eliminate the JAK2 mutated clone in selected cases. Available at www.clinicaltrials.gov as #NCT00241241 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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