Peg IFNα-2a in Polycythemia Vera (PV). Results of a Phase 2 Study by the French 'PV-NORD' Group

Autor:	Nathalie Cambier, Pascal Turlure, Murielle Roussel, Bernard Grandchamp, Bruno Cassinat, Jean-Didier Rain, Sylvia Bellucci, Pierre Fenaux, Jean-Jacques Kiladjian, Christine Chomienne, Marie-José Grange
Rok vydání:	2006
Předmět:	medicine.medical_specialty business.industry Immunology Phases of clinical research Cell Biology Hematology NOT EVALUABLE Phlebotomy medicine.disease Biochemistry Thrombosis Gastroenterology Surgery Polycythemia vera Peg ifnα Median time Internal medicine medicine Adverse effect business
Zdroj:	Blood. 108:670-670
ISSN:	1528-0020 0006-4971
DOI:	10.1182/blood.v108.11.670.670
Popis:	Background: IFNα can control erythrocytosis in 75% of PV while avoiding leukemogenicity of myelosuppressive drugs, but 20–25% of patients stop therapy due to side effects. Peg IFNα −2b, allowing weekly use, showed similar efficacy but no better tolerance in 3 trials. We conducted a phase 2 trial of peg-IFNα 2a in PV, a drug never tested in MPD to our knowledge. Study design: Inclusion criteria in PVN1 trial (www.clinicaltrials.gov as #NCT00241241). were PV diagnosis (PVSG criteria), age 18–65 years, no previous treatment or only phlebotomies, or cytoreductive treatment Results: 33 of the 40 pts enrolled had a 12 mos FU: M/F : 14/19, median age 50 yrs (range 22–65). Median time from diagnosis: 6 months (range 1–65). 9 pts (27%) had previously received HU, 6 (18%) had a history of thrombosis. Median Ht: 60% in males and 50% in females. Median WBC and plt counts: 9.109/l (range 4–23) and 598.109/l (range 171–1428), resp. 7 pts (21%) had splenomegaly. 1 patient was not evaluable for response (allergic reaction at first injection). At 6 mos, all pts were responders: 26 CR (81%), 6 PR (19%). At 12 mos, 2/32 pts had stopped treatment (1 grade 2 thrombocytopenia, 1 skin reaction), 27 (84%) were in CR and 3 pts in PR. Median peg-IFNα 2a dose received during the 1st year was 113 μ g/w (range 30–180). Neither thrombosis nor hemorrhage was reported. Only grade 1 to 3 toxicities were reported, lasting Conclusion: After 1 year, 94% hematological and 89% molecular response is obtained with peg-IFN-α 2a in PV, treatment being stopped due to side effects in only 9% of pts. Pts with 9pLOH had similar hematological and molecular response rates, although molecular response was slower. Peg-IFNα 2a could be a treatment of choice for PV, until specific targeted therapies are available.
Databáze:	OpenAIRE
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