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Chronic Myeloid Leukemia

A phase II study of α-interferon and oral arabinosyl cytosine (YNK01) in chronic myeloid leukemia

Leukemia volume 17, pages 554–559 (2003)Cite this article

Abstract

YNK01 (Starasid) is a prodrug that is adsorbed in the gut and is transformed in the liver in arabinosyl cytosine (AC). Low-dose AC (LDAC) is useful for the treatment of Philadelphia positive (Ph+) chronic myeloid leukemia (CML), especially in combination with α-interferon (αIFN). The use of YNK01 can avoid the daily s.c. injection of conventional AC. To assess the safety and the efficacy of αIFN and YNK01, we enrolled 86 consecutive previously untreated chronic phase Ph+ CML patients in a phase II study of αIFN (Intron-A) 5 MIU/m2 daily and YNK01 600 mg daily 14 days a month. The 6-month complete hematologic response and the 12-month major cytogenetic response rates were 78 and 28%, respectively. In a prior study of αIFN and conventional LDAC, they were 62 and 22%, respectively. However, the compliance to the treatment was poor, with 25% of cases discontinuing the treatment within the first year. This was not because of the severity of the side effects but because of the frequency, duration and repetition of the side effects, for an overall frequency of 13.17 adverse events, mostly grade 1 and 2, per patient per year. Therefore, the study of this effective combination is being pursued, testing lower doses of αIFN and YNK01.

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Acknowledgements

The technical assistance of Katia Vecchi is greatly appreciated. This work was supported by MURST, COFIN 2001, by the University of Bologna, 60%, and by Fondazione Monte, Bologna.

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Authors and Affiliations

  1. Institute of Hematology and Clinical Oncology ‘L. and A. Seràgnoli’, University of Bologna, S. Orsola Hospital, Bologna, Italy

    G Rosti, F Bonifazi, E Trabacchi, A de Vivo, S Bassi, G Martinelli, N Testoni & M Baccarani

  2. Chair of Hematology, University of Brescia, Italy

    D Russo

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  1. G Rosti
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  2. F Bonifazi
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  3. E Trabacchi
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for the Italian Cooperative Study Group on Chronic Myeloid Leukemia

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Active members of this study were A Peta and F Iuliano, Catanzaro; B Rotoli and L Luciano, Napoli; R Fanin and M Tiribelli, Udine; M Boccadoro and D Ferrero, Torino; G Fioritoni and R Di Lorenzo, Pescara; E Volpe and F Palmieri, Avellino; F Frigeri, Napoli; F Lauria and M Bocchia, Siena; F Grignani and AM Liberati, Perugia; AM Carella and CA Bodenizza, San Giovanni Rotondo; F Mandelli and E Montefusco, Roma; P Leoni and S Rupoli, Ancona; E Gallo and M Bertini, Torino; T Chisesi and A Polacco, Venezia; V Liso and G Specchia, Bari; G Leone and S Sica, Roma; A Blasio and F Ciccone, Latina; G Pizzolo and A Ambrosetti, Verona; E Pogliani and C Miccolis, Monza; A Gabbas and D Noli, Nuoro; P Mazza and M Cervellera, Taranto; GL Gaidano, Novara; MA Pistone, Cuneo; EM Schiavone, Napoli; E Zuffa, Ravenna; R Battista, Chioggia; S Pardini, Sassari; M Candela, Ancona; L Garetto, Torino; M Michieli, Aviano; C Bergonzi, Cremona.

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Rosti, G., Bonifazi, F., Trabacchi, E. et al. A phase II study of α-interferon and oral arabinosyl cytosine (YNK01) in chronic myeloid leukemia. Leukemia 17, 554–559 (2003). https://doi.org/10.1038/sj.leu.2402850

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