A prospective randomized study of alpha-2b interferon plus hydroxyurea or cytarabine for patients with early chronic phase chronic myelogenous leukemia: The international oncology study group CML1 study

Francis J. Giles*, Jianqin Shan, Shanshan Chen, Suresh H. Advani, Iman Supandiman, Zeba Aziz, Alendry P. Caviles, Goh Yeow Tee, Martin R. Chasen, Zahira Fahed, Tsu Yi Chao, Ismet Aydogdu, Anne M. Lynott

*Corresponding author for this work

Research output: Contribution to journalArticle

15 Scopus citations

Abstract

A prospective randomized international study of 143 patients showed no apparent early survival advantage conferred by combining cytarabine, rather than hydroxyurea, with INF as first-line CML therapy. Combinations of alpha-interferon (INF) and chemotherapeutic agents are currently first-line therapy for the majority of patients with chronic myeloid leukemia (CML). The International Oncology Study Group conducted a prospective randomized study comparing INF combined with hydroxyurea or cytarabine. The primary study aim was to compare the survival durations in these patient cohorts. Patients with early chronic phase CML were randomized to receive INF 5 million units (Mu) given five times per week subcutaneously plus hydroxyurea or cytarabine as required to achieve a complete hematologic response and to maintain a WBC count between 2 x 109/L and 10 x 109/L and a platelet count between 75 x 109/L and 100 x 109/L. Therapy continued as tolerated unless progressive or blast phase disease occurred. At 36 months, the actuarial survival rate was equivalent in both groups: HI group (79 patients) survival was 85% (95% CI, 68-100%), as compared to 95% (95% CI, 79-100%) in the CI group (64 patients). In conclusion if seems that there is no apparent early survival advantage conferred by combining cytarabine, rather than hydroxyurea, with INF as first-line CML therapy.

Original languageEnglish (US)
Pages (from-to)367-377
Number of pages11
JournalLeukemia and Lymphoma
Volume37
Issue number3-4
StatePublished - Apr 3 2000

Keywords

  • CML hydroxyurea
  • Cytarabine
  • Interferon
  • Survival

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Giles, F. J., Shan, J., Chen, S., Advani, S. H., Supandiman, I., Aziz, Z., Caviles, A. P., Tee, G. Y., Chasen, M. R., Fahed, Z., Chao, T. Y., Aydogdu, I., & Lynott, A. M. (2000). A prospective randomized study of alpha-2b interferon plus hydroxyurea or cytarabine for patients with early chronic phase chronic myelogenous leukemia: The international oncology study group CML1 study. Leukemia and Lymphoma, 37(3-4), 367-377.