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

Research output: Contribution to journalArticle

15 Citations (Scopus)

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
Pages (from-to)367-377
Number of pages11
JournalLeukemia and Lymphoma
Volume37
Issue number3-4
Publication statusPublished - 2000
Externally publishedYes

Fingerprint

interferon alfa-2b
Leukemia, Myeloid, Chronic Phase
Hydroxyurea
Cytarabine
Prospective Studies
Interferons
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Survival
Blast Crisis
Therapeutics
Platelet Count
Interferon-alpha
Survival Rate

Keywords

  • CML hydroxyurea
  • Cytarabine
  • Interferon
  • Survival

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

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

In: Leukemia and Lymphoma, Vol. 37, No. 3-4, 2000, p. 367-377.

Research output: Contribution to journalArticle

Giles, FJ, Shan, J, Chen, S, Advani, SH, Supandiman, I, Aziz, Z, Caviles, AP, Tee, GY, Chasen, MR, Fahed, Z, Chao, TY, Aydogdu, I & Lynott, AM 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, vol. 37, no. 3-4, pp. 367-377.
Giles, Francis J. ; Shan, Jianqin ; Chen, Shanshan ; Advani, Suresh H. ; Supandiman, Iman ; Aziz, Zeba ; Caviles, Alendry P. ; Tee, Goh Yeow ; Chasen, Martin R. ; Fahed, Zahira ; Chao, Tsu Yi ; Aydogdu, Ismet ; Lynott, Anne M. / 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. In: Leukemia and Lymphoma. 2000 ; Vol. 37, No. 3-4. pp. 367-377.
@article{f27126d20fc248c79e0fbf0abe3da4ed,
title = "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",
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.",
keywords = "CML hydroxyurea, Cytarabine, Interferon, Survival",
author = "Giles, {Francis J.} and Jianqin Shan and Shanshan Chen and Advani, {Suresh H.} and Iman Supandiman and Zeba Aziz and Caviles, {Alendry P.} and Tee, {Goh Yeow} and Chasen, {Martin R.} and Zahira Fahed and Chao, {Tsu Yi} and Ismet Aydogdu and Lynott, {Anne M.}",
year = "2000",
language = "English",
volume = "37",
pages = "367--377",
journal = "Leukemia and Lymphoma",
issn = "1042-8194",
publisher = "Informa Healthcare",
number = "3-4",

}

TY - JOUR

T1 - A prospective randomized study of alpha-2b interferon plus hydroxyurea or cytarabine for patients with early chronic phase chronic myelogenous leukemia

T2 - The international oncology study group CML1 study

AU - Giles, Francis J.

AU - Shan, Jianqin

AU - Chen, Shanshan

AU - Advani, Suresh H.

AU - Supandiman, Iman

AU - Aziz, Zeba

AU - Caviles, Alendry P.

AU - Tee, Goh Yeow

AU - Chasen, Martin R.

AU - Fahed, Zahira

AU - Chao, Tsu Yi

AU - Aydogdu, Ismet

AU - Lynott, Anne M.

PY - 2000

Y1 - 2000

N2 - 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.

AB - 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.

KW - CML hydroxyurea

KW - Cytarabine

KW - Interferon

KW - Survival

UR - http://www.scopus.com/inward/record.url?scp=0034066911&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0034066911&partnerID=8YFLogxK

M3 - Article

VL - 37

SP - 367

EP - 377

JO - Leukemia and Lymphoma

JF - Leukemia and Lymphoma

SN - 1042-8194

IS - 3-4

ER -