Phase II trial of infusional cyclophosphamide, idarubicin, and etoposide in poor prognosis non-Hodgkin's lymphoma

Huda Salman, Alejandra Perez, Joseph A. Sparano, Howard Ratech, Abdissa Negassa, Una Hopkins, Gina Villani, Joachim Fuks, Peter H. Wiernik

Research output: Contribution to journalArticle

Abstract

The purpose of this study was to determine the complete response (CR) rate, failure-free survival (FFS), and overall survival (OS) of patients with poor-prognosis intermediate-grade non-Hodgkin's lymphoma (NHL) after treatment with cyclophosphamide, idarubicin, and etoposide given as a continuous intravenous infusion (CIVI) over 96 hours (infusional CIE), including patients with relapsed/refractory disease and patients with no prior therapy but at least two poor-risk features by the age-adjusted International Prognostic Index. Forty-two patients with previously untreated NHL (N = 24) or relapsed/refractory (N = 18) NHL received cyclophosphamide (200 mg/m2/d), idarubicin (2.5-3.0 mg/m2/d) and etoposide (60 mg/m2/d) given by a 96-hour CIVI every 3 weeks for a maximum of 8 cycles. All patients also received granulocyte-colony-stimulating factor. CR occurred in 10 of 24 patients (42%; 95% confidence intervals [CI] 22%, 62%) treated with CIE as first-line therapy, and in 3 of 18 patients (17%; 95% CI 20%, 32%) treated with CIE as second-line or greater therapy. One-year FFS and OS were 42% and 64%, respectively, in patients with no prior therapy, and 17% and 56% in patients with prior therapy. Severe (grade III) or life-threatening (grade IV) toxicity included leukopenia (59%), anemia (61%), thrombocytopenia (31%), and infection (10%). Two patients (4%) died due to treatment related infectious complications. It is unlikely that infusional CIE produces a CR rate more than about 60% in poor-risk patients with intermediate-grade NHL when used as first-line therapy, or more than about 30% in patients receiving the regimen as second-line therapy. Substitution of idarubicin for doxorubicin in this setting, therefore, is not associated with an improved response rate.

Original languageEnglish (US)
Pages (from-to)338-343
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume26
Issue number4
DOIs
StatePublished - Aug 1 2003

Fingerprint

Idarubicin
Etoposide
Non-Hodgkin's Lymphoma
Cyclophosphamide
Therapeutics
Survival
Intravenous Infusions
Confidence Intervals
Leukopenia
Granulocyte Colony-Stimulating Factor
Thrombocytopenia
Doxorubicin
Anemia

Keywords

  • Idarubicin
  • Infusional therapy
  • Non-Hodgkin's lymphoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Phase II trial of infusional cyclophosphamide, idarubicin, and etoposide in poor prognosis non-Hodgkin's lymphoma. / Salman, Huda; Perez, Alejandra; Sparano, Joseph A.; Ratech, Howard; Negassa, Abdissa; Hopkins, Una; Villani, Gina; Fuks, Joachim; Wiernik, Peter H.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 26, No. 4, 01.08.2003, p. 338-343.

Research output: Contribution to journalArticle

Salman, Huda ; Perez, Alejandra ; Sparano, Joseph A. ; Ratech, Howard ; Negassa, Abdissa ; Hopkins, Una ; Villani, Gina ; Fuks, Joachim ; Wiernik, Peter H. / Phase II trial of infusional cyclophosphamide, idarubicin, and etoposide in poor prognosis non-Hodgkin's lymphoma. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2003 ; Vol. 26, No. 4. pp. 338-343.
@article{037c1a4001474d0faa1906881cb57142,
title = "Phase II trial of infusional cyclophosphamide, idarubicin, and etoposide in poor prognosis non-Hodgkin's lymphoma",
abstract = "The purpose of this study was to determine the complete response (CR) rate, failure-free survival (FFS), and overall survival (OS) of patients with poor-prognosis intermediate-grade non-Hodgkin's lymphoma (NHL) after treatment with cyclophosphamide, idarubicin, and etoposide given as a continuous intravenous infusion (CIVI) over 96 hours (infusional CIE), including patients with relapsed/refractory disease and patients with no prior therapy but at least two poor-risk features by the age-adjusted International Prognostic Index. Forty-two patients with previously untreated NHL (N = 24) or relapsed/refractory (N = 18) NHL received cyclophosphamide (200 mg/m2/d), idarubicin (2.5-3.0 mg/m2/d) and etoposide (60 mg/m2/d) given by a 96-hour CIVI every 3 weeks for a maximum of 8 cycles. All patients also received granulocyte-colony-stimulating factor. CR occurred in 10 of 24 patients (42{\%}; 95{\%} confidence intervals [CI] 22{\%}, 62{\%}) treated with CIE as first-line therapy, and in 3 of 18 patients (17{\%}; 95{\%} CI 20{\%}, 32{\%}) treated with CIE as second-line or greater therapy. One-year FFS and OS were 42{\%} and 64{\%}, respectively, in patients with no prior therapy, and 17{\%} and 56{\%} in patients with prior therapy. Severe (grade III) or life-threatening (grade IV) toxicity included leukopenia (59{\%}), anemia (61{\%}), thrombocytopenia (31{\%}), and infection (10{\%}). Two patients (4{\%}) died due to treatment related infectious complications. It is unlikely that infusional CIE produces a CR rate more than about 60{\%} in poor-risk patients with intermediate-grade NHL when used as first-line therapy, or more than about 30{\%} in patients receiving the regimen as second-line therapy. Substitution of idarubicin for doxorubicin in this setting, therefore, is not associated with an improved response rate.",
keywords = "Idarubicin, Infusional therapy, Non-Hodgkin's lymphoma",
author = "Huda Salman and Alejandra Perez and Sparano, {Joseph A.} and Howard Ratech and Abdissa Negassa and Una Hopkins and Gina Villani and Joachim Fuks and Wiernik, {Peter H.}",
year = "2003",
month = "8",
day = "1",
doi = "10.1097/00000421-200308000-00006",
language = "English (US)",
volume = "26",
pages = "338--343",
journal = "American Journal of Clinical Oncology",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "4",

}

TY - JOUR

T1 - Phase II trial of infusional cyclophosphamide, idarubicin, and etoposide in poor prognosis non-Hodgkin's lymphoma

AU - Salman, Huda

AU - Perez, Alejandra

AU - Sparano, Joseph A.

AU - Ratech, Howard

AU - Negassa, Abdissa

AU - Hopkins, Una

AU - Villani, Gina

AU - Fuks, Joachim

AU - Wiernik, Peter H.

PY - 2003/8/1

Y1 - 2003/8/1

N2 - The purpose of this study was to determine the complete response (CR) rate, failure-free survival (FFS), and overall survival (OS) of patients with poor-prognosis intermediate-grade non-Hodgkin's lymphoma (NHL) after treatment with cyclophosphamide, idarubicin, and etoposide given as a continuous intravenous infusion (CIVI) over 96 hours (infusional CIE), including patients with relapsed/refractory disease and patients with no prior therapy but at least two poor-risk features by the age-adjusted International Prognostic Index. Forty-two patients with previously untreated NHL (N = 24) or relapsed/refractory (N = 18) NHL received cyclophosphamide (200 mg/m2/d), idarubicin (2.5-3.0 mg/m2/d) and etoposide (60 mg/m2/d) given by a 96-hour CIVI every 3 weeks for a maximum of 8 cycles. All patients also received granulocyte-colony-stimulating factor. CR occurred in 10 of 24 patients (42%; 95% confidence intervals [CI] 22%, 62%) treated with CIE as first-line therapy, and in 3 of 18 patients (17%; 95% CI 20%, 32%) treated with CIE as second-line or greater therapy. One-year FFS and OS were 42% and 64%, respectively, in patients with no prior therapy, and 17% and 56% in patients with prior therapy. Severe (grade III) or life-threatening (grade IV) toxicity included leukopenia (59%), anemia (61%), thrombocytopenia (31%), and infection (10%). Two patients (4%) died due to treatment related infectious complications. It is unlikely that infusional CIE produces a CR rate more than about 60% in poor-risk patients with intermediate-grade NHL when used as first-line therapy, or more than about 30% in patients receiving the regimen as second-line therapy. Substitution of idarubicin for doxorubicin in this setting, therefore, is not associated with an improved response rate.

AB - The purpose of this study was to determine the complete response (CR) rate, failure-free survival (FFS), and overall survival (OS) of patients with poor-prognosis intermediate-grade non-Hodgkin's lymphoma (NHL) after treatment with cyclophosphamide, idarubicin, and etoposide given as a continuous intravenous infusion (CIVI) over 96 hours (infusional CIE), including patients with relapsed/refractory disease and patients with no prior therapy but at least two poor-risk features by the age-adjusted International Prognostic Index. Forty-two patients with previously untreated NHL (N = 24) or relapsed/refractory (N = 18) NHL received cyclophosphamide (200 mg/m2/d), idarubicin (2.5-3.0 mg/m2/d) and etoposide (60 mg/m2/d) given by a 96-hour CIVI every 3 weeks for a maximum of 8 cycles. All patients also received granulocyte-colony-stimulating factor. CR occurred in 10 of 24 patients (42%; 95% confidence intervals [CI] 22%, 62%) treated with CIE as first-line therapy, and in 3 of 18 patients (17%; 95% CI 20%, 32%) treated with CIE as second-line or greater therapy. One-year FFS and OS were 42% and 64%, respectively, in patients with no prior therapy, and 17% and 56% in patients with prior therapy. Severe (grade III) or life-threatening (grade IV) toxicity included leukopenia (59%), anemia (61%), thrombocytopenia (31%), and infection (10%). Two patients (4%) died due to treatment related infectious complications. It is unlikely that infusional CIE produces a CR rate more than about 60% in poor-risk patients with intermediate-grade NHL when used as first-line therapy, or more than about 30% in patients receiving the regimen as second-line therapy. Substitution of idarubicin for doxorubicin in this setting, therefore, is not associated with an improved response rate.

KW - Idarubicin

KW - Infusional therapy

KW - Non-Hodgkin's lymphoma

UR - http://www.scopus.com/inward/record.url?scp=0043064250&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0043064250&partnerID=8YFLogxK

U2 - 10.1097/00000421-200308000-00006

DO - 10.1097/00000421-200308000-00006

M3 - Article

C2 - 12902881

AN - SCOPUS:0043064250

VL - 26

SP - 338

EP - 343

JO - American Journal of Clinical Oncology

JF - American Journal of Clinical Oncology

SN - 0277-3732

IS - 4

ER -