Vinblastine, ifosfamide, and gallium nitrate - An active new regimen in patients with advanced carcinoma of the urothelium

A phase II trial of the eastern cooperative oncology group (E5892)

Robert Dreicer, Kathleen J. Propert, Bruce J. Roth, Lawrence Einhorn, Patrick Loehrer

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Abstract

BACKGROUND. This study was conducted to assess the efficacy and toxicity of vinblastine, ifosfamide, and gallium nitrate (VIG) as first-line chemotherapy in patients with locally advanced or metastatic carcinoma of the urothelium. METHODS. Forty-five eligible patients were enrolled and stratified into good and poor risk groups. Poor risk was defined as age ≤ 70 years, 1 functioning kidney, and prior adjuvant or neoadjuvant chemotherapy. Good risk patients were treated with vinblastine, 0.11 mg/kg, on Days 1 and 2; ifosfamide, 1.2 g/m2, on Days 1-5 with mesna uroprotection; and gallium nitrate, 300 mg/m2, as a continuous infusion on Days 1-5. Poor risk patients received similar therapy with doses decreased by 20% and administered over 4 days. All patients received recombinant human granulocyte-colony stimulating factor. Cycles were repeated at 21-day intervals until disease progression or to a maximum of 6 cycles. RESULTS. Twenty of 45 patients (44%; 95% confidence interval, 30-60%) demonstrated an objective response, with 6 patients (13%) achieving a complete clinical response. The median duration of response was 47 weeks and the median survival duration for all patients was 10 months. Hematologic toxicity was significant, with 28 patients and 31 patients experiencing Grade 3 or 4 leukopenia and anemia, respectively. Six patients had clinically significant cardiac events (primarily atrial arrhythmias). There were two early deaths that were possibly treatment related. CONCLUSIONS. VIG is an active regimen in patients with advanced urothelial carcinoma. Toxicity is significant but acceptable. Patients with significant cardiac disease (especially arrhythmias) should be treated with extra care. The 4-day regimen appears to have similar therapeutic efficacy with less toxicity.

Original languageEnglish
Pages (from-to)110-114
Number of pages5
JournalCancer
Volume79
Issue number1
DOIs
StatePublished - Jan 1 1997

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gallium nitrate
Urothelium
Ifosfamide
Vinblastine
Carcinoma
Cardiac Arrhythmias
Mesna

Keywords

  • bladder carcinoma
  • chemotherapy
  • gallium nitrate
  • ifosfamide
  • metastatic
  • vinblastine

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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title = "Vinblastine, ifosfamide, and gallium nitrate - An active new regimen in patients with advanced carcinoma of the urothelium: A phase II trial of the eastern cooperative oncology group (E5892)",
abstract = "BACKGROUND. This study was conducted to assess the efficacy and toxicity of vinblastine, ifosfamide, and gallium nitrate (VIG) as first-line chemotherapy in patients with locally advanced or metastatic carcinoma of the urothelium. METHODS. Forty-five eligible patients were enrolled and stratified into good and poor risk groups. Poor risk was defined as age ≤ 70 years, 1 functioning kidney, and prior adjuvant or neoadjuvant chemotherapy. Good risk patients were treated with vinblastine, 0.11 mg/kg, on Days 1 and 2; ifosfamide, 1.2 g/m2, on Days 1-5 with mesna uroprotection; and gallium nitrate, 300 mg/m2, as a continuous infusion on Days 1-5. Poor risk patients received similar therapy with doses decreased by 20{\%} and administered over 4 days. All patients received recombinant human granulocyte-colony stimulating factor. Cycles were repeated at 21-day intervals until disease progression or to a maximum of 6 cycles. RESULTS. Twenty of 45 patients (44{\%}; 95{\%} confidence interval, 30-60{\%}) demonstrated an objective response, with 6 patients (13{\%}) achieving a complete clinical response. The median duration of response was 47 weeks and the median survival duration for all patients was 10 months. Hematologic toxicity was significant, with 28 patients and 31 patients experiencing Grade 3 or 4 leukopenia and anemia, respectively. Six patients had clinically significant cardiac events (primarily atrial arrhythmias). There were two early deaths that were possibly treatment related. CONCLUSIONS. VIG is an active regimen in patients with advanced urothelial carcinoma. Toxicity is significant but acceptable. Patients with significant cardiac disease (especially arrhythmias) should be treated with extra care. The 4-day regimen appears to have similar therapeutic efficacy with less toxicity.",
keywords = "bladder carcinoma, chemotherapy, gallium nitrate, ifosfamide, metastatic, vinblastine",
author = "Robert Dreicer and Propert, {Kathleen J.} and Roth, {Bruce J.} and Lawrence Einhorn and Patrick Loehrer",
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T1 - Vinblastine, ifosfamide, and gallium nitrate - An active new regimen in patients with advanced carcinoma of the urothelium

T2 - A phase II trial of the eastern cooperative oncology group (E5892)

AU - Dreicer, Robert

AU - Propert, Kathleen J.

AU - Roth, Bruce J.

AU - Einhorn, Lawrence

AU - Loehrer, Patrick

PY - 1997/1/1

Y1 - 1997/1/1

N2 - BACKGROUND. This study was conducted to assess the efficacy and toxicity of vinblastine, ifosfamide, and gallium nitrate (VIG) as first-line chemotherapy in patients with locally advanced or metastatic carcinoma of the urothelium. METHODS. Forty-five eligible patients were enrolled and stratified into good and poor risk groups. Poor risk was defined as age ≤ 70 years, 1 functioning kidney, and prior adjuvant or neoadjuvant chemotherapy. Good risk patients were treated with vinblastine, 0.11 mg/kg, on Days 1 and 2; ifosfamide, 1.2 g/m2, on Days 1-5 with mesna uroprotection; and gallium nitrate, 300 mg/m2, as a continuous infusion on Days 1-5. Poor risk patients received similar therapy with doses decreased by 20% and administered over 4 days. All patients received recombinant human granulocyte-colony stimulating factor. Cycles were repeated at 21-day intervals until disease progression or to a maximum of 6 cycles. RESULTS. Twenty of 45 patients (44%; 95% confidence interval, 30-60%) demonstrated an objective response, with 6 patients (13%) achieving a complete clinical response. The median duration of response was 47 weeks and the median survival duration for all patients was 10 months. Hematologic toxicity was significant, with 28 patients and 31 patients experiencing Grade 3 or 4 leukopenia and anemia, respectively. Six patients had clinically significant cardiac events (primarily atrial arrhythmias). There were two early deaths that were possibly treatment related. CONCLUSIONS. VIG is an active regimen in patients with advanced urothelial carcinoma. Toxicity is significant but acceptable. Patients with significant cardiac disease (especially arrhythmias) should be treated with extra care. The 4-day regimen appears to have similar therapeutic efficacy with less toxicity.

AB - BACKGROUND. This study was conducted to assess the efficacy and toxicity of vinblastine, ifosfamide, and gallium nitrate (VIG) as first-line chemotherapy in patients with locally advanced or metastatic carcinoma of the urothelium. METHODS. Forty-five eligible patients were enrolled and stratified into good and poor risk groups. Poor risk was defined as age ≤ 70 years, 1 functioning kidney, and prior adjuvant or neoadjuvant chemotherapy. Good risk patients were treated with vinblastine, 0.11 mg/kg, on Days 1 and 2; ifosfamide, 1.2 g/m2, on Days 1-5 with mesna uroprotection; and gallium nitrate, 300 mg/m2, as a continuous infusion on Days 1-5. Poor risk patients received similar therapy with doses decreased by 20% and administered over 4 days. All patients received recombinant human granulocyte-colony stimulating factor. Cycles were repeated at 21-day intervals until disease progression or to a maximum of 6 cycles. RESULTS. Twenty of 45 patients (44%; 95% confidence interval, 30-60%) demonstrated an objective response, with 6 patients (13%) achieving a complete clinical response. The median duration of response was 47 weeks and the median survival duration for all patients was 10 months. Hematologic toxicity was significant, with 28 patients and 31 patients experiencing Grade 3 or 4 leukopenia and anemia, respectively. Six patients had clinically significant cardiac events (primarily atrial arrhythmias). There were two early deaths that were possibly treatment related. CONCLUSIONS. VIG is an active regimen in patients with advanced urothelial carcinoma. Toxicity is significant but acceptable. Patients with significant cardiac disease (especially arrhythmias) should be treated with extra care. The 4-day regimen appears to have similar therapeutic efficacy with less toxicity.

KW - bladder carcinoma

KW - chemotherapy

KW - gallium nitrate

KW - ifosfamide

KW - metastatic

KW - vinblastine

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