A review of hemolytic uremic syndrome in patients treated with gemcitabine therapy

Man C. Fung, Anna Maria Storniolo, Binh Nguyen, Michael Arning, William Brookfield, James Vigil

Research output: Contribution to journalArticle

127 Citations (Scopus)

Abstract

BACKGROUND. Hemolytic uremic syndrome (HUS) is a rare condition that occasionally is reported in cancer patients. Recently it has been observed that gemcitabine rarely may be associated with this condition. METHODS. The manufacturer's safety database and literature were reviewed for any report regarding gemcitabine associated with renal and hematologic abnormalities. Descriptive analysis was used to examine each case for an association between gemcitabine therapy and HUS and to identify its incidence and risk factors. RESULTS. Through December 31, 1997, 12 cases were identified that fit either the clinical (uremia, microangiopathic hemolytic anemia, and thrombocytopenia) or pathologic (renal biopsy) criteria for HUS. There were 7 males (58%) and 5 females (42%) with a median age of 55.5 years (range, 37- 73 years). The median duration of gemcitabine therapy was 5.8 months (range, 3.8-13.1 months). Six patients died, five improved, and one patient's outcome was unknown. Among the six deaths, three patients died of cancer progression, one patient died of an unrelated myocardial infarction, and two patients died of HUS or HUS-related complications. For the five patients who improved, treatment was comprised of dialysis, plasmapheresis, splenectomy, or a combination. Attempts to correlate patient demographics, primary malignancy, and cumulative gemcitabine dose failed to identify consistent risk factors in predisposing patients to HUS. Confounding factors were common, including mitomycin-C and/or 5-fluorouracil exposure, advanced stage tumors, or preexisting renal dysfunction. CONCLUSIONS. Based on a patient exposure of 78,800, a crude overall incidence rate of 0.015% (range, 0.008-0.078%) was determined, showing that HUS associated with gemcitabine treatment appears to be rare. Nonetheless, as with other cancer treatments, clinicians should weigh the appropriate risk/benefit ratio in using gemcitabine to treat their patients.

Original languageEnglish (US)
Pages (from-to)2023-2032
Number of pages10
JournalCancer
Volume85
Issue number9
DOIs
StatePublished - May 1 1999
Externally publishedYes

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gemcitabine
Hemolytic-Uremic Syndrome
Therapeutics
Neoplasms
Kidney
Plasmapheresis
Uremia

Keywords

  • Acute uremia
  • Gemcitabine
  • Hemolytic uremic syndrome
  • Microangiopathic hemolytic anemia
  • Thrombotic microangiopathy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A review of hemolytic uremic syndrome in patients treated with gemcitabine therapy. / Fung, Man C.; Storniolo, Anna Maria; Nguyen, Binh; Arning, Michael; Brookfield, William; Vigil, James.

In: Cancer, Vol. 85, No. 9, 01.05.1999, p. 2023-2032.

Research output: Contribution to journalArticle

Fung, Man C. ; Storniolo, Anna Maria ; Nguyen, Binh ; Arning, Michael ; Brookfield, William ; Vigil, James. / A review of hemolytic uremic syndrome in patients treated with gemcitabine therapy. In: Cancer. 1999 ; Vol. 85, No. 9. pp. 2023-2032.
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title = "A review of hemolytic uremic syndrome in patients treated with gemcitabine therapy",
abstract = "BACKGROUND. Hemolytic uremic syndrome (HUS) is a rare condition that occasionally is reported in cancer patients. Recently it has been observed that gemcitabine rarely may be associated with this condition. METHODS. The manufacturer's safety database and literature were reviewed for any report regarding gemcitabine associated with renal and hematologic abnormalities. Descriptive analysis was used to examine each case for an association between gemcitabine therapy and HUS and to identify its incidence and risk factors. RESULTS. Through December 31, 1997, 12 cases were identified that fit either the clinical (uremia, microangiopathic hemolytic anemia, and thrombocytopenia) or pathologic (renal biopsy) criteria for HUS. There were 7 males (58{\%}) and 5 females (42{\%}) with a median age of 55.5 years (range, 37- 73 years). The median duration of gemcitabine therapy was 5.8 months (range, 3.8-13.1 months). Six patients died, five improved, and one patient's outcome was unknown. Among the six deaths, three patients died of cancer progression, one patient died of an unrelated myocardial infarction, and two patients died of HUS or HUS-related complications. For the five patients who improved, treatment was comprised of dialysis, plasmapheresis, splenectomy, or a combination. Attempts to correlate patient demographics, primary malignancy, and cumulative gemcitabine dose failed to identify consistent risk factors in predisposing patients to HUS. Confounding factors were common, including mitomycin-C and/or 5-fluorouracil exposure, advanced stage tumors, or preexisting renal dysfunction. CONCLUSIONS. Based on a patient exposure of 78,800, a crude overall incidence rate of 0.015{\%} (range, 0.008-0.078{\%}) was determined, showing that HUS associated with gemcitabine treatment appears to be rare. Nonetheless, as with other cancer treatments, clinicians should weigh the appropriate risk/benefit ratio in using gemcitabine to treat their patients.",
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AU - Fung, Man C.

AU - Storniolo, Anna Maria

AU - Nguyen, Binh

AU - Arning, Michael

AU - Brookfield, William

AU - Vigil, James

PY - 1999/5/1

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N2 - BACKGROUND. Hemolytic uremic syndrome (HUS) is a rare condition that occasionally is reported in cancer patients. Recently it has been observed that gemcitabine rarely may be associated with this condition. METHODS. The manufacturer's safety database and literature were reviewed for any report regarding gemcitabine associated with renal and hematologic abnormalities. Descriptive analysis was used to examine each case for an association between gemcitabine therapy and HUS and to identify its incidence and risk factors. RESULTS. Through December 31, 1997, 12 cases were identified that fit either the clinical (uremia, microangiopathic hemolytic anemia, and thrombocytopenia) or pathologic (renal biopsy) criteria for HUS. There were 7 males (58%) and 5 females (42%) with a median age of 55.5 years (range, 37- 73 years). The median duration of gemcitabine therapy was 5.8 months (range, 3.8-13.1 months). Six patients died, five improved, and one patient's outcome was unknown. Among the six deaths, three patients died of cancer progression, one patient died of an unrelated myocardial infarction, and two patients died of HUS or HUS-related complications. For the five patients who improved, treatment was comprised of dialysis, plasmapheresis, splenectomy, or a combination. Attempts to correlate patient demographics, primary malignancy, and cumulative gemcitabine dose failed to identify consistent risk factors in predisposing patients to HUS. Confounding factors were common, including mitomycin-C and/or 5-fluorouracil exposure, advanced stage tumors, or preexisting renal dysfunction. CONCLUSIONS. Based on a patient exposure of 78,800, a crude overall incidence rate of 0.015% (range, 0.008-0.078%) was determined, showing that HUS associated with gemcitabine treatment appears to be rare. Nonetheless, as with other cancer treatments, clinicians should weigh the appropriate risk/benefit ratio in using gemcitabine to treat their patients.

AB - BACKGROUND. Hemolytic uremic syndrome (HUS) is a rare condition that occasionally is reported in cancer patients. Recently it has been observed that gemcitabine rarely may be associated with this condition. METHODS. The manufacturer's safety database and literature were reviewed for any report regarding gemcitabine associated with renal and hematologic abnormalities. Descriptive analysis was used to examine each case for an association between gemcitabine therapy and HUS and to identify its incidence and risk factors. RESULTS. Through December 31, 1997, 12 cases were identified that fit either the clinical (uremia, microangiopathic hemolytic anemia, and thrombocytopenia) or pathologic (renal biopsy) criteria for HUS. There were 7 males (58%) and 5 females (42%) with a median age of 55.5 years (range, 37- 73 years). The median duration of gemcitabine therapy was 5.8 months (range, 3.8-13.1 months). Six patients died, five improved, and one patient's outcome was unknown. Among the six deaths, three patients died of cancer progression, one patient died of an unrelated myocardial infarction, and two patients died of HUS or HUS-related complications. For the five patients who improved, treatment was comprised of dialysis, plasmapheresis, splenectomy, or a combination. Attempts to correlate patient demographics, primary malignancy, and cumulative gemcitabine dose failed to identify consistent risk factors in predisposing patients to HUS. Confounding factors were common, including mitomycin-C and/or 5-fluorouracil exposure, advanced stage tumors, or preexisting renal dysfunction. CONCLUSIONS. Based on a patient exposure of 78,800, a crude overall incidence rate of 0.015% (range, 0.008-0.078%) was determined, showing that HUS associated with gemcitabine treatment appears to be rare. Nonetheless, as with other cancer treatments, clinicians should weigh the appropriate risk/benefit ratio in using gemcitabine to treat their patients.

KW - Acute uremia

KW - Gemcitabine

KW - Hemolytic uremic syndrome

KW - Microangiopathic hemolytic anemia

KW - Thrombotic microangiopathy

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