Randomized comparison of diaziquone and carmustine in the treatment of adults with anaplastic glioma

S. Clifford Schold, James E. Herndon, Peter C. Burger, Edward C. Halperin, Nicholas A. Vick, J. Gregory Cairncross, David R. Macdonald, Edward J. Dropcho, Richard Morawetz, Darell D. Bigner, M. Stephen Mahaley

Research output: Contribution to journalArticle

Abstract

Purpose: We conducted a phase III trial comparing intravenous (IV) diaziquone (AZQ) and carmustine (BCNU) as single agents in patients with cerebral anaplastic gliomas who had received surgery and radiotherapy. Its purpose was to compare the efficacy of AZQ with that of BCNU, the standard agent for brain tumor chemotherapy. Patients and Methods: Randomization between the two regimens occurred 8 weeks after completion of radiotherapy. A total of 251 patients were randomized to receive either AZQ or BCNU, and there were no significant differences between the two treatment arms in any of the known prognostic variables, including age, histologic grade, and Karnofsky performance status (KPS). Results: There was no significant difference in either time to tumor progression or survival between the two treatment arms. Age and histology were strong predictors of outcome, whereas KPS had relatively less effect. Three groups of patients with distinctly different outcomes could be identified: (1) older age (45+) and glio-blastoma/gliosarcoma (GBM/GS) patients had a median survival of 37 weeks after randomization; (2) patients with either older age or GBM/GS had a median survival of 61 weeks; and (3) younger age (<45) and non-GBM/GS (usually anaplastic astrocytoma) patients had a median survival of 147 weeks. Toxicity was primarily hematologic, although acute gastrointestinal toxicity and chronic pulmonary toxicity were more common with BCNU. Patients randomized to AZQ who had significant hematologic toxicity that required dose reduction after the first treatment cycle had significantly longer time to tumor progression and survival than those who did not require dose reduction (P =.011 and .016, respectively). Conclusion: There was no significant difference in efficacy between AZQ and BCNU in patients with anaplastic gliomas as tested in this study, although AZQ was somewhat better tolerated.

Original languageEnglish (US)
Pages (from-to)77-83
Number of pages7
JournalJournal of Clinical Oncology
Volume11
Issue number1
StatePublished - 1993
Externally publishedYes

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diaziquone
Carmustine
Glioma
Gliosarcoma
Survival
Karnofsky Performance Status
Therapeutics
Random Allocation
Radiotherapy
Astrocytoma
Proxy
Brain Neoplasms
Neoplasms
Histology

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Schold, S. C., Herndon, J. E., Burger, P. C., Halperin, E. C., Vick, N. A., Cairncross, J. G., ... Mahaley, M. S. (1993). Randomized comparison of diaziquone and carmustine in the treatment of adults with anaplastic glioma. Journal of Clinical Oncology, 11(1), 77-83.

Randomized comparison of diaziquone and carmustine in the treatment of adults with anaplastic glioma. / Schold, S. Clifford; Herndon, James E.; Burger, Peter C.; Halperin, Edward C.; Vick, Nicholas A.; Cairncross, J. Gregory; Macdonald, David R.; Dropcho, Edward J.; Morawetz, Richard; Bigner, Darell D.; Mahaley, M. Stephen.

In: Journal of Clinical Oncology, Vol. 11, No. 1, 1993, p. 77-83.

Research output: Contribution to journalArticle

Schold, SC, Herndon, JE, Burger, PC, Halperin, EC, Vick, NA, Cairncross, JG, Macdonald, DR, Dropcho, EJ, Morawetz, R, Bigner, DD & Mahaley, MS 1993, 'Randomized comparison of diaziquone and carmustine in the treatment of adults with anaplastic glioma', Journal of Clinical Oncology, vol. 11, no. 1, pp. 77-83.
Schold SC, Herndon JE, Burger PC, Halperin EC, Vick NA, Cairncross JG et al. Randomized comparison of diaziquone and carmustine in the treatment of adults with anaplastic glioma. Journal of Clinical Oncology. 1993;11(1):77-83.
Schold, S. Clifford ; Herndon, James E. ; Burger, Peter C. ; Halperin, Edward C. ; Vick, Nicholas A. ; Cairncross, J. Gregory ; Macdonald, David R. ; Dropcho, Edward J. ; Morawetz, Richard ; Bigner, Darell D. ; Mahaley, M. Stephen. / Randomized comparison of diaziquone and carmustine in the treatment of adults with anaplastic glioma. In: Journal of Clinical Oncology. 1993 ; Vol. 11, No. 1. pp. 77-83.
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abstract = "Purpose: We conducted a phase III trial comparing intravenous (IV) diaziquone (AZQ) and carmustine (BCNU) as single agents in patients with cerebral anaplastic gliomas who had received surgery and radiotherapy. Its purpose was to compare the efficacy of AZQ with that of BCNU, the standard agent for brain tumor chemotherapy. Patients and Methods: Randomization between the two regimens occurred 8 weeks after completion of radiotherapy. A total of 251 patients were randomized to receive either AZQ or BCNU, and there were no significant differences between the two treatment arms in any of the known prognostic variables, including age, histologic grade, and Karnofsky performance status (KPS). Results: There was no significant difference in either time to tumor progression or survival between the two treatment arms. Age and histology were strong predictors of outcome, whereas KPS had relatively less effect. Three groups of patients with distinctly different outcomes could be identified: (1) older age (45+) and glio-blastoma/gliosarcoma (GBM/GS) patients had a median survival of 37 weeks after randomization; (2) patients with either older age or GBM/GS had a median survival of 61 weeks; and (3) younger age (<45) and non-GBM/GS (usually anaplastic astrocytoma) patients had a median survival of 147 weeks. Toxicity was primarily hematologic, although acute gastrointestinal toxicity and chronic pulmonary toxicity were more common with BCNU. Patients randomized to AZQ who had significant hematologic toxicity that required dose reduction after the first treatment cycle had significantly longer time to tumor progression and survival than those who did not require dose reduction (P =.011 and .016, respectively). Conclusion: There was no significant difference in efficacy between AZQ and BCNU in patients with anaplastic gliomas as tested in this study, although AZQ was somewhat better tolerated.",
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T1 - Randomized comparison of diaziquone and carmustine in the treatment of adults with anaplastic glioma

AU - Schold, S. Clifford

AU - Herndon, James E.

AU - Burger, Peter C.

AU - Halperin, Edward C.

AU - Vick, Nicholas A.

AU - Cairncross, J. Gregory

AU - Macdonald, David R.

AU - Dropcho, Edward J.

AU - Morawetz, Richard

AU - Bigner, Darell D.

AU - Mahaley, M. Stephen

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Y1 - 1993

N2 - Purpose: We conducted a phase III trial comparing intravenous (IV) diaziquone (AZQ) and carmustine (BCNU) as single agents in patients with cerebral anaplastic gliomas who had received surgery and radiotherapy. Its purpose was to compare the efficacy of AZQ with that of BCNU, the standard agent for brain tumor chemotherapy. Patients and Methods: Randomization between the two regimens occurred 8 weeks after completion of radiotherapy. A total of 251 patients were randomized to receive either AZQ or BCNU, and there were no significant differences between the two treatment arms in any of the known prognostic variables, including age, histologic grade, and Karnofsky performance status (KPS). Results: There was no significant difference in either time to tumor progression or survival between the two treatment arms. Age and histology were strong predictors of outcome, whereas KPS had relatively less effect. Three groups of patients with distinctly different outcomes could be identified: (1) older age (45+) and glio-blastoma/gliosarcoma (GBM/GS) patients had a median survival of 37 weeks after randomization; (2) patients with either older age or GBM/GS had a median survival of 61 weeks; and (3) younger age (<45) and non-GBM/GS (usually anaplastic astrocytoma) patients had a median survival of 147 weeks. Toxicity was primarily hematologic, although acute gastrointestinal toxicity and chronic pulmonary toxicity were more common with BCNU. Patients randomized to AZQ who had significant hematologic toxicity that required dose reduction after the first treatment cycle had significantly longer time to tumor progression and survival than those who did not require dose reduction (P =.011 and .016, respectively). Conclusion: There was no significant difference in efficacy between AZQ and BCNU in patients with anaplastic gliomas as tested in this study, although AZQ was somewhat better tolerated.

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