Superiority of PCNU over AZQ in the treatment of primary brain tumors

results of a prospective randomized trial (81-20) by the brain tumor study group

Mark G. Malkin, Sylvan B. Green, David P. Byar, Thomas A. Strike, Peter C. Burger, F. Stephen Vogel, David A. Pistenmaa, M. Stephen Mahaley, Joseph Ransohoff, William R. Shapiro, John Mealey, James T. Robertson, Robert G. Selker, John C. Van Gilder

Research output: Contribution to journalArticle

Abstract

Purpose: A two-arm randomized clinical trial was performed to determine the efficacy of PCNU and AZQ in the treatment of de novo or recurrent primary brain tumors. An additional objective was to gather information on the administration and toxicity of these compounds, supplementing that obtained previously in phase I/II studies. Methods: During 1982 and 1983 the Brain Tumor Study Group randomized 152 adult patients with primary brain tumors to receive PCNU 75-100 mg/m2 intravenously (IV) every 8 weeks or AZQ 15 mg/m2 IV once a week for 4 weeks, every 6-8 weeks. All patients who had not received 'full dose' radiotherapy before randomization received it concurrently with the first course of protocol chemotherapy. The data were analyzed for the total randomized population (RP), and for 130 patients in the valid study group (VSG) formed by excluding 22 patients for whom the histologic diagnosis was not documented by central review. Results: Median survival times were 11.0 months for the PCNU group and 8.4 months for the AZQ group. The difference in survival curves was statistically significant for the RP (p=0.01) and the VSG (p=0.02). Lifetable analysis of the VSG showed estimated 2-year survivals of 34% for PCNU and 11% for AZQ. The advantage of PCNU remained significant (p=0.006) after adjustment for histopathologic category, age, initial performance status, and interval from initial reported surgery. Myelosuppression was the principal toxicity in both groups.

Original languageEnglish (US)
Pages (from-to)55-65
Number of pages11
JournalJournal of Neuro-Oncology
Volume22
Issue number1
DOIs
StatePublished - Feb 1994
Externally publishedYes

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diaziquone
Brain Neoplasms
Survival
Therapeutics
Random Allocation
Population
Radiotherapy
Randomized Controlled Trials
1-(2-chloroethyl)-3-(2,6-dioxo-3-piperidinyl)-1-nitrosourea
Drug Therapy

Keywords

  • AZQ
  • brain tumors
  • PCNU
  • radiation therapy

ASJC Scopus subject areas

  • Neuroscience(all)
  • Oncology
  • Clinical Neurology
  • Cancer Research

Cite this

Superiority of PCNU over AZQ in the treatment of primary brain tumors : results of a prospective randomized trial (81-20) by the brain tumor study group. / Malkin, Mark G.; Green, Sylvan B.; Byar, David P.; Strike, Thomas A.; Burger, Peter C.; Vogel, F. Stephen; Pistenmaa, David A.; Mahaley, M. Stephen; Ransohoff, Joseph; Shapiro, William R.; Mealey, John; Robertson, James T.; Selker, Robert G.; Van Gilder, John C.

In: Journal of Neuro-Oncology, Vol. 22, No. 1, 02.1994, p. 55-65.

Research output: Contribution to journalArticle

Malkin, MG, Green, SB, Byar, DP, Strike, TA, Burger, PC, Vogel, FS, Pistenmaa, DA, Mahaley, MS, Ransohoff, J, Shapiro, WR, Mealey, J, Robertson, JT, Selker, RG & Van Gilder, JC 1994, 'Superiority of PCNU over AZQ in the treatment of primary brain tumors: results of a prospective randomized trial (81-20) by the brain tumor study group', Journal of Neuro-Oncology, vol. 22, no. 1, pp. 55-65. https://doi.org/10.1007/BF01058355
Malkin, Mark G. ; Green, Sylvan B. ; Byar, David P. ; Strike, Thomas A. ; Burger, Peter C. ; Vogel, F. Stephen ; Pistenmaa, David A. ; Mahaley, M. Stephen ; Ransohoff, Joseph ; Shapiro, William R. ; Mealey, John ; Robertson, James T. ; Selker, Robert G. ; Van Gilder, John C. / Superiority of PCNU over AZQ in the treatment of primary brain tumors : results of a prospective randomized trial (81-20) by the brain tumor study group. In: Journal of Neuro-Oncology. 1994 ; Vol. 22, No. 1. pp. 55-65.
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abstract = "Purpose: A two-arm randomized clinical trial was performed to determine the efficacy of PCNU and AZQ in the treatment of de novo or recurrent primary brain tumors. An additional objective was to gather information on the administration and toxicity of these compounds, supplementing that obtained previously in phase I/II studies. Methods: During 1982 and 1983 the Brain Tumor Study Group randomized 152 adult patients with primary brain tumors to receive PCNU 75-100 mg/m2 intravenously (IV) every 8 weeks or AZQ 15 mg/m2 IV once a week for 4 weeks, every 6-8 weeks. All patients who had not received 'full dose' radiotherapy before randomization received it concurrently with the first course of protocol chemotherapy. The data were analyzed for the total randomized population (RP), and for 130 patients in the valid study group (VSG) formed by excluding 22 patients for whom the histologic diagnosis was not documented by central review. Results: Median survival times were 11.0 months for the PCNU group and 8.4 months for the AZQ group. The difference in survival curves was statistically significant for the RP (p=0.01) and the VSG (p=0.02). Lifetable analysis of the VSG showed estimated 2-year survivals of 34{\%} for PCNU and 11{\%} for AZQ. The advantage of PCNU remained significant (p=0.006) after adjustment for histopathologic category, age, initial performance status, and interval from initial reported surgery. Myelosuppression was the principal toxicity in both groups.",
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AU - Ransohoff, Joseph

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AU - Robertson, James T.

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