Results of a randomized trial comparing intra-arterial cisplatin and intravenous PCNU for the treatment of primary brain tumors in adults

Brain Tumor Cooperative Group trial 8420A

Emile M. Hiesiger, Sylvan B. Green, William R. Shapiro, Peter C. Burger, Robert G. Selker, M. Stephen Mahaley, Joseph Ransohoff, John C. VanGilder, John Mealey, James T. Robertson, Fred H. Hochberg, Ronald F. Young

Research output: Contribution to journalArticle

Abstract

Purpose: To test the efficacy of intra-arterial (IA) cisplatin versus intravenous (IV) PCNU for treating primary brain tumors, in a randomized trial (Brain Tumor Cooperative Group [BTCG] Trial 8420A). Methods: 311 adult patients (ages 19-79 years; median 45) with supratentorial tumors (confirmed histologically) were randomized by nine participating institutions. Patients were required to have completed radiotherapy (4500-6020 cGy to the tumor bed) before randomization. Patients were stratified as either nonprogressive (clinically and radiologically stable) or progressive. Results were analyzed for the 311 patients in the randomized population (RP), and for the 281 patients in the Valid Study Group (VSG) meeting protocol eligibility requirements. 56% of patients in the VSG had glioblastoma multiforme, 33% had other malignant glioma, and 11% had low-grade glioma. 64% were stratified as progressive. 12% had received prior chemotherapy. Results: The group randomized to PCNU had the longer survival (p = 0.06 for the RP, p = 0.07 for the VSG). In the VSG, median survival was 10 months for the cisplatin group, 13 months for the PCNU group. The difference between treatment groups was significant (p ≤0.02) when adjusted for important prognostic factors. PCNU lead to greater hematotoxicity; cisplatin lead to greater renal toxicity and some ototoxicity. Some cisplatin patients experienced complications associated with IA administration, including six cases of encephalopathy. Conclusion: The trial showed a survival advantage to the group randomized to PCNU, although the difference was modest. Coupled with previous BTCG results, these trials suggest that PCNU is an active drug for brain tumors.

Original languageEnglish (US)
Pages (from-to)143-154
Number of pages12
JournalJournal of Neuro-Oncology
Volume25
Issue number2
DOIs
StatePublished - Jun 1995
Externally publishedYes

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Brain Neoplasms
Cisplatin
Glioma
Therapeutics
Survival
Supratentorial Neoplasms
Group Processes
Brain Diseases
Glioblastoma
Random Allocation
1-(2-chloroethyl)-3-(2,6-dioxo-3-piperidinyl)-1-nitrosourea
Population
Radiotherapy
Kidney
Drug Therapy
Pharmaceutical Preparations
Neoplasms

Keywords

  • glioma
  • intra-arterial cisplatin
  • PCNU
  • randomized trial

ASJC Scopus subject areas

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

Cite this

Results of a randomized trial comparing intra-arterial cisplatin and intravenous PCNU for the treatment of primary brain tumors in adults : Brain Tumor Cooperative Group trial 8420A. / Hiesiger, Emile M.; Green, Sylvan B.; Shapiro, William R.; Burger, Peter C.; Selker, Robert G.; Mahaley, M. Stephen; Ransohoff, Joseph; VanGilder, John C.; Mealey, John; Robertson, James T.; Hochberg, Fred H.; Young, Ronald F.

In: Journal of Neuro-Oncology, Vol. 25, No. 2, 06.1995, p. 143-154.

Research output: Contribution to journalArticle

Hiesiger, EM, Green, SB, Shapiro, WR, Burger, PC, Selker, RG, Mahaley, MS, Ransohoff, J, VanGilder, JC, Mealey, J, Robertson, JT, Hochberg, FH & Young, RF 1995, 'Results of a randomized trial comparing intra-arterial cisplatin and intravenous PCNU for the treatment of primary brain tumors in adults: Brain Tumor Cooperative Group trial 8420A', Journal of Neuro-Oncology, vol. 25, no. 2, pp. 143-154. https://doi.org/10.1007/BF01057758
Hiesiger, Emile M. ; Green, Sylvan B. ; Shapiro, William R. ; Burger, Peter C. ; Selker, Robert G. ; Mahaley, M. Stephen ; Ransohoff, Joseph ; VanGilder, John C. ; Mealey, John ; Robertson, James T. ; Hochberg, Fred H. ; Young, Ronald F. / Results of a randomized trial comparing intra-arterial cisplatin and intravenous PCNU for the treatment of primary brain tumors in adults : Brain Tumor Cooperative Group trial 8420A. In: Journal of Neuro-Oncology. 1995 ; Vol. 25, No. 2. pp. 143-154.
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abstract = "Purpose: To test the efficacy of intra-arterial (IA) cisplatin versus intravenous (IV) PCNU for treating primary brain tumors, in a randomized trial (Brain Tumor Cooperative Group [BTCG] Trial 8420A). Methods: 311 adult patients (ages 19-79 years; median 45) with supratentorial tumors (confirmed histologically) were randomized by nine participating institutions. Patients were required to have completed radiotherapy (4500-6020 cGy to the tumor bed) before randomization. Patients were stratified as either nonprogressive (clinically and radiologically stable) or progressive. Results were analyzed for the 311 patients in the randomized population (RP), and for the 281 patients in the Valid Study Group (VSG) meeting protocol eligibility requirements. 56{\%} of patients in the VSG had glioblastoma multiforme, 33{\%} had other malignant glioma, and 11{\%} had low-grade glioma. 64{\%} were stratified as progressive. 12{\%} had received prior chemotherapy. Results: The group randomized to PCNU had the longer survival (p = 0.06 for the RP, p = 0.07 for the VSG). In the VSG, median survival was 10 months for the cisplatin group, 13 months for the PCNU group. The difference between treatment groups was significant (p ≤0.02) when adjusted for important prognostic factors. PCNU lead to greater hematotoxicity; cisplatin lead to greater renal toxicity and some ototoxicity. Some cisplatin patients experienced complications associated with IA administration, including six cases of encephalopathy. Conclusion: The trial showed a survival advantage to the group randomized to PCNU, although the difference was modest. Coupled with previous BTCG results, these trials suggest that PCNU is an active drug for brain tumors.",
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AU - Green, Sylvan B.

AU - Shapiro, William R.

AU - Burger, Peter C.

AU - Selker, Robert G.

AU - Mahaley, M. Stephen

AU - Ransohoff, Joseph

AU - VanGilder, John C.

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AU - Robertson, James T.

AU - Hochberg, Fred H.

AU - Young, Ronald F.

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N2 - Purpose: To test the efficacy of intra-arterial (IA) cisplatin versus intravenous (IV) PCNU for treating primary brain tumors, in a randomized trial (Brain Tumor Cooperative Group [BTCG] Trial 8420A). Methods: 311 adult patients (ages 19-79 years; median 45) with supratentorial tumors (confirmed histologically) were randomized by nine participating institutions. Patients were required to have completed radiotherapy (4500-6020 cGy to the tumor bed) before randomization. Patients were stratified as either nonprogressive (clinically and radiologically stable) or progressive. Results were analyzed for the 311 patients in the randomized population (RP), and for the 281 patients in the Valid Study Group (VSG) meeting protocol eligibility requirements. 56% of patients in the VSG had glioblastoma multiforme, 33% had other malignant glioma, and 11% had low-grade glioma. 64% were stratified as progressive. 12% had received prior chemotherapy. Results: The group randomized to PCNU had the longer survival (p = 0.06 for the RP, p = 0.07 for the VSG). In the VSG, median survival was 10 months for the cisplatin group, 13 months for the PCNU group. The difference between treatment groups was significant (p ≤0.02) when adjusted for important prognostic factors. PCNU lead to greater hematotoxicity; cisplatin lead to greater renal toxicity and some ototoxicity. Some cisplatin patients experienced complications associated with IA administration, including six cases of encephalopathy. Conclusion: The trial showed a survival advantage to the group randomized to PCNU, although the difference was modest. Coupled with previous BTCG results, these trials suggest that PCNU is an active drug for brain tumors.

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