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

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). 311 adult patients (ages 19-79 years; median 45) with supratentorial tumors (confirmed histologically) were...

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Bibliographic Details
Published in:	Journal of neuro-oncology Vol. 25; no. 2; pp. 143 - 154
Main Authors:	HIESIGER, E. M, GREEN, S. B, HOCHBERG, F. H, YOUNG, R. F, SHAPIRO, W. R, BURGER, P. C, SELKER, R. G, MAHALEY, M. S, RANSOFF, J. II, VAN GILDER, J. C, MEALEY, J. JR, ROBERTSON, J. T
Format:	Journal Article
Language:	English
Published:	Dordrecht Springer 01-06-1995
Subjects:	Adult Aged Aging Antineoplastic agents Antineoplastic Agents - administration & dosage Antineoplastic Agents - therapeutic use Antineoplastic Agents, Alkylating - administration & dosage Antineoplastic Agents, Alkylating - therapeutic use Biological and medical sciences Chemotherapy Cisplatin - administration & dosage Cisplatin - therapeutic use Combined Modality Therapy Disease Progression Humans Injections, Intra-Arterial Injections, Intravenous Karnofsky Performance Status Medical sciences Middle Aged Nitrosourea Compounds - administration & dosage Nitrosourea Compounds - therapeutic use Pharmacology. Drug treatments Supratentorial Neoplasms - drug therapy Supratentorial Neoplasms - mortality Supratentorial Neoplasms - pathology Supratentorial Neoplasms - surgery Survival Analysis Antineoplastic agent Human Malignant glioma Nervous system diseases Chemotherapy Treatment Intravenous administration Central nervous system disease Malignant tumor Comparative study
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Summary:	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). 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. 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 < or = 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. The trial showed a survival advantage to the group randomized to PCNU, although the difference was modest. Coupled with previous BTCG results, these trails suggest that PCNU is an active drug for brain tumors.
ISSN:	0167-594X 1573-7373
DOI:	10.1007/BF01057758