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CLINICAL TRIAL
CLINICAL TRIAL, PHASE I
JOURNAL ARTICLE
Gliadel for pituitary adenomas and craniopharyngiomas.
Neurosurgery 2003 August
OBJECTIVE: We developed a protocol for a clinical trial of postresection implantation of Gliadel wafers in patients with aggressive, relentlessly recurring pituitary adenomas and craniopharyngiomas.
METHODS: Ten patients, nine with pituitary adenomas and one with a craniopharyngioma, underwent implantation of from two to eight Gliadel wafers.
RESULTS: No obvious adverse reactions occurred. Death as a result of disease progression occurred in two patients with malignant adenomas. One patient died as a result of a stroke after undergoing five surgical procedures and prior radiotherapy. The seven living patients have been followed for 5 to 27 months (mean follow-up, 19 mo). Four patients have been free of recurrent or residual tumor, two have stable residual disease, and one has experienced tumor progression.
CONCLUSION: The results of this study suggest a role for Gliadel implantation in patients with recurring aggressive pituitary adenomas and craniopharyngiomas.
METHODS: Ten patients, nine with pituitary adenomas and one with a craniopharyngioma, underwent implantation of from two to eight Gliadel wafers.
RESULTS: No obvious adverse reactions occurred. Death as a result of disease progression occurred in two patients with malignant adenomas. One patient died as a result of a stroke after undergoing five surgical procedures and prior radiotherapy. The seven living patients have been followed for 5 to 27 months (mean follow-up, 19 mo). Four patients have been free of recurrent or residual tumor, two have stable residual disease, and one has experienced tumor progression.
CONCLUSION: The results of this study suggest a role for Gliadel implantation in patients with recurring aggressive pituitary adenomas and craniopharyngiomas.
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