Phase II study of monthly pasireotide LAR (SOM230C) for recurrent or progressive meningioma
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Abstract
Objective: A subset of meningiomas recur after surgery and radiation therapy, but no medical therapy for recurrent meningioma has proven effective.
Methods: Pasireotide LAR is a long-acting somatostatin analog that may inhibit meningioma growth. This was a phase II trial in patients with histologically confirmed recurrent or progressive meningioma designed to evaluate whether pasireotide LAR prolongs progression-free survival at 6 months (PFS6). Patients were stratified by histology (atypical [World Health Organization grade 2] and malignant [grade 3] meningiomas in cohort A and benign [grade 3] in cohort B).
Results: Eighteen patients were accrued in cohort A and 16 in cohort B. Cohort A had median age 59 years, median Karnofsky performance status 80, 17 (94%) had previous radiation therapy, and 11 (61%) showed high octreotide uptake. Cohort B had median age 52 years, median Karnofsky performance status 90, 11 (69%) had previous radiation therapy, and 12 (75%) showed high octreotide uptake. There were no radiographic responses to pasireotide LAR therapy in either cohort. Twelve patients (67%) in cohort A and 13 (81%) in cohort B achieved stable disease. In cohort A, PFS6 was 17% and median PFS 15 weeks (95% confidence interval: 8–20). In cohort B, PFS6 was 50% and median PFS 26 weeks (12–43). Treatment was well tolerated. Octreotide uptake and insulin-like growth factor–1 levels did not predict outcome. Expression of somatostatin receptor 3 predicted favorable PFS and overall survival.
Conclusions: Pasireotide LAR has limited activity in recurrent meningiomas. The finding that somatostatin receptor 3 is associated with favorable outcomes warrants further investigation.
Classification of evidence: This study provides Class IV evidence that in patients with recurrent or progressive meningioma, pasireotide LAR does not significantly increase the proportion of patients with PFS at 6 months.
GLOSSARY
- CI=
- confidence interval;
- IGF-1=
- insulin-like growth factor–1;
- OS=
- overall survival;
- PFS=
- progression-free survival;
- PFS6=
- progression-free survival at 6 months;
- RANO=
- Response Assessment in Neuro-Oncology;
- SSTR=
- somatostatin receptor;
- WHO=
- World Health Organization
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Supplemental data at Neurology.org
- Received April 17, 2014.
- Accepted in final form September 10, 2014.
- © 2014 American Academy of Neurology
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Disputes & Debates: Rapid online correspondence
- "Author Response: What constitutes activity of systemic therapy in recurrent meningioma?"
- Patrick Y. Wen, Professor of Neurology, Harvard Medical SchoolPatrick_Wen@dfci.harvard.edu
- Andrew D. Norden, Boston, MA
Submitted May 27, 2015 - What constitutes activity of systemic therapy in recurrent meningioma?
- Marc C. Chamberlain, Professor, Physician, University of Washington Department of Neurology and Neurological Surgery Division of Neuro-Oncologychambemc@uw.edu
Submitted February 17, 2015
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