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Neurology. 2015 Jan 20;84(3):280-6. doi: 10.1212/WNL.0000000000001153. Epub 2014 Dec 19.

Phase II study of monthly pasireotide LAR (SOM230C) for recurrent or progressive meningioma.

Author information

1
From the Division of Cancer Neurology, Department of Neurology (A.D.N., E.Q.L., P.Y.W.), and Departments of Pathology (K.L.L.) and Medicine (R.B.), Brigham and Women's Hospital, Boston, MA; Center for Neuro-Oncology (A.D.N., S.N.H., D.A.R., R.B., E.Q.L., L.D., D.L., M.G., K.H.S., C.M., P.Y.W.), Dana-Farber/Brigham and Women's Cancer Center; Department of Medicine (R.B.), Harvard Medical School (A.D.N., K.L.L., D.A.R., T.T.B., S.R.P., E.T.W., R.B., E.Q.L., P.Y.W.), Boston; Department of Medical Oncology, Center for Molecular Oncologic Pathology (K.L.L., S.H.), and Departments of Medical Oncology and Cancer Biology (R.B.), Dana-Farber Cancer Institute, Boston; Massachusetts General Hospital Biostatistics Center (A.M.); Brain Tumor Center (T.J.K.), Memorial Sloan-Kettering Cancer Center, New York, NY; Pappas Center for Neuro-Oncology (T.T.B., S.R.P.), Massachusetts General Hospital, Boston; Department of Neurology (J.J.R.), Northwestern University Feinberg School of Medicine, Chicago, IL; Brain Tumor Center (E.T.W.), Beth-Israel Deaconess Medical Center, Boston; Adult Neuro-Oncology Program (J.D.), University of Pittsburgh Medical Center, Pittsburgh, PA; Comprehensive Cancer Center (G.J.L.), Wake Forest University Baptist Medical Center, Winston-Salem, NC; and Departments of Neurosurgery and Neurology (S.P.), Cedars-Sinai Medical Center, Los Angeles, CA.
2
From the Division of Cancer Neurology, Department of Neurology (A.D.N., E.Q.L., P.Y.W.), and Departments of Pathology (K.L.L.) and Medicine (R.B.), Brigham and Women's Hospital, Boston, MA; Center for Neuro-Oncology (A.D.N., S.N.H., D.A.R., R.B., E.Q.L., L.D., D.L., M.G., K.H.S., C.M., P.Y.W.), Dana-Farber/Brigham and Women's Cancer Center; Department of Medicine (R.B.), Harvard Medical School (A.D.N., K.L.L., D.A.R., T.T.B., S.R.P., E.T.W., R.B., E.Q.L., P.Y.W.), Boston; Department of Medical Oncology, Center for Molecular Oncologic Pathology (K.L.L., S.H.), and Departments of Medical Oncology and Cancer Biology (R.B.), Dana-Farber Cancer Institute, Boston; Massachusetts General Hospital Biostatistics Center (A.M.); Brain Tumor Center (T.J.K.), Memorial Sloan-Kettering Cancer Center, New York, NY; Pappas Center for Neuro-Oncology (T.T.B., S.R.P.), Massachusetts General Hospital, Boston; Department of Neurology (J.J.R.), Northwestern University Feinberg School of Medicine, Chicago, IL; Brain Tumor Center (E.T.W.), Beth-Israel Deaconess Medical Center, Boston; Adult Neuro-Oncology Program (J.D.), University of Pittsburgh Medical Center, Pittsburgh, PA; Comprehensive Cancer Center (G.J.L.), Wake Forest University Baptist Medical Center, Winston-Salem, NC; and Departments of Neurosurgery and Neurology (S.P.), Cedars-Sinai Medical Center, Los Angeles, CA. pwen@partners.org.

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.

PMID:
25527270
PMCID:
PMC4335993
DOI:
10.1212/WNL.0000000000001153
[Indexed for MEDLINE]
Free PMC Article

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