Biomarker response to high-specific-activity I-131 meta-iodobenzylguanidine in pheochromocytoma/paraganglioma

Camilo Jimenez; Bennett B Chin; Richard B Noto; Joseph S Dillon; Lilja Solnes; Nancy Stambler; Vincent A DiPippo; Daniel A Pryma

doi:10.1530/ERC-22-0236

Back

Biomarker response to high-specific-activity I-131 meta-iodobenzylguanidine in pheochromocytoma/paraganglioma

Journal article

Open access

Peer reviewed

Biomarker response to high-specific-activity I-131 meta-iodobenzylguanidine in pheochromocytoma/paraganglioma

Camilo Jimenez, Bennett B Chin, Richard B Noto, Joseph S Dillon, Lilja Solnes, Nancy Stambler, Vincent A DiPippo and Daniel A Pryma

Endocrine-related cancer, Vol.30(2), e220236

02/01/2023

DOI: 10.1530/ERC-22-0236

PMCID: PMC9874967

PMID: 36472300

Files and links (1)

url

https://doi.org/10.1530/ERC-22-0236View

Published (Version of record) Open Access

Abstract

The objective of this study is to present the complete biomarker response dataset from a pivotal trial evaluating the efficacy and safety of high-specific-activity I-131 meta-iodobenzylguanidine in patients with advanced pheochromocytoma or paraganglioma. Biomarker status was assessed and post-treatment responses were analyzed for catecholamines, metanephrines, and serum chromogranin A. Complete biomarker response (normalization) or partial response, defined as at least 50% reduction from baseline if above the normal range, was evaluated at specified time points over a 12-month period. These results were correlated with two other study objectives: blood pressure control and objective tumor response as per RECIST 1.0. In this open-label, single-arm study, 68 patients received at least one therapeutic dose (~18.5 GBq (~500 mCi)) of high-specific-activity I-131 meta-iodobenzylguanidine. Of the patients, 79% and 72% had tumors associated with elevated total plasma free metanephrines and serum chromogranin A levels, respectively. Best overall biomarker responses (complete or partial response) for total plasma free metanephrines and chromogranin A were observed in 69% (37/54) and 80% (39/49) of patients, respectively. The best response for individual biomarkers was observed 6-12 months following the first administration of high-specific-activity I-131 meta-iodobenzylguanidine. Biochemical tumor marker response was significantly associated with both reduction in antihypertensive medication use (correlation coefficient 0.35; P = 0.006) as well as objective tumor response (correlation coefficient 0.36; P = 0.007). Treatment with high-specific-activity I-131 meta-iodobenzylguanidine resulted in long-lasting biomarker responses in patients with advanced pheochromocytoma or paraganglioma that correlated with blood pressure control and objective response rate. ClinicalTrials.gov number: NCT00874614.

3-Iodobenzylguanidine - adverse effects

Adrenal Gland Neoplasms - diagnostic imaging

Adrenal Gland Neoplasms - radiotherapy

Biomarkers, Tumor

Chromogranin A

Humans

Iodine Radioisotopes - therapeutic use

Metanephrine

Paraganglioma - diagnostic imaging

Paraganglioma - drug therapy

Paraganglioma - radiotherapy

Pheochromocytoma - diagnostic imaging

Pheochromocytoma - radiotherapy

Details

Title: Subtitle: Biomarker response to high-specific-activity I-131 meta-iodobenzylguanidine in pheochromocytoma/paraganglioma
Creators: Camilo Jimenez - The University of Texas MD Anderson Cancer Center
Bennett B Chin - University of Colorado Anschutz Medical Campus
Richard B Noto - Brown University
Joseph S Dillon - University of Iowa
Lilja Solnes - Johns Hopkins University
Nancy Stambler - Progenics Pharmaceuticals (United States)
Vincent A DiPippo - Progenics Pharmaceuticals (United States)
Daniel A Pryma - Hospital of the University of Pennsylvania
Resource Type: Journal article
Publication Details: Endocrine-related cancer, Vol.30(2), e220236
DOI: 10.1530/ERC-22-0236
PMID: 36472300
PMCID: PMC9874967
NLM abbreviation: Endocr Relat Cancer
ISSN: 1351-0088
eISSN: 1479-6821
Language: English
Date published: 02/01/2023
Academic Unit: Fraternal Order of Eagles Diabetes Research Center; Endocrinology and Metabolism; Internal Medicine
Record Identifier: 9984359895302771

Metrics

26 Record Views

11 Times Cited - Web of Science

See more details