90Y glass microspheres for the treatment of unresectable metastatic liver disease from chemotherapy-refractory gastrointestinal cancers: a pilot study.

Abstract

PURPOSE:

This prospective pilot single-institution study was undertaken to document the feasibility, safety, and efficacy of treatment of liver-dominant metastatic gastrointestinal cancer using (90)Y glass microspheres.

METHODS:

Between June 2010 and November 2012, 30 adult patients (22 men, eight women; median age 61 years) with metastatic chemotherapy-refractory unresectable colorectal (n = 15), neuroendocrine (n = 9), intrahepatic cholangiocarcinoma (n = 3), pancreas (n = 2), and esophageal (n = 1) carcinomas underwent 45 lobar or segmental administrations of (90)Y glass microspheres. Data regarding clinical and laboratory adverse events (AE) were collected prospectively for 6 months after each treatment. Radiographic responses were evaluated using Response Evaluation Criteria in Solid Tumors, version 1.1. Time to maximum response, response duration, progression-free survival (hepatic and extrahepatic), and overall survival were measured.

RESULTS:

Median target dose and activity were 111.6 Gy and 2.5 GBq per treatment session, respectively. All but three clinical AE were grade 1 or 2 in severity. Serious AE included an unplanned hospital admission for carcinoid crisis, grade 3 vomiting, and grade 4 gastric ulcer. Patients with colorectal cancer had hepatic objective response rate (ORR) of 27 % and a disease control rate (DCR) of 73 %. Median progression-free and overall survival were 1.0 and 4.9 months, respectively. Patients with neuroendocrine tumors had hepatic ORR and DCR of 78 % and 100 %, respectively. Median progression-free survival was 18.5 months for this cohort.

CONCLUSIONS:

Y glass microspheres device has a favorable safety profile and achieved prolonged disease control of hepatic tumor burden in a subset of patients, including all patients enrolled in the neuroendocrine cohort.

• Authors: Nicholas Fidelman, Robert K Kerlan Jr, Randall A Hawkins, Andrew G Taylor, Maureen P Kohi, K Pallav Kolli, Emily K Bergsland, R Kate Kelley, Andrew H Ko, W Michael Korn, Ryan M McWhirter, Jennifer Luan, Alan P Venook
• Journal: Journal of gastrointestinal cancer (J Gastrointest Cancer) Vol. 45 Issue 2 Pg. 168-80 (Jun 2014) ISSN: 1941-6636 [Electronic] United States
• PMID: 24448917 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Yttrium Radioisotopes

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (pharmacology)
• Drug Resistance, Neoplasm (radiation effects)
• Feasibility Studies
• Female
• Follow-Up Studies
• Gastrointestinal Neoplasms (drug therapy, pathology, radiotherapy)
• Humans
• Liver Neoplasms (drug therapy, radiotherapy, secondary)
• Male
• Microspheres
• Middle Aged
• Neoplasm Staging
• Neuroendocrine Tumors (drug therapy, pathology, radiotherapy)
• Pilot Projects
• Prognosis
• Prospective Studies
• Yttrium Radioisotopes (therapeutic use)