Radioembolisation for liver metastases: Results from a prospective 151 patient multi-institutional phase II study

Al B Benson III, Jean Francois Geschwind, Mary Frances Mulcahy, William Rilling, Gary Siskin, Greg Wiseman, James Cunningham, Bonny Houghton, Mason Ross, Khairuddin Memon, James Andrews, Chad J. Fleming, Joseph Herman, Halla Nimeiri, Robert J Lewandowski, Riad Salem*

*Corresponding author for this work

Research output: Contribution to journalArticle

50 Citations (Scopus)

Abstract

Purpose To investigate the safety, response rate, progression-free and overall survival of patients with liver metastases treated with 90Y (glass) radioembolisation in a prospective, multicenter phase II study. Methods 151 patients with liver metastases (colorectal n = 61, neuroendocrine n = 43 and other tumour types n = 47) refractory to standard of care therapies were enrolled in this prospective, multicenter, phase II study under an investigational device exemption. Clinical/laboratory/imaging follow-up were obtained at 30 days followed by 3-month intervals for 1 year and every 6 months thereafter. The primary end-point was progression-free survival (PFS); secondary end-points included safety, hepatic progression-free survival (HPFS), response rate and overall survival. Results Median age was 66 (range 25-88). Grade 3/4 adverse events included pain (12.8%), elevated alkaline phospatase (8.1%), hyperbilirubinemia (5.3%), lymphopaenia (4.1%), ascites (3.4%) and vomiting (3.4%). Treatment parameters including dose delivery were reproducible among centers. Disease control rates were 59%, 93% and 63% for colorectal, neuroendocrine and other primaries, respectively. Median PFS was 2.9 and 2.8 months for colorectal and other primaries, respectively. PFS was not achieved in the neuroendocrine group. Median survival from 90Y treatment was 8.8 months for colorectal and 10.4 months for other primaries. Median survival for neuroendocrine patients has not been reached. Conclusion Patients with liver metastases can be safely treated with 90Y microspheres. This study is the first to demonstrate technical and dose reproducibility of 90Y glass microspheres between centers in a prospective setting. Based on these promising data, three international, multicenter, randomised phase III studies in colorectal and hepatocellular carcinoma have been initiated.

Original languageEnglish (US)
Pages (from-to)3122-3130
Number of pages9
JournalEuropean Journal of Cancer
Volume49
Issue number15
DOIs
StatePublished - Oct 1 2013

Fingerprint

Disease-Free Survival
Neoplasm Metastasis
Liver
Microspheres
Glass
Survival
Safety
Lymphopenia
Hyperbilirubinemia
Standard of Care
Ascites
Vomiting
Hepatocellular Carcinoma
Colorectal Neoplasms
Therapeutics
Survival Rate
Pain
Equipment and Supplies
Neoplasms

Keywords

  • Chemotherapy
  • Liver metastases
  • Progressive disease
  • Radioembolisation
  • TheraSphere
  • Yttrium-90

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Benson III, Al B ; Geschwind, Jean Francois ; Mulcahy, Mary Frances ; Rilling, William ; Siskin, Gary ; Wiseman, Greg ; Cunningham, James ; Houghton, Bonny ; Ross, Mason ; Memon, Khairuddin ; Andrews, James ; Fleming, Chad J. ; Herman, Joseph ; Nimeiri, Halla ; Lewandowski, Robert J ; Salem, Riad. / Radioembolisation for liver metastases : Results from a prospective 151 patient multi-institutional phase II study. In: European Journal of Cancer. 2013 ; Vol. 49, No. 15. pp. 3122-3130.
@article{a2637e10abe84bb38e92293e85577afc,
title = "Radioembolisation for liver metastases: Results from a prospective 151 patient multi-institutional phase II study",
abstract = "Purpose To investigate the safety, response rate, progression-free and overall survival of patients with liver metastases treated with 90Y (glass) radioembolisation in a prospective, multicenter phase II study. Methods 151 patients with liver metastases (colorectal n = 61, neuroendocrine n = 43 and other tumour types n = 47) refractory to standard of care therapies were enrolled in this prospective, multicenter, phase II study under an investigational device exemption. Clinical/laboratory/imaging follow-up were obtained at 30 days followed by 3-month intervals for 1 year and every 6 months thereafter. The primary end-point was progression-free survival (PFS); secondary end-points included safety, hepatic progression-free survival (HPFS), response rate and overall survival. Results Median age was 66 (range 25-88). Grade 3/4 adverse events included pain (12.8{\%}), elevated alkaline phospatase (8.1{\%}), hyperbilirubinemia (5.3{\%}), lymphopaenia (4.1{\%}), ascites (3.4{\%}) and vomiting (3.4{\%}). Treatment parameters including dose delivery were reproducible among centers. Disease control rates were 59{\%}, 93{\%} and 63{\%} for colorectal, neuroendocrine and other primaries, respectively. Median PFS was 2.9 and 2.8 months for colorectal and other primaries, respectively. PFS was not achieved in the neuroendocrine group. Median survival from 90Y treatment was 8.8 months for colorectal and 10.4 months for other primaries. Median survival for neuroendocrine patients has not been reached. Conclusion Patients with liver metastases can be safely treated with 90Y microspheres. This study is the first to demonstrate technical and dose reproducibility of 90Y glass microspheres between centers in a prospective setting. Based on these promising data, three international, multicenter, randomised phase III studies in colorectal and hepatocellular carcinoma have been initiated.",
keywords = "Chemotherapy, Liver metastases, Progressive disease, Radioembolisation, TheraSphere, Yttrium-90",
author = "{Benson III}, {Al B} and Geschwind, {Jean Francois} and Mulcahy, {Mary Frances} and William Rilling and Gary Siskin and Greg Wiseman and James Cunningham and Bonny Houghton and Mason Ross and Khairuddin Memon and James Andrews and Fleming, {Chad J.} and Joseph Herman and Halla Nimeiri and Lewandowski, {Robert J} and Riad Salem",
year = "2013",
month = "10",
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language = "English (US)",
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Benson III, AB, Geschwind, JF, Mulcahy, MF, Rilling, W, Siskin, G, Wiseman, G, Cunningham, J, Houghton, B, Ross, M, Memon, K, Andrews, J, Fleming, CJ, Herman, J, Nimeiri, H, Lewandowski, RJ & Salem, R 2013, 'Radioembolisation for liver metastases: Results from a prospective 151 patient multi-institutional phase II study', European Journal of Cancer, vol. 49, no. 15, pp. 3122-3130. https://doi.org/10.1016/j.ejca.2013.05.012

Radioembolisation for liver metastases : Results from a prospective 151 patient multi-institutional phase II study. / Benson III, Al B; Geschwind, Jean Francois; Mulcahy, Mary Frances; Rilling, William; Siskin, Gary; Wiseman, Greg; Cunningham, James; Houghton, Bonny; Ross, Mason; Memon, Khairuddin; Andrews, James; Fleming, Chad J.; Herman, Joseph; Nimeiri, Halla; Lewandowski, Robert J; Salem, Riad.

In: European Journal of Cancer, Vol. 49, No. 15, 01.10.2013, p. 3122-3130.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Radioembolisation for liver metastases

T2 - Results from a prospective 151 patient multi-institutional phase II study

AU - Benson III, Al B

AU - Geschwind, Jean Francois

AU - Mulcahy, Mary Frances

AU - Rilling, William

AU - Siskin, Gary

AU - Wiseman, Greg

AU - Cunningham, James

AU - Houghton, Bonny

AU - Ross, Mason

AU - Memon, Khairuddin

AU - Andrews, James

AU - Fleming, Chad J.

AU - Herman, Joseph

AU - Nimeiri, Halla

AU - Lewandowski, Robert J

AU - Salem, Riad

PY - 2013/10/1

Y1 - 2013/10/1

N2 - Purpose To investigate the safety, response rate, progression-free and overall survival of patients with liver metastases treated with 90Y (glass) radioembolisation in a prospective, multicenter phase II study. Methods 151 patients with liver metastases (colorectal n = 61, neuroendocrine n = 43 and other tumour types n = 47) refractory to standard of care therapies were enrolled in this prospective, multicenter, phase II study under an investigational device exemption. Clinical/laboratory/imaging follow-up were obtained at 30 days followed by 3-month intervals for 1 year and every 6 months thereafter. The primary end-point was progression-free survival (PFS); secondary end-points included safety, hepatic progression-free survival (HPFS), response rate and overall survival. Results Median age was 66 (range 25-88). Grade 3/4 adverse events included pain (12.8%), elevated alkaline phospatase (8.1%), hyperbilirubinemia (5.3%), lymphopaenia (4.1%), ascites (3.4%) and vomiting (3.4%). Treatment parameters including dose delivery were reproducible among centers. Disease control rates were 59%, 93% and 63% for colorectal, neuroendocrine and other primaries, respectively. Median PFS was 2.9 and 2.8 months for colorectal and other primaries, respectively. PFS was not achieved in the neuroendocrine group. Median survival from 90Y treatment was 8.8 months for colorectal and 10.4 months for other primaries. Median survival for neuroendocrine patients has not been reached. Conclusion Patients with liver metastases can be safely treated with 90Y microspheres. This study is the first to demonstrate technical and dose reproducibility of 90Y glass microspheres between centers in a prospective setting. Based on these promising data, three international, multicenter, randomised phase III studies in colorectal and hepatocellular carcinoma have been initiated.

AB - Purpose To investigate the safety, response rate, progression-free and overall survival of patients with liver metastases treated with 90Y (glass) radioembolisation in a prospective, multicenter phase II study. Methods 151 patients with liver metastases (colorectal n = 61, neuroendocrine n = 43 and other tumour types n = 47) refractory to standard of care therapies were enrolled in this prospective, multicenter, phase II study under an investigational device exemption. Clinical/laboratory/imaging follow-up were obtained at 30 days followed by 3-month intervals for 1 year and every 6 months thereafter. The primary end-point was progression-free survival (PFS); secondary end-points included safety, hepatic progression-free survival (HPFS), response rate and overall survival. Results Median age was 66 (range 25-88). Grade 3/4 adverse events included pain (12.8%), elevated alkaline phospatase (8.1%), hyperbilirubinemia (5.3%), lymphopaenia (4.1%), ascites (3.4%) and vomiting (3.4%). Treatment parameters including dose delivery were reproducible among centers. Disease control rates were 59%, 93% and 63% for colorectal, neuroendocrine and other primaries, respectively. Median PFS was 2.9 and 2.8 months for colorectal and other primaries, respectively. PFS was not achieved in the neuroendocrine group. Median survival from 90Y treatment was 8.8 months for colorectal and 10.4 months for other primaries. Median survival for neuroendocrine patients has not been reached. Conclusion Patients with liver metastases can be safely treated with 90Y microspheres. This study is the first to demonstrate technical and dose reproducibility of 90Y glass microspheres between centers in a prospective setting. Based on these promising data, three international, multicenter, randomised phase III studies in colorectal and hepatocellular carcinoma have been initiated.

KW - Chemotherapy

KW - Liver metastases

KW - Progressive disease

KW - Radioembolisation

KW - TheraSphere

KW - Yttrium-90

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