Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for 90Y resin microspheres

Andrew S. Kennedy, David Ball, Steven J. Cohen, Michael Cohn, Douglas M. Coldwell, Alain Drooz, Eduardo Ehrenwald, Samir Kanani, Steven C. Rose, Charles W. Nutting, Fred M. Moeslein, Michael A. Savin, Sabine Schirm, Samuel G. Putnam, Navesh K. Sharma, Eric A. Wang

Research output: Contribution to journalArticle

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Abstract

Background: Metastatic colorectal cancer liver metastases Outcomes after RadioEmbolization (MORE) was an investigator-initiated case-control study to assess the experience of 11 US centers who treated liverdominant metastases from colorectal cancer (mCRC) using radioembolization [selective internal radiation therapy (SIRT)] with yttrium-90-(90Y)-labeled resin microspheres. Methods: Data from 606 consecutive patients who received radioembolization between July 2002 and December 2011 were collected by an independent research organization. Adverse events (AEs) and survival were compared across lines of treatment using Fisher's exact test and Kaplan-Meier estimates, respectively. Results: Patients received a median of 2 (range, 0-6) lines of prior chemotherapy; 35.1% had limited extrahepatic metastases. Median tumor-to-liver ratio and -activity administered at first procedure were 15% and 1.17 GBq, respectively. Hospital stay was < 24 hours in 97.8% cases. Common grade =3 AEs over 184 days follow-up were: abdominal pain (6.1%), fatigue (5.5%), hyperbilirubinemia (5.4%), ascites (3.6%) and gastrointestinal ulceration (1.7%). There was no statistical difference in AEs across treatment lines (P>0.05). Median survivals [95% confidence interval (CI)] following radioembolization as a 2nd-line, 3rd-line, or 4thplus line were 13.0 (range, 10.5-14.6), 9.0 (range, 7.8-11.0), and 8.1 (range, 6.4-9.3) months, respectively; and significantly prolonged in patients with ECOG 0 vs. =1 (P=0.009). Statistically significant independent variables for survival at radioembolization were: disease stage [extrahepatic metastases, extent of liver involvement (tumor-to-treated-liver ratio)], liver function (uncontrolled ascites, albumin, alkaline phosphatase, aspartate transaminase), leukocytes, and prior chemotherapy. Conclusions: Radioembolization appears to have a favorable risk/benefit profile, even among mCRC patients who had received ≥3 prior lines of chemotherapy.

Original languageEnglish (US)
Pages (from-to)134-142
Number of pages9
JournalJournal of Gastrointestinal Oncology
Volume6
Issue number2
DOIs
StatePublished - Jan 1 2015

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Microspheres
Neoplasm Metastasis
Safety
Liver
Colorectal Neoplasms
Drug Therapy
Survival
Yttrium
Kaplan-Meier Estimate
Liver Neoplasms
Aspartate Aminotransferases
Ascites
Alkaline Phosphatase
Case-Control Studies
Albumins
Length of Stay
Neoplasms
Leukocytes
Radiotherapy
Research Personnel

All Science Journal Classification (ASJC) codes

  • Oncology
  • Gastroenterology

Cite this

Kennedy, Andrew S. ; Ball, David ; Cohen, Steven J. ; Cohn, Michael ; Coldwell, Douglas M. ; Drooz, Alain ; Ehrenwald, Eduardo ; Kanani, Samir ; Rose, Steven C. ; Nutting, Charles W. ; Moeslein, Fred M. ; Savin, Michael A. ; Schirm, Sabine ; Putnam, Samuel G. ; Sharma, Navesh K. ; Wang, Eric A. / Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for 90Y resin microspheres. In: Journal of Gastrointestinal Oncology. 2015 ; Vol. 6, No. 2. pp. 134-142.
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title = "Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for 90Y resin microspheres",
abstract = "Background: Metastatic colorectal cancer liver metastases Outcomes after RadioEmbolization (MORE) was an investigator-initiated case-control study to assess the experience of 11 US centers who treated liverdominant metastases from colorectal cancer (mCRC) using radioembolization [selective internal radiation therapy (SIRT)] with yttrium-90-(90Y)-labeled resin microspheres. Methods: Data from 606 consecutive patients who received radioembolization between July 2002 and December 2011 were collected by an independent research organization. Adverse events (AEs) and survival were compared across lines of treatment using Fisher's exact test and Kaplan-Meier estimates, respectively. Results: Patients received a median of 2 (range, 0-6) lines of prior chemotherapy; 35.1{\%} had limited extrahepatic metastases. Median tumor-to-liver ratio and -activity administered at first procedure were 15{\%} and 1.17 GBq, respectively. Hospital stay was < 24 hours in 97.8{\%} cases. Common grade =3 AEs over 184 days follow-up were: abdominal pain (6.1{\%}), fatigue (5.5{\%}), hyperbilirubinemia (5.4{\%}), ascites (3.6{\%}) and gastrointestinal ulceration (1.7{\%}). There was no statistical difference in AEs across treatment lines (P>0.05). Median survivals [95{\%} confidence interval (CI)] following radioembolization as a 2nd-line, 3rd-line, or 4thplus line were 13.0 (range, 10.5-14.6), 9.0 (range, 7.8-11.0), and 8.1 (range, 6.4-9.3) months, respectively; and significantly prolonged in patients with ECOG 0 vs. =1 (P=0.009). Statistically significant independent variables for survival at radioembolization were: disease stage [extrahepatic metastases, extent of liver involvement (tumor-to-treated-liver ratio)], liver function (uncontrolled ascites, albumin, alkaline phosphatase, aspartate transaminase), leukocytes, and prior chemotherapy. Conclusions: Radioembolization appears to have a favorable risk/benefit profile, even among mCRC patients who had received ≥3 prior lines of chemotherapy.",
author = "Kennedy, {Andrew S.} and David Ball and Cohen, {Steven J.} and Michael Cohn and Coldwell, {Douglas M.} and Alain Drooz and Eduardo Ehrenwald and Samir Kanani and Rose, {Steven C.} and Nutting, {Charles W.} and Moeslein, {Fred M.} and Savin, {Michael A.} and Sabine Schirm and Putnam, {Samuel G.} and Sharma, {Navesh K.} and Wang, {Eric A.}",
year = "2015",
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language = "English (US)",
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pages = "134--142",
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Kennedy, AS, Ball, D, Cohen, SJ, Cohn, M, Coldwell, DM, Drooz, A, Ehrenwald, E, Kanani, S, Rose, SC, Nutting, CW, Moeslein, FM, Savin, MA, Schirm, S, Putnam, SG, Sharma, NK & Wang, EA 2015, 'Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for 90Y resin microspheres', Journal of Gastrointestinal Oncology, vol. 6, no. 2, pp. 134-142. https://doi.org/10.3978/j.issn.2078-6891.2014.109

Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for 90Y resin microspheres. / Kennedy, Andrew S.; Ball, David; Cohen, Steven J.; Cohn, Michael; Coldwell, Douglas M.; Drooz, Alain; Ehrenwald, Eduardo; Kanani, Samir; Rose, Steven C.; Nutting, Charles W.; Moeslein, Fred M.; Savin, Michael A.; Schirm, Sabine; Putnam, Samuel G.; Sharma, Navesh K.; Wang, Eric A.

In: Journal of Gastrointestinal Oncology, Vol. 6, No. 2, 01.01.2015, p. 134-142.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for 90Y resin microspheres

AU - Kennedy, Andrew S.

AU - Ball, David

AU - Cohen, Steven J.

AU - Cohn, Michael

AU - Coldwell, Douglas M.

AU - Drooz, Alain

AU - Ehrenwald, Eduardo

AU - Kanani, Samir

AU - Rose, Steven C.

AU - Nutting, Charles W.

AU - Moeslein, Fred M.

AU - Savin, Michael A.

AU - Schirm, Sabine

AU - Putnam, Samuel G.

AU - Sharma, Navesh K.

AU - Wang, Eric A.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Background: Metastatic colorectal cancer liver metastases Outcomes after RadioEmbolization (MORE) was an investigator-initiated case-control study to assess the experience of 11 US centers who treated liverdominant metastases from colorectal cancer (mCRC) using radioembolization [selective internal radiation therapy (SIRT)] with yttrium-90-(90Y)-labeled resin microspheres. Methods: Data from 606 consecutive patients who received radioembolization between July 2002 and December 2011 were collected by an independent research organization. Adverse events (AEs) and survival were compared across lines of treatment using Fisher's exact test and Kaplan-Meier estimates, respectively. Results: Patients received a median of 2 (range, 0-6) lines of prior chemotherapy; 35.1% had limited extrahepatic metastases. Median tumor-to-liver ratio and -activity administered at first procedure were 15% and 1.17 GBq, respectively. Hospital stay was < 24 hours in 97.8% cases. Common grade =3 AEs over 184 days follow-up were: abdominal pain (6.1%), fatigue (5.5%), hyperbilirubinemia (5.4%), ascites (3.6%) and gastrointestinal ulceration (1.7%). There was no statistical difference in AEs across treatment lines (P>0.05). Median survivals [95% confidence interval (CI)] following radioembolization as a 2nd-line, 3rd-line, or 4thplus line were 13.0 (range, 10.5-14.6), 9.0 (range, 7.8-11.0), and 8.1 (range, 6.4-9.3) months, respectively; and significantly prolonged in patients with ECOG 0 vs. =1 (P=0.009). Statistically significant independent variables for survival at radioembolization were: disease stage [extrahepatic metastases, extent of liver involvement (tumor-to-treated-liver ratio)], liver function (uncontrolled ascites, albumin, alkaline phosphatase, aspartate transaminase), leukocytes, and prior chemotherapy. Conclusions: Radioembolization appears to have a favorable risk/benefit profile, even among mCRC patients who had received ≥3 prior lines of chemotherapy.

AB - Background: Metastatic colorectal cancer liver metastases Outcomes after RadioEmbolization (MORE) was an investigator-initiated case-control study to assess the experience of 11 US centers who treated liverdominant metastases from colorectal cancer (mCRC) using radioembolization [selective internal radiation therapy (SIRT)] with yttrium-90-(90Y)-labeled resin microspheres. Methods: Data from 606 consecutive patients who received radioembolization between July 2002 and December 2011 were collected by an independent research organization. Adverse events (AEs) and survival were compared across lines of treatment using Fisher's exact test and Kaplan-Meier estimates, respectively. Results: Patients received a median of 2 (range, 0-6) lines of prior chemotherapy; 35.1% had limited extrahepatic metastases. Median tumor-to-liver ratio and -activity administered at first procedure were 15% and 1.17 GBq, respectively. Hospital stay was < 24 hours in 97.8% cases. Common grade =3 AEs over 184 days follow-up were: abdominal pain (6.1%), fatigue (5.5%), hyperbilirubinemia (5.4%), ascites (3.6%) and gastrointestinal ulceration (1.7%). There was no statistical difference in AEs across treatment lines (P>0.05). Median survivals [95% confidence interval (CI)] following radioembolization as a 2nd-line, 3rd-line, or 4thplus line were 13.0 (range, 10.5-14.6), 9.0 (range, 7.8-11.0), and 8.1 (range, 6.4-9.3) months, respectively; and significantly prolonged in patients with ECOG 0 vs. =1 (P=0.009). Statistically significant independent variables for survival at radioembolization were: disease stage [extrahepatic metastases, extent of liver involvement (tumor-to-treated-liver ratio)], liver function (uncontrolled ascites, albumin, alkaline phosphatase, aspartate transaminase), leukocytes, and prior chemotherapy. Conclusions: Radioembolization appears to have a favorable risk/benefit profile, even among mCRC patients who had received ≥3 prior lines of chemotherapy.

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