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Radioembolization with chemotherapy for colorectal liver metastases: a randomized, open-label, international, multicenter, phase III trial
Mulcahy, M. F. Mahvash, A. Pracht, M. Montazeri, A. H. Bandula, S. Herrmann, K. Brown, E. Zuckerman, D. Wilson, Gregory Kim, T. Y.
Mulcahy, M. F.
Mahvash, A.
Pracht, M.
Montazeri, A. H.
Bandula, S.
Herrmann, K.
Brown, E.
Zuckerman, D.
Wilson, Gregory
Kim, T. Y.
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Abstract
Purpose: To study the impact of transarterial Yttrium-90 radioembolization (TARE) in combination with second-line systemic chemotherapy for colorectal liver metastases (CLM).
Methods: In this international, multicenter, open-label phase III trial, patients with CLM who progressed on oxaliplatin- or irinotecan-based first-line therapy were randomly assigned 1:1 to receive second-line chemotherapy with or without TARE. The two primary end points were progression-free survival (PFS) and hepatic PFS (hPFS), assessed by blinded independent central review. Random assignment was performed using a web- or voice-based system stratified by unilobar or bilobar disease, oxaliplatin- or irinotecan-based first-line chemotherapy, and KRAS mutation status.
Results: Four hundred twenty-eight patients from 95 centers in North America, Europe, and Asia were randomly assigned to chemotherapy with or without TARE; this represents the intention-to-treat population and included 215 patients in the TARE plus chemotherapy group and 213 patients in the chemotherapy alone group. The hazard ratio (HR) for PFS was 0.69 (95% CI, 0.54 to 0.88; 1-sided P = .0013), with a median PFS of 8.0 (95% CI, 7.2 to 9.2) and 7.2 (95% CI, 5.7 to 7.6) months, respectively. The HR for hPFS was 0.59 (95% CI, 0.46 to 0.77; 1-sided P < .0001), with a median hPFS of 9.1 (95% CI, 7.8 to 9.7) and 7.2 (95% CI, 5.7 to 7.6) months, respectively. Objective response rates were 34.0% (95% CI, 28.0 to 40.5) and 21.1% (95% CI, 16.2 to 27.1; 1-sided P = .0019) for the TARE and chemotherapy groups, respectively. Median overall survival was 14.0 (95% CI, 11.8 to 15.5) and 14.4 months (95% CI, 12.8 to 16.4; 1-sided P = .7229) with a HR of 1.07 (95% CI, 0.86 to 1.32) for TARE and chemotherapy groups, respectively. Grade 3 adverse events were reported more frequently with TARE (68.4% v 49.3%). Both groups received full chemotherapy dose intensity.
Conclusion: The addition of TARE to systemic therapy for second-line CLM led to longer PFS and hPFS. Further subset analyses are needed to better define the ideal patient population that would benefit from TARE.
Authors
Mulcahy, M. F.
Mahvash, A.
Pracht, M.
Montazeri, A. H.
Bandula, S.
Herrmann, K.
Brown, E.
Zuckerman, D.
Wilson, Gregory
Kim, T. Y.
Weaver, A.
Ross, P.
Harris, W. P.
Graham, J.
Mills, J.
Yubero Esteban, A.
Johnson, M. S.
Sofocleous, C. T.
Padia, S. A.
Lewandowski, R. J.
Garin, E.
Sinclair, P.
Salem, R.
Martin, R C G
Mahvash, A.
Pracht, M.
Montazeri, A. H.
Bandula, S.
Herrmann, K.
Brown, E.
Zuckerman, D.
Wilson, Gregory
Kim, T. Y.
Weaver, A.
Ross, P.
Harris, W. P.
Graham, J.
Mills, J.
Yubero Esteban, A.
Johnson, M. S.
Sofocleous, C. T.
Padia, S. A.
Lewandowski, R. J.
Garin, E.
Sinclair, P.
Salem, R.
Martin, R C G
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Date
2021
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Citation
Mulcahy MF, Mahvash A, Pracht M, Montazeri AH, Bandula S, Martin RCG II, et al. Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial. JCO. 2021 Sep 20;JCO.21.01839.