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dc.contributor.authorMulcahy, M. F.
dc.contributor.authorSalem, R.
dc.contributor.authorMahvash, A.
dc.contributor.authorPracht, M.
dc.contributor.authorMontazeri, A. H.
dc.contributor.authorBandula, S.
dc.contributor.authorHermann, K.
dc.contributor.authorBrown, E.
dc.contributor.authorZuckerman, D.
dc.contributor.authorWilson, Gregory
dc.contributor.authorKim, T. Y.
dc.contributor.authorWeaver, A.
dc.contributor.authorRoss, P.
dc.contributor.authorHarris, W. P.
dc.contributor.authorJohnson, M. S.
dc.contributor.authorSofocleous, C. T.
dc.contributor.authorPadia, S. A.
dc.contributor.authorLewandowski, R. J.
dc.contributor.authorGarin, E.
dc.contributor.authorSinclair, P.
dc.date.accessioned2021-10-28T09:26:18Z
dc.date.available2021-10-28T09:26:18Z
dc.date.issued2021en
dc.identifier.citationMulcahy MF, Salem R, Mahvash A, Pracht M, Montazeri AH, Bandula S, et al. LBA21 Radioembolization with chemotherapy for colorectal liver metastases: A randomized, open-label, international, multicenter, phase III trial (EPOCH study). Vol. 32, Annals of Oncology. Elsevier BV; 2021. p. S1295.en
dc.identifier.doi10.1016/j.annonc.2021.08.2095en
dc.identifier.urihttp://hdl.handle.net/10541/624731
dc.description.abstractBackground Safety and efficacy of trans-arterial Yttrium-90 radioembolization (TARE) in combination with systemic chemotherapy in the second-line setting for colorectal liver metastases is unknown. Methods In this phase 3 trial, patients with colorectal liver metastases who progressed on first-line therapy were randomized 1:1 to receive second-line chemotherapy with or without glass microsphere TARE. The two primary endpoints were progression-free survival (PFS) and hepatic PFS (hPFS), assessed by blinded-independent central review. Randomization was stratified by unilobar/bilobar disease, oxaliplatin/irinotecan-based first-line chemotherapy, and KRAS mutation status. Results 428 patients from 94 centers were randomized to chemotherapy +/- TARE. The hazard ratio (HR) for PFS was 0.69 (95% confidence interval [CI], 0.54-0.88; 1-sided p=0.0013), with a median PFS of 8.0 (CI, 7.2-9.2) and 7.2 (CI, 5.7-7.6) months, respectively. The HR for hPFS was 0.59 (CI, 0.46-0.77; 1-sided p<0.0001), with a median hPFS of 9.1 (CI, 7.8-9.7) and 7.2 (CI, 5.7-7.6) months, respectively. Objective response rates were 34.0% (CI, 28.0-40.5%) and 21.1% (CI, 16.2-27.1%; 1-sided p=0.0019) for TARE and chemotherapy groups, respectively. Median overall survival was 14.0 (CI, 11.8-15.5) and 14.4 months (CI, 12.8-16.4; 1-sided p=0.7229) with a HR of 1.07 (CI, 0.86-1.32) for TARE and chemotherapy groups, respectively. Grade 3 adverse events were reported more frequently in the TARE group (68.4 vs 49.3%). The PFS benefit of TARE was observed for tumors with KRAS mutation (HR 0.57, CI: 0.40-0.80), left-side primary tumor (HR 0.65, CI: 0.48-0.88), hepatic tumor burden 10-25% (HR 0.43, CI: 0.26-0.72), ?3 lesions (HR 0.33, CI: 0.14-0.76), addition of a biologic agent (HR 0.58, CI: 0.40-0.84), and resected primary (HR 0.63, CI: 0.46-0.85). Conclusions EPOCH study met both primary endpoints, demonstrating the addition of TARE to systemic therapy for second-line colorectal liver metastases leads to significantly longer PFS and hPFS. Further subset analyses will better define the ideal patient population benefitting from TARE.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.annonc.2021.08.2095en
dc.titleRadioembolization with chemotherapy for colorectal liver metastases: A randomized, open-label, international, multicenter, phase III trial (EPOCH study)en
dc.typeOtheren
dc.contributor.departmentMedical Oncology, Northwestern University, Chicago, IL, USAen
dc.identifier.journalAnnals of Oncologyen
dc.description.noteen]
refterms.dateFOA2021-11-03T10:35:58Z


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