Browsing by Author "Sofocleous, Constantinos T."

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    Development of a Research Agenda for the Management of Metastatic Colorectal Cancer: Proceedings from a Multidisciplinary Research Consensus Panel
    (Elsevier, 2012-02) d’Othée, Bertrand Janne; Sofocleous, Constantinos T.; Hanna, Nader; Lewandowski, Robert J.; Soulen, Michael C.; Vauthey, Jean-Nicolas; Cohen, Steven J.; Venook, Alan P.; Johnson, Matthew S.; Kennedy, Andrew S.; Murthy, Ravi; Geschwind, Jean-Francois; Kee, Stephen T.; Department of Radiology and Imaging Sciences, IU School of Medicine
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    Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial
    (American Society of Clinical Oncology, 2021) Mulcahy, Mary F.; Mahvash, Armeen; Pracht, Marc; Montazeri, Amir H.; Bandula, Steve; Martin, Robert C. G., II; Herrmann, Ken; Brown, Ewan; Zuckerman, Darryl; Wilson, Gregory; Kim, Tae-You; Weaver, Andrew; Ross, Paul; Harris, William P.; Graham, Janet; Mills, Jamie; Yubero Esteban, Alfonso; Johnson, Matthew S.; Sofocleous, Constantinos T.; Padia, Siddharth A.; Lewandowski, Robert J.; Garin, Etienne; Sinclair, Philip; Salem, Riad; EPOCH Investigators; Radiology and Imaging Sciences, School of Medicine
    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.