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Yttrium Radioembolization with Second-Line Chemotherapy in CRC
Transarterial Yttrium-90 radioembolization (TARE) is a treatment option for patients with refractory colorectal cancer and unresectable liver-confined metastases. In a recent randomized trial, combining regional radioembolization with chemotherapy in the first-line treatment of metastatic colorectal cancer failed to improve survival over chemotherapy alone (NEJM JW Oncol Hematol Nov 2017 and Lancet Oncol 2017; 18:1159)
Investigators now report results of an industry-sponsored, multicenter, open-label randomized phase 3 trial evaluating the addition of TARE to second-line chemotherapy in metastatic colorectal cancer with liver-dominant metastatic disease. Of 428 patients randomized, median age was 61, 36% had the primary tumor in place, 26% had right-sided primaries, 64% had extrahepatic metastases, 47% had KRAS mutant status, and 59% received irinotecan-based chemotherapy.
Progression-free survival (PFS), a coprimary endpoint, favored TARE/chemotherapy over chemotherapy alone (median, 8.0 vs. 7.2 months; hazard ratio, 0.69; 1-sided P=0.0013). The second coprimary endpoint, hepatic PFS, also favored combination therapy (median, 9.1 vs. 7.2 months; HR, 0.59; 1-sided P< 0.0001). Overall survival, however, did not differ with TARE or chemotherapy alone (median, 15.2 and 14.3 months; HR 0.96; P=0.3841). Incidence of grade 3/4 adverse events was higher with TARE (68.4% vs. 49.3%) and there were more grade 5 events in the TARE arm (8 vs. 4). No cost analysis or quality-of-life data were presented.
Comment
Hepatic PFS remains a controversial endpoint for evaluating intrahepatic treatments, particularly in patients with the primary tumor in place and extrahepatic disease. The absence of an overall survival benefit in this study calls into question the utility and applicability of this therapy in the patient population studied.
Citation(s)
Author:
Mulcahy MF et al.
Title:
Radioembolization with chemotherapy for colorectal liver metastases: A randomized, open-label, international, multicenter, phase III trial.
Source:
J Clin Oncol
2021
Sep
20; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
David H. Ilson, MD, PhD