EPOCH trial: Subgroup analyses and additional endpoints for TARE plus chemo

Patients with liver-dominant metastatic colorectal cancer (mCRC) benefit from the addition of trans-arterial radio-embolisation (TARE) to chemotherapy, according to subgroup analyses of the phase 3 EPOCH trial. Compared with chemotherapy alone, the combination regimen improved depth of response, objective response rate, and duration of disease control in these patients [1].

The phase 3 EPOCH trial (NCT01483027) randomised 428 patients with liver-dominant mCRC 1:1 to Y-90 glass TARE plus chemotherapy or chemotherapy alone to compare the efficacy of these therapies in the second-line [2]. The primary analysis showed improved progression-free survival (PFS), and hepatic PFS in the combination arm compared with the chemotherapy arm. Dr William Harris (Seattle Cancer Care Alliance, WA, USA) presented the results from subgroup analyses and additional endpoints of this trial.

Subgroup analyses showed that males (HR 0.65), patients with KRAS mutations (HR 0.57), patients with a hepatic tumour burden between 10 and 25% (HR 0.43), patients with a biological agent added to their treatment regimen (HR 0.58), and patients with baseline carcinoembryonic antigen (CEA) levels ≥35 ng/mL benefitted significantly from the combination regimen compared with chemotherapy alone, with regard to PFS. In addition, all other subgroups displayed numerical trends towards a PFS benefit for the combination regimen over the standard of care arm.

Furthermore, objective response rates were higher in the combination arm (34.0%) than in the chemotherapy arm (21.1%; P=0.0019). In addition, the disease control rates numerically favoured the TARE plus chemotherapy arm over the standard of care arm (79.5% vs 72.8%; P=0.063). Also, the median duration of disease control was higher in patients treated with TARE and chemotherapy (7.2 vs 5.8 months; P=0.0009). Finally, the mean depth of response was significantly improved in the combination arm compared with the chemotherapy arm, as displayed by the mean change from baseline to nadir (-25.6% vs -13.0%; P=0.0001).

1. Harris WP, et al. Radioembolization with chemotherapy for liver-dominant colorectal cancer: Analysis of Patient Subgroups in the EPOCH Trial. Abstract 115, ASCO GI 2022, 20–22 January.
2. Mulcahy MF, et al. J Clin Oncol. 2021;39(35):3897­–3907.

 

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Posted on 21 March 202217 May 2024