Author: By Laura Cowen, medwireNews Reporter
medwireNews: Adding trans-arterial Yttrium-90 radioembolisation (TARE) to second-line chemotherapy significantly delays disease progression in people with colorectal cancer (CRC) liver metastases who had progressed on first-line treatment, EPOCH investigators reported at the ESMO Congress 2021.
The global phase III trial included 428 participants who were randomly assigned to receive second-line chemotherapy with (n=215) or without (n=213) glass microsphere TARE.
Mary Mulcahy, from Northwestern University in Chicago, Illinois, USA, explained that TARE was delivered as a single dose to the whole liver instead of cycle 2 of chemotherapy to allow for patients to initiate second-line therapy while undergoing treatment planning for TARE.
In all, 87.0% of participants in the TARE arm and 89.7% of those in the chemotherapy alone arm received their assigned therapy, and the presenter noted that TARE “did not compromise ability to receive additional chemotherapy.”
Indeed, individuals in the TARE arm received a median 9.0 cycles of second-line irinotecan-based therapy or a median 8.5 cycles of oxaliplatin-based therapy, while those in the no TARE arm received a median of 9.5 or 8.8 cycles, respectively.
Mary Mulcahy reported that the first co-primary endpoint of progression-free survival (PFS) was significantly longer with versus without TARE, at a median 8.0 versus 7.2 months, corresponding to a significant hazard ratio (HR) of 0.69 in favour of TARE.
For the second co-primary endpoint – hepatic (h)PFS – there was a significant HR of 0.59 in favour of TARE, with a median hPFS of 9.1 months in the TARE arm and 7.2 months in the no TARE arm.
Furthermore, the investigators observed similar PFS and hPFS benefits in a number of prespecificed subgroup analyses, including patients with KRAS tumour mutations, left-sided primary CRC, a hepatic tumour burden of 10–25%, or three or fewer lesions at baseline, and people who received a second-line biological agent.
The overall response rate was “nominally higher” with versus without TARE, at 34.0% versus 21.1%, but the was no difference between the two arms in median overall survival, at 14.0 and 14.4 months, respectively.
Mary Mulcahy noted that there were no unexpected safety signals between the two arms. Individuals who received TARE experienced higher rates of adverse device events (55.1 vs 0.0%) and angiographic procedure-related events (29.4 vs 1.0%), serious adverse events (AEs; 37.4 vs 20.8%) and AEs leading to death (4.3 vs 1.9%).
Conversely, the rate of AEs leading to chemotherapy discontinuation was similar between the TARE and no TARE arms (12.8 vs 12.1%).
The speaker concluded: “This is the first arterial radiotherapy device study to demonstrate a statistically significant delay of progression in metastatic colorectal cancer isolated to the liver.”
The study findings were simultaneously published in the Journal of Clinical Oncology.
LBA21 - Mulcahy MF, Salem R, Mahvash A, et al. LBA21: Radioembolization with chemotherapy for colorectal liver metastases: A randomized, open-label, international, multicenter, phase III trial (EPOCH study). Ann Oncol 2021;32(suppl_5):S1283–S1346. doi: 10.1016/annonc/annonc741
Mulcahy MF, Mahvash A, Pracht M, et al. Radioembolization with chemotherapy for colorectal liver metastases: A randomized, open-label, international, multicenter, phase III trial. J Clin Oncol; Advance online publication 20 September 2021. Doi:10.1200/JCO.21.01839
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