6533b832fe1ef96bd129a19a

RESEARCH PRODUCT

REsect: Blinded assessment of amenability to potentially curative treatment of previously unresectable colorectal cancer liver metastases (CRC LM) after chemotherapy ± RadioEmbolization (SIRT) in the randomized SIRFLOX trial.

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3532 Background: Secondary resection and radiofrequency ablation (RFA) of primarily unresectable LM from CRC can prolong survival and cure some patients (pts). Effective downsizing treatments are needed but their impact on secondary amenability to surgery/RFA is difficult to evaluate objectively. The added value of SIRT is not well established. Methods: Baseline (BL) and follow-up (FU) imaging at best response for CRC pts treated with FOLFOX chemotherapy±bevacizumab (bev) (CT) vs. CT+SIRT in the phase III SIRFLOX RCT were reviewed by 3−5 expert HPB surgeons (from a panel of 15) for resectability of LM. Reviewers were blinded to each other and to all clinical information incl. time of imaging (BL/FU). Resectability was defined as ≥60% of reviewers assessing a pt as resectable. For non-resectable cases, surgeons indicated whether a combination of surgery and RFA could completely remove all LM. Lesions deemed suitable for RFA by a surgeon needed to be confirmed by an interventional radiologist. Pts were defined as “clearable” if ≥60% of reviewers assessed them as amenable to complete removal of LM by surgery alone or surgery+RFA. Results: 472 pts were evaluable (CT, n = 228; CT+SIRT, n = 244). There was no significant difference in LM resectability at BL (CT, n = 25, 10.96%; CT+SIRT, n = 29, 11.89%; p = 0.77). At FU, significantly more pts in the SIRT arm had resectable LM (CT, n = 66, 28.95%; CT+SIRT, n = 93, 38.11%; p < 0.0001). Of 203 pts in the CT arm and 215 pts in the CT+SIRT arm deemed unresectable at BL, 46 (22.66%) and 67 (31.16%), respectively, were converted to resectability (p < 0.0001). Assessing “clearability” using surgery and RFA, again no difference was noted at BL (CT, n = 31, 13.60%; CT+SIRT, n = 42, 17.21%; p = 0.309). At FU, a trend in favor of CT+SIRT was seen (CT, n = 79, 34.65%; CT+SIRT, n = 102, 41.80%; p = 0.1296). Conclusions: The addition of SIRT to FOLFOX(±bev) based CT significantly increased the gain in resectability of primarily unresectable CRC LM compared with CT alone. For amenability to the combination of surgery+RFA, this effect was still seen, albeit attenuated. Subgroup analyses are ongoing. Clinical trial information: NCT00724503.