Another interesting finding to be presented at ASCO. Resection...

Another interesting finding to be presented at ASCO.  Resection rate in the trials didn't differ, but the scans have been independently reviewed by expert hepatobiliary surgeons blinded to treatment group, showing a significantly higher rate of respectability in the SIRT arm (38% vs 29%, p<0.0001).  You get a big gain in survival if you can resect the metastasis, another point for the marketing team.

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.

Sub-category:
Advanced Disease
Category:
Gastrointestinal (Colorectal) Cancer
Meeting:
2017 ASCO Annual Meeting
Abstract No:
3532
Poster Board Number:
Poster Session (Board #155)
Citation:
J Clin Oncol 35, 2017 (suppl; abstr 3532)
Author(s): Benjamin Garlipp, Peter Gibbs, Guy A. Van Hazel, Rohan Jeyarajah, Robert C. G. Martin, Christiane J. Bruns, Hauke Lang, Derek M. Manas, Giuseppe Maria Ettorre, Fernando Pardo, Vincent Donckier, Christoph Benckert, Thomas M van Gulik, Diane Goere, Michael Schoen, Johann Pratschke, Wolf O. Bechstein, Antonio Martínez de la Cuesta, Shola Adeyemi, Max Seidensticker; Otto-von-Guericke-University Hospital, Magdeburg, Germany; Department of Medical Oncology, Royal Melbourne Hospital Western Health, Melbourne, Australia; Sir Charles Gairdner Hospital, Perth, Australia; Methodist Dallas Medical Center, Dallas, TX; Norton Healthcare Pavillion, Louisville, KY; University Hospital Cologne, Cologne, Germany; University Medical Center of the Johannes Gutenberg University, General, Visceral and Transplant Surgery, Mainz, Germany; Department of Hepato-Pancreato-Biliary Surgery, Freeman Hospital, Newcastle-upon-Tyne, United Kingdom; Ospedale San Camillo-Forlanini, Rome, Italy; HPB Surgery and HPB Oncology Area, Clinica Universidad de Navarra, and IDISNA, Pamplona, Spain; Jules Bordet Institute, Brussels, Belgium; Vivantes Klinikum Am Friedrichshain, Berlin, Germany; Academic Medical Center, Amsterdam, Netherlands; Institut Gustave Roussy, Villejuif, France; Städtisches Klinikum Karlsruhe, Karlsruhe, Germany; Charité Universitätsmedizin Berlin, Berlin, Germany; Department of General and Visceral Surgery, University Hospital Frankfurt, Frankfurt, Germany; Radcon Hispania, S.L, Pamplona, Spain; Sirtex Technology Germany GmbH, Bonn, Germany; Otto-von-Guericke-University Medical School, Magdeburg, Germany
Abstract Disclosures
Abstract:

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