Author(s): Caballero C.I.; Mauer M.; Alvarez L.C.; Nilsson H.; Ruers T.; Senellart P.; Rivoire M.; Staettner S.; Primavesi F.; Troisi R.; Gruenberger T.; Heil J.; Schnitzbauer A.; Rahbari N.; Swijnenburg R.J.; Malik H.; Protic M.; Neven A.; Poston G.; Evrard S.
Source: European Journal of Surgical Oncology; Feb 2019; vol. 45 (no. 2)
Publication Date: Feb 2019
Publication Type(s): Conference Abstract
Available at European Journal of Surgical Oncology – from ScienceDirect
Abstract:EORTC & ESSO developed an infrastructure for surgical quality assurance (QA) in clinical trials (SURCARE) to advance the surgical research agenda in Europe. The first project is CLIMB, a prospective study to benchmark practices for unresectable or borderline resectable colorectal liver metastasis (CRLM) surgery. Quality indicators included multidisciplinary team (MDT), use of biomarker testing, type of chemotherapy regimen, imaging used pre-surgery and complications rates. CLIMB included 14 specialized centers in 9 countries. Eligible patients were registered after MDT & pre-surgery. Primary endpoint was 30 & 90 day surgical complication rate (Clavien-Dindo Classification). Onsite visits and central review ensured prospective data collection of current practices per country on biomarker testing, imaging, chemotherapy & liver surgery. Over all complication rates until post-op day 90 were analyzed. Trend of complications will be given to sites with at least 10 postop patients. Long-term outcome, correlation of complication with recurrences & overall survival will be reported when all patients will have been followed for 2 years after registration. Among 210 patients registered, 126 (60%) who had at least one liver surgery were analyzed. 73% had left-sided or rectal primary tumor, 95.2% had synchronous primary and liver metastasis, 19.8% had extra-hepatic lesions and CRLM. An MDT with liver surgeon, oncologist and radiologist assessed patients with a median of 30.5 days from last MDT to surgery. AT, FR, BE, DE, ES performed biomarker testing for 70-100% of their patients while < 40% was done in NL or SW. 122 (96.8%) received pre-surgery chemotherapy with a median duration of 4.9 months. Among those, 86.9% used only 1 regimen, usually FOLFOX. Only 65.1 % received targeted therapy, with >70% from BE, FR, AT and ES in contrast to SW with only 5.6%. Median time interval of last pre-surgery imaging was 34.5 days. Among those with pre-surgery image data (87.7%), 54.1% received less than CT scan with MRI while 45.9% received at least CT with MRI (mostly in AT & NL). Most patients (N = 95, 75.4%) had one stage liver surgery while 30 (23.8%) had two stage liver surgery, 10 of whom had ALPSS. Over-all complication rates for one stage surgery were 53.7% (95% CI 43%- 64%), 17.9% (95% CI: 11%-27%) with grade>=3 and 93.3% (95% CI: 78%- 99%) for two stage surgery, 46.7% (95% CI:28%- 66%) with grade>=3 including two deaths. Infections, bile leak, post hepatectomy liver failure grade A, fluid retention and anemia were most commonly reported. CLIMB prospectively collected data on upfront unresectable CRLM surgery. Two-stage surgery had more Clavien-Dindo grade>=3 complications. Harmonizing standards in MDT evaluation, biomarker testing and imaging may improve outcomes. SURCARE will use these indicators to develop trials with enhanced QA methods to improve cancer surgery. Conflict of interest: No conflict of interest.
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Database: EMBASE