Dataset Information

Intersurgeon Variability in Local Treatment Planning for Patients with Initially Unresectable Colorectal Cancer Liver Metastases: Analysis of the Liver Expert Panel of the Dutch Colorectal Cancer Group.

ABSTRACT:

Background

Consensus on resectability criteria for colorectal cancer liver metastases (CRLM) is lacking, resulting in differences in therapeutic strategies. This study evaluated variability of resectability assessments and local treatment plans for patients with initially unresectable CRLM by the liver expert panel from the randomised phase III CAIRO5 study.

Methods

The liver panel, comprising surgeons and radiologists, evaluated resectability by predefined criteria at baseline and 2-monthly thereafter. If surgeons judged CRLM as resectable, detailed local treatment plans were provided. The panel chair determined the conclusion of resectability status and local treatment advice, and forwarded it to local surgeons.

Results

A total of 1149 panel evaluations of 496 patients were included. Intersurgeon disagreement was observed in 50% of evaluations and was lower at baseline than follow-up (36% vs. 60%, p < 0.001). Among surgeons in general, votes for resectable CRLM at baseline and follow-up ranged between 0-12% and 27-62%, and for permanently unresectable CRLM between 3-40% and 6-47%, respectively. Surgeons proposed different local treatment plans in 77% of patients. The most pronounced intersurgeon differences concerned the advice to proceed with hemihepatectomy versus parenchymal-preserving approaches. Eighty-four percent of patients judged by the panel as having resectable CRLM indeed received local treatment. Local surgeons followed the technical plan proposed by the panel in 40% of patients.

Conclusion

Considerable variability exists among expert liver surgeons in assessing resectability and local treatment planning of initially unresectable CRLM. This stresses the value of panel-based decisions, and the need for consensus guidelines on resectability criteria and technical approach to prevent unwarranted variability in clinical practice.

SUBMITTER: Bond MJG

PROVIDER: S-EPMC10409679 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

Intersurgeon Variability in Local Treatment Planning for Patients with Initially Unresectable Colorectal Cancer Liver Metastases: Analysis of the Liver Expert Panel of the Dutch Colorectal Cancer Group.

Bond Marinde J G MJG Kuiper Babette I BI Bolhuis Karen K Komurcu Aysun A van Amerongen Martinus J MJ Chapelle Thiery T Dejong Cornelis H C CHC Engelbrecht Marc R W MRW Gerhards Michael F MF Grünhagen Dirk J DJ van Gulik Thomas T Hermans John J JJ de Jong Koert P KP Klaase Joost M JM Kok Niels F M NFM Leclercq Wouter K G WKG Liem Mike S L MSL van Lienden Krijn P KP Molenaar I Quintus IQ Neumann Ulf P UP Patijn Gijs A GA Rijken Arjen M AM Ruers Theo M TM Verhoef Cornelis C de Wilt Johannes H W JHW Kazemier Geert G May Anne M AM Punt Cornelis J A CJA Swijnenburg Rutger-Jan RJ

Annals of surgical oncology 20230428 9

<h4>Background</h4>Consensus on resectability criteria for colorectal cancer liver metastases (CRLM) is lacking, resulting in differences in therapeutic strategies. This study evaluated variability of resectability assessments and local treatment plans for patients with initially unresectable CRLM by the liver expert panel from the randomised phase III CAIRO5 study.<h4>Methods</h4>The liver panel, comprising surgeons and radiologists, evaluated resectability by predefined criteria at baseline an ...[more]

PMID: 37118612

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Project description:BackgroundColorectal cancer patients with unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and the lack of consensus on criteria for (un)resectability complicates the interpretation of published results.Methods/designCAIRO5 is a multicentre, randomised, phase 3 clinical study. Colorectal cancer patients with initially unresectable liver-only metastases are eligible, and will not be selected for potential resectability. The (un)resectability status is prospectively assessed by a central panel consisting of at least one radiologist and three liver surgeons, according to predefined criteria. Tumours of included patients will be tested for RAS mutation status. Patients with RAS wild type tumours will be treated with doublet chemotherapy (FOLFOX or FOLFIRI) and randomised between the addition of either bevacizumab or panitumumab, and patients with RAS mutant tumours will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab or triple chemotherapy (FOLFOXIRI) plus bevacizumab. Radiological evaluation to assess conversion to resectability will be performed by the central panel, at an interval of two months. The primary study endpoint is median progression-free survival. Secondary endpoints are the R0/1 resection rate, median overall survival, response rate, toxicity, pathological response of resected lesions, postoperative morbidity, and correlation of baseline and follow-up evaluation with respect to outcomes by the central panel.DiscussionCAIRO5 is a prospective multicentre trial that investigates the optimal systemic induction therapy for patients with initially unresectable, liver-only colorectal cancer metastases.Trial registrationCAIRO 5 is registered at European Clinical Trials Database (EudraCT) (2013-005435-24). CAIRO 5 is registered at ClinicalTrials.gov: NCT02162563 , June 10, 2014.

Project description:BackgroundPatients with initially unresectable colorectal cancer liver metastases (IU-CRLM) might benefit from using an effective systemic treatment followed by resection of liver metastases but the curative success rate is quite low. Indeed, nearly one-third of patients exhibit early recurrence within the first 6 months after surgery, and these individuals often have poor overall survival.ObjectivesThis study aims to clarify the application value of serial circulating tumor DNA (ctDNA) analysis in predicting the clinical outcome of IU-CRLM patients following liver metastasectomy.DesignA retrospective study was conducted on a cohort of patients with IU-CRLM between February 2018 and April 2021.MethodsPlasma samples at different time points during CRLM treatment [baseline (BL), preoperation (PRE), postoperation (POST), end-of-treatment (EOT), and progressive disease (PD)] were retrospectively collected from patients with initially unresectable CRLM enrolled at the Sun Yat-sen University Cancer Center. Dynamic changes of SEPTIN 9 (SEPT9) and Neuropeptide Y (NPY) methylated circulating tumor DNA (MetctDNA) levels in serial plasma samples were detected using droplet-digital PCR (ddPCR).ResultsSEPT9 and NPY genes were hypermethylated in colon cancer cell lines and tissues while no difference was observed between primary and metastatic tumors. Patients with MetctDNA positive at POST or EOT had significantly lower recurrence-free survival (RFS) compared to patients with MetctDNA negative at these time points [POST: Hazard ratio (HR) 9.44, 95% confidence interval (CI) 5.15-17.30, p < 0.001; EOT: HR 11.48, 95% CI 3.27-40.31, p < 0.001]. Multivariate analysis demonstrated that POST (OR 33.96, 95% CI 4.03-286.10, p = 0.001) and EOT (OR 18.36, 95% CI 1.14-295.71, p = 0.04) MetctDNA was an independent risk factor for early recurrence. Time-dependent receiver operating characteristic curve (T-ROC) analysis revealed that area under the curve (AUC) value was greatest at the relapse time point of 6 months post-intervention, with POST-AUC and EOT-AUC values of 0.74 (95% CI 0.66-0.81) and 0.73 (95% CI 0.53-0.94), respectively. Serial MetctDNA analysis showed that RFS was significantly lower in patients with no MetctDNA clearance compared with those with MetctDNA clearance (HR 26.05, 95% CI 4.92-137.81, p < 0.001).ConclusionOur study confirmed that serial ctDNA analysis of NPY and SEPT9 gene methylation could effectively predict early recurrence in IU-CRLM patients, especially at POST and EOT.

Project description:BackgroundPatients with initially unresectable colorectal liver metastases (CRLM) could achieve survival benefit from successful conversion therapy. Recently, Tumor Burden Score (TBS) was proposed as a valuable index to predict outcome following resection of CRLM. The study is aimed to investigate the association of TBS with conversion outcome.MethodsA total of 234 patients who underwent first-line treatment in our center were enrolled as training cohort. The validation cohort was developed from 89 patients in our previous study. Cut-off value of TBS was calculated to stratify patients into two groups. Significance test and logistic regression model were used to examine the prediction value of TBS for conversion outcome after first-line systemic therapy. Kaplan-Meier method and Cox proportional hazard model were applied to assess the prognostic value of TBS.ResultsTBS showed good discriminatory power [area under curve (AUC) 0.726, p < 0.001] with cut-off value defined as 14.3 in training cohort, which was validated in the validation cohort. Increasing TBS was related to adverse chemotherapy response and conversion outcome. Low TBS group had three times higher conversion rate than that in high TBS group (57.3% versus 19.0%, p < 0.001). Multivariate analysis indicated that high TBS [odds ratio (OR) = 3.676, 95% confidence interval (CI) 1.671-8.429, p = 0.002], first-line treatment response as stable disease (SD) or progressive disease (PD) (OR = 9.247; 95% CI 4.736-18.846, p < 0.001), and absence of targeted therapy (OR = 2.453, 95% CI 1.139-5.455, p = 0.024) were three independent risk factors for failure conversion outcome. High TBS was significantly associated with conversion outcome whatever chemotherapy response, addition of targeted therapy, and Kirsten rat sarcoma viral oncogene homolog (KRAS) status. High TBS was also associated with worse overall survival.ConclusionTBS should be applied in clinical practice to predict conversion outcome in patients with initially unresectable CRLM.

Project description:ImportanceColorectal cancer is a leading cause of cancer-related death, and nearly 70% of patients with this cancer have unresectable colorectal cancer liver metastases (CRLMs). Compared with chemotherapy, liver transplant has been reported to improve survival in patients with CRLMs, but in North America, liver allograft shortages make the use of deceased-donor allografts for this indication problematic.ObjectiveTo examine survival outcomes of living-donor liver transplant (LDLT) for unresectable, liver-confined CRLMs.Design, setting, and participantsThis prospective cohort study included patients at 3 North American liver transplant centers with established LDLT programs, 2 in the US and 1 in Canada. Patients with liver-confined, unresectable CRLMs who had demonstrated sustained disease control on oncologic therapy met the inclusion criteria for LDLT. Patients included in this study underwent an LDLT between July 2017 and October 2020 and were followed up until May 1, 2021.ExposuresLiving-donor liver transplant.Main outcomes and measuresPerioperative morbidity and mortality of treated patients and donors, assessed by univariate statistics, and 1.5-year Kaplan-Meier estimates of recurrence-free and overall survival for transplant recipients.ResultsOf 91 evaluated patients, 10 (11%) underwent LDLT (6 [60%] male; median age, 45 years [range, 35-58 years]). Among the 10 living donors, 7 (70%) were male, and the median age was 40.5 years (range, 27-50 years). Kaplan-Meier estimates for recurrence-free and overall survival at 1.5 years after LDLT were 62% and 100%, respectively. Perioperative morbidity for both donors and recipients was consistent with established standards (Clavien-Dindo complications among recipients: 3 [10%] had none, 3 [30%] had grade II, and 4 [40%] had grade III; donors: 5 [50%] had none, 4 [40%] had grade I, and 1 had grade III).Conclusions and relevanceThis study's findings of recurrence-free and overall survival rates suggest that select patients with unresectable, liver-confined CRLMs may benefit from total hepatectomy and LDLT.

Dataset Information

Intersurgeon Variability in Local Treatment Planning for Patients with Initially Unresectable Colorectal Cancer Liver Metastases: Analysis of the Liver Expert Panel of the Dutch Colorectal Cancer Group.

Background

Methods

Results

Conclusion

Publications

Intersurgeon Variability in Local Treatment Planning for Patients with Initially Unresectable Colorectal Cancer Liver Metastases: Analysis of the Liver Expert Panel of the Dutch Colorectal Cancer Group.

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