Early repeat resection of liver metastases from colorectal cancer may not be justified without controlled trial evidence

2021 ◽  
pp. 101981
Author(s):  
Fergus Macbeth ◽  
Tom Treasure
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Controlled Trial ◽  
Repeat Resection ◽  
Trial Evidence

Outcome after repeat resection of liver metastases from colorectal cancer

2013 ◽  
Vol 28 (8) ◽  
pp. 1135-1141 ◽  
Author(s):  
Hannes P. Neeff ◽  
Oliver Drognitz ◽  
Philipp Holzner ◽  
Andrea Klock ◽  
Peter Bronsert ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Repeat Resection

scholarly journals Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sheraz Yaqub ◽  
Bjørn Atle Bjørnbeth ◽  
Jon-Helge Angelsen ◽  
Claus Wilki Fristrup ◽  
Jon Erik Grønbech ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Secondary Prevention ◽  
Liver Metastases ◽  
Adjuvant Treatment ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Controlled Study ◽  
Western World ◽  
National Guidelines ◽  
Colorectal Cancer Liver Metastases

Abstract Background Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of choice although almost half of the resected patients get recurrence in the liver. Methods The ASAC trial is a Scandinavian, multicentre, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose aspirin (acetylsalicylic acid (ASA)) can improve disease-free survival in patients treated for colorectal cancer liver metastases (CRCLM). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo, for a period of 3 years or until disease recurrence. The patients will be recruited at all major hepatobiliary surgical units in Norway, Sweden and Denmark and have follow-up according to standard of care and the National Guidelines. Discussion The ASAC trial will be the first clinical interventional trial to assess the potential beneficial role of ASA in recurrence of CRCLM and survival. ASA is an inexpensive, well-tolerated and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRCLM if the study shows a beneficial effect. We will also determine the effect of ASA as adjuvant treatment on Health-Related Quality of Life and the cost-effectiveness. Trial registration ClinicalTrials.gov NCT03326791. Registered on 31 October 2017.

scholarly journals Management of the Hepatic Lymph Nodes during Resection of Liver Metastases from Colorectal Cancer: A Systematic Review

HPB Surgery ◽  
2008 ◽  
Vol 2008 ◽  
pp. 1-10 ◽  
Author(s):  
Kurinchi S. Gurusamy ◽  
Charles Imber ◽  
Brian R. Davidson
Keyword(s):  
Colorectal Cancer ◽  
Lymph Nodes ◽  
Liver Metastases ◽  
Survival Data ◽  
Survival Benefit ◽  
Controlled Trial ◽  
Survival Rates ◽  
Node Negative ◽  
Node Positive ◽  
Selective Lymphadenectomy

Background. Hepatic lymph node involvement is generally considered a contraindication for liver resection performed for colorectal liver metastases. However, some advocate hepatic lymphadenectomy in the presence of macroscopic involvement and others routine lymphadenectomy. The aim of this review is to assess the role of lymphadenectomy in resection of liver metastases from colorectal cancer. Methods. Medline, Embase and Central databases were searched using a formal search strategy. Trials with survival data with a minimum follow-up of 1 year were considered for inclusion. Meta-analysis was performed using Revman. Results. A total of 4230 references were identified. Ten reports of nine studies including 926 patients qualified for the review. The prevalence of nodal metastases after routine lymphadenectomy was 16.3%. The overall 3-year and 5-year survival rates in node-positive patients were 9/151 (11.3%) and 2/137 (1.5%), respectively, compared to 3-year and 5-year survival rates of 424/787 (53.9%) and 246/767 (32.1%) in node-negative patients. The odds ratios for 3-year and 5-year survivals in node positive disease compared to node-negative disease were 0.12 (95% CI 0.06 to 0.24) and 0.08 (95% CI 0.03 to 0.22). There was no randomized controlled trial which assessed the survival benefit of routine or “selective” lymphadenectomy. Conclusion. Currently, there is no evidence of survival benefit for routine or selective lymphadenectomy. Survival rates are low in patients with positive lymph nodes draining the liver irrespective of whether they are detected by routine lymphadenectomy or by macroscopic involvement. Further trials in this patient group are required.

scholarly journals Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): Study protocol for a multicentre randomized placebo-controlled trial

2021 ◽  
Author(s):  
Sheraz Yaqub ◽  
Bjørn Atle Bjørnbeth ◽  
Jon-Helge Angelsen ◽  
Claus Wilki Fristrup ◽  
Jon Erik Grønbech ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Secondary Prevention ◽  
Liver Metastases ◽  
Adjuvant Treatment ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Controlled Study ◽  
Western World ◽  
National Guidelines ◽  
Colorectal Cancer Liver Metastases

Abstract Background: Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is treatment of choice although almost half of the resected patients get recurrence in the liver.Methods: The ASAC trial is a Scandinavian, multi-centre, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose Aspirin (acetylsalicylic acid (ASA)) can improve disease-free survival in patients treated for colorectal cancer liver metastases (CRCLM). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo, for a period of 3 years or until disease recurrence. The patients will be recruited at all major hepatobiliary surgical units in Norway, Sweden and Denmark and have follow-up according to standard of care and the National Guidelines.Discussion: The ASAC trial will be the first clinical interventional trial to assess the potential beneficial role of ASA in recurrence of CRCLM and survival. ASA is an inexpensive, well tolerated, and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRCLM if the study shows a beneficial effect. We will also determine the effect of ASA as adjuvant treatment on Health-Related Quality of Life and the cost-effectiveness.Trial registration: ClinicalTrials.gov Identifier: NCT03326791. Registered 31 October 2017, https://clinicaltrials.gov/ct2/show/NCT03326791?term=asac&draw=2&rank=1

A randomized, double-blind, placebo-controlled, multicenter, multinational, phase II trial of L-BLP25 in patients with colorectal carcinoma following R0/R1 hepatic metastasectomy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS3641-TPS3641
Author(s):  
Carl Christoph Schimanski ◽  
Markus Hermann Moehler ◽  
Hauke Lang ◽  
Michael Schoen ◽  
Victoria Smith-Machnow ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Hepatic Metastases ◽  
Primary Objective ◽  
R0 Resection ◽  
Double Blind ◽  
Double Blind Placebo

TPS3641^ Background: Approximately 15-20% of patients diagnosed with colorectal cancer (crc) develop metastatic disease. Surgical resection remains the only potentially curative treatment. 5-year survival following R0-resection of liver metastases lies ~28 -39%. Recurrence occurs in ~70% of pts. Adjuvant chemotherapy has not significantly improved clinical outcomes. The primary objective of the LICC trial (L-BLP25 in Colorectal Cancer) is to analyze whether L-BLP25, an active cancer immunotherapy, extends recurrence-free survival (RFS) time over placebo in colorectal cancer pts following R0/R1 resection of hepatic metastases. L-BLP25 targets MUC1 glycoprotein, which is highly expressed in hepatic metastases from crc. In a phase IIB trial, L-BLP25 showed acceptable tolerability and a trend toward longer survival in pts with stage IIIB NSCLC. Methods: This is a multinational, phase II, multicenter, randomized, double-blind, placebo-controlled trial with a sample size of 159 pts from 20 centers in 3 countries. Pts must have stage IV cr adenocarcinoma limited to liver metastases. Following complete resection of the primary tumor and all syn-/metachronous metastases, eligible pts are randomized 2:1 to receive either L-BLP25 or placebo. Those allocated to L-BLP25 receive a single dose of 300 mg/m2 cyclophosphamide (CP) 3 days before first L-BLP25 dose, then primary treatment with sc L-BLP25 930 μg once weekly for 8 weeks, followed by maintenance doses at 6-week (years 1 and 2) and 12-week (year 3) intervals until recurrence. In the control arm, CP is replaced by saline solution and L-BLP25 by placebo. Primary endpoint: RFS time. Secondary endpoints: OS time, safety status, tolerability, RFS/OS in MUC-1 positive cancers. Exploratory immune response analyses are planned. First recruitment was of Q3 2011. To date, 8 of 20 centers are initiated and 4 pts recruited. Completion of recruitment is scheduled for Q3 2013. Primary endpoint will be assessed in Q3 2016: Follow-up will end Q3 2017. No interim analysis is planned. Design and implementation of this vaccination study in colorectal cancer is feasible. No major issues identified during setup of the study.

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