M Milosevic1, J Edwards2, D Tsang3, J Dunning4, M Shackcloth5, T Batchelor6, A Coonar7, J Hasan8, B Davidson9, A Marchbank10, S Grumett11, N R Williams12, F Macbeth13, V Farewell14, T Treasure15. 1. Institute for Lung Diseases of Vojvodina, Thoracic Surgery Clinic, Sremska Kamenica, Serbia. 2. Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. 3. Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon, UK. 4. South Tees Hospitals NHS Foundation Trust, The James Cook University Hospital, Middlesbrough, UK. 5. Liverpool Heart And Chest Hospital NHS Foundation Trust, Liverpool, UK. 6. Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust, Bristol, UK. 7. Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK. 8. The Christie NHS Foundation Trust, Manchester, UK. 9. Division of Surgery, Royal Free London NHS Foundation Trust, UCL, London, UK. 10. Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, UK. 11. The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton, UK. 12. Surgical & Interventional Trials Unit (SITU), University College London, London, UK. 13. Centre for Trials Research, Cardiff University, Cardiff, UK. 14. MRC Biostatistics Unit, Cambridge, UK. 15. Clinical Operational Research Unit, University College London, London, UK.
Abstract
AIM: Lung metastases from colorectal cancer are resected in selected patients in the belief that this confers a significant survival advantage. It is generally assumed that the 5-year survival of these patients would be near zero without metastasectomy. We tested the clinical effectiveness of this practice in Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC), a randomized, controlled noninferiority trial. METHOD: Multidisciplinary teams in 14 hospitals recruited patients with resectable lung metastases into a two-arm trial. Randomization was remote and stratified according to site, with minimization for age, sex, primary cancer stage, interval since primary resection, prior liver involvement, number of metastases and carcinoembryonic antigen level. The trial management group was blind to patient allocation until after intention-to-treat analysis. RESULTS:From 2010 to 2016, 93 participants were randomized. These patients were 35-86 years of age and had between one and six lung metastases at a median of 2.7 years after colorectal cancer resection; 29% had prior liver metastasectomy. The patient groups were well matched and the characteristics of these groups were similar to those of observational studies. The median survival after metastasectomy was 3.5 (95% CI: 3.1-6.6) years compared with 3.8 (95% CI: 3.1-4.6) years for controls. The estimated unadjusted hazard ratio for death within 5 years, comparing the metastasectomy group with the control group, was 0.93 (95% CI: 0.56-1.56). Use of chemotherapy or local ablation was infrequent and similar in each group. CONCLUSION: Patients in the control group (who did not undergo lung metastasectomy) have better survival than is assumed. Survival in the metastasectomy group is comparable with the many single-arm follow-up studies. The groups were well matched with features similar to those reported in case series.
RCT Entities:
AIM: Lung metastases from colorectal cancer are resected in selected patients in the belief that this confers a significant survival advantage. It is generally assumed that the 5-year survival of these patients would be near zero without metastasectomy. We tested the clinical effectiveness of this practice in Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC), a randomized, controlled noninferiority trial. METHOD: Multidisciplinary teams in 14 hospitals recruited patients with resectable lung metastases into a two-arm trial. Randomization was remote and stratified according to site, with minimization for age, sex, primary cancer stage, interval since primary resection, prior liver involvement, number of metastases and carcinoembryonic antigen level. The trial management group was blind to patient allocation until after intention-to-treat analysis. RESULTS: From 2010 to 2016, 93 participants were randomized. These patients were 35-86 years of age and had between one and six lung metastases at a median of 2.7 years after colorectal cancer resection; 29% had prior liver metastasectomy. The patient groups were well matched and the characteristics of these groups were similar to those of observational studies. The median survival after metastasectomy was 3.5 (95% CI: 3.1-6.6) years compared with 3.8 (95% CI: 3.1-4.6) years for controls. The estimated unadjusted hazard ratio for death within 5 years, comparing the metastasectomy group with the control group, was 0.93 (95% CI: 0.56-1.56). Use of chemotherapy or local ablation was infrequent and similar in each group. CONCLUSION:Patients in the control group (who did not undergo lung metastasectomy) have better survival than is assumed. Survival in the metastasectomy group is comparable with the many single-arm follow-up studies. The groups were well matched with features similar to those reported in case series.
Authors: Jonah Popp; David S Weinberg; Eva Enns; John A Nyman; J Robert Beck; Karen M Kuntz Journal: Value Health Date: 2021-10-13 Impact factor: 5.101
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Authors: Chris Brew-Graves; Vernon Farewell; Kathryn Monson; Mišel Milošević; Norman R Williams; Eva Morris; Fergus Macbeth; Tom Treasure; Lesley Fallowfield Journal: Colorectal Dis Date: 2020-10-21 Impact factor: 3.788