Quality-of-life outcomes in older patients with early-stage rectal cancer receiving organ-preserving treatment with hypofractionated short-course radiotherapy followed by transanal endoscopic microsurgery (TREC): non-randomised registry of patients unsuitable for total mesorectal excision

The Lancet Healthy Longevity - Tập 3 - Trang e825-e838 - 2022
Alexandra Gilbert1, Victoria Homer2, Kristian Brock2, Stephan Korsgen3, Ian Geh4, James Hill5, Talvinder Gill6, Paul Hainsworth7, Matthew Tutton8, Jim Khan9, Jonathan Robinson10, Mark Steward10, Christopher Cunningham11, Manjinder Kaur12, Laura Magill12, Ann Russell13, Philip Quirke14, Nicholas P West14, David Sebag-Montefiore1, Simon P Bach3
1Leeds Institute for Medical Research, University of Leeds, Leeds, UK
2Cancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK
3Department of Colorectal Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
4Department of Radiation Oncology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
5Department of Colorectal Surgery, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK
6Department of Colorectal Surgery, North Tees and Hartlepool NHS Foundation Trust, Durham, UK
7Department of Colorectal Surgery, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
8Department of Colorectal Surgery, East Suffolk and North Essex NHS Foundation Trust, Colchester, UK
9Department of Colorectal Surgery, Portsmouth Hospital NHS Trust, Portsmouth, UK
10Department of Colorectal Surgery, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK
11Department of Colorectal Surgery, Oxford University Hospitals, NHS Foundation Trust, Oxford, UK
12Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK
13National Cancer Research Institute, London, UK
14Division of Pathology and Data Analytics, School of Medicine, University of Leeds, Leeds, UK

Tài liệu tham khảo

Gollins, 2017, Association of Coloproctology of Great Britain & Ireland (ACPGBI): guidelines for the management of cancer of the colon, rectum and anus (2017) - multidisciplinary management, Colorectal Dis, 19, 37, 10.1111/codi.13705 Rutten, 2008, Controversies of total mesorectal excision for rectal cancer in elderly patients, Lancet Oncol, 9, 494, 10.1016/S1470-2045(08)70129-3 Aquina, 2017, The impact of age on complications, survival, and cause of death following colon cancer surgery, Br J Cancer, 116, 389, 10.1038/bjc.2016.421 de Neree Tot Babberich, 2018, Achievements in colorectal cancer care during 8 years of auditing in the Netherlands, Eur J Surg Oncol, 44, 1361, 10.1016/j.ejso.2018.06.001 Sedrak, 2021, Older adult participation in cancer clinical trials: a systematic review of barriers and interventions, CA Cancer J Clin, 71, 78, 10.3322/caac.21638 Bach, 2021, Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study, Lancet Gastroenterol Hepatol, 6, 92, 10.1016/S2468-1253(20)30333-2 Spencer, 2021, The impact of the COVID-19 pandemic on radiotherapy services in England, UK: a population-based study, Lancet Oncol, 22, 309, 10.1016/S1470-2045(20)30743-9 Bach, 2009, A predictive model for local recurrence after transanal endoscopic microsurgery for rectal cancer, Br J Surg, 96, 280, 10.1002/bjs.6456 Whistance, 2009, Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer, Eur J Cancer, 45, 3017, 10.1016/j.ejca.2009.08.014 Aaronson, 1993, The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology, J Natl Cancer Inst, 85, 365, 10.1093/jnci/85.5.365 Bakx, 2005, Development and validation of a colorectal functional outcome questionnaire, Int J Colorectal Dis, 20, 126, 10.1007/s00384-004-0638-9 Rabin, 2001, EQ-5D: a measure of health status from the EuroQol Group, Ann Med, 33, 337, 10.3109/07853890109002087 Fayers, 1999 Osoba, 1998, Interpreting the significance of changes in health-related quality-of-life scores, J Clin Oncol, 16, 139, 10.1200/JCO.1998.16.1.139 Dolan, 1997, Modeling valuations for EuroQol health states, Med Care, 35, 1095, 10.1097/00005650-199711000-00002 McNair, 2016, Core outcomes for colorectal cancer surgery: a consensus study, PLoS Med, 13, e1002071, 10.1371/journal.pmed.1002071 Soo, 2021, The Elderly Functional Index (ELFI), a patient-reported outcome measure of functional status in patients with cancer: a multicentre, prospective validation study, Lancet Healthy Longev, 2, e24, 10.1016/S2666-7568(20)30036-2 Carpenter, 2017, A probabilistic programming language, J Stat Softw, 76, 10.18637/jss.v076.i01 Bürkner, 2017, brms: an R package for Bayesian multilevel models using Stan, J Stat Softw, 80, 10.18637/jss.v080.i01 Bürkner, 2018, Advanced Bayesian multilevel modeling with the R package brms, R J, 10, 395, 10.32614/RJ-2018-017 Albert, 2019 Nolte, 2019, General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States, Eur J Cancer, 107, 153, 10.1016/j.ejca.2018.11.024 Szende, 2014, Cross-country analysis of EQ-5D data, 31 Coretti, 2014, The minimum clinically important difference for EQ-5D index: a critical review, Expert Rev Pharmacoecon Outcomes Res, 14, 221, 10.1586/14737167.2014.894462 Podda, 2021, World J Emerg Surg, 16, 35, 10.1186/s13017-021-00378-9 Manceau, 2012, Comparative outcomes of rectal cancer surgery between elderly and non-elderly patients: a systematic review, Lancet Oncol, 13, e525, 10.1016/S1470-2045(12)70378-9 Boakye, 2018, Impact of comorbidity and frailty on prognosis in colorectal cancer patients: a systematic review and meta-analysis, Cancer Treat Rev, 64, 30, 10.1016/j.ctrv.2018.02.003 Claassen, 2018, Treatment and survival of rectal cancer patients over the age of 80 years: a EURECCA international comparison, Br J Cancer, 119, 517, 10.1038/s41416-018-0215-6 Garcia-Aguilar, 2015, Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial, Lancet Oncol, 16, 1537, 10.1016/S1470-2045(15)00215-6 Rullier, 2020, Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial, Lancet Gastroenterol Hepatol, 5, 465, 10.1016/S2468-1253(19)30410-8 Stijns, 2019, Long-term oncological and functional outcomes of chemoradiotherapy followed by organ-sparing transanal endoscopic microsurgery for distal rectal cancer: the CARTS study, JAMA Surg, 154, 47, 10.1001/jamasurg.2018.3752 Martens, 2016, Long-term outcome of an organ preservation program after neoadjuvant treatment for rectal cancer, J Natl Cancer Inst, 108, djw171, 10.1093/jnci/djw171 Ngan, 2012, Randomized trial of short-course radiotherapy versus long-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial 01.04, J Clin Oncol, 30, 3827, 10.1200/JCO.2012.42.9597 Glynne-Jones, 2017, Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Ann Oncol, 28, iv22, 10.1093/annonc/mdx224 Erlandsson, 2017, Optimal fractionation of preoperative radiotherapy and timing to surgery for rectal cancer (Stockholm III): a multicentre, randomised, non-blinded, phase 3, non-inferiority trial, Lancet Oncol, 18, 336, 10.1016/S1470-2045(17)30086-4 Glimelius, 2017, What conclusions can be drawn from the Stockholm III rectal cancer trial in the era of watch and wait?, Acta Oncol, 56, 1139, 10.1080/0284186X.2017.1344359 Smart, 2016, Multicentre study of short-course radiotherapy and transanal endoscopic microsurgery for early rectal cancer, Br J Surg, 103, 1069, 10.1002/bjs.10171 Bujko, 2017, The feasibility of short-course radiotherapy in a watch-and-wait policy for rectal cancer, Acta Oncol, 56, 1152, 10.1080/0284186X.2017.1327721 Arezzo, 2015, Results of neoadjuvant short-course radiation therapy followed by transanal endoscopic microsurgery for t1-t2 n0 extraperitoneal rectal cancer, Int J Radiat Oncol Biol Phys, 92, 299, 10.1016/j.ijrobp.2015.01.024 Cummings, 2019, Short course radiation therapy for rectal cancer in the elderly: can radical surgery be avoided?, J Gastrointest Oncol, 10, 357, 10.21037/jgo.2018.09.05 Fokas, 2021, International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer, Nat Rev Clin Oncol, 18, 805, 10.1038/s41571-021-00538-5 Perez, 2011, Transanal endoscopic microsurgery for residual rectal cancer after neoadjuvant chemoradiation therapy is associated with significant immediate pain and hospital readmission rates, Dis Colon Rectum, 54, 545, 10.1007/DCR.0b013e3182083b84 Rullier, 2017, Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial, Lancet, 390, 469, 10.1016/S0140-6736(17)31056-5 Gérard, 2019, Planned organ preservation for early T2-3 rectal adenocarcinoma: a French, multicentre study, Eur J Cancer, 108, 1, 10.1016/j.ejca.2018.11.022 Appelt, 2015, High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study, Lancet Oncol, 16, 919, 10.1016/S1470-2045(15)00120-5 Rijkmans, 2018, Evaluation of clinical and endoscopic toxicity after external beam radiotherapy and endorectal brachytherapy in elderly patients with rectal cancer treated in the HERBERT study, Radiother Oncol, 126, 417, 10.1016/j.radonc.2017.12.023 Garant, 2022, MORPHEUS phase II-III study: a pre-planned interim safety analysis and preliminary results, Cancers (Basel), 14, 3665, 10.3390/cancers14153665 Bach, 2022, Colorectal Dis, 24, 639, 10.1111/codi.16056