Endocrine therapy with accelerated Partial breast irradiatiOn or exclusive ultra-accelerated Partial breast irradiation for women aged ≥ 60 years with Early-stage breast cancer (EPOPE): The rationale for a GEC-ESTRO randomized phase III-controlled trial

Clinical and Translational Radiation Oncology - Tập 29 - Trang 1-8 - 2021
Jean-Michel Hannoun-Levi1, Emmanuel Chamorey2, Rabia Boulahssass3, Csaba Polgar4, Vratislav Strnad5
1Department of Radiation Oncology, Antoine Lacassagne Cancer Centre, University of Côte d’Azur, Nice, France
2Department of Epidemiology and Biostatistics, Antoine Lacassagne Cancer Centre, University of Cote d’Azur, Nice, France
3Geriatric Unit. CHU de NICE, FHU ONCOAGE, University of Cote d’Azur, Nice, France
4Department of Oncology, Semmelweis University, Budapest, Hungary
5Department of Radiation Oncology, Erlangen University Hospital, Erlangen, Germany

Tài liệu tham khảo

Veronesi, 2002, Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer, N. Engl. J. Med., 347, 1227, 10.1056/NEJMoa020989 EBCTCG (Early Breast Cancer Trialists' Collaborative Group), McGale, P., Taylor, C., Correa, C., Cutter, D., Duane, F., et al., 2014 Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: Meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet 383:9935, 2127–2235. Bartelink, 2015, Lancet Oncol., 16, 47, 10.1016/S1470-2045(14)71156-8 Trialists' Group, 2008, The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: A randomised trial, Lancet, 371, 1098, 10.1016/S0140-6736(08)60348-7 Whelan, 2010, Long-term results of hypofractionated radiation therapy for breast cancer, N. Engl .J. Med., 362, 513, 10.1056/NEJMoa0906260 Coles, 2017, Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial, Lancet, 390, 1048, 10.1016/S0140-6736(17)31145-5 A.M. Brunt, J.S. Haviland, D.A. Wheatley, M.A. Sydenham, A. Alhasso, D.J. Bloomfield, C. Chan, M. Churn, S. Cleator, C.E. Coles, A. Goodman, A. Harnett, P. Hopwood, A.M. Kirby, C.C. Kirwan, C. Morris, Z. Nabi, E. Sawyer, N. Somaiah, L. Stones, I. Syndikus, J.M. Bliss, J.R. Yarnold, on behalf of the FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. https://doi.org/10.1016/S0140-6736(20)30932-6. B.V. Offersen, J. Alsner, H.M. Nielsen, E.H. Jakobsen, M.H. Nielsen, M. Krause, L. Stenbygaard, I. Mjaaland, A. Schreiber, U.M. Kasti, J. Overgaard; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated versus standard fractionated radiotherapy in patients with early breast cancer or ductal carcinoma in situ in a randomized phase iii trial: The DBCG HYPO trial. J. Clin. Oncol. 2020 38(31):3615–3625. doi:10.1200/JCO.20.01363. Epub 2020 Sep 10. PMID: 32910709. Trialists, 2011, First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015), Radiother. Oncol., 100, 93, 10.1016/j.radonc.2011.06.026 Trialists' Group, 2008, The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: A randomised trial, Lancet Oncol., 9, 331, 10.1016/S1470-2045(08)70077-9 Haviland, 2013, Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials, Lancet Oncol., 14, 1086, 10.1016/S1470-2045(13)70386-3 Hannoun-Levi, 2004, Partial breast irradiation: Revolution or evolution?, Cancer Treat Rev., 30, 599, 10.1016/j.ctrv.2004.06.009 Polgár, 2010, Radiother. Oncol., 94, 264, 10.1016/j.radonc.2010.01.014 Smith, 2009, Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO), Int. J. Radiat. Oncol. Biol. Phys., 74, 987, 10.1016/j.ijrobp.2009.02.031 Shah, 2018, The American Brachytherapy Society consensus statement for accelerated partial-breast irradiation, Brachytherapy., 17, 154, 10.1016/j.brachy.2017.09.004 Strnad, 2016, Lancet, 387, 229, 10.1016/S0140-6736(15)00471-7 Polgár, 2017, Lancet Oncol., 18, 259, 10.1016/S1470-2045(17)30011-6 Schäfer, 2018, Lancet Oncol., 19, 834, 10.1016/S1470-2045(18)30195-5 Polgár, 2021, Breast-conserving surgery followed by partial or whole breast irradiation: Twenty-year results of a phase 3 clinical study, Int. J. Radiat. Oncol. Biol. Phys., 109, 998, 10.1016/j.ijrobp.2020.11.006 Veronesi, 2013, Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): A randomised controlled equivalence trial, Lancet Oncol., 14, 1269, 10.1016/S1470-2045(13)70497-2 Vaidya, 2021, Single-dose intraoperative radiotherapy during lumpectomy for breast cancer: An innovative patient-centred treatment, Br. J. Cancer, 1 Rodríguez, 2013, Five-year outcomes, cosmesis, and toxicity with 3-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation, Int. J. Radiat. Oncol. Biol. Phys., 87, 1051, 10.1016/j.ijrobp.2013.08.046 Olivotto, 2013, Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy, J. Clin. Oncol., 31, 4038, 10.1200/JCO.2013.50.5511 Whelan, 2019, External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): A randomised controlled trial, Lancet, 394, 2165, 10.1016/S0140-6736(19)32515-2 Vicini, 2019, Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: A randomised, phase 3, equivalence trial, Lancet, 394, 2155, 10.1016/S0140-6736(19)32514-0 Livi, 2010, Accelerated partial breast irradiation with IMRT: New technical approach and interim analysis of acute toxicity in a phase III randomized clinical trial, Int. J. Radiat. Oncol. Biol. Phys., 77, 509, 10.1016/j.ijrobp.2009.04.070 Meattini, 2020, Accelerated partial-breast irradiation compared with whole-breast irradiation for early breast cancer: Long-term results of the randomized phase III APBI-IMRT-florence trial, J. Clin. Oncol., 38, 4175, 10.1200/JCO.20.00650 Hannoun-Levi, 2019, In Regard to Khan et al, Int. J. Radiat. Oncol. Biol. Phys., 104, 698, 10.1016/j.ijrobp.2019.03.025 Hannoun-Levi, 2019, In regard to Jethwa et al, Int. J. Radiat. Oncol. Biol. Phys., 104, 1176, 10.1016/j.ijrobp.2019.04.018 Kirkpatrick, 2008, The linear-quadratic model is inappropriate to model high dose per fraction effects in radiosurgery, Semin. Radiat. Oncol., 18, 240, 10.1016/j.semradonc.2008.04.005 Sacchini, 2008, Study of quadrant high-dose intraoperative radiation therapy for early-stage breast cancer, Br. J. Surg., 95, 1105, 10.1002/bjs.6208 Showalter, 2016, A novel form of breast intraoperative radiation therapy with CT-guided high-dose-rate brachytherapy: Results of a prospective phase 1 clinical trial, Int. J. Radiat. Oncol. Biol. Phys., 96, 46, 10.1016/j.ijrobp.2016.04.035 Kinj, 2018, Single fraction of accelerated partial breast irradiation in the elderly:early clinical outcome, Radiat. Oncol., 13, 1, 10.1186/s13014-018-1119-6 Hannoun-Lévi, 2018, Accelerated partial breast irradiation for suitable elderly women using a single fraction of multicatheter interstitial high-dose-rate brachytherapy: Early results of the single-fraction elderly breast irradiation (SiFEBI) phase I/II trial, Brachytherapy, 17, 407, 10.1016/j.brachy.2017.11.008 Latorre, 2018, Accelerated partial breast irradiation in a single 18 Gy fraction with high-dose-rate brachytherapy: Preliminary results, J. Contemp. Brachytherapy, 10, 58, 10.5114/jcb.2018.73994 Kinj, 2019141234, Five-year oncological outcome after a single fraction of accelerated partial breast irradiation in the elderly, Radiat. Oncol. Hannoun-Lévi, 2020, Accelerated partial breast irradiation in the elderly: 5-Year results of the single fraction elderly breast irradiation (SiFEBI) phase I/II trial, Brachytherapy, 19, 90, 10.1016/j.brachy.2019.10.007 Guinot, 2020, Very accelerated partial breast irradiation phase I/II multicenter trial vAPBI: Feasability and early results, Brachytherapy Jethwa, 2019, Three-fraction intracavitary accelerated partial breast brachytherapy: Early provider and patient-reported outcomes of a novel regimen, Int. J. Radiat. Oncol. Biol. Phys., 104, 75, 10.1016/j.ijrobp.2018.12.025 Khan, 2013, Dosimetric feasibility and acute toxicity in a prospective trial of ultrashort-course accelerated partial breast irradiation (APBI) using a multi-lumen balloon brachytherapy device, Ann. Surg. Oncol., 20, 1295, 10.1245/s10434-012-2671-1 Khan, 2019, Three-fraction accelerated partial breast irradiation (apbi) delivered with brachytherapy applicators is feasible and safe: First results from the triumph-T trial, Int. J. Radiat. Oncol. Biol. Phys., 104, 67, 10.1016/j.ijrobp.2018.12.050 Wilkinson, 2018, Six-year results from a phase i/ii trial for hypofractionated accelerated partial breast irradiation using a 2-day dose schedule, Am. J. Clin. Oncol., 41, 986, 10.1097/COC.0000000000000402 Hannoun-Levi, 2012, Dose gradient impact on equivalent dose at 2 Gy for high dose rate interstitial brachytherapy, J. Contemp. Brachytherapy, 4, 14, 10.5114/jcb.2012.27947 World health organization. International agency for research on cancer. Globocan. http://gco.iarc.fr/tomorrow/graphic-line?type=0&population=900&mode=population&sex=2&cancer=39&age_group=65%2B&apc_male=0&apc_female=0. Access on line 02/20/20. United Nations – UN projects world population to reach 8.5 billion by 2030, driven by growth in developing countries. 2015. https://news.un.org/en/story/2015/07/505352-un-projects-world-population-reach-85-billion-2030-driven-growth-developing#.WNfKh3fpM_U. Access on line 02/20/20. United Nations. Department of Economic and social affairs. World population ageing 2019. https://www.un.org/en/development/desa/population/publications/pdf/ageing/WorldPopulationAgeing2019-Highlights.pdf. Access on line 02/20/20. Hannoun-Levi, 2019, Radiation therapy after breast-conserving surgery in women 70 years of age and older: How wisely do we choose? In regard to Downs-Canner et al., Ann. Surg. Oncol., 26, 859, 10.1245/s10434-019-07762-5 Fyles, 2004, Tamoxifen with or without breast irradiation in women 50 years of age or older with early breast cancer, N. Engl. J. Med., 351, 963, 10.1056/NEJMoa040595 Hughes, 2004, Cancer and Leukemia Group B; Radiation Therapy Oncology Group; Eastern Cooperative Oncology Group. Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer, N. Engl. J. Med., 351, 971, 10.1056/NEJMoa040587 Pötter, 2007, Austrian Breast and Colorectal Cancer Study Group. Lumpectomy plus tamoxifen or anastrozole with or without whole breast irradiation in women with favorable early breast cancer, Int. J. Radiat. Oncol. Biol. Phys., 68, 334, 10.1016/j.ijrobp.2006.12.045 Kunkler, 2015, PRIME II investigators. Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): A randomised controlled trial, Lancet Oncol., 16, 266, 10.1016/S1470-2045(14)71221-5 Tinterri, 2014, Breast-conservative surgery with and without radiotherapy in patients aged 55–75 years with early-stage breast cancer: A prospective, randomized, multicenter trial analysis after 108 months of median follow-up, Ann. Surg. Oncol., 21, 408, 10.1245/s10434-013-3233-x Matuschek, 2017, The benefit of adjuvant radiotherapy after breast conserving surgery in older patients with low risk breast cancer: a meta-analysis of randomized trials, Radiat. Oncol., 12, 60, 10.1186/s13014-017-0796-x Jayasekera, 2018, CISNET-BOLD Collaborative Group. Effects of radiotherapy in early-stage, low-recurrence risk, hormone-sensitive breast cancer, J. Natl. Cancer Inst., 110, 1370, 10.1093/jnci/djy128 EXamining PErsonalised Radiation Therapy for Low-risk Early Breast cancer (EXPERT). ClinicalTrials.gov Identifier: NCT02889874. https://clinicaltrials.gov/ct2/show/NCT02889874?term=EXPERT&cond=Breast+Cancer&draw=2&rank=1. DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for an Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial. ClinicalTrials.gov Identifier: NCT03646955. https://clinicaltrials.gov/ct2/show/NCT03646955. Meattini, 2021, J. Geriatr. Oncol., 12, 182, 10.1016/j.jgo.2020.07.013 de Boer, A.Z., Bastiaannet, E., de Glas, N.A., Marang-van de Mheen P.J., Dekkers, O.M., et al., 2019 Effectiveness of radiotherapy after breast-conserving surgery in older patients with T1-2N0 breast cancer. Breast Cancer Res. Treat. 17(3), 637–645. 10.1007/s10549-019-05412-8 (Epub 2019 Aug 26 PMID:31451977 PMCID:PMC6817758). Kirwan, 2016, It’s PRIMETIME Postoperative avoidance of radiotherapy: biomarker selection of women at very low risk of local recurrence, Clin. Oncol., 28, 594, 10.1016/j.clon.2016.06.007 IDEA Study (Individualized Decisions for Endocrine Therapy Alone). ClinicalTrials.gov Identifier: NCT02400190. https://clinicaltrials.gov/ct2/show/NCT02400190?term=Reshma+Jagsi&cond=Breast+Cancer&draw=2&rank=3. Poortmans, 2017, Over-irradiation, Breast, 31, 295, 10.1016/j.breast.2016.07.022 Sumodhee, 2017, Accelerated partial breast irradiation for elderly women with early breast cancer: A compromise between whole breast irradiation and omission of radiotherapy, Brachytherapy, 16, 929, 10.1016/j.brachy.2017.06.006 Buszek, 2019, Lumpectomy plus hormone or radiation therapy alone for women aged 70 years or older with hormone receptor-positive early stage breast cancer in the modern era: An analysis of the National Cancer Database, Int. J. Radiat. Oncol. Biol. Phys., 105, 795, 10.1016/j.ijrobp.2019.07.052 Ward, 2019, Radiation therapy without hormone therapy for women age 70 or above with low-risk early breast cancer: A microsimulation, Int. J. Radiat. Oncol. Biol. Phys., 105, 296, 10.1016/j.ijrobp.2019.06.014 Roberts, 2020, Exercise therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer, Cochrane Database Syst. Rev., 1, CD012988 Ferreira, 2019, Differential impact of endocrine therapy and chemotherapy on quality of life of breast cancer survivors: A prospective patient-reported outcomes analysis, Ann Oncol., 30, 1784, 10.1093/annonc/mdz298 Chirgwin, 2016, Treatment adherence and its impact on disease-free survival in the breast international group 1–98 trial of tamoxifen and letrozole, alone and in sequence, J. Clin. Oncol., 34, 2452, 10.1200/JCO.2015.63.8619 Blamey, 2013, Radiotherapy or tamoxifen after conserving surgery for breast cancers of excellent prognosis: British Association of Surgical Oncology (BASO) II trial, Eur. J. Cancer, 49, 2294, 10.1016/j.ejca.2013.02.031 Kurian, 2021, Adjuvant breast radiotherapy, endocrine therapy, or both after breast conserving surgery in older women with low-risk breast cancer: Results from a population-based study, Radiother. Oncol., 154, 93, 10.1016/j.radonc.2020.09.017 Pandit, 2019, Prevalence of molecular subtypes of breast cancer: A single institutional experience of 2062 patients, Eur. J. Breast Health, 16, 39, 10.5152/ejbh.2019.4997 Perou, 2000, Molecular portraits of human breast tumours, Nature, 406, 747, 10.1038/35021093 J.M. Hannoun-Lévi, L. Montagne, S. Sumodhee, R. Schiappa, R. Boulahssass, M. Gautier, J. Gal, M.E. Chand ME. APBI versus ultra APBI in the elderly with low-risk breast cancer: A comparative analysis of oncological outcome and late toxicity. IJROBP 2021 (in press). Harris, 1979, Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast, Int. J. Radiat. Oncol. Biol. Phys., 5, 257, 10.1016/0360-3016(79)90729-6