Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial

Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J. 2021;134(7):783–91.

Article  PubMed  PubMed Central  Google Scholar 

Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, et al. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet (London England). 2011;378(9804):1707–16.

Article  CAS  PubMed  Google Scholar 

Veronesi U, Luini A, Del Vecchio M, Greco M, Galimberti V, Merson M, et al. Radiotherapy after breast-preserving surgery in women with localized cancer of the breast. N Engl J Med. 1993;328(22):1587–91.

Article  CAS  PubMed  Google Scholar 

Overgaard M, Jensen MB, Overgaard J, Hansen PS, Rose C, Andersson M, et al. Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish breast cancer cooperative group DBCG 82c randomised trial. Lancet (London England). 1999;353(9165):1641–8.

Article  CAS  PubMed  Google Scholar 

Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347(16):1233–41.

Article  PubMed  Google Scholar 

Ragaz J, Jackson SM, Le N, Plenderleith IH, Spinelli JJ, Basco VE, et al. Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. N Engl J Med. 1997;337(14):956–62.

Article  CAS  PubMed  Google Scholar 

Owen JR, Ashton A, Bliss JM, Homewood J, Harper C, Hanson J, et al. Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: long-term results of a randomised trial. Lancet Oncol. 2006;7(6):467–71.

Article  PubMed  Google Scholar 

Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, et al. The UK standardisation of breast radiotherapy (START) trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet (London England). 2008;371(9618):1098–107.

Article  CAS  PubMed  Google Scholar 

Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, et al. The UK standardisation of breast radiotherapy (START) trial a of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008;9(4):331–41.

Article  CAS  PubMed  Google Scholar 

Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, et al. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010;362(6):513–20.

Article  CAS  PubMed  Google Scholar 

Smith BD, Bellon JR, Blitzblau R, Freedman G, Haffty B, Hahn C, et al. Radiation therapy for the whole breast: executive summary of an American Society for Radiation Oncology (ASTRO) evidence-based guideline. Practical Radiation Oncol. 2018;8(3):145–52.

Article  Google Scholar 

Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, et al. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881 – 10882 trial. J Clin Oncology: Official J Am Soc Clin Oncol. 2007;25(22):3259–65.

Article  Google Scholar 

Jones HA, Antonini N, Hart AA, Peterse JL, Horiot JC, Collin F, et al. Impact of pathological characteristics on local relapse after breast-conserving therapy: a subgroup analysis of the EORTC boost versus no boost trial. J Clin Oncology: Official J Am Soc Clin Oncol. 2009;27(30):4939–47.

Article  Google Scholar 

van der Laan HP, Dolsma WV, Maduro JH, Korevaar EW, Hollander M, Langendijk JA. Three-dimensional conformal simultaneously integrated boost technique for breast-conserving radiotherapy. Int J Radiat Oncol Biol Phys. 2007;68(4):1018–23.

Article  PubMed  Google Scholar 

van der Laan HP, Dolsma WV, Schilstra C, Korevaar EW, de Bock GH, Maduro JH, et al. Limited benefit of inversely optimised intensity modulation in breast conserving radiotherapy with simultaneously integrated boost. Radiotherapy Oncology: J Eur Soc Therapeutic Radiol Oncol. 2010;94(3):307–12.

Article  Google Scholar 

Hörner-Rieber J, Forster T, Hommertgen A, Haefner MF, Arians N, König L, et al. Intensity modulated radiation therapy (IMRT) with simultaneously integrated boost shortens treatment time and is noninferior to conventional radiation therapy followed by sequential boost in adjuvant breast cancer treatment: results of a large randomized phase III trial (IMRT-MC2 trial). Int J Radiat Oncol Biol Phys. 2021;109(5):1311–24.

Article  PubMed  Google Scholar 

Coles CE, Haviland JS, Kirby AM, Griffin CL, Sydenham MA, Titley JC et al. Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial. Lancet. 2023.

Haviland JS, Mannino M, Griffin C, Porta N, Sydenham M, Bliss JM, et al. Late normal tissue effects in the arm and shoulder following lymphatic radiotherapy: results from the UK START (standardisation of breast radiotherapy) trials. Radiotherapy Oncology: J Eur Soc Therapeutic Radiol Oncol. 2018;126(1):155–62.

Article  Google Scholar 

罗菊锐 陈星星. 杨昭志, 张丽, 马金利. 梅欣 et al 早期乳腺癌保乳术后大分割放疗II期临床研究——中期安全性及有效性分析 J China Oncol. 2018;28(10):769–75.

Google Scholar 

杨昭志 孟晋. 马金利, 梅欣, 陈星星. 张晓萌 et al 早期乳腺癌术后靶区勾画共识 J China Oncol. 2019;29(9):753–60.

Google Scholar 

Pavy JJ, Denekamp J, Letschert J, Littbrand B, Mornex F, Bernier J, EORTC Late Effects Working Group, et al. Late effects toxicity scoring: the SOMA scale. Radiotherapy Oncology: J Eur Soc Therapeutic Radiol Oncol. 1995;35(1):11–5.

Article  CAS  Google Scholar 

LENT SOMA tables. Radiotherapy Oncology: J Eur Soc Therapeutic Radiol Oncol. 1995;35(1):17–60.

Article  Google Scholar 

Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979;5(2):257–61.

Article  CAS  PubMed  Google Scholar 

Wang SL, Fang H, Hu C, Song YW, Wang WH, Jin J, et al. Hypofractionated versus conventional fractionated radiotherapy after breast-conserving surgery in the modern treatment era: a multicenter, randomized controlled trial from China. J Clin Oncology: Official J Am Soc Clin Oncol. 2020;38(31):3604–14.

Article  CAS  Google Scholar 

Qu FL, Mao R, Liu ZB, Lin CJ, Cao AY, Wu J, et al. Spatiotemporal patterns of loco-regional recurrence after breast-conserving surgery. Front Oncol. 2021;11:690658.

Article  PubMed  PubMed Central  Google Scholar 

Bartelink H, Maingon P, Poortmans P, Weltens C, Fourquet A, Jager J, et al. Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol. 2015;16(1):47–56.

Article  PubMed  Google Scholar 

Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, et al. 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. 2013;14(11):1086–94.

Article  PubMed  Google Scholar 

Romestaing P, Lehingue Y, Carrie C, Coquard R, Montbarbon X, Ardiet JM, et al. Role of a 10-Gy boost in the conservative treatment of early breast cancer: results of a randomized clinical trial in Lyon, France. J Clin Oncology: Official J Am Soc Clin Oncol. 1997;15(3):963–8.

Article  CAS  Google Scholar 

Hurkmans CW, Meijer GJ, van Vliet-Vroegindeweij C, van der Sangen MJ, Cassee J. High-dose simultaneously integrated breast boost using intensity-modulated radiotherapy and inverse optimization. Int J Radiat Oncol Biol Phys. 2006;66(3):923–30.

Article  PubMed  Google Scholar 

Chen GP, Liu F, White J, Vicini FA, Freedman GM, Arthur DW, et al. A planning comparison of 7 irradiation options allowed in RTOG 1005 for early-stage breast cancer. Med Dosimetry: Official J Am Association Med Dosimetrists. 2015;40(1):21–5.

Article  CAS  Google Scholar 

Dunst J, Krug D, Schreiber A, Boicev AD, Zimmer J, Laubach R et al. Patient reported experience with treatment modalities and safety of adjuvant breast radiotherapy - first results of the randomized HYPOSIB – study. International Journal of Radiation Oncology*Biology*Physics. 2020;108(3, Supplement):S13.

Meng J, Huang W, Mei X, Yu X, Pan Z, Ma J et al. Adjuvant breast inversely planned intensity-modulated radiotherapy with simultaneous integrated boost for early stage breast cancer: results from a phase II trial. Strahlentherapie Und Onkologie : Organ Der Deutschen Rontgengesellschaft. 2020;196(9):764–70.

Poortmans PM, Collette S, Kirkove C, Van Limbergen E, Budach V, Struikmans H, et al. Internal mammary and medial supraclavicular irradiation in breast cancer. N Engl J Med. 2015;373(4):317–27.

Article  CAS  PubMed  Google Scholar 

Whelan TJ, Olivotto IA, Parulekar WR, Ackerman I, Chua BH, Nabid A, et al. Regional nodal irradiation in early-stage breast cancer. N Engl J Med. 2015;373(4):307–16.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Thorsen LB, Offersen BV, Danø H, Berg M, Jensen I, Pedersen AN, et al. DBCG-IMN: a population-based cohort study on the effect of internal mammary node irradiation in early node-positive breast cancer. J Clin Oncology: Official J Am Soc Clin Oncol. 2016;34(4):314–20.

Article  Google Scholar 

Kim YB, Byun HK, Kim DY, Ahn SJ, Lee HS, Park W, et al. Effect of elective internal mammary node irradiation on disease-free survival in women with node-positive breast cancer: a randomized phase 3 clinical trial. JAMA Oncol. 2022;8(1):96–105.

Article  PubMed  Google Scholar 

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