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Comparison of Clinical Outcomes Between Low- and High-Risk Groups of Early Breast Cancer Patients Treated with Intraoperative Radiotherapy in Addition to External Beam Radiation: A Multi-Centre Prospective Study

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Abstract

Background

There is a paucity of data on the use of intraoperative radiotherapy (IORT) with low-energy X-rays in Malaysian women with early breast cancer. The aim of this study is to evaluate the clinical, cosmetic, and patient-reported outcomes in low- and high-risk early breast cancer patients treated with breast conserving surgery (BCS) and IORT.

Methodology

Patients suitable for BCS who were treated with IORT between January 2016 and June 2019 from three centres were analysed. They were divided into low-risk and high-risk groups based on the risk of recurrence according to the TARGeted Intraoperative radioTherapy (TARGIT) A and B study criteria. Outcomes of interest included local recurrence, wound complications, and radiation toxicity, with a subset analysed for cosmetic and patient-reported outcomes.

Results

Within a median follow-up of 31 months, there were 104 and 211 patients in the low- and high-risk groups, respectively. No significant difference was observed in local recurrence rates (low-risk, 1.0% vs. high-risk, 1.4%; p = 1.000). Both cohorts exhibited low frequencies of severe wound complications ranging between 1.4 and 1.9%. No major radiation toxicities were reported in either group. In the subgroup analysis, low-risk patients had significantly better mean scores in the subscales of inframammary fold and scar. Based on the BREAST-Q patient-reported outcomes questionnaire, seven out of nine parameters were scored similarly between both groups with no significant difference.

Conclusion

This study showed that the use of IORT in both low- and high-risk early breast cancers is efficacious and safe with low recurrence rates and an acceptable toxicity profile.

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References

  1. Ministry of Health, Malaysia. Clinical practice guidelines on Management of Breast Cancer (2019)

  2. National Cancer Institute. Malaysia National Cancer Registry Report (MNCRR) 2012–2016. National Cancer Registry. 2019. 1–116

  3. Kementerian Kesihatan Malaysia. Summary of Malaysian National Cancer Registry Report 20017-2011. National Cancer Registry Department, National Cancer Institute, Ministry of Health Malaysia. 2017;3000/01/20:1–17

  4. Fisher B, Redmond C, Poisson R, Margolese R, Wolmark N, Wickerham L, Fisher E, Deutsch M, Caplan R, Pilch Y, Glass A (1989) Eight-year results of a randomised clinical trial comparing total mastectomy and lumpectomy with or without irradiation in the treatment of breast cancer. NEJM 320(13):822–828

    Article  CAS  Google Scholar 

  5. Veronesi U, Saccozzi R, Del Vecchio M, Banfi A, Clemente C, De Lena M, Gallus G, Greco M, Luini A, Marubini E, Muscolino G (1981) Comparing radical mastectomy with quadrantectomy, axillary dissection, and radiotherapy in patients with small cancers of the breast. NEJM 305(1):6–11

    Article  CAS  Google Scholar 

  6. Breast Cancer Trialists E, Group C (2011) 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. 378(9804):1707–16

    Article  Google Scholar 

  7. Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L (2001) Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. NEJM 345(19):1378–1387

    Article  CAS  Google Scholar 

  8. Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ et al (2013) 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(11):1086–1094

    Article  Google Scholar 

  9. Whelan TJ, Pignol J-P, Levine MN, Julian JA, MacKenzie R, Parpia S et al (2010) Long-term results of hypofractionated radiation therapy for breast cancer. NEJM 362(6):513–520

    Article  CAS  Google Scholar 

  10. Veronesi U, Marubini E, Mariani L, Galimberti V, Luini A, Veronesi P et al (2001) Radiotherapy after breast-conserving surgery in small breast carcinoma: long-term results of a randomized trial. Ann of Oncol 12(7):997–1003

    Article  CAS  Google Scholar 

  11. Viani GA, Arruda CV, Faustino AC, de Fendi LI (2020) Partial-breast irradiation versus whole-breast radiotherapy for early breast cancer: a systematic review and update meta-analysis. Brachyther 19(4):491–498

    Article  Google Scholar 

  12. Veronesi U, Orecchia R, Maisonneuve P, Viale G, Rotmensz N, Sangalli C et al (2013) Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial. Lancet Oncol 14(13):1269–1277

    Article  Google Scholar 

  13. Goldberg H, Prosnitz RG, Olson JA, Marks LB (2005) Definition of postlumpectomy tumor bed for radiotherapy boost field planning: CT versus surgical clips. Int J Radiat Oncol Biol Phys 63(1):209–213

    Article  Google Scholar 

  14. Belletti B, Vaidya JS, D’Andrea S, Entschladen F, Roncadin M, Lovat F et al (2008) Targeted intraoperative radiotherapy impairs the stimulation of breast cancer cell proliferation and invasion caused by surgical wounding. Clin Cancer Res 14(5):1325–1332

    Article  CAS  Google Scholar 

  15. Vaidya JS, Joseph DJ, Tobias JS, Bulsara M, Wenz F, Saunders C et al (2010) Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet 376(9735):91–102

    Article  Google Scholar 

  16. Vaidya JS, Baum M, Tobias JS, Wenz F, Massarut S, Keshtgar M et al (2011) Long-term results of TARGeted Intraoperative radiotherapy (Targit) boost during breast-conserving surgery. Int J Radiat Oncol Biol Phys 81(4):1091

    Article  Google Scholar 

  17. Hoeller U, Tribius S, Kuhlmey A, Grader K, Fehlauer F, Alberti W (2003) Increasing the rate of late toxicity by changing the score? a comparison of RTOG/EORTC and LENT/SOMA scores. Int J Radiat Oncol Biol Phys 55(4):1013–1018

    Article  Google Scholar 

  18. Veiga DF, Veiga-Filho J, Ribeiro LM, Archangelo-Junior I, Mendes DA, Andrade VO et al (2011) Evaluations of aesthetic outcomes of oncoplastic surgery by surgeons of different gender and specialty: a prospective controlled study. Breast 20(5):407–412

    Article  Google Scholar 

  19. Pusic AL, Chen CM, Cano S, Klassen A, McCarthy C, Collins ED et al (2007) Measuring quality of life in cosmetic and reconstructive breast surgery: a systematic review of patient-reported outcomes instruments. Plast Reconstr Surg 120(4):823–837

    Article  CAS  Google Scholar 

  20. Bland JM, Altman DG (1997) Statistics notes: cronbach’s alpha. BMJ 314(7080):572

    Article  CAS  Google Scholar 

  21. Lichter BS, Lippman ME, Danforth DN, Steinberg SM, deMoss E, MacDonald HD et al (1992) Mastectomy versus breast-conserving therapy in the treatment of stage I and II carcinoma of the breast: a randomized trial at the national cancer instiatute. J Clin Oncol 10(6):976–983

    Article  CAS  Google Scholar 

  22. Vaidya JS, Wenz F, Bulsara M, Tobias JS, Joseph DJ, Keshtgar M et al (2014) Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer:5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet 383(9917):603–613

    Article  Google Scholar 

  23. Rana S, Naik A, Pillai S, Vetto J, Pommier R, Kubicky CD (2020) Outcomes of intraoperative radiotherapy for early-stage breast cancer: experience from a multidisciplinary breast oncology program. Am J Surg 219(4):655–659

    Article  Google Scholar 

  24. Onthong K, Chakkabat C, Nantavithya C, Shotelersuk K, Denariyakoon S, Vongsaisuwon M et al (2020) Results of intraoperative radiotherapy given as a boost after breast conserving-surgery. Gland Surg 9(5):1389–1395

    Article  Google Scholar 

  25. Pez M, Keller A, Welzel G, Abo-Madyan Y, Ehmann M, Tuschy B et al (2020) Long-term outcome after intraoperative radiotherapy as a boost in breast cancer. Int J Radiat Oncol Biol Phys 196(4):349–355

    Google Scholar 

  26. Obi E, Tom MC, Manyam BV, Grobmyer SR, Al HZ, Valente S et al (2020) Outcomes with intraoperative radiation therapy for early-stage breast cancer. Breast J 26(3):454–457

    Article  CAS  Google Scholar 

  27. Benítez VMV, Cardenas JCR, Pérez NO, Ibarria NR, Chico JCD, García-Granados Alayón JJ et al (2020) Complications and local relapse after intraoperative low-voltage X-ray radiotherapy in breast cancer. Ann Surg Tr Res 98(6):299–306

    Article  Google Scholar 

  28. Hu X, He Y, Chen X, Xia T, Cao T, Jia H et al (2020) Impact of intraoperative radiotherapy on the perioperative period of patients after breast-conserving surgery. Gland Surg 9(5):1535–1542

    Article  Google Scholar 

  29. Ahn SG, Bae SJ, Lee HW, Yoon CI, Kim JW, Lee IJ et al (2019) A phase II study investigating the acute toxicity of targeted intraoperative radiotherapy as tumor-bed boost plus whole breast irradiation after breast-conserving surgery in Korean patients. Breast Cancer Res Tr 174(1):157–163

    Article  Google Scholar 

  30. Valente SA, Tendulkar RD, Cherian S, O’Rourke C, Greif JM, Bailey L et al (2016) TARGIT-R (Retrospective): north American experience with intraoperative radiation using low-kilovoltage X-Rays for breast cancer. Ann Surg Oncol 23(9):2809–2815

    Article  Google Scholar 

  31. Melnik I, Yerushalmi R, Sobol Y, Magen A, Givon-Madhala O, Birinbaum Y et al (2020) Intraoperative radiation therapy for breast cancer—Immediate and 30-month oncological outcomes. Breast J 26(5):946–951

    Article  Google Scholar 

  32. d’Illiers LB, Lafay F, Faure C, Klingler S, Pleynet E, Racadot S (2018) Up to 5 years outcomes following intraoperative radiotherapy for early breast cancer. Transl Cancer Res 7(4):859–870

    Article  Google Scholar 

  33. Key S, Miglierini P, Dupré PF, Guilbert S, Lucia AS, Abgral R et al (2017) Cosmetic outcome and chronic breast toxicity after intraoperative radiation therapy (IORT) as a single modality or as a boost using the intrabeam® device: a prospective study. Ann Surg Oncol 24(9):2547–2555

    Article  Google Scholar 

  34. Mi Y, Lv P, Wang F, Li L, Zhu M, Cao Q et al (2019) Efficacy, late complications, and cosmetic outcomes of targeted intraoperative radiotherapy in breast-conserving surgery for early-stage breast cancer: a single-centre study in China. Jpn J Clin Oncol 49(12):1120–1125

    Article  Google Scholar 

  35. Lowery JC, Wilkins EG, Kuzon WM, Davis JA (1996) Evaluations of aesthetic results in breast reconstruction: an analysis of realibility. Ann Plast Surg 36(6):601

    Article  CAS  Google Scholar 

  36. Corica T, Nowak AK, Saunders CM, Bulsara M, Taylor M, Vaidya JS et al (2016) Cosmesis and breast-related quality of life outcomes after intraoperative radiation therapy for early breast cancer: a substudy of the TARGIT-A trial. Int J Radiat Oncol Biol Phys 96(1):55–64

    Article  Google Scholar 

  37. Wang L, Zhu M, Cui Y, Zhang X, Li G (2020) Efficacy analysis of intraoperative radiotherapy in patients with early-stage breast cancer. Cancer Cell Int 20(1):1–7

    Article  Google Scholar 

  38. Elfgen C, Güth U, Gruber G, Birrer S, Bjelic-Radisic V, Fleisch M et al (2020) Breast-conserving surgery with intraoperative radiotherapy in recurrent breast cancer: the patient’s perspective. Breast Cancer 27(6):1107–1113

    Article  Google Scholar 

  39. Krzos A, Stanisławek A, Edrych MJ, Łuczyk M, Slusarska B (2019) Satisfaction with the aesthetic effect and quality of life for women after breast conserving therapy (BCT)—preliminary research. Int J Environ Res Public Health 16(23):1–10

    Article  Google Scholar 

  40. O’Connell RL, DiMicco R, Khabra K, O’Flynn EA, deSouza N, Roche N et al (2016) Initial experience of the BREAST-Q breast-conserving therapy module. Breast Cancer Res Tr 160(1):79–89

    Article  Google Scholar 

  41. Dahlbäck C, Ullmark JH, Rehn M, Ringberg A, Manjer J (2017) Aesthetic result after breast-conserving therapy is associated with quality of life several years after treatment swedish women evaluated with BCCT. core and BREAST-QTM. Breast Cancer Res Tr 164(3):679–87

    Article  Google Scholar 

  42. Dahlbäck C, Ringberg A, Manjer J (2019) Aesthetic outcome following breast-conserving surgery assessed by three evaluation modalities in relation to health-related quality of life. Br J Surg 106(1):90–99

    Article  Google Scholar 

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Acknowledgements

The authors acknowledge and thank the following persons for their support in this study: Madam Azleen Binti Mohd Zain, Miss Faizah Binti Ahmad and Madam Anis Suhana Ahmad from the Medical Physics Unit of the University of Malaya Medical Centre (UMMC). The assistance from staff of the breast cancer resource centre Pn Zarinah bt Abdul Rahman in University Malaya Medical Centre for their contribution and assistance in this research project.

Funding

This study was not funded by any grant.

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Correspondence to Mee-Hoong See.

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The other authors declare that they have no competing interests.

Ethical approvel

Data of the study was from Institution Breast Cancer Registry which was approved by the University of Malaya Medical Centre’s Medical Ethics Committee UMMC MECID. NO: 2018716-6489 and conformed to the Declaration of Helsinki 1975. This study has been registered with the National Medical Research Register (NMRR-21-1405-59293).

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Mosiun, J.A., See, MH., Teoh, LY. et al. Comparison of Clinical Outcomes Between Low- and High-Risk Groups of Early Breast Cancer Patients Treated with Intraoperative Radiotherapy in Addition to External Beam Radiation: A Multi-Centre Prospective Study. World J Surg 47, 201–208 (2023). https://doi.org/10.1007/s00268-022-06753-0

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