早期乳腺癌患者接受术中放疗联合体外放射治疗后，低危组和高危组临床疗效比较：一项多中心前瞻性研究

28 October 2022


J A Mosiun, Mee-Hoong See, Li-Ying Teoh, Mahmoud Danaee, Lee-Lee Lai, Char-Hong Ng, Cheng-Har Yip, Mei-Sze The, Nur Aishah Md Taib , Anita Bustam, Rozita Abdul Malik, Marniza Saad, Suniza Jamaris, Ngie-Min Ung

在此查看研究
复制引用
已复制！

摘要

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.

参考资料

  1. Ahn, S. G., Bae, S. J., Lee, H. W., Yoon, C. I., Kim, JW., Lee, I. J., ... & TARGIT-A Trial Investigators. (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 Research and Treatment, 174(1), 157–163. https://doi.org/10.1007/s10549-018-5038-x
  2. Bartelink, H., Horiot, J. C., 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. The New England Journal of Medicine, 345(19), 1378–1387. https://doi.org/10.1056/NEJMoa010874
  3. Belletti, B., Vaidya, J. S., D’Andrea, S., Entschladen, F., Roncadin, M., Lovat, F., ... & Baldassarre, G. (2008). Targeted intraoperative radiotherapy impairs the stimulation of breast cancer cell proliferation and invasion caused by surgical wounding. Clinical Cancer Research, 14(5), 1325–1332. https://doi.org/10.1158/1078-0432.CCR-07-4453
  4. Benítez, V. M. V., Cardenas, J. C. R., Pérez, N. O., Ibarria, N. R., Chico, J. C. D., García-Granados Alayón, J. J., ... & Alva, A. M. (2020). Complications and local relapse after intraoperative low-voltage X-ray radiotherapy in breast cancer. Annals of Surgical Treatment and Research, 98(6), 299–306. https://doi.org/10.4174/astr.2020.98.6.299
  5. Bland, J. M., & Altman, D. G. (1997). Statistics notes: Cronbach's alpha. BMJ, 314(7080), 572. https://doi.org/10.1136/bmj.314.7080.572
  6. Early Breast Cancer Trialists' Collaborative Group. (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. The Lancet, 378(9804), 1707–1716. https://doi.org/10.1016/S0140-6736(11)61629-2
  7. Corica, T., Nowak, A. K., Saunders, C. M., Bulsara, M., Taylor, M., Vaidya, J. S., ... & Joseph, D. J. (2016). Cosmesis and breast-related quality of life outcomes after intraoperative radiation therapy for early breast cancer: A substudy of the TARGIT-A trial. International Journal of Radiation Oncology•Biology•Physics, 96(1), 55–64. https://doi.org/10.1016/j.ijrobp.2016.04.024
  8. 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. British Journal of Surgery, 106(1), 90–99. https://doi.org/10.1002/bjs.10963
  9. Dahlbäck, C., Ullmark, J. H., 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-Q™. Breast Cancer Research and Treatment, 164(3), 679–687. https://doi.org/10.1007/s10549-017-4306-5
  10. d’Illiers, L. B., Lafay, F., Faure, C., Klingler, S., Pleynet, E., & Racadot, S. (2018). Up to 5 years outcomes following intraoperative radiotherapy for early breast cancer. Translational Cancer Research, 7(4), 859–870. https://doi.org/10.21037/tcr.2018.06.07
  11. Elfgen, C., Güth, U., Gruber, G., Birrer, S., Bjelic-Radisic, V., Fleisch, M., ... & Tausch, C. (2020). Breast-conserving surgery with intraoperative radiotherapy in recurrent breast cancer: The patient’s perspective. Breast Cancer, 27(6), 1107–1113. https://doi.org/10.1007/s12282-020-01114-y
  12. 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. The New England Journal of Medicine, 320(13), 822–828. https://doi.org/10.1056/NEJM198903303201302
  13. Goldberg, H., Prosnitz, R. G., Olson, J. A., & Marks, L. B. (2005). Definition of postlumpectomy tumor bed for radiotherapy boost field planning: CT versus surgical clips. International Journal of Radiation Oncology•Biology•Physics, 63(1), 209–213. https://doi.org/10.1016/j.ijrobp.2005.01.044
  14. Haviland, J. S., Owen, J. R., Dewar, J. A., Agrawal, R. K., Barrett, J., Barrett-Lee, P. J., ... & START Trialists' Group. (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. The Lancet Oncology, 14(11), 1086–1094. https://doi.org/10.1016/S1470-2045(13)70386-3
  15. 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. International Journal of Radiation Oncology•Biology•Physics, 55(4), 1013–1018. https://doi.org/10.1016/S0360-3016(02)04202-5
  16. Hu, X., He, Y., Chen, X., Xia, T., Cao, T., Jia, H., ... & Zhang, J. (2020). Impact of intraoperative radiotherapy on the perioperative period of patients after breast-conserving surgery. Gland Surgery, 9(5), 1535–1542. https://doi.org/10.21037/gs-20-727
  17. Kementerian Kesihatan Malaysia. (2017). Summary of Malaysian National Cancer Registry Report 2007-2011. National Cancer Registry Department, National Cancer Institute, Ministry of Health Malaysia.
  18. Key, S., Miglierini, P., Dupré, P. F., Guilbert, S., Lucia, A. S., Abgral, R., ... & Pradier, O. (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. Annals of Surgical Oncology, 24(9), 2547–2555. https://doi.org/10.1245/s10434-017-5920-5
  19. Krzos, A., Stanisławek, A., Edrych, M. J., Łuczyk, M., & Ślusarska, B. (2019). Satisfaction with the aesthetic effect and quality of life for women after breast conserving therapy (BCT)—Preliminary research. International Journal of Environmental Research and Public Health, 16(23), Article 4682. https://doi.org/10.3390/ijerph16234682
  20. Lichter, B. S., Lippman, M. E., Danforth, D. N., Steinberg, M. S., deMoss, E., MacDonald, H. D., ... & d’Angelo, T. (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 Institute. Journal of Clinical Oncology, 10(6), 976–983. https://doi.org/10.1200/JCO.1992.10.6.976
  21. Lowery, J. C., Wilkins, E. G., Kuzon, W. M., & Davis, J. A. (1996). Evaluations of aesthetic results in breast reconstruction: An analysis of reliability. Annals of Plastic Surgery, 36(6), 601–606. https://doi.org/10.1097/00000637-199606000-00007
  22. Melnik, I., Yerushalmi, R., Sobol, Y., Magen, A., Givon-Madhala, O., Birinbaum, Y., ... & Fenig, E. (2020). Intraoperative radiation therapy for breast cancer—Immediate and 30-month oncological outcomes. The Breast Journal, 26(5), 946–951. https://doi.org/10.1111/tbj.13708
  23. Mi, Y., Lv, P., Wang, F., Li, L., Zhu, M., Cao, Q., ... & TARGIT-A Consortium China Branch. (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. Japanese Journal of Clinical Oncology, 49(12), 1120–1125. https://doi.org/10.1093/jjco/hyz128
  24. Ministry of Health, Malaysia. (2019). Clinical practice guidelines on management of breast cancer (2nd ed.). Ministry of Health Malaysia.
  25. National Cancer Institute. (2019). Malaysia National Cancer Registry Report (MNCRR) 2012-2016 (pp. 1–116). National Cancer Registry, Ministry of Health Malaysia.
  26. O’Connell, R. L., DiMicco, R., Khabra, K., O’Flynn, E. A., deSouza, N., Roche, N., ... & BREAST-Q BCT Steering Committee. (2016). Initial experience of the BREAST-Q breast-conserving therapy module. Breast Cancer Research and Treatment, 160(1), 79–89. https://doi.org/10.1007/s10549-016-3966-x
  27. Obi, E., Tom, M. C., Manyam, B. V., Grobmyer, S. R., Al-Hilli, Z., Valente, S., ... & Tendulkar, R. D. (2020). Outcomes with intraoperative radiation therapy for early-stage breast cancer. The Breast Journal, 26(3), 454–457. https://doi.org/10.1111/tbj.13574
  28. Onthong, K., Chakkabat, C., Nantavithya, C., Shotelersuk, K., Denariyakoon, S., Vongsaisuwon, M., ... & Charfa-Arsa, S. (2020). Results of intraoperative radiotherapy given as a boost after breast conserving-surgery. Gland Surgery, 9(5), 1389–1395. https://doi.org/10.21037/gs-20-249
  29. Pez, M., Keller, A., Welzel, G., Abo-Madyan, Y., Ehmann, M., Tuschy, B., ... & Wenz, F. (2020). Long-term outcome after intraoperative radiotherapy as a boost in breast cancer. Strahlentherapie und Onkologie, 196(4), 349–355. https://doi.org/10.1007/s00066-019-01538-4
  30. Pusic, A. L., Chen, C. M., Cano, S., Klassen, A., McCarthy, C., Collins, E. D., & Cordeiro, P. G. (2007). Measuring quality of life in cosmetic and reconstructive breast surgery: A systematic review of patient-reported outcomes instruments. Plastic and Reconstructive Surgery, 120(4), 823–837. https://doi.org/10.1097/01.prs.0000278162.82906.81
  31. Rana, S., Naik, A., Pillai, S., Vetto, J., Pommier, R., & Kubicky, C. D. (2020). Outcomes of intraoperative radiotherapy for early-stage breast cancer: Experience from a multidisciplinary breast oncology program. The American Journal of Surgery, 219(4), 655–659. https://doi.org/10.1016/j.amjsurg.2019.06.014
  32. Valente, S. A., Tendulkar, R. D., Cherian, S., O’Rourke, C., Greif, J. M., Bailey, L., ... & Grobmyer, S. R. (2016). TARGIT-R (Retrospective): North American experience with intraoperative radiation using low-kilovoltage X-rays for breast cancer. Annals of Surgical Oncology, 23(9), 2809–2815. https://doi.org/10.1245/s10434-016-5240-1
  33. Vaidya, J. S., Baum, M., Tobias, J. S., Wenz, F., Massarut, S., Keshtgar, M., ... & TARGIT-A Trialists' Group. (2011). Long-term results of TARGeted Intraoperative radiotherapy (Targit) boost during breast-conserving surgery. International Journal of Radiation Oncology•Biology•Physics, 81(4), 1091–1097. https://doi.org/10.1016/j.ijrobp.2010.07.1996
  34. Vaidya, J. S., Joseph, D. J., Tobias, J. S., Bulsara, M., Wenz, F., Saunders, C., ... & TARGIT Trialists' Group. (2010). Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): An international, prospective, randomised, non-inferiority phase 3 trial. The Lancet, 376(9735), 91–102. https://doi.org/10.1016/S0140-6736(10)60837-9
  35. Vaidya, J. S., Wenz, F., Bulsara, M., Tobias, J. S., Joseph, D. J., Keshtgar, M., ... & TARGIT-A Investigators. (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. The Lancet, 383(9917), 603–613. https://doi.org/10.1016/S0140-6736(13)61950-9
  36. Veiga, D. F., Veiga-Filho, J., Ribeiro, L. M., Archangelo-Junior, I., Mendes, D. A., Andrade, V. O., ... & Ferreira, L. M. (2011). Evaluations of aesthetic outcomes of oncoplastic surgery by surgeons of different gender and specialty: A prospective controlled study. The Breast, 20(5), 407–412. https://doi.org/10.1016/j.breast.2011.04.001
  37. Veronesi, U., Marubini, E., Mariani, L., Galimberti, V., Luini, A., Veronesi, P., ... & Zucali, R. (2001). Radiotherapy after breast-conserving surgery in small breast carcinoma: Long-term results of a randomized trial. Annals of Oncology, 12(7), 997–1003. https://doi.org/10.1023/A:1011136326943
  38. Veronesi, U., Orecchia, R., Maisonneuve, P., Viale, G., Rotmensz, N., Sangalli, C., ... & Luini, A. (2013). Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): A randomised controlled equivalence trial. The Lancet Oncology, 14(13), 1269–1277. https://doi.org/10.1016/S1470-2045(13)70497-2
  39. 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. The New England Journal of Medicine, 305(1), 6–11. https://doi.org/10.1056/NEJM198107023050102
  40. Viani, G. A., Arruda, C. V., Faustino, A. C., & de Fendi, L. I. (2020). Partial-breast irradiation versus whole-breast radiotherapy for early breast cancer: A systematic review and update meta-analysis. Brachytherapy, 19(4), 491–498. https://doi.org/10.1016/j.brachy.2020.03.003
  41. 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 International, 20(1), Article 410. https://doi.org/10.1186/s12935-020-01533-z
  42. Whelan, T. L., Pignol, J. P., Levine, M. N., Julian, J. A., MacKenzie, R., Parpia, S., ... & Olivotto, I. A. (2010). Long-term results of hypofractionated radiation therapy for breast cancer. The New England Journal of Medicine, 362(6), 513–520. https://doi.org/10.1056/NEJM198006123022401

引用

Mosiun, J.A., See, M.-H., Teoh, L.-Y., Danaee, M., Lai, L.-L., Ng, C.-H., Yip, C.-H., Teh, M.-S., Taib, N.A.M., Bustam, A., Malik, R.A., Saad, M., Jamaris, S. and Ung, N.-M. (2023), 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 1. https://doi.org/10.1007/s00268-022-06753-0

复制引用 已复制！
在此查看研究