Cosmetic Results and Side Effects of Accelerated Partial-Breast Irradiation Versus Whole-Breast Irradiation for Low-Risk Invasive Carcinoma of the Breast: The Randomized Phase III IRMA Trial

被引:30
作者
Meduri, Bruno [1 ,11 ]
Baldissera, Antonella [2 ]
Iotti, Cinzia [3 ]
Scheijmans, Luc J. E. E. [4 ]
Stam, Marcel R. [5 ]
Parisi, Salvatore [6 ]
Boersma, Liesbeth J. [7 ]
Ammendolia, Ilario [8 ]
Koiter, Eveline [9 ]
Valli, Mariacarla [10 ]
Scandolaro, Luciano
Busz, Dianne
Stenfert Kroese, Marika C.
Ciabatti, Selena [2 ]
Giacobazzi, Patrizia [1 ]
Ruggieri, Maria P. [3 ]
Engelen, Antoine [4 ]
Munafo, Tindara [6 ]
Westenberg, A. Helen [5 ]
Verhoeven, Karolien [7 ]
Vicini, Roberto
D'Amico, Roberto
Lohr, Frank [1 ]
Bertoni, Filippo [1 ]
Poortmans, Philip
Frezza, Giovanni P. [2 ]
机构
[1] Univ Hosp Modena, Dept Radiat Oncol, Modena, Italy
[2] AUSL Bologna, Dept Radiat Oncol, Bellaria Hosp, Bologna, Italy
[3] Azienda USL IRCCS Reggio Emilia, Dept Radiat Oncol, Reggio Emilia, Italy
[4] Inst Verbeeten, Dept Radiat Oncol, Tilburg, Netherlands
[5] Radiotherapiegroep, Ede, Netherlands
[6] Casa Sollievo Sofferenza, Dept Radiat Oncol, San Giovanni Rotondo, Italy
[7] Maastricht Univ, GROW Sch Oncol & Reprod, Dept Radiat Oncol Maastro, Med Ctr, Maastricht, Netherlands
[8] IRCCS Azienda Osped Univ Bologna, Dept Radiat Oncol, Bologna, Italy
[9] Med Spectrum Twente, Dept Radiat Oncol, Enschede, Netherlands
[10] IOSI Oncol Inst Italian Switzerland, Dept Radiat Oncol, Bellinzona, Switzerland
[11] Univ Hosp Modena, Dept Radiat Oncol, Via Pozzo, 71, I-41124 Modena, Italy
关键词
PATIENT-REPORTED OUTCOMES; CONSERVING THERAPY; IN-SITU; LONGITUDINAL ANALYSIS; RADIATION-THERAPY; CANCER; RADIOTHERAPY; SURGERY; MASTECTOMY; SURVIVAL;
D O I
10.1200/JCO.22.01485
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
PURPOSE The results in terms of side effects vary among the published accelerated partial-breast irradiation (APBI) studies. Here, we report the 5-year results for cosmetic outcomes and toxicity of the IRMA trial.METHODS We ran this randomized phase III trial in 35 centers. Women with stage I-IIA breast cancer treated with breast-conserving surgery, age >= 49 years, were randomly assigned 1:1 to receive either whole-breast irradiation (WBI) or external beam radiation therapy APBI (38.5 Gy/10 fraction twice daily). Patients and investigators were not masked to treatment allocation. The primary end point was ipsilateral breast tumor recurrence. We hereby present the analysis of the secondary outcomes, cosmesis, and normal tissue toxicity. All side effects were graded with the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer Radiation Morbidity Scoring Schema. Analysis was performed with both intention-to-treat and as-treated approaches.RESULTS Between March 2007 and March 2019, 3,309 patients were randomly assigned to 1,657 WBI and 1,652 APBI; 3,225 patients comprised the intention-to-treat population (1,623 WBI and 1,602 APBI). At a median follow-up of 5.6 (interquartile range, 4.0-8.4) years, adverse cosmesis in the APBI patients was higher than that in the WBI patients at 3 years (12.7% v 9.2%; P = .009) and at 5 years (14% v 9.8%; P = .012). Late soft tissue toxicity (grade= 3: 2.8% APBI v 1% WBI, P < .0001) and late bone toxicity (grade =3: 1.1% APBI v 0% WBI, P < .0001) were significantly higher in the APBI arm. There were no significant differences in late skin and lung toxicities.CONCLUSION External beam radiation therapy-APBI with a twice-daily IRMA schedule was associated with increased rates of late moderate soft tissue and bone toxicities, with a slight decrease in patient-reported cosmetic outcomes at 5 years when compared with WBI, although overall toxicity was in an acceptable range.
引用
收藏
页码:2201 / +
页数:12
相关论文
共 26 条
[1]   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].
Bartelink, Harry ;
Horiot, Jean-Claude ;
Poortmans, Philip M. ;
Struikmans, Henk ;
Van den Bogaert, Walter ;
Fourquet, Alain ;
Jager, Jos J. ;
Hoogenraad, Willem J. ;
Oei, S. Bing ;
Warlam-Rodenhuis, Carla C. ;
Pierart, Marianne ;
Collette, Laurence .
JOURNAL OF CLINICAL ONCOLOGY, 2007, 25 (22) :3259-3265
[2]   Repair halftimes estimated from observations of treatment-related morbidity after CHART or conventional radiotherapy in head and neck cancer [J].
Bentzen, SM ;
Saunders, MI ;
Dische, S .
RADIOTHERAPY AND ONCOLOGY, 1999, 53 (03) :219-226
[3]   REPORTS OF UNEXPECTED LATE SIDE EFFECTS OF ACCELERATED PARTIAL BREAST IRRADIATION-RADIOBIOLOGICAL CONSIDERATIONS [J].
Bentzen, Soren M. ;
Yarnold, John R. .
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2010, 77 (04) :969-973
[4]   Patient-Reported Outcomes Over 5 Years After Whole-or Partial-Breast Radiotherapy: Longitudinal Analysis of the IMPORT LOW (CRUK/06/003) Phase III Randomized Controlled Trial [J].
Bhattacharya, Indrani S. ;
Haviland, Joanne S. ;
Kirby, Anna M. ;
Kirwan, Cliona C. ;
Hopwood, Penelope ;
Yarnold, John R. ;
Bliss, Judith M. ;
Coles, Charlotte E. .
JOURNAL OF CLINICAL ONCOLOGY, 2019, 37 (04) :305-+
[5]   Once Daily Versus Twice Daily External Beam Accelerated Partial Breast Irradiation: A Randomized Prospective Study [J].
Boutrus, Rimoun R. ;
El Sherif, Sara ;
Abdelazim, Yasser ;
Bayomy, Mohammed ;
Gaber, Ayman S. ;
Farahat, Ahmed ;
Hashem, Tarek ;
El Sebaie, Medhat .
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2021, 109 (05) :1296-1300
[6]   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 [J].
Coles, Charlotte E. ;
Griffin, Clare L. ;
Kirby, Anna M. ;
Titley, Jenny ;
Agrawal, Rajiv K. ;
Alhasso, Abdulla ;
Bhattacharya, Indrani S. ;
Brunt, Adrian M. ;
Ciurlionis, Laura ;
Chan, Charlie ;
Donovan, Ellen M. ;
Emson, Marie A. ;
Harnett, Adrian N. ;
Haviland, Joanne S. ;
Hopwood, Penelope ;
Jefford, Monica L. ;
Kaggwa, Ronald ;
Sawyer, Elinor J. ;
Syndikus, Isabel ;
Tsang, Yat M. ;
Wheatley, Duncan A. ;
Wilcox, Maggie ;
Yarnold, John R. ;
Bliss, Judith M. .
LANCET, 2017, 390 (10099) :1048-1060
[7]   TOXICITY CRITERIA OF THE RADIATION-THERAPY ONCOLOGY GROUP (RTOG) AND THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER (EORTC) [J].
COX, JD ;
STETZ, J ;
PAJAK, TF .
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 1995, 31 (05) :1341-1346
[8]   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 [J].
Darby S. ;
McGale P. ;
Correa C. ;
Taylor C. ;
Arriagada R. ;
Clarke M. ;
Cutter D. ;
Davies C. ;
Ewertz M. ;
Godwin J. ;
Gray R. ;
Pierce L. ;
Whelan T. ;
Wang Y. ;
Peto R. ;
Albain K. ;
Anderson S. ;
Barlow W. ;
Bergh J. ;
Bliss J. ;
Buyse M. ;
Cameron D. ;
Carrasco E. ;
Coates A. ;
Collins R. ;
Costantino J. ;
Cuzick J. ;
Davidson N. ;
Davies K. ;
Delmestri A. ;
Di Leo A. ;
Dowsett M. ;
Elphinstone P. ;
Evans V. ;
Gelber R. ;
Gettins L. ;
Geyer C. ;
Goldhirsch A. ;
Gregory C. ;
Hayes D. ;
Hill C. ;
Ingle J. ;
Jakesz R. ;
James S. ;
Kaufmann M. ;
Kerr A. ;
MacKinnon E. ;
McHugh T. ;
Norton L. ;
Ohashi Y. .
LANCET, 2011, 378 (9804) :1707-1716
[9]   External-beam partial-breast irradiation [J].
Formenti, SC .
SEMINARS IN RADIATION ONCOLOGY, 2005, 15 (02) :92-99
[10]   Review of Factors Influencing Women's Choice of Mastectomy Versus Breast Conserving Therapy in Early Stage Breast Cancer: A Systematic Review [J].
Gu, Jeffrey ;
Groot, Gary ;
Boden, Catherine ;
Busch, Angela ;
Holtslander, Lorraine ;
Lim, Hyun .
CLINICAL BREAST CANCER, 2018, 18 (04) :E539-E554