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

Whelan, Timothy J.; Julian, Jim A.; Berrang, Tanya; Kim, Do-Hoon; Germain, Isabelle; Nichol, Alan; Akra, Mohamed; Lavertu, Sophie; Germain, François; Fyles, Anthony; Trotter, Theresa; Perera, Francisco; Balkwill, Susan; Chafe, Susan; McGowan, Thomas; Muanza, Thierry; Beckham, Wayne; Chua, Boon; Gu, Chu Shu; Levine, Mark; Olivotto, Ivo A.; Leong, Carson; Lester, Beverly; Kwan, Winkle; Abd-El-Malek, Medhat Zikry; Cheung, Arthur; Almahmudi, Maha; Broomfield, J.A.; Sia, Michael; Reed, Melanie; Wilson, J. Frank; Mohamed, Islam; Holloway, Catherine; Mills, Kenneth Ian; Petrik, David; Crook, Juanita; Wong, Frances; Carolan, Hannah; Voduc, D.; Ingledew, Paris-Ann; Nguyen, Sonia; Keyes, Mira; Weir, Lorna; Tyldesley, Scott; Lim, Peter; Parsons, Christina; Olson, Robert; Blood, Paul; Wai, Elaine S.; Truong, Pauline T.; Kader, Hosam A.; Alexander, Abraham; Mydin, Aminudin R.; Smith, Sally; Vlachaki, María T.; Panet-Raymond, Valérie; Lupe, Krystine; Goulart, Jennifer; Nguyen, David; Chu, Karen; Canavan, Joycelin F.; Caon, Julianna; Tyler, S A; Shahid, Negin; Lam, Jacqueline; Amanie, John; Severin, Diane; Karim, Bassam Abdul; Tankel, Keith; Pervez, Nadeem; Joseph, Kurian; Gabos, Zsolt; Krause, Barbara; Huang, Fleur; Phan, Tien; Craighead, Peter; Yan, Elizabeth; MacKinnon, Jill; Nordal, Robert; Husain, Siraj; Voroney, Jon-Paul; Sinha, Richie; Pinilla, James; Cooke, Andrew; Vijayraghavan, Kalyani; Latosinsky, Steven; Saettler, Elizabeth; Lau, Yiu-Keung; Krahn, Marianne; MacIntosh, Ethel; Nashed, Maged N. F.; Bashir, Bashir; Torri, V.; Goldenberg, Benjamin; Kim, Christina; Basrur, V.; Rachakonda, Ramana; Gopaul, Darin; Shahi, Sundeep; Kobeleva, Sofya; Dayes, Ian S.; Hodson, David; Strang, Barbara; Voruganti, S.; McMillan, William; Reiter, Harold I.; Wright, Jim; Sussman, Jonathan; Mukherjee, Som D.; Gudelis, Susan; D’Souza, David; Lock, Michael; Read, Nancy; Vujovic, Olga; Yaremko, Brian; Yu, Edward; Vandenberg, Theodore A.; Younus, Jawaid; Potvin, Kylea; Sexton, Tracy; Dingle, Brian; Findlay, B.; Giesbrecht, Janice; Hughes, Philip F.; Samosh, Martin; Levesque, Michael A.; Yelamanchili, Radhika; Lee, Linda; Vandermeer, R; Wasserman, David H.; Bowen, Julie; Want, David; Bissett, Randall; Andronowski, A.; Shehata, Sarwat; Prichard, Hugh L.; Koll, W; Chan, Philip; Mui, Jimmy; Youssef, Youssef M.; Campbell, Holly R.; El-Mallah, Medhat; Iqbal, Fawaad O.; Banihashemi, Behzad; Dixon, Peter; Grimard, Lával; Lochrin, C.; Meng, Joanne; Cross, P.; El‐Sayed, Samy; Esche, B.; Genest, P.; Caudrelier, Jean-Michel; Morgan, Scott C.; Bourque, Jean‐Marc; Nair, Vimoj; Senthelal, Senti; Jones, Glenn; Tsao, Jonathan; Radwan, John S.; Hayter, Charles; Finlay, M.; Lian, JD; Wang, Yongjin; Yuen, Jasper; Khan, Luleul; Cho, B.C. John; Koch, Christine; Liu, Feifei; Manchul, L.; McLean, Michael; Catton, Pamela; Dinniwell, Robert; Wells, Woodrow; Levin, Wilfred; Walsh, L.; Chung, Caroline; Han, Kathy; Conrad, Tatiana; Helou, Joelle; Barry, Aisling; Schneider, Ken; Hirmiz, Khalid; Abu-Zahra, Hakam; Roy, Isabelle; Ayllon, Jose; Vecchio, P. Del; Fortin, Marie-Andrée; Guay, Jean‐Pierre; Méthot, F; Rousseau, Pierre; Jolicoeur, M.; Vu, Toni; Igidbashian, Levon; Dagnault, Anne; Bedoya, Luis-Victor Diaz de; Wang, Chang Shu; Fortin, A.; Vigneault, Éric; Vallières, Isabelle; Raymond, Paul-Émile; Martin, André‐Guy; Blondeau, Lucie; Larochelle, Marie; Lessard, N.; Gaudreault, M; Théberge, Valérie; Nabid, Abdenour; Ballivy, Olivier; Bujold, Rachel; Ébacher, Annie; Provencher, Sawyna; Chabot, Pierre; Lemaire, C.; Vavassis, Peter; Menkarios, C.; Yassa, M.; Sultanem, Khalil; Panasci, Lawrence; Melnychuk, David; Patenaude, François; Miller, Wilson H.; Mihalioiu, Catalin; Ahlgren, Paul; Dalfen, Richard; Langleben, Adrian; Stern, Donna; Wan, Jonathan; Lambert, Christine; David, Marc; Kopek, Neil; Carbonneau, Annie; Hijal, Tarek; Grant, Nancy J.; Naz, Farah; Mohiuddin, M.; Kumar, Sri; Rutledge, Robert; Rheaume, D.; Nolan, Maureen; Cwajna, Wladyslawa; Gill, Suki; Gleisner, Tracie; Grenfell, Solveig; Bishop, Michelle; Thiruthaneeswaran, Niluja; Liu, Chen; Philips, Claire; Drummond, Roslyn; King, Bronwyn; David, Steven; Dwyer, Mary; Campbell, Gillian; Brooks, Susan A.; Arunachalam, Ramesh; Sasso, Giuseppe; Benjamin, Chelleraj; Jose, C.C.; Elder, Christine; Krawitz, Hedley; Lee, Dominique; Huang, Roger; Purchuri, Sudha; Pearse, Maria; Hemanth, Thayavalappil; Angell, Ruth; Patel, Vikash; Round, Glenys; Chaudhuri, A.; Ford, C. H. J.

doi:10.1016/s0140-6736(19)32515-2

Cited by 289 publications

(195 citation statements)

References 26 publications

Supporting

Mentioning

188

Contrasting

Unclassified

Order By: Relevance

“…There were no statistically significant differences in late G3-5 toxicities. In the same issue of the Lancet, the long-term results of the RAPID 3D-CRT APBI trial were also presented by Whelan et al [42]. After 8.6 years of median follow-up, the LR rate was 2.8% in the WBI, and 3% in the PBI arm, but the difference was not statistically significant [HR = 1.27 (90%CI, 0.84-1.91)].…”

Section: Discussionmentioning

confidence: 91%

Implementation of Stereotactic Accelerated Partial Breast Irradiation Using Cyber-Knife – Technical Considerations and Early Experiences of a Phase II Clinical Study

Mészáros

Smanykó

Major

et al. 2020

Pathol. Oncol. Res.

View full text Add to dashboard Cite

To report the implementation, dosimetric results of and early experiences with stereotactic accelerated partial breast irradiation (SAPBI) following breast conserving surgery (BCS) for postmenopausal low-risk St I-II invasive breast cancer (IBC) patients. Between November 2018 and August 2019, 27 patients were registered in our phase II prospective study. SAPBI was performed with Cyber-Knife (CK) M6 machine, in 4 daily fractions of 6.25 Gy to a total dose of 25 Gy. Respiratory movements were followed with implanted gold markers and Synchrony system. Corrections for patient displacement and respiratory movement during treatment were performed with the robotic arm. Early side effects, cosmetic results, and dosimetric parameters were assessed. The average volume of the surgical cavity, clinical target volume (CTV), and planning target volume (PTV_EVAL) were 8.1 cm 3 (range: 1.75-27.3 cm 3), 55.3 cm 3 (range: 26.2-103.5 cm 3), and 75.7 cm 3 (range: 40-135.4 cm 3), respectively. The mean value of the PTV_eval/whole breast volume ratio was 0.09 (range: 0.04-0.19). No grade 2 or worst acute side-effect was detected. Grade 1 (G1) erythema occurred in 6 (22.2%) patients, while G1 oedema was reported by 3 (11.1%) cases. G1 pain was observed in 1 (3.4%) patient. Cosmetic result were excellent in 17 (62.9%) and good in 10 (37.1%) patients. SAPBI with CK is a suitable and practicable technique for the delivery of APBI after BCS for low-risk, St. I-II. IBC. Our early findings are encouraging, CK-SAPBI performed with four daily fractions is convenient and perfectly tolerated by the patients.

show abstract

Section: Discussionmentioning

confidence: 91%

Implementation of Stereotactic Accelerated Partial Breast Irradiation Using Cyber-Knife – Technical Considerations and Early Experiences of a Phase II Clinical Study

Mészáros

Smanykó

Major

et al. 2020

Pathol. Oncol. Res.

View full text Add to dashboard Cite

show abstract

“…When the TARGIT-A trial protocol was published in 1999,8 restricting radiotherapy to only the area around the tumour had been explored in small patient series9 and one randomised trial,10 which had reported inferior results. At that time whole breast radiotherapy was the standard of care, and it remains so today, despite the publication of our initial results111213 and several other approaches 1415161718192021…”

Section: Introductionmentioning

confidence: 99%

Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial

Vaidya

Bulsara

Baum

et al. 2020

BMJ

187

166

View full text Add to dashboard Cite

ObjectiveTo determine whether risk adapted intraoperative radiotherapy, delivered as a single dose during lumpectomy, can effectively replace postoperative whole breast external beam radiotherapy for early breast cancer.DesignProspective, open label, randomised controlled clinical trial.Setting32 centres in 10 countries in the United Kingdom, Europe, Australia, the United States, and Canada.Participants2298 women aged 45 years and older with invasive ductal carcinoma up to 3.5 cm in size, cN0-N1, eligible for breast conservation and randomised before lumpectomy (1:1 ratio, blocks stratified by centre) to either risk adapted targeted intraoperative radiotherapy (TARGIT-IORT) or external beam radiotherapy (EBRT).InterventionsRandom allocation was to the EBRT arm, which consisted of a standard daily fractionated course (three to six weeks) of whole breast radiotherapy, or the TARGIT-IORT arm. TARGIT-IORT was given immediately after lumpectomy under the same anaesthetic and was the only radiotherapy for most patients (around 80%). TARGIT-IORT was supplemented by EBRT when postoperative histopathology found unsuspected higher risk factors (around 20% of patients).Main outcome measuresNon-inferiority with a margin of 2.5% for the absolute difference between the five year local recurrence rates of the two arms, and long term survival outcomes.ResultsBetween 24 March 2000 and 25 June 2012, 1140 patients were randomised to TARGIT-IORT and 1158 to EBRT. TARGIT-IORT was non-inferior to EBRT: the local recurrence risk at five year complete follow-up was 2.11% for TARGIT-IORT compared with 0.95% for EBRT (difference 1.16%, 90% confidence interval 0.32 to 1.99). In the first five years, 13 additional local recurrences were reported (24/1140 v 11/1158) but 14 fewer deaths (42/1140 v 56/1158) for TARGIT-IORT compared with EBRT. With long term follow-up (median 8.6 years, maximum 18.90 years, interquartile range 7.0-10.6) no statistically significant difference was found for local recurrence-free survival (hazard ratio 1.13, 95% confidence interval 0.91 to 1.41, P=0.28), mastectomy-free survival (0.96, 0.78 to 1.19, P=0.74), distant disease-free survival (0.88, 0.69 to 1.12, P=0.30), overall survival (0.82, 0.63 to 1.05, P=0.13), and breast cancer mortality (1.12, 0.78 to 1.60, P=0.54). Mortality from other causes was significantly lower (0.59, 0.40 to 0.86, P=0.005).ConclusionFor patients with early breast cancer who met our trial selection criteria, risk adapted immediate single dose TARGIT-IORT during lumpectomy was an effective alternative to EBRT, with comparable long term efficacy for cancer control and lower non-breast cancer mortality. TARGIT-IORT should be discussed with eligible patients when breast conserving surgery is planned.Trial registrationISRCTN34086741, NCT00983684.

show abstract

“…With a median follow-up of 10.2 years, the NSABP B-39/RTOG 0413 (34) reported a LRFS rate of 95.4%. With a similar 8year median follow-up, the LRFS rate reported in the RAPID trial was 97% (32).…”

Section: Discussionmentioning

confidence: 63%

Accelerated Partial Breast Irradiation in the Elderly:8-year Oncological Outcome and Prognostic Factors

Sumodhee

PUJALTE-MARTIN

Gal

et al. 2020

Preprint

View full text Add to dashboard Cite

Introduction: To evaluate long term clinical outcome and prognostic factors after accelerated partial breast irradiation (APBI) in the elderly using high-dose-rate interstitial multi-catheter brachytherapy (HIBT).Material and methods: Between 2005 and 2018, 109 patients underwent APBI using HIBT (34 Gy/10f/5d or 32 Gy/8f/4d). Based on a prospective database, outcomes were retrospectively analyzed (local relapse-free survival (LRFS), metastatic-free survival (MFS), specific survival (SS) and overall survival (OS). Prognostic factors were investigated. Late toxicity and cosmetic evaluation were reported.Results: With a median follow-up of 97 months [7–159], median age was 81.7 years [58-89]. According to the GEC-ESTRO APBI classification, 72.5%, 11.9% and 15.6% were classified as low, intermediate and high-risk respectively. The histological type was mainly invasive ductal carcinoma (87.1%). The median tumor size was 10 mm [range 1-35]. Eight-year LRFS, SS and OS were 96.7% [95% CI [0.923; 1]), 96.7% [95% CI [0.924; 1] and 72%[95% CI [0.616; 0.837] respectively. In univariate analysis, APBI classification was not cosidered as prognostic factor, whilemolecular classification was prognostic factor for OS (p<0.0001), SS (p=0.007) and MFS (p=0.009) but not for LR (p=0.586). No Grade ³3 late toxicity was observed while 61 patients (88.4%) and 8 patients (11.6%) presented grade 1 and 2 toxicities respectively. Cosmetic outcome was excellent/good for 96.4%.Conclusion: Long-term follow-up confirms that HIBT is safe and effective for elderly early breast cancer. Our results suggest that selected elderly women presenting with high-risk breast cancer could be also considered for APBI.

show abstract

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

Cited by 289 publications

References 26 publications

Implementation of Stereotactic Accelerated Partial Breast Irradiation Using Cyber-Knife – Technical Considerations and Early Experiences of a Phase II Clinical Study

Implementation of Stereotactic Accelerated Partial Breast Irradiation Using Cyber-Knife – Technical Considerations and Early Experiences of a Phase II Clinical Study

Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial

Accelerated Partial Breast Irradiation in the Elderly:8-year Oncological Outcome and Prognostic Factors

Contact Info

Product

Resources

About