Vratislav Strnad1, Oliver J Ott2, Guido Hildebrandt3, Daniela Kauer-Dorner4, Hellen Knauerhase5, Tibor Major6, Jaroslaw Lyczek7, Jose Luis Guinot8, Jürgen Dunst9, Cristina Gutierrez Miguelez10, Pavel Slampa11, Michael Allgäuer12, Kristina Lössl13, Bülent Polat14, György Kovács15, Arnt-René Fischedick16, Thomas G Wendt17, Rainer Fietkau18, Marion Hindemith19, Alexandra Resch4, Anna Kulik20, Leo Arribas8, Peter Niehoff21, Fernando Guedea10, Annika Schlamann19, Richard Pötter4, Christine Gall22, Martina Malzer22, Wolfgang Uter22, Csaba Polgár6. 1. Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany. Electronic address: vratislav.strnad@uk-erlangen.de. 2. Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany. 3. Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany. 4. Department of Radiation Oncology, University Hospital AKH Wien, Vienna, Austria. 5. Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany. 6. Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary. 7. Brachytherapy Department, Centrum Onkologii-Instytut im Marii Skłodowskej, Warsaw, Poland; Podkarpacki Hospital Cancer Center Brzozów, Brzozów, Poland. 8. Department of Radiation Oncology, Valencian Institute of Oncology, Valencia, Spain. 9. Department of Radiation Oncology, University Hospital Kiel, Germany. 10. Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain. 11. Department of Radiation Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic. 12. Department of Radiation Oncology, Hospital Barmherzige Brüder Regensburg, Regensburg, Germany. 13. Department of Radiation Oncology, University Hospital Bern, Inselspital, Bern, Switzerland. 14. Department of Radiation Oncology, University Hospital Würzburg, Würzburg, Germany. 15. Interdisciplinary Brachytherapy Unit, University of Lübeck/UKSH Campus Lübeck, Lübeck, Germany. 16. Department of Radiation Oncology, Clemens Hospital, Münster, Germany. 17. Department of Radiation Oncology, University Hospital Jena, Jena, Germany. 18. Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany. 19. Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany. 20. Brachytherapy Department, Centrum Onkologii-Instytut im Marii Skłodowskej, Warsaw, Poland. 21. Department of Radiation Oncology, University Hospital Kiel, Germany; Department of Radiotherapy, Municipal Hospital Cologne, University Witten-Herdecke, Witten, Germany. 22. Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Erlangen, Germany.
Abstract
BACKGROUND: In a phase 3, randomised, non-inferiority trial, accelerated partial breast irradiation (APBI) for patients with stage 0, I, and IIA breast cancer who underwentbreast-conserving treatment was compared with whole-breast irradiation. Here, we present 5-year follow-up results. METHODS: We did a phase 3, randomised, non-inferiority trial at 16 hospitals and medical centres in seven European countries. 1184 patients with low-risk invasive and ductal carcinoma in situ treated with breast-conserving surgery were centrally randomised to either whole-breast irradiation or APBI using multicatheter brachytherapy. The primary endpoint was local recurrence. Analysis was done according to treatment received. This trial is registered with ClinicalTrials.gov, number NCT00402519. FINDINGS:Between April 20, 2004, and July 30, 2009, 551 patients had whole-breast irradiation with tumour-bed boost and 633 patients receivedAPBI using interstitial multicatheter brachytherapy. At 5-year follow-up, nine patients treated with APBI and five patients receiving whole-breast irradiation had a local recurrence; the cumulative incidence of local recurrence was 1.44% (95% CI 0.51-2.38) with APBI and 0.92% (0.12-1.73) with whole-breast irradiation (difference 0.52%, 95% CI -0.72 to 1.75; p=0.42). No grade 4 late side-effects were reported. The 5-year risk of grade 2-3 late side-effects to the skin was 3.2% with APBI versus 5.7% with whole-breast irradiation (p=0.08), and 5-year risk of grade 2-3 subcutaneous tissue late side-effects was 7.6% versus 6.3% (p=0.53). The risk of severe (grade 3) fibrosis at 5 years was 0.2% with whole-breast irradiation and 0% with APBI (p=0.46). INTERPRETATION: The difference between treatments was below the relevance margin of 3 percentage points. Therefore, adjuvant APBI using multicatheter brachytherapy after breast-conserving surgery in patients with early breast cancer is not inferior to adjuvant whole-breast irradiation with respect to 5-year local control, disease-free survival, and overall survival. FUNDING: German Cancer Aid.
RCT Entities:
BACKGROUND: In a phase 3, randomised, non-inferiority trial, accelerated partial breast irradiation (APBI) for patients with stage 0, I, and IIA breast cancer who underwent breast-conserving treatment was compared with whole-breast irradiation. Here, we present 5-year follow-up results. METHODS: We did a phase 3, randomised, non-inferiority trial at 16 hospitals and medical centres in seven European countries. 1184 patients with low-risk invasive and ductal carcinoma in situ treated with breast-conserving surgery were centrally randomised to either whole-breast irradiation or APBI using multicatheter brachytherapy. The primary endpoint was local recurrence. Analysis was done according to treatment received. This trial is registered with ClinicalTrials.gov, number NCT00402519. FINDINGS: Between April 20, 2004, and July 30, 2009, 551 patients had whole-breast irradiation with tumour-bed boost and 633 patients received APBI using interstitial multicatheter brachytherapy. At 5-year follow-up, nine patients treated with APBI and five patients receiving whole-breast irradiation had a local recurrence; the cumulative incidence of local recurrence was 1.44% (95% CI 0.51-2.38) with APBI and 0.92% (0.12-1.73) with whole-breast irradiation (difference 0.52%, 95% CI -0.72 to 1.75; p=0.42). No grade 4 late side-effects were reported. The 5-year risk of grade 2-3 late side-effects to the skin was 3.2% with APBI versus 5.7% with whole-breast irradiation (p=0.08), and 5-year risk of grade 2-3 subcutaneous tissue late side-effects was 7.6% versus 6.3% (p=0.53). The risk of severe (grade 3) fibrosis at 5 years was 0.2% with whole-breast irradiation and 0% with APBI (p=0.46). INTERPRETATION: The difference between treatments was below the relevance margin of 3 percentage points. Therefore, adjuvant APBI using multicatheter brachytherapy after breast-conserving surgery in patients with early breast cancer is not inferior to adjuvant whole-breast irradiation with respect to 5-year local control, disease-free survival, and overall survival. FUNDING: German Cancer Aid.
Authors: Laura S Dominici; Monica Morrow; Elizabeth Mittendorf; Jennifer Bellon; Tari A King Journal: Curr Probl Surg Date: 2016-11-29 Impact factor: 1.909
Authors: Jacob S Witt; Robert W Gao; Lisa J Sudmeier; Stephen A Rosenberg; David M Francis; Charles R Wallace; Rupak K Das; Bethany M Anderson Journal: Brachytherapy Date: 2018-09-24 Impact factor: 2.362