Universität zu Köln

Bartelink, Harry, Maingon, Philippe, Poortmans, Philip, Weltens, Caroline, Fourquet, Alain, Jager, Jos, Schinagl, Dominic, Oei, Bing, Rodenhuis, Carla, Horiot, Jean-Claude, Struikmans, Henk, Van Limbergen, Erik, Kirova, Youlia, Elkhuizen, Paula, Bongartz, Rudolf, Miralbell, Raymond, Morgan, David, Dubois, Jean-Bernard, Remouchamps, Vincent, Mirimanoff, Rene-Olivier, Collette, Sandra and Collette, Laurence (2015). Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol., 16 (1). S. 47 - 57. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1474-5488

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Abstract

Background Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results. Methods Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT02295033. Findings Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17.2 years (IQR 13.0-19.0). 20-year overall survival was 59.7% (99% CI 56.3-63.0) in the boost group versus 61.1% (57.6-64.3) in the no boost group, hazard ratio (HR) 1.05 (99% CI 0.92-1.19, p=0.323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0.65 (99% CI 0.52-0.81, p<0.0001). The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16.4% (99% CI 14.1-18.8) in the no boost group versus 12.0% (9.8-14.4) in the boost group. Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 (79%) of 354 patients in the no boost group versus 178 (75%) of 237 in the boost group. The cumulative incidence of severe fibrosis at 20 years was 1.8% (99% CI 1.1-2.5) in the no boost group versus 5.2% (99% CI 3.9-6.4) in the boost group (p<0.0001). Interpretation A radiation boost after whole-breast irradiation has no effect on long-term overall survival, but can improve local control, with the largest absolute benefit in young patients, although it increases the risk of moderate to severe fibrosis. The extra radiation dose can be avoided in most patients older than age 60 years.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Bartelink, Harry UNSPECIFIED UNSPECIFIED UNSPECIFIED Maingon, Philippe UNSPECIFIED UNSPECIFIED UNSPECIFIED Poortmans, Philip UNSPECIFIED UNSPECIFIED UNSPECIFIED Weltens, Caroline UNSPECIFIED UNSPECIFIED UNSPECIFIED Fourquet, Alain UNSPECIFIED UNSPECIFIED UNSPECIFIED Jager, Jos UNSPECIFIED UNSPECIFIED UNSPECIFIED Schinagl, Dominic UNSPECIFIED UNSPECIFIED UNSPECIFIED Oei, Bing UNSPECIFIED UNSPECIFIED UNSPECIFIED Rodenhuis, Carla UNSPECIFIED UNSPECIFIED UNSPECIFIED Horiot, Jean-Claude UNSPECIFIED UNSPECIFIED UNSPECIFIED Struikmans, Henk UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Limbergen, Erik UNSPECIFIED UNSPECIFIED UNSPECIFIED Kirova, Youlia UNSPECIFIED UNSPECIFIED UNSPECIFIED Elkhuizen, Paula UNSPECIFIED UNSPECIFIED UNSPECIFIED Bongartz, Rudolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Miralbell, Raymond UNSPECIFIED UNSPECIFIED UNSPECIFIED Morgan, David UNSPECIFIED UNSPECIFIED UNSPECIFIED Dubois, Jean-Bernard UNSPECIFIED UNSPECIFIED UNSPECIFIED Remouchamps, Vincent UNSPECIFIED UNSPECIFIED UNSPECIFIED Mirimanoff, Rene-Olivier UNSPECIFIED UNSPECIFIED UNSPECIFIED Collette, Sandra UNSPECIFIED UNSPECIFIED UNSPECIFIED Collette, Laurence UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-419290
DOI:	10.1016/S1470-2045(14)71156-8
Journal or Publication Title:	Lancet Oncol.
Volume:	16
Number:	1
Page Range:	S. 47 - 57
Date:	2015
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1474-5488
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language STAGE-I; LOCAL RECURRENCE; INTRAOPERATIVE RADIOTHERAPY; CONSERVATIVE TREATMENT; CLINICAL-TRIAL; EORTC BOOST; THERAPY; RADIATION; BRACHYTHERAPY; MASTECTOMY Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/41929