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Open Access 01-12-2012 | Research

Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial

Authors: Hilde Van Parijs, Geertje Miedema, Vincent Vinh-Hung, Sylvia Verbanck, Nele Adriaenssens, Dirk Kerkhove, Truus Reynders, Daniel Schuermans, Katrien Leysen, Shane Hanon, Guy Van Camp, Walter Vincken, Guy Storme, Dirk Verellen, Mark De Ridder

Published in: Radiation Oncology | Issue 1/2012

Abstract

Background

TomoBreast is a unicenter, non-blinded randomized trial comparing conventional radiotherapy (CR) vs. hypofractionated Tomotherapy (TT) for post-operative treatment of breast cancer. The purpose of the trial is to compare whether TT can reduce heart and pulmonary toxicity. We evaluate early toxicities.

Methods

The trial started inclusion in May 2007 and reached its recruitment in August 2011. Women with stage T1-3N0M0 or T1-2N1M0 breast cancer completely resected by tumorectomy (BCS) or by mastectomy (MA) who consented to participate were randomized, according to a prescribed computer-generated randomization schedule, between control arm of CR 25x2 Gy/5 weeks by tangential fields on breast/chest wall, plus supraclavicular-axillary field if node-positive, and sequential boost 8x2 Gy/2 weeks if BCS (cumulative dose 66 Gy/7 weeks), versus experimental TT arm of 15x2.8 Gy/3 weeks, including nodal areas if node-positive and simultaneous integrated boost of 0.6 Gy if BCS (cumulative dose 51 Gy/3 weeks). Outcomes evaluated were the pulmonary and heart function. Comparison of proportions used one-sided Fisher's exact test.

Results

By May 2010, 70 patients were randomized and had more than 1 year of follow-up. Out of 69 evaluable cases, 32 were assigned to CR (21 BCS, 11 MA), 37 to TT (20 BCS, 17 MA). Skin toxicity of grade ≥1 at 2 years was 60% in CR, vs. 30% in TT arm. Heart function showed no significant difference for left ventricular ejection fraction at 2 years, CR 4.8% vs. TT 4.6%. Pulmonary function tests at 2 years showed grade ≥1 decline of FEV1 in 21% of CR, vs. 15% of TT and decline of DLco in 29% of CR, vs. 7% of TT (P = 0.05).

Conclusions

There were no unexpected severe toxicities. Short course radiotherapy of the breast with simultaneous integrated boost over 3 weeks proved feasible without excess toxicities. Pulmonary tests showed a slight trend in favor of Tomotherapy, which will need confirmation with longer follow-up of patients.

Trail registration

ClinicalTrials.gov NCT00459628

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Title: Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial
Authors: Hilde Van Parijs
Geertje Miedema
Vincent Vinh-Hung
Sylvia Verbanck
Nele Adriaenssens
Dirk Kerkhove
Truus Reynders
Daniel Schuermans
Katrien Leysen
Shane Hanon
Guy Van Camp
Walter Vincken
Guy Storme
Dirk Verellen
Mark De Ridder
Publication date: 01-12-2012
Publisher: BioMed Central
Published in: Radiation Oncology / Issue 1/2012
Electronic ISSN: 1748-717X
DOI: https://doi.org/10.1186/1748-717X-7-80

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial

Abstract

Background

Methods

Results

Conclusions

Trail registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trail registration

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