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

Radiation Oncology

Mark De Ridder⁴  Dirk Verellen⁴  Guy Storme⁴  Walter Vincken²  Guy Van Camp¹  Shane Hanon²  Katrien Leysen⁴  Daniel Schuermans²  Truus Reynders⁴  Dirk Kerkhove¹  Nele Adriaenssens³  Sylvia Verbanck²  Vincent Vinh-Hung⁴  Geertje Miedema⁴  Hilde Van Parijs⁴ 

[1] Department of Cardiology, UZ Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium;Department of Pneumology, UZ Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium;Department of Physical Therapy, UZ Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium;Department of Radiotherapy, UZ Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium

关键词: Intensity modulated radiotherapy (IMRT);    Image guided radiation treatment (IGRT);    Simultaneous integrated boost (SIB);    Hypofractionation;    Early breast cancer;   

Others  :  1160836
DOI  :  10.1186/1748-717X-7-80

 received in 2012-03-02, accepted in 2012-05-13,  发布年份 2012

【 摘 要 】

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

【 授权许可】

   
2012 Van Parijs et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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