The UK HeartSpare Study: randomised evaluation of voluntary deep-inspiratory breath-hold in women undergoing breast radiotherapy.

PURPOSE To determine whether voluntary deep-inspiratory breath-hold (v_DIBH) and deep-inspiratory breath-hold with the active breathing coordinator™ (ABC_DIBH) in patients undergoing left breast radiotherapy are comparable in terms of normal-tissue sparing, positional reproducibility and feasibility of delivery. METHODS Following surgery for early breast cancer, patients underwent planning-CT scans in v_DIBH and ABC_DIBH. Patients were randomised to receive one technique for fractions 1-7 and the second technique for fractions 8-15 (40 Gy/15 fractions total). Daily electronic portal imaging (EPI) was performed and matched to digitally-reconstructed radiographs. Cone-beam CT (CBCT) images were acquired for 6/15 fractions and matched to planning-CT data. Population systematic (Σ) and random errors (σ) were estimated. Heart, left-anterior-descending coronary artery, and lung doses were calculated. Patient comfort, radiographer satisfaction and scanning/treatment times were recorded. Within-patient comparisons between the two techniques used the paired t-test or Wilcoxon signed-rank test. RESULTS Twenty-three patients were recruited. All completed treatment with both techniques. EPI-derived Σ were ≤ 1.8mm (v_DIBH) and ≤ 2.0mm (ABC_DIBH) and σ ≤ 2.5mm (v_DIBH) and ≤ 2.2mm (ABC_DIBH) (all p non-significant). CBCT-derived Σ were ≤ 3.9 mm (v_DIBH) and ≤ 4.9 mm (ABC_DIBH) and σ ≤ 4.1mm (v_DIBH) and ≤ 3.8mm (ABC_DIBH). There was no significant difference between techniques in terms of normal-tissue doses (all p non-significant). Patients and radiographers preferred v_DIBH (p=0.007, p=0.03, respectively). Scanning/treatment setup times were shorter for v_DIBH (p=0.02, p=0.04, respectively). CONCLUSIONS v_DIBH and ABC_DIBH are comparable in terms of positional reproducibility and normal tissue sparing. v_DIBH is preferred by patients and radiographers, takes less time to deliver, and is cheaper than ABC_DIBH.

[1]  Michael B Sharpe,et al.  Initial clinical experience with moderate deep-inspiration breath hold using an active breathing control device in the treatment of patients with left-sided breast cancer using external beam radiation therapy. , 2003, International journal of radiation oncology, biology, physics.

[2]  Jan-Jakob Sonke,et al.  Breast patient setup error assessment: comparison of electronic portal image devices and cone-beam computed tomography matching results. , 2010, International journal of radiation oncology, biology, physics.

[3]  A. Hayden,et al.  Deep inspiration breath hold technique reduces heart dose from radiotherapy for left‐sided breast cancer , 2012, Journal of medical imaging and radiation oncology.

[4]  Stine Korreman,et al.  Breathing adapted radiotherapy of breast cancer: reduction of cardiac and pulmonary doses using voluntary inspiration breath-hold. , 2004, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[5]  I. Mjaaland,et al.  Radiation during deep inspiration allows loco-regional treatment of left breast and axillary-, supraclavicular- and internal mammary lymph nodes without compromising target coverage or dose restrictions to organs at risk , 2012, Acta oncologica.

[6]  R Peto,et al.  Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10 801 women in 17 randomised trials , 2011, The Lancet.

[7]  Hans Garmo,et al.  Distribution of coronary artery stenosis after radiation for breast cancer. , 2012, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[8]  J R Yarnold,et al.  The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial , 2008, The Lancet.

[9]  P. Remeijer,et al.  Set-up verification using portal imaging; review of current clinical practice. , 2001, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[10]  E. Harris,et al.  Clinical implementation of kilovoltage cone beam CT for the verification of sequential and integrated photon boost treatments for breast cancer patients. , 2012, The British journal of radiology.

[11]  Jan-Jakob Sonke,et al.  Clinical results of image-guided deep inspiration breath hold breast irradiation. , 2010, International journal of radiation oncology, biology, physics.

[12]  Lena Specht,et al.  Reduction of cardiac and pulmonary complication probabilities after breathing adapted radiotherapy for breast cancer. , 2006, International journal of radiation oncology, biology, physics.

[13]  Y. Ung,et al.  Deep inspiration breath hold to reduce irradiated heart volume in breast cancer patients , 2001 .

[14]  J. Fowler,et al.  Reduction in Radiation Dose to Lung and Other Normal Tissues Using Helical Tomotherapy to Treat Lung Cancer, in Comparison to Conventional Field Arrangements , 2003, American journal of clinical oncology.

[15]  I. Mjaaland,et al.  Cardiac and pulmonary dose reduction for tangentially irradiated breast cancer, utilizing deep inspiration breath-hold with audio-visual guidance, without compromising target coverage , 2011, Acta oncologica.

[16]  Andrew Nisbet,et al.  Cardiac exposures in breast cancer radiotherapy: 1950s-1990s. , 2007, International journal of radiation oncology, biology, physics.

[17]  Michael B Sharpe,et al.  Significant reductions in heart and lung doses using deep inspiration breath hold with active breathing control and intensity-modulated radiation therapy for patients treated with locoregional breast irradiation. , 2003, International journal of radiation oncology, biology, physics.

[18]  C. Mathers,et al.  Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008 , 2010, International journal of cancer.

[19]  Philip M Evans,et al.  A randomised trial of supine versus prone breast radiotherapy (SuPr study): comparing set-up errors and respiratory motion. , 2011, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[20]  R. Collins,et al.  Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials , 2005, The Lancet.

[21]  S. Darby,et al.  Cardiac dose from tangential breast cancer radiotherapy in the year 2006. , 2008, International journal of radiation oncology, biology, physics.

[22]  A. Kuten,et al.  Current technological clinical practice in breast radiotherapy; results of a survey in EORTC-Radiation Oncology Group affiliated institutions. , 2010, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[23]  Wei-Ting Hwang,et al.  Coronary artery findings after left-sided compared with right-sided radiation treatment for early-stage breast cancer. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[24]  Lawrence B Marks,et al.  Myocardial perfusion changes in patients irradiated for left-sided breast cancer and correlation with coronary artery distribution. , 2001, International journal of radiation oncology, biology, physics.

[25]  B. Heijmen,et al.  Practical use of the extended no action level (eNAL) correction protocol for breast cancer patients with implanted surgical clips. , 2012, International journal of radiation oncology, biology, physics.

[26]  R. Peto,et al.  Long-term mortality from heart disease and lung cancer after radiotherapy for early breast cancer: prospective cohort study of about 300,000 women in US SEER cancer registries. , 2005, The Lancet. Oncology.

[27]  M. Utley,et al.  Projections of cancer prevalence in the United Kingdom, 2010–2040 , 2012, British Journal of Cancer.

[28]  I. Mjaaland,et al.  Dose evaluation and risk estimation for secondary cancer in contralateral breast and a study of correlation between thorax shape and dose to organs at risk following tangentially breast irradiation during deep inspiration breath-hold and free breathing , 2011, Acta oncologica.

[29]  J. Yarnold,et al.  The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial , 2008, The Lancet. Oncology.

[30]  Philip M Evans,et al.  Prone versus supine positioning for whole and partial-breast radiotherapy: a comparison of non-target tissue dosimetry. , 2010, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[31]  Jacques Ferlay,et al.  GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 11 [Internet] , 2013 .

[32]  M. Herk.  Errors and margins in radiotherapy. , 2004 .

[33]  John Wong,et al.  MRI-based volumetric assessment of cardiac anatomy and dose reduction via active breathing control during irradiation for left-sided breast cancer. , 2005, International journal of radiation oncology, biology, physics.

[34]  C. Mathers,et al.  GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer , 2013 .

[35]  Lena Specht,et al.  Breathing adapted radiotherapy for breast cancer: comparison of free breathing gating with the breath-hold technique. , 2005, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.