Skip to main content

Advertisement

SpringerLink
Log in

Hypofractionation with simultaneous integrated boost for early breast cancer

Results of the German multicenter phase II trial (ARO-2010-01)

Hypofraktionierte Bestrahlung mit simultan-integriertem Boost beim frühen Mammakarzinom

Ergebnisse einer deutschen Phase-II-Multizenterstudie (ARO-2010-01)

  • Original article
  • Published:
Strahlentherapie und Onkologie Aims and scope Submit manuscript

Abstract

Purpose

To evaluate the feasibility of hypofractionation with SIB in all settings in Germany to prepare a multicenter treatment comparison.

Methods

Eligible patients had histopathologically confirmed breast cancer operated by BCS. Patients received WBI 40.0 Gy in 16 fractions of 2.5 Gy. A SIB with 0.5 Gy per fraction was administered to the tumor bed, thereby giving 48.0 Gy in 16 fractions to the boost-PTV sparing heart, LAD, lung, contralateral breast. The primary study objective was feasibility, administration of specified dose in 16 fractions within 22–29 days with adherence to certain dose constraints (heart; LAD; contralateral breast); secondary endpoints were toxicity, QoL.

Results

151 patients were recruited from 7 institutions between 07/11-10/12. 10 patients met exclusion criteria prior to irradiation. All but two patients (99 %) received the prescribed dose in the PTVs. Adherence to dose constraints and time limits was achieved in 89 % (95 % CI 82 % to 93 %). 11 AE were reported in 10 patients; five related to concurrent endocrine therapy. Two of the AEs were related to radiotherapy: grade 3 hot flushes in two cases. QoL remained unchanged.

Conclusion

Hypofractionation with a SIB is feasible and was well tolerated in this study.

Zusammenfassung

Hintergrund

Die ARO-2010-01-Studie prüfte die Durchführbarkeit einer hypofraktionierten Bestrahlung mit simultan-integriertem Boost (SIB) in unterschiedlichen Versorgungseinrichtungen zur Vorbereitung einer multizentrischen Vergleichsstudie.

Methoden

In die Studie rekrutiert wurden Patientinnen mit histopathologisch gesichertem Mammakarzinom nach brusterhaltender Operation. Bestrahlt wurde die Brust mit 40,0 Gy in 16 Fraktionen à 2,5 Gy Einzeldosis; zusätzlich wurde bei jeder Fraktion ein simultan- integrierter Boost mit 0,5 Gy appliziert, so dass im Boost-PTV (Planungszielvolumen) eine Dosis von 48 Gy in 16 Fraktionen erreicht wurde. Das primäre Zielkriterium war die Durchführbarkeit, definiert als Verabreichung von 48 Gy GD in 16 Fraktionen in mindestens 22 d bis maximal 29 d Therapiezeit unter Einhaltung von Grenzdosen (Lunge, Herz, LAD, kontralaterale Brust); sekundäre Endpunkte waren Toxizität und Lebensqualität.

Ergebnisse

Zwischen 07/2011 und 10/2012 wurden 151 Patientinnen in 7 Prüfzentren rekrutiert. Bei 10 Patientinnen wurden vor der Strahlentherapie Ausschlusskriterien festgestellt. Fast alle Patientinnen (99 %) erhielten die verschriebene Dosis im PTV. Grenzdosen und Zeitlimits wurden in 89 % (95 % CI 82 % bis 93 %) eingehalten. 11 unerwünschte Ereignisse wurden bei 10 Patientinnen gemeldet; fünf in Verbindung mit gleichzeitiger endokriner Therapie. In 2 Fällen wurde eine kausale Beziehung zur Strahlentherapie angegeben: Grad-3-Hitzewallungen. Die Lebensqualität blieb unverändert.

Schlussfolgerungen

Die hypofraktionierte Bestrahlung mit simultan-integriertem Boost konnte in dieser multizentrischen Studie in Praxen und Strahlenkliniken problemlos durchgeführt werden. Die Verträglichkeit war in dieser Studie gut.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

Abbreviations

3D-CRT:

Three-dimensional conformal radiotherapy

AE:

Adverse event

ARO:

Arbeitsgemeinschaft Radiologische Onkologie (Research Group on Radiological Oncology in the German Cancer Society)

BCS:

Breast-conserving surgery

CR:

Conventional radiotherapy

DLco:

Diffusing capacity of the lung for carbon monoxide

DVH:

Dose–volume histogram

EORTC:

European Organisation for Research and Treatment of Cancer

FEV1:

Forced expiratory volume in 1 s

IMRT:

Intensity modulated radiotherapy

LAD:

Left coronary artery

NCI-CTC:

National Cancer Institute Common Toxicity Criteria

PTV:

Planning target volume

RIVA:

Ramus interventriculares anterior

SIB:

Simultaneous integrated boost

TT:

Tomotherapy

VMAT:

Volumetric modulated arc therapy

WBI:

Whole breast irradiation

References

  1. Clarke M, Collins R, Darby S et al, Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) (2005) 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. Lancet 366:2087–2106

    Article  CAS  PubMed  Google Scholar 

  2. Darby S, McGale P, Correa C et al (2011) 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. Lancet 378:1707–1716

    Article  CAS  PubMed  Google Scholar 

  3. Whelan TJ, Julian J, Wright J et al (2000) Does locoregional RT improve survival in breast cancer? A meta-analysis. J Clin Oncol 18:1220–1229

    CAS  PubMed  Google Scholar 

  4. Bartelink H, Horiot JC, Poortmans P et al (2007) Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol 22:3259–3326

    Article  Google Scholar 

  5. Livi L, Borghesi S, Saieva C et al (2009) Benefit of radiation boost after whole-breast radiotherapy. Int J Radiat Oncol Biol Phys 75:1029–1034

    Article  PubMed  Google Scholar 

  6. Azria D, Auvray H, Barillot I et al (2008) Ductal carcinoma in situ: role of the boost. Cancer Radiother 12:571–576

    Article  CAS  PubMed  Google Scholar 

  7. Whelan TJ, Pignol JP, Levine MN et al (2010) Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med 362:513–520

    Article  CAS  PubMed  Google Scholar 

  8. START Trialists’ Group, Bentzen SM, Agrawal RK, Aird EG et al (2008) The UK Standardization of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol 9:331–341

    Article  CAS  PubMed  Google Scholar 

  9. START Trialists’ Group, Bentzen SM, Agrawal RK, Aird EG et al (2008) The UK Standardization of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet 371:1098–1107

    Article  CAS  PubMed  Google Scholar 

  10. Owen JR, Ashton A, Bliss JM et al (2006) Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: long-term results of a randomized trial. Lancet Oncol 7:467–471

    Article  PubMed  Google Scholar 

  11. Sedlmayer F, Sautter-Bihl ML, Budach W et al (2013) Breast Cancer Expert Panel of the German Society of Radiation Oncology (DEGRO). Is the simultaneously integrated boost (SIB) technique for early breast cancer ready to be adopted for routine adjuvant radiotherapy? Statement of the German and the Austrian Societies of Radiooncology (DEGRO/ÖGRO). Strahlenther Onkol 189:193–196

    Article  CAS  PubMed  Google Scholar 

  12. Sedlmayer F, Sautter-Bihl ML, Budach W et al (2013) Breast Cancer Expert Panel of the German Society of Radiation Oncology (DEGRO). DEGRO practical guidelines: radiotherapy of breast cancer I. Radiotherapy following breast conserving therapy for invasive breast cancer. Strahlenther Onkol 189:825–833

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  13. Chadha M, Vongtama D, Friedmann P et al (2012) Comparative acute toxicity from whole breast irradiation using 3-week accelerated schedule with concomitant boost and the 6.5-week conventional schedule with sequential boost for early-stage breast cancer. Clin Breast Cancer 12:57–62

    Article  PubMed  Google Scholar 

  14. Van Parijs HM, Vinh-Hung V et al (2012) Short course radiotherapy with simultaneous integrated boost for stage I–II breast cancer, early toxicities of a randomized clinical trial. Radiat Oncol 7:80

    Article  PubMed Central  PubMed  Google Scholar 

  15. Scorsetti M, Alongi F, Fogliata A et al (2012) Phase I–II study of hypofractionated simultaneous integrated boost using volumetric modulated arc therapy for adjuvant radiation therapy in breast cancer patients: a report of feasibility and early toxicity results in the first 50 treatments. Radiat Oncol 28:145

    Article  Google Scholar 

  16. Darby SC, Ewertz M, McGale P et al (2012) Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med 368:987–998

    Article  Google Scholar 

Download references

Compliance with ethical guidelines

Conflict of interest

K. Dellas, R. Vonthein, J. Zimmer, S. Dinges, A.D. Boivcev, P. Andreas, D. Fischer, C. Winkler, A. Ziegler, and J. Dunst state that there are no conflicts of interest.

Author information

Authors and Affiliations

  1. Department of Radiooncology, University of Kiel, A.-Heller-Str. 3, 24105, Kiel, Germany

    Kathrin Dellas MD &  Jürgen Dunst MD

  2. Department of Radiooncology, University of Lübeck, Lübeck, Germany

    Kathrin Dellas MD &  Jürgen Dunst MD

  3. Institute of Medical Biometry and Statistics, University of Lübeck, University Medical Center Schleswig-Holstein, Campus Lübeck, Lübeck, Germany

    Reinhard Vonthein &  Andreas Ziegler

  4. Center for Clinical Trials, University of Lübeck, Lübeck, Germany

    Reinhard Vonthein &  Andreas Ziegler

  5. Private Practice of Radiooncology, Dresden-Friedrichstadt, Dresden, Germany

    Jörg Zimmer MD

  6. Department of Radiooncology, Klinikum Lüneburg, Lüneburg, Germany

    Stefan Dinges MD

  7. Department of Radiooncology, Klinikum Zwickau, Zwickau, Germany

    Alexander D. Boicev MD

  8. Department of Radiooncology, Krankenhaus Buchholz, Buchholz, Germany

    Peter Andreas MD

  9. Department of Gynecology, University of Lübeck, Lübeck, Germany

    Dorothea Fischer MD

  10. Department of Radiooncology, TU Munich, Munich, Germany

    Cornelia Winkler MD

  11. University of Copenhagen, Copenhagen, Denmark

    Jürgen Dunst MD

Authors
  1. Kathrin Dellas MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Reinhard Vonthein
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jörg Zimmer MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Stefan Dinges MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Alexander D. Boicev MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Peter Andreas MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Dorothea Fischer MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Cornelia Winkler MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Andreas Ziegler
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Jürgen Dunst MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. ARO Study Group
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kathrin Dellas MD.

Additional information

ARO Study Group

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Dellas, K., Vonthein, R., Zimmer, J. et al. Hypofractionation with simultaneous integrated boost for early breast cancer. Strahlenther Onkol 190, 646–653 (2014). https://doi.org/10.1007/s00066-014-0658-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00066-014-0658-5

Keywords

Schlüsselwörter

Search

Navigation