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Strahlentherapie und Onkologie

, Volume 190, Issue 7, pp 646–653 | Cite as

Hypofractionation with simultaneous integrated boost for early breast cancer

Results of the German multicenter phase II trial (ARO-2010-01)
  • Kathrin DellasEmail author
  • Reinhard Vonthein
  • Jörg Zimmer
  • Stefan Dinges
  • Alexander D. Boicev
  • Peter Andreas
  • Dorothea Fischer
  • Cornelia Winkler
  • Andreas Ziegler
  • Jürgen Dunst
  • ARO Study Group
Original article

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.

Keywords

Breast cancer Hypofractionation Simultaneous integrated boost Feasibility Toxicity 

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

Hypofraktionierte Bestrahlung mit simultan-integriertem Boost beim frühen Mammakarzinom

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

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.

Schlüsselwörter

Mammakarzinom Hypofraktionierung Simultan-integrierter Boost Durchführbarkeit Toxizität 

Notes

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.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Kathrin Dellas
    • 1
    • 2
    Email author
  • Reinhard Vonthein
    • 3
    • 4
  • Jörg Zimmer
    • 5
  • Stefan Dinges
    • 6
  • Alexander D. Boicev
    • 7
  • Peter Andreas
    • 8
  • Dorothea Fischer
    • 9
  • Cornelia Winkler
    • 10
  • Andreas Ziegler
    • 3
    • 4
  • Jürgen Dunst
    • 1
    • 2
    • 11
  • ARO Study Group
  1. 1.Department of RadiooncologyUniversity of KielKielGermany
  2. 2.Department of RadiooncologyUniversity of LübeckLübeckGermany
  3. 3.Institute of Medical Biometry and Statistics, University of Lübeck, University Medical Center Schleswig-HolsteinCampus LübeckLübeckGermany
  4. 4.Center for Clinical TrialsUniversity of LübeckLübeckGermany
  5. 5.Private Practice of RadiooncologyDresdenGermany
  6. 6.Department of RadiooncologyKlinikum LüneburgLüneburgGermany
  7. 7.Department of RadiooncologyKlinikum ZwickauZwickauGermany
  8. 8.Department of RadiooncologyKrankenhaus BuchholzBuchholzGermany
  9. 9.Department of GynecologyUniversity of LübeckLübeckGermany
  10. 10.Department of RadiooncologyTU MunichMunichGermany
  11. 11.University of CopenhagenCopenhagenDenmark

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