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Accelerated partial breast irradiation with external beam radiotherapy

First results of the German phase 2 trial

Akzelerierte Teilbrustbestrahlung mit der externen Strahlentherapie

Erste Ergebnisse der deutschen Phase-2-Studie

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Abstract

Background and purpose

To evaluate the feasibility and efficacy of external beam three-dimensional (3D) conformal accelerated partial breast irradiation (APBI) for selected patients with early breast cancer.

Patients and methods

Between 2011 and 2016, 72 patients were recruited for this prospective phase 2 trial. Patients were eligible for APBI if they had histologically confirmed breast cancer or pure ductal carcinoma in situ (DCIS), a tumor diameter ≤3 cm, clear resection margins ≥2 mm, no axillary lymph node involvement, no distant metastases, tumor bed clips, and were aged ≥50 years. Patients were excluded if mammography showed a multicentric invasive growth pattern, or if they had residual diffuse microcalcifications postoperatively, an extensive intraductal component, or vessel invasion. Patients received 3D conformal external beam APBI with a total dose of 38 Gy in 10 fractions in 1–2 weeks. The trial had been registered at the German Clinical Trials Register, DRKS-ID: DRKS00004417.

Results

Median follow-up was 25.5 months (range 1–61 months). Local control was maintained in 71 of 72 patients. The 3‑year local recurrence rate was 2.1% (95% confidence interval, CI: 0–6.1%). Early toxicity (grade 1 radiodermatitis) was seen in 34.7% (25/72). Late side effects ≥ grade 3 did not occur. Cosmetic results were rated as excellent/good in 96.7% (59/61).

Conclusion

APBI with external beam radiotherapy techniques is feasible with low toxicity and, according to the results of the present and other studies, on the way to becoming a standard treatment option for a selected subgroup of patients.

Zusammenfassung

Hintergrund und Ziel

Untersuchung der Verträglichkeit und Sicherheit der externen, 3‑D-konformalen akzelerierten Teilbrustbestrahlung (APBI) für ausgewählte Patientinnen mit einem frühen Mammakarzinom.

Patienten und Methode

Von 2011 bis 2016 wurden 72 Patientinnen in diese prospektive Phase-2-Studie eingebracht. Einschlusskriterien waren ein histologisch gesichertes Mammakarzinom oder DCIS, ein Tumordurchmesser ≤ 3 cm, tumorfreie Resektionsränder ≥ 2 mm, kein axillärer Lymphknotenbefall, keine Fernmetastasen, Tumorbett-Clips und ein Mindestalter von 50 Jahren. Die Patientinnen wurden nicht aufgenommen bei mammographischen Hinweisen auf ein multizentrisches Wachstumsmuster, bei postoperativ verbliebenen diffusen Mikrokalzifikationen, einer extensiven intraduktalen Komponente sowie bei Lymph- oder Hämangiosis carcinomatosa. Die Patientinnen erhielten eine 3‑D-konformale, externe APBI mit einer Dosis von 38 Gy/10 Fraktionen in 1–2 Wochen. Die Studie wurde beim Deutschen Register Klinischer Studien registriert (DRKS-ID: DRKS00004417).

Ergebnisse

Die mediane Nachbeobachtungszeit betrug 25,5 Monate (Spanne 1–61 Monate). Lokale Kontrolle bestand bei 71 von 72 Patientinnen. Die 3‑Jahres-Lokalrezidivrate war 2,1% (95%-KI 0–6,1%). Akute Nebenwirkungen (ausschließlich Grad-1-Radiodermatitis) traten bei 35% (25/72) auf. Spätnebenwirkungen ≥ Grad 3 gab es nicht. Das kosmetische Ergebnis wurde bei 97% (59/61) der auswertbaren Fälle als gut oder sehr gut eingeschätzt.

Schlussfolgerung

Die APBI mit einer externen 3-D-konformalen Radiotherapietechnik ist verträglich und effektiv und nach unseren bisherigen Ergebnissen und den Ergebnissen anderer Arbeitsgruppen auf dem Weg zu einer Standardtechnik für ausgewählte Fälle.

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Authors and Affiliations

  1. Department of Radiation Oncology, University Hospital Erlangen, Universitätsstraße 27, 91054, Erlangen, Germany

    Oliver J. Ott, Vratislav Strnad, Wilhelm Stillkrieg & Rainer Fietkau

  2. Dept. of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Erlangen, Germany

    Wolfgang Uter

  3. Dept. of Gynecology, University Hospital Erlangen, Erlangen, Germany

    Matthias W. Beckmann

Authors
  1. Oliver J. Ott
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  2. Vratislav Strnad
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  4. Wolfgang Uter
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  5. Matthias W. Beckmann
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  6. Rainer Fietkau
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Corresponding author

Correspondence to Oliver J. Ott.

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Conflict of interest

O.J. Ott, V. Strnad, W. Stillkrieg, W. Uter, M.W. Beckmann, and R. Fietkau declare that they have no competing interests.

Ethical standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

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Ott, O.J., Strnad, V., Stillkrieg, W. et al. Accelerated partial breast irradiation with external beam radiotherapy. Strahlenther Onkol 193, 55–61 (2017). https://doi.org/10.1007/s00066-016-1066-9

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  • DOI: https://doi.org/10.1007/s00066-016-1066-9

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