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Review
. 2015 Jun;75(6):566-573.
doi: 10.1055/s-0035-1546172.

Subcutaneous Trastuzumab for HER2-positive Breast Cancer - Evidence and Practical Experience in 7 German Centers

C Jackisch  1 , V Müller  2 , P Dall  3 , R Neumeister  4 , T-W Park-Simon  5 , A Ruf-Dördelmann  6 , S Seiler  1 , H Tesch  7 , B Ataseven  8
Affiliations
Review

Subcutaneous Trastuzumab for HER2-positive Breast Cancer - Evidence and Practical Experience in 7 German Centers

C Jackisch et al. Geburtshilfe Frauenheilkd. 2015 Jun.

Abstract
in English, German

A subcutaneous formulation of trastuzumab to treat patients with HER2-positive breast cancer is available since August 2013. The subcutaneous formulation is administered as a fixed dose of 600 mg over a period of up to 5 minutes. The HannaH trial compared subcutaneous with intravenous administration and found comparable pharmacokinetics, efficacy and tolerability for both administration forms of trastuzumab in the neoadjuvant setting. The randomized crossover study PrefHer reported a clear preference from the patient's point of view for subcutaneous over intravenous administration of trastuzumab. The accompanying time-and-motion study reported a reduction concerning the total time spent for the institution as well as for the patient receiving trastuzumab s. c.. The experience of 7 German centers largely corresponded with the results of these studies. Patients expressed a clear preference for subcutaneous trastuzumab administration, with the time saved by the subcutaneous administration route cited as the greatest benefit. Although the existing reimbursement terms mean that centers will receive a lower remuneration, the centers' overall evaluation of the subcutaneous administration route for trastuzumab was overwhelmingly positive. The greatest benefit cited by the centers was the flexibility in scheduling patient appointments. This increased flexibility improved conditions in some centers which were experiencing pressures due to a shortage of staff, particularly at peak times. The general consensus, however, was that the remuneration systems for oncological treatments urgently need to be amended to ensure that the real costs of treatment are covered, even if the administration route has changed.

Seit August 2013 steht für Patientinnen mit HER2-positivem Mammakarzinom die subkutane Applikationsform von Trastuzumab zur Verfügung, die in einer Fixdosis von 600 mg über rund 5 Minuten verabreicht wird. In der HannaH-Studie wurden in der neoadjuvanten Therapie eine vergleichbare Pharmakokinetik, Wirksamkeit und Verträglichkeit beider Applikationsformen von Trastuzumab gezeigt. Die randomisierte Crossover-Studie PrefHer wies eine deutliche Präferenz der Patientinnen für die subkutane Gabe von Trastuzumab gegenüber der intravenösen nach. In der begleitenden Time-and-Motion-Studie reduzierten sich unter der subkutanen Therapie die effektive Behandlungszeit der Patientinnen und der insgesamt für die Verabreichung von Trastuzumab notwendige Zeitaufwand des medizinischen Personals. Erfahrungen aus 7 deutschen Zentren decken sich weitgehend mit den Studienergebnissen. Vonseiten der Patientinnen bestand auch in der Praxis eine klare Präferenz für die subkutane Anwendung von Trastuzumab, wobei die Zeitersparnis durch die subkutane Anwendung als größter Vorteil wahrgenommen wurde. Trotz geringerer Vergütung aufgrund der bestehenden Abrechnungsmodalitäten fiel die Bilanz der Zentren für die subkutane Applikationsform von Trastuzumab positiv aus. Für sie bestand der wichtigste Vorteil in einer größeren Terminflexibilität, die in einigen Zentren zu einer Verbesserung einer angespannten Situation bei dünner Personaldecke und in Belastungsspitzen beitrug. Konsens war allerdings auch, dass die Vergütung onkologischer Behandlungen unbedingt angepasst werden muss, um eine Deckung des realen Betreuungsaufwands auch bei geänderten Applikationsformen zu gewährleisten.

Keywords: breast cancer; subcutaneous administration; trastuzumab.

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Conflict of interest statement

Conflict of Interest The authors declare that in the last 3 years they have provided the following services or received the following support or grants: CJ speakerʼs fees and travel expenses from Roche; VM consultancy fees and speakerʼs fees from Amgen, Celgene, Eisai, Pierre Fabre, Roche as well as research funding from Celgene and Roche; PD speakerʼs fees and travel expenses from Roche; RN speakerʼs fees from Roche; T-WP-S consultancy fees and speakerʼs fees from Roche; SS consultancy fees and speakerʼs fees from Astra-Zeneca, GSK, Novartis, Riemser, Roche, TEVA; HT consultancy fees and speakerʼs fees from Roche; BA consultancy fees and speakerʼs fees from Roche.

Figures

Fig. 1
Fig. 1
Study design of the PrefHer study (based on , 19).
Fig. 2
Fig. 2
Preference of patients for a specific type of trastuzumab administration (based on 19).
Fig. 3
Fig. 3
Time spent by patient in the treatment chair (= patient chair time) – s. c. administration* vs. i. v. administration (based on 20). * Subcutaneous administration of trastuzumab using single-use injection device.
Fig. 4
Fig. 4
Active Healthcare Professional (HCP) time required to administer trastuzumab to a patient over a period of 1 year – s. c. administration* vs. i. v. administration (based on 20). * Subcutaneous administration of trastuzumab using single-use injection device.
See this image and copyright information in PMC

References

    1. Giordano S H, Temin S, Kirshner J J. et al.Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014;32:2078–2099. - PMC - PubMed
    1. Senkus E, Kyriakides S, Penault-Llorca F. et al.ESMO Guidelines Working Group Primary breast cancer . ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24 06:vi7–vi23. - PubMed
    1. Cardoso F, Costa A, Norton L. et al.ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)†. Ann Oncol. 2014;25:1871–1888. - PMC - PubMed
    1. DKG Interdisziplinäre S3-Leitlinie für die Diagnostik, Therapie und Nachsorge des Mammakarzinoms Langversion 3.0, Aktualisierung 2012Online:http://www.krebsgesellschaft.de/download/S3_Brustkrebs_Update_2012_OL_La...last access: 03.03.2015
    1. AGO Diagnostik und Therapie von Patientinnen mit primärem und metastasiertem Brustkrebs: Version 2015. 1D [online] 03.2015Online:http://www.ago-online.de/fileadmin/downloads/leitlinien/mamma/maerz2015/...last access: 03.03.2015