Literature DB >> 26166837

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

C Jackisch1, V Müller2, P Dall3, R Neumeister4, T-W Park-Simon5, A Ruf-Dördelmann6, S Seiler1, H Tesch7, B Ataseven8.   

Abstract

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.

Entities:  

Keywords:  breast cancer; subcutaneous administration; trastuzumab

Year:  2015        PMID: 26166837      PMCID: PMC4490923          DOI: 10.1055/s-0035-1546172

Source DB:  PubMed          Journal:  Geburtshilfe Frauenheilkd        ISSN: 0016-5751            Impact factor:   2.915


  12 in total

1.  A recombinant human enzyme for enhanced interstitial transport of therapeutics.

Authors:  L H Bookbinder; A Hofer; M F Haller; M L Zepeda; G-A Keller; J E Lim; T S Edgington; H M Shepard; J S Patton; G I Frost
Journal:  J Control Release       Date:  2006-06-07       Impact factor: 9.776

Review 2.  Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration.

Authors:  Gregory I Frost
Journal:  Expert Opin Drug Deliv       Date:  2007-07       Impact factor: 6.648

3.  Comparison of subcutaneous and intravenous administration of trastuzumab: a phase I/Ib trial in healthy male volunteers and patients with HER2-positive breast cancer.

Authors:  Chris Wynne; Vernon Harvey; Christian Schwabe; Devonie Waaka; Christine McIntyre; Beate Bittner
Journal:  J Clin Pharmacol       Date:  2013-02       Impact factor: 3.126

4.  Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study.

Authors:  C Jackisch; S-B Kim; V Semiglazov; B Melichar; X Pivot; C Hillenbach; D Stroyakovskiy; B L Lum; R Elliott; H A Weber; G Ismael
Journal:  Ann Oncol       Date:  2014-11-17       Impact factor: 32.976

Review 5.  Hyaluronidase.

Authors:  D Watson
Journal:  Br J Anaesth       Date:  1993-09       Impact factor: 9.166

6.  Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial.

Authors:  Gustavo Ismael; Roberto Hegg; Susanne Muehlbauer; Dominik Heinzmann; Bert Lum; Sung-Bae Kim; Tadeusz Pienkowski; Mikhail Lichinitser; Vladimir Semiglazov; Bohuslav Melichar; Christian Jackisch
Journal:  Lancet Oncol       Date:  2012-08-09       Impact factor: 41.316

7.  Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study.

Authors:  Xavier Pivot; Joseph Gligorov; Volkmar Müller; Peter Barrett-Lee; Sunil Verma; Ann Knoop; Giuseppe Curigliano; Vladimir Semiglazov; Guillermo López-Vivanco; Valerie Jenkins; Nana Scotto; Stuart Osborne; Lesley Fallowfield
Journal:  Lancet Oncol       Date:  2013-08-19       Impact factor: 41.316

8.  ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)†.

Authors:  F Cardoso; A Costa; L Norton; E Senkus; M Aapro; F André; C H Barrios; J Bergh; L Biganzoli; K L Blackwell; M J Cardoso; T Cufer; N El Saghir; L Fallowfield; D Fenech; P Francis; K Gelmon; S H Giordano; J Gligorov; A Goldhirsch; N Harbeck; N Houssami; C Hudis; B Kaufman; I Krop; S Kyriakides; U N Lin; M Mayer; S D Merjaver; E B Nordström; O Pagani; A Partridge; F Penault-Llorca; M J Piccart; H Rugo; G Sledge; C Thomssen; L Van't Veer; D Vorobiof; C Vrieling; N West; B Xu; E Winer
Journal:  Ann Oncol       Date:  2014-09-18       Impact factor: 32.976

9.  Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study.

Authors:  X Pivot; J Gligorov; V Müller; G Curigliano; A Knoop; S Verma; V Jenkins; N Scotto; S Osborne; L Fallowfield
Journal:  Ann Oncol       Date:  2014-07-28       Impact factor: 32.976

10.  Use of a population pharmacokinetic approach for the clinical development of a fixed-dose subcutaneous formulation of trastuzumab.

Authors:  F Hourcade-Potelleret; A Lemenuel-Diot; C McIntyre; M Brewster; B Lum; B Bittner
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2014-01-02
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  14 in total

Review 1.  Subcutaneous Trastuzumab: A Review in HER2-Positive Breast Cancer.

Authors:  Young-A Heo; Yahiya Y Syed
Journal:  Target Oncol       Date:  2019-12       Impact factor: 4.493

2.  Discovering Novel Small Molecule Compound for Prevention of Monoclonal Antibody Self-Association.

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3.  An Open-Label, Multinational, Multicenter, Phase IIIb Study with Subcutaneous Administration of Trastuzumab in Patients with HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction.

Authors:  İrfan Cicin; Mohammed Oukkal; Hassen Mahfouf; Amel Mezlini; Blaha Larbaoui; Slim Ben Ahmed; Hassan Errihani; Khalid Alsaleh; Rhizlane Belbaraka; Perran Fulden Yumuk; Burce Goktas; Mustafa Özgüroğlu
Journal:  Eur J Breast Health       Date:  2021-12-30

4.  Cost minimization analysis of treatment with intravenous or subcutaneous trastuzumab in patients with HER2-positive breast cancer in Spain.

Authors:  G Lopez-Vivanco; J Salvador; R Diez; D López; M De Salas-Cansado; B Navarro; J De la Haba-Rodríguez
Journal:  Clin Transl Oncol       Date:  2017-06-02       Impact factor: 3.405

Review 5.  Current Therapies for Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Patients.

Authors:  Alexey A Larionov
Journal:  Front Oncol       Date:  2018-04-03       Impact factor: 6.244

6.  Patient and physician preferences for attributes of biologic medications for severe asthma.

Authors:  Heather L Gelhorn; Zaneta Balantac; Christopher S Ambrose; Yen N Chung; Brian Stone
Journal:  Patient Prefer Adherence       Date:  2019-07-25       Impact factor: 2.711

7.  Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects.

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Journal:  Clin Transl Sci       Date:  2021-03-25       Impact factor: 4.689

8.  Real-World Data on Health-Related Quality of Life Assessment in Patients With Breast Cancer Receiving Subcutaneous Trastuzumab.

Authors:  John Syrios; Evelina Pappa; Nikolaos Volakakis; Anastasios Grivas; John Alafis; Sofia Manioudaki; Vasiliki Tzouda; Athanasios Korogiannos; Cleopatra Rapti; Nektarios Koufopoulos; Adamantia Nikolaidou; Eleftheria Kanavou; Athanasios Alexopoulos; Anna Koumarianou
Journal:  Breast Cancer (Auckl)       Date:  2018-02-20

Review 9.  Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities.

Authors:  Beate Bittner; Wolfgang Richter; Johannes Schmidt
Journal:  BioDrugs       Date:  2018-10       Impact factor: 5.807

Review 10.  Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!

Authors:  Binita Dutta; Isabelle Huys; Arnold G Vulto; Steven Simoens
Journal:  BioDrugs       Date:  2020-04       Impact factor: 5.807

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