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

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

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Abstract

Background: Subcutaneous trastuzumab has shown non-inferior efficacy and a similar pharmacokinetic and safety profile when compared with intravenous trastuzumab in patients with HER2-positive early breast cancer. We assessed patient preference for either subcutaneous or intravenous trastuzumab in the international, randomised PrefHer study. Methods: Eligible patients were women aged 18 years or older with HER2-positive, histologically confirmed primary invasive breast adenocarcinoma, no evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant), an Eastern Cooperative Oncology Group performance status of 0 or 1, and a baseline left-ventricular ejection fraction of 55% or more before the first dose of trastuzumab. Radiotherapy or hormone therapy was allowed. Patients were randomised (randomly permuted blocks of four) to receive four cycles of 600 mg fixed-dose subcutaneous adjuvant trastuzumab via a single-use injection device or hand-held syringe followed by four cycles of standard intravenous trastuzumab, or the reverse sequence. Randomisation was stratified by de-novo versus non-de-novo use of intravenous trastuzumab. The primary endpoint was the proportion of patients indicating an overall preference for subcutaneous or intravenous trastuzumab, assessed by patient interview in the evaluable intention-to-treat (ITT) population (patients who completed both interviews and had at least one administration of both subcutaneous and intravenous trastuzumab). Data collection for PrefHer is ongoing. This study is registered with ClinicalTrials.gov, number NCT01401166. Findings: 124 patients were randomly allocated to receive subcutaneous followed by intravenous trastuzumab, and 124 to receive the reverse sequence. 117 patients in the subcutaneous first group and 119 in the intravenous first group were included in the evaluable ITT population. Subcutaneous trastuzumab via the single-use injection device was preferred by 216 patients (91·5%, 95% CI 87·2-94·7; p

Original languageEnglish
Pages (from-to)962-970
Number of pages9
JournalThe Lancet Oncology
Volume14
Issue number10
DOIs
Publication statusPublished - Sep 2013

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Intravenous Administration
Breast Neoplasms
Trastuzumab
Interviews
Equipment and Supplies
Injections
Patient Preference
Syringes
Random Allocation
Stroke Volume
Population
Adenocarcinoma
Breast
Radiotherapy
Hand
Pharmacokinetics
Hormones
Safety
Drug Therapy

ASJC Scopus subject areas

  • Oncology

Cite this

Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer) : An open-label randomised study. / Pivot, Xavier; Gligorov, Joseph; Müller, Volkmar; Barrett-Lee, Peter; Verma, Sunil; Knoop, Ann; Curigliano, Giuseppe; Semiglazov, Vladimir; López-Vivanco, Guillermo; Jenkins, Valerie; Scotto, Nana; Osborne, Stuart; Fallowfield, Lesley.

In: The Lancet Oncology, Vol. 14, No. 10, 09.2013, p. 962-970.

Research output: Contribution to journalArticle

Pivot, X, Gligorov, J, Müller, V, Barrett-Lee, P, Verma, S, Knoop, A, Curigliano, G, Semiglazov, V, López-Vivanco, G, Jenkins, V, Scotto, N, Osborne, S & Fallowfield, L 2013, 'Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): An open-label randomised study', The Lancet Oncology, vol. 14, no. 10, pp. 962-970. https://doi.org/10.1016/S1470-2045(13)70383-8
Pivot, Xavier ; Gligorov, Joseph ; Müller, Volkmar ; Barrett-Lee, Peter ; Verma, Sunil ; Knoop, Ann ; Curigliano, Giuseppe ; Semiglazov, Vladimir ; López-Vivanco, Guillermo ; Jenkins, Valerie ; Scotto, Nana ; Osborne, Stuart ; Fallowfield, Lesley. / Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer) : An open-label randomised study. In: The Lancet Oncology. 2013 ; Vol. 14, No. 10. pp. 962-970.
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AU - Gligorov, Joseph

AU - Müller, Volkmar

AU - Barrett-Lee, Peter

AU - Verma, Sunil

AU - Knoop, Ann

AU - Curigliano, Giuseppe

AU - Semiglazov, Vladimir

AU - López-Vivanco, Guillermo

AU - Jenkins, Valerie

AU - Scotto, Nana

AU - Osborne, Stuart

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AB - Background: Subcutaneous trastuzumab has shown non-inferior efficacy and a similar pharmacokinetic and safety profile when compared with intravenous trastuzumab in patients with HER2-positive early breast cancer. We assessed patient preference for either subcutaneous or intravenous trastuzumab in the international, randomised PrefHer study. Methods: Eligible patients were women aged 18 years or older with HER2-positive, histologically confirmed primary invasive breast adenocarcinoma, no evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant), an Eastern Cooperative Oncology Group performance status of 0 or 1, and a baseline left-ventricular ejection fraction of 55% or more before the first dose of trastuzumab. Radiotherapy or hormone therapy was allowed. Patients were randomised (randomly permuted blocks of four) to receive four cycles of 600 mg fixed-dose subcutaneous adjuvant trastuzumab via a single-use injection device or hand-held syringe followed by four cycles of standard intravenous trastuzumab, or the reverse sequence. Randomisation was stratified by de-novo versus non-de-novo use of intravenous trastuzumab. The primary endpoint was the proportion of patients indicating an overall preference for subcutaneous or intravenous trastuzumab, assessed by patient interview in the evaluable intention-to-treat (ITT) population (patients who completed both interviews and had at least one administration of both subcutaneous and intravenous trastuzumab). Data collection for PrefHer is ongoing. This study is registered with ClinicalTrials.gov, number NCT01401166. Findings: 124 patients were randomly allocated to receive subcutaneous followed by intravenous trastuzumab, and 124 to receive the reverse sequence. 117 patients in the subcutaneous first group and 119 in the intravenous first group were included in the evaluable ITT population. Subcutaneous trastuzumab via the single-use injection device was preferred by 216 patients (91·5%, 95% CI 87·2-94·7; p

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