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Ann Oncol. 2014 Oct;25(10):1979-87. doi: 10.1093/annonc/mdu364. Epub 2014 Jul 28.

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.

Author information

  • 1Department of Medical Oncology, University Hospital Jean Minjoz, Besançon xavier.pivot@univ-fcomte.fr.
  • 2Medical Oncology Department, APHP Hôpital Tenon, Paris UPMC, Institut Universitaire de Cancérologie, Paris, France.
  • 3Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • 4Early Drug Development for Innovative Therapies Division, European Institute of Oncology, Milan, Italy.
  • 5Department of Oncology, Copenhagen University Hospital, Copenhagen, Denmark.
  • 6Division of Medical Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.
  • 7Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Falmer, UK.
  • 8Global Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Abstract

BACKGROUND:

Patients with HER2-positive early breast cancer (EBC) preferred subcutaneous (s.c.) trastuzumab, delivered via single-use injection device (SID), over the intravenous (i.v.) formulation (Cohort 1 of the PrefHer study: NCT01401166). Here, we report patient preference, healthcare professional satisfaction, and safety data pooled from Cohort 1 and also Cohort 2, where s.c. trastuzumab was delivered via hand-held syringe.

PATIENTS AND METHODS:

Patients were randomized to receive four adjuvant cycles of 600 mg fixed-dose s.c. trastuzumab followed by four cycles of standard i.v. trastuzumab, or vice versa. The primary endpoint was overall preference proportions for s.c. or i.v., assessed by patient interviews in the evaluable ITT population.

RESULTS:

A total of 245 patients were randomized to receive s.c. followed by i.v. and 243 received i.v. followed by s.c. (evaluable ITT populations: 235 and 232 patients, respectively). s.c. was preferred by 415/467 [88.9%; 95% confidence interval (CI) 85.7-91.6; P < 0.0001; two-sided test against null hypothesis of 65% s.c. preference]; 45/467 preferred i.v. (9.6%; 95% CI 7-13); 7/467 indicated no preference (1.5%; 95% CI 1-3). Clinician-reported adverse events occurred in 292/479 (61.0%) and 245/478 (51.3%) patients during the pooled s.c. and i.v. periods, respectively (P < 0.05; 2 × 2 χ(2)); 16 patients (3.3%) in each period experienced grade 3 events; none were grade 4/5.

CONCLUSIONS:

PrefHer revealed compelling and consistent patient preferences for s.c. over i.v. trastuzumab, regardless of SID or hand-held syringe delivery. s.c. was well tolerated and safety was consistent with previous reports, including the HannaH study (NCT00950300). No new safety signals were identified compared with the known i.v. profile in EBC. PrefHer and HannaH confirm that s.c. trastuzumab is a validated and preferred option over i.v. for improving patients' care in HER2-positive breast cancer.

CLINICALTRIALSGOV REGISTRATION NUMBER:

NCT01401166.

© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

KEYWORDS:

HER2/neu; breast cancer; patient preference; subcutaneous; trastuzumab

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