title: 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.
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.
  
  
  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.
  
  
  BACKGROUND
  NCT01401166.
authors: Department of Medical Oncology, University Hospital Jean Minjoz, Besançon. Electronic address: xavier.pivot@univ-fcomte.fr.
authors: X
authors: X
authors: Pivot
authors: Medical Oncology Department, APHP Hôpital Tenon, Paris; UPMC, Institut Universitaire de Cancérologie, Paris, France.
authors: J
authors: J
authors: Gligorov
authors: Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors: V
authors: V
authors: Müller
authors: Early Drug Development for Innovative Therapies Division, European Institute of Oncology, Milan, Italy.
authors: G
authors: G
authors: Curigliano
authors: Department of Oncology, Copenhagen University Hospital, Copenhagen, Denmark.
authors: A
authors: A
authors: Knoop
authors: Division of Medical Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.
authors: S
authors: S
authors: Verma
authors: Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Falmer, UK.
authors: V
authors: V
authors: Jenkins
authors: Global Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors: N
authors: N
authors: Scotto
authors: Global Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors: S
authors: S
authors: Osborne
authors: Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Falmer, UK.
authors: L
authors: L
authors: Fallowfield
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D015331:Cohort Studies; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: HER2/neu; breast cancer; patient preference; subcutaneous; trastuzumab