title: A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer.
abstract: Within PrefHer (NCT01401166), patients and healthcare professionals (HCPs) preferred subcutaneous (SC) over intravenous (IV) trastuzumab. We undertook a prospective, observational time and motion study to quantify patients' time in infusion chairs and active HCP time in PrefHer. Patients with HER2-positive early breast cancer received four adjuvant cycles of SC trastuzumab (600 mg fixed dose via SC single-use injection device [SID, Cohort 1] or SC handheld syringe [HHS, Cohort 2]) then four cycles of standard IV trastuzumab or the reverse sequence. Generic case report forms for IV and SC management, both in the treatment room and the drug preparation area, were tailored to reflect center practices. Patient chair time and active HCP time were recorded. We compared pooled Cohort 1 + 2 IV with Cohort 1 SC SID and Cohort 2 SC HHS mean times across eight countries and individually within them utilizing a random intercept generalized linear mixed-effects model. Per session, the SC SID saved a mean of 57 min of patient chair time versus IV (range across countries: 47-86; P < 0.0001); the SC HHS saved 55 min (40-81; P < 0.0001). Active HCP time was reduced by a mean of 13 min per session with the SC SID (range across countries: 4-16; P < 0.0001) and 17 min with the SC HHS (5-28; P < 0.0001) versus IV. SC trastuzumab, delivered via SID or HHS, saved patient chair and active HCP times versus IV infusion, supporting a transition to either SC method.
authors.affiliation: United BioSource Corporation, Barcelona, Spain.
authors.forename: Erwin
authors.initials: E
authors.lastname: De Cock
authors.affiliation: CHU Jean Minjoz, Besançon, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Pivot
authors.affiliation: Department of Gynecology and Obstetrics, Kantonsspital Baden AG, Baden, Switzerland.
authors.forename: Nik
authors.initials: N
authors.lastname: Hauser
authors.affiliation: Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada.
authors.forename: Sunil
authors.initials: S
authors.lastname: Verma
authors.affiliation: United BioSource Corporation, Hammersmith, United Kingdom.
authors.forename: Persefoni
authors.initials: P
authors.lastname: Kritikou
authors.affiliation: F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: Douglas
authors.initials: D
authors.lastname: Millar
authors.affiliation: Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Ann
authors.initials: A
authors.lastname: Knoop
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics*; D013996:Time and Motion Studies; D000068878:Trastuzumab / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: Breast cancer; human epidermal growth factor receptor 2; subcutaneous; time factors; trastuzumab