323PPATIENT SATISFACTION WITH SELF-ADMINISTRATION OF SUBCUTANEOUS (SC) TRASTUZUMAB VIA SINGLE-USE INJECTION DEVICE (SID) IN THE INTERNATIONAL, RANDOMISED PREFHER STUDY

ABSTRACT Aim: Patients in PrefHer (NCT01401166) preferred SC trastuzumab (Herceptin® SC) via healthcare professional (HCP)-administered SID over the intravenous (IV) formulation. The design of the SID makes it suitable for self-administration by patients; therefore, patient satisfaction with SID self-administration was assessed as a pre-defined exploratory endpoint. We also assessed safety in cycles where patients self-administered. Methods: All patients received four adjuvant cycles of SC trastuzumab via an SID administered by HCPs, followed by four cycles of IV trastuzumab or vice versa as part of their 18 standard cycles, including pre-enrolment IV. Those patients with two or more cycles remaining had the option to self-administer SC trastuzumab via the SID in the clinic. One cycle was used by trial staff to train the patients, who were then given a guide and video. Satisfaction was assessed by a questionnaire after first and last self-administrations. There was no maximum number of self-administrations. Adverse events (AEs) and serious AEs (SAEs) were reported according to NCI-CTCAE V4 and ICH E2A. Results: Two hundred and forty-four patients were randomised and 35 successfully self-administered: 32 patients once and three patients twice. Thirty-seven questionnaires were completed by 34 patients (three patients completed two questionnaires). Twenty-five of 34 patients (74%) strongly agreed that the first self-administration was satisfactory. An additional eight patients (24%) agreed that the experience was satisfactory and one patient (3%) was unsure. Table 1 shows the AE profile. The most frequent AE was injection site pain (two patients). Patients, n (%)a N = 35 AEsb 6 (17) Grade 1 4 (11) 2 4 (11) 3–5 0 Related to study drug 2 (6) Leading to study drug discontinuation 0 SAEs 0 aCould be counted once per grade but more than once overall bSix after one self-administration, two after two Conclusions: In this exploratory analysis of PrefHer, patients were satisfied with self-administration of SC trastuzumab via the SID in the clinic and it was well tolerated, although the number of cycles was limited. Home administration is a possible future option. Disclosure: S. Verma: Membership on an advisory board: F. Hoffmann-La Roche Ltd; P.J. Barrett-Lee: Membership on an advisory board: F. Hoffmann-La Roche Ltd for trastuzumab; L. Fallowfield: Membership on an advisory board: F. Hoffman-La Roche Ltd. Corporate-sponsored research: F. Hoffman-La Roche Ltd to conduct the PrefHer study; A. Knoop: Membership on an advisory board: F. Hoffmann-La Roche Ltd (Nov 2013); Corporate-sponsored research: F. Hoffmann-La Roche Ltd (PI in the Danish PrefHer study and co-investigator in APHINITY and VELVET); V. Muller: Membership on an advisory board: F. Hoffmann-La Roche Ltd; E. Brewczynska: Corporate-sponsored research: Poland (PI of the Polish PrefHer study and co-investigator of the APHINITY, MARIANNE and EMILIA studies), R. El-Maraghi: Membership on an advisory board: Amgen, Boehringer Ingelheim, Celgene, Lilly, Novartis, Pfizer, F. Hoffmann-La Roche Ltd; Z. Machackova: Other substantive relationships: Employee of F. Hoffmann-La Roche Ltd; S. Osborne: Other substantive relationships: Employee of F. Hoffmann-La Roche Ltd; X. Pivot: Membership on an advisory board: F. Hoffmann-La Roche Ltd, GlaxoSmithKline, Teva, Pierre Fabre. All other authors have declared no conflicts of interest.