323P - Patient satisfaction with self-administration of subcutaneous (SC) trastuzumab via single-use injection device (SID) in the international, randomis...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Early Stage
Presenter Sunil Verma
Citation Annals of Oncology (2014) 25 (suppl_4): iv85-iv109. 10.1093/annonc/mdu327
Authors S. Verma1, P.J. Barrett-Lee2, G. Curigliano3, L. Fallowfield4, A. Knoop5, V. Müller6, E. Brewczynska7, R. El-Maraghi8, G. Lopez-Vivanco9, S. Sehdev10, Z. Machackova11, S. Osborne11, X. Pivot12
  • 1Division Of Medical Oncology, Sunnybrook Odette Cancer Center, M4N 3M5 - Toronto/CA
  • 2Velindre Nhs Trust, Velindre Cancer Centre, Cardiff/GB
  • 3Early Drug Development For Innovative Therapies Division, European Institute of Oncology, Milan/IT
  • 4Sussex Health Outcomes Research & Education In Cancer (shore-c), Brighton and Sussex Medical School, University of Sussex, Brighton/GB
  • 5Department Of Oncology, Copenhagen University Hospital, Copenhagen/DK
  • 6Department Of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg/DE
  • 7Department Of Breast Cancer And Reconstructive Surgery, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw/PL
  • 8Department Of Oncology, Royal Victoria Regional Health Centre, Barrie/CA
  • 9Department Of Oncology, University Hospital Cruces, San Vicente de Barakaldo, Vizcaya/ES
  • 10Oncology, William Osler Health System Brampton Civic Hospital, CA-L7M 4A4 - Brampton/CA
  • 11Global Medical Affairs, F. Hoffmann-La Roche Ltd, Basel/CH
  • 12Chemotherapy – Oncology, CHU Jean Minjoz, 25030 - Besançon/FR

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. Müller: 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.