Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study.

Abstract

HannaH (NCT00950300) and PrefHer (NCT01401166) studies validated the subcutaneous (H-s.c.) formulation of trastuzumab as effective and safe as intravenous (H-i.v.) and highly preferred by patients in early breast cancer. The present randomised MetaspHer trial (NCT01810393) is the first study assessing patient's preference in metastatic setting.

METHODS:

Patients with HER2-positive metastatic breast cancer who completed a first line chemotherapy with trastuzumab and achieved a long-term response lasting more than 3 years were randomised to receive 3 cycles of 600-mg fixed-dose adjuvant H-s.c., followed by 3 cycles of standard H-i.v., or the reverse sequence. Primary end-point was overall preference for H-s.c. or H-i.v. at cycle six, assessed by Patient Preference Questionnaire (PPQ). Secondary end-points included healthcare professional (HCP) satisfaction; safety and tolerability; quality of life.

RESULTS:

Hundred and thirteen patients were randomised and treated. H-s.c. was preferred by 79/92 evaluable intent-to-treat patients (85.9%, 95% confidence interval [CI; 78.8-93.0]; p < 0.001), 13/92 preferred H-i.v. (14.1%, 95% CI [7.0-21.3]). HCPs were most satisfied with H-s.c. (56/88 available data, 63.6%, [53.6-73.7]). On the safety population, adverse events occurred in 73 (67.6%) and 49 (44.1%) patients during the H-s.c. and H-i.v. periods, respectively; 7 (6.5%) and 4 (3.6%) were grade ≥ III, 3 (2.8%) and 2 (1.8%) were serious.

CONCLUSION:

The safety was consistent with the known H-i.v. and H-s.c. profiles without safety concern raised. Definitively, patients preferred H-s.c. as reported in early stage by PrefHer study.

• Authors: X Pivot, J P Spano, M Espie, P Cottu, C Jouannaud, V Pottier, L Moreau, J M Extra, A Lortholary, P Rivera, D Spaeth, H Attar-Rabia, C Benkanoun, L Dima-Martinez, N Esposito, J Gligorov
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 82 Pg. 230-236 (09 2017) ISSN: 1879-0852 [Electronic] England
• PMID: 28648618 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2017 Elsevier Ltd. All rights reserved.

Chemical References

• Antineoplastic Agents
• Trastuzumab

Topics

• Administration, Intravenous
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage)
• Breast Neoplasms (drug therapy, secondary)
• Female
• Humans
• Injections, Subcutaneous
• Middle Aged
• Patient Preference
• Quality of Life
• Trastuzumab (administration & dosage)