Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study. (September 2017)

• Record Type: Journal Article
• Authors: Pivot, X.; Spano, J.P.; Espie, M.; Cottu, P.; Jouannaud, C.; Pottier, V.; Moreau, L.; Extra, J.M.; Lortholary, A.; Rivera, P.; Spaeth, D.; Attar-Rabia, H.; Benkanoun, C.; Dima-Martinez, L.; Esposito, N.; Gligorov, J.
• Is Part Of: European journal of cancer. Volume 82(2017)
• Page Start: 230
• Page End: 236
• Publication Date: 2017-09
• Subjects: Trastuzumab -- Subcutaneous -- Preference -- Metastatic breast cancer; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2017.05.009
• Languages: English
• ISSNs: 0959-8049

Abstract

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. Highlights: First assessment of preference for subcutaneous versus intravenous trastuzumab at metastatic setting. Patient's preference for subcutaneous formulation was established. Safety was consistent with well known toxicity profile of trastuzumab.