274P - Patient preference of trastuzumab administration (SC versus IV) in HER2-positive metastatic breast cancer: Results of the randomised Metaspher study

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Breast Cancer
Presenter Xavier Pivot
Citation Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365
Authors X. Pivot1, J. Spano2, E. Marc3, P. Cottu4, C. Jouannaud5, V. Pottier6, L. Moreau7, J. Extra8, A. Lortholary9, P. Rivera10, D. Spaeth11, H. Attar-Rabia12, C. Benkamoun12, L. Dima-Martinez12, N. Esposito13, J. Gligorov14
  • 1Oncology, CHU Besançon, Hôpital Jean Minjoz, 25000 - Besançon/FR
  • 2Medical Oncology, Pitié-Salpêtrière Hospital, 75013 - Paris/FR
  • 3Oncology, Hôpital St. Louis, Paris/FR
  • 4Medical Oncology, Institut Curie, 75248 - Paris/FR
  • 5Oncology, Institut Jean Godinot, Reims/FR
  • 6Oncology, Centre Léonard de Vinci, Dechy/FR
  • 7Oncology, Pole Sante Republique, Clermont-Ferrand/FR
  • 8Oncologie Médicale, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 9Oncology, Centre Catherine de Sienne, Nantes/FR
  • 10Oncology, Centre Claudius-Regaud, Toulouse/FR
  • 11Oncology, Centre d’Oncologie de Gentilly, 54000 - Nancy/FR
  • 12Clinical Research, laboratoire Roche, Boulogne-Billancourt/FR
  • 13Statistical Research Department, laboratoire Roche, Boulogne-Billancourt/FR
  • 14Medical Oncology Department, Assistance Publique Hôpitaux de Paris – Tenon, Paris/FR

Abstract

Background

HANNAH (NCT00950300) and PREFHER (NCT01401166) international, randomised studies validated the subcutaneous (SC) formulation of trastuzumab as effective and safe as intravenous (IV) and highly preferred by patients in early breast cancer. The present randomized Metaspher trial (NCT 01810393) assessed patient's preference in metastatic setting.

Methods

Patients with HER2-positive metastatic breast cancer who completed a first line chemotherapy with trastuzumab (IV) and achieved a long term response lasting more than 3 years were randomised to receive 3 cycles of 600 mg fixed-dose adjuvant trastuzumab SC, followed by 3 cycles of standard IV, or the reverse sequence. Primary endpoint was overall preference for SC or IV at cycle 6, assessed by Patient Preference Questionnaire (PPQ). Secondary endpoints included healthcare professional (HCP) satisfaction, assessed by questionnaire; safety and tolerability, assessed by NCI-CTCAE v4.0; quality of life assessed by QLQ C30 questionnaire. The modified-Intent-To-Treat population (m-ITT) included patients who received both routes of administration and who completed the last question of PPQ. The safety population included all enrolled patients who received at least one dose of treatment.

Results

113 patients were randomised. SC was preferred by 79/92 evaluable m-ITT patients (85.9%, 95% CI [78.8;93.0]; p 

Conclusions

Patients preferred trastuzumab SC. The safety profile was consistent with the known IV profile with no safety concerns raised. Next step will assess the follow up of this cohort of long responder patient with metastatic breast cancer.

Clinical trial identification

NCT 01810393

Legal entity responsible for the study

Roche

Funding

Roche

Disclosure

X. Pivot: consultant for Roche Amgen Novartis Pierre Fabre Eisai. J-P. Spano: Consultant for Roche.

E. Marc, D. Spaeth: Roche. H. Attar-Rabia, C. Benkamoun, L. Dima-Martinez, N. Esposito: Employed by Roche. J. Gligorov: Consultant for Roche, Novartis, Eisai, Pfizer, Genomic Health. All other authors have declared no conflicts of interest.