Abstract P4-21-16: Phase III trial to evaluate patient´s preference for subcutaneous versus intravenous trastuzumab administration in patients with HER2 positive advanced breast cancer (ABC) under IV trastuzumab (IV-t) treatment for at least 4 months. ChangHER-SC study (GEICAM/2012-07)
Authors: Ciruelos EM , Montaño Á , Rodríguez CA , González-Flores E , Lluch A , Garrigós L , Quiroga V , Antón A , Malón D , Chacón JI , Velasco M , Gonzalez-Cortijo L , Jolis L , Pascual T , Amigo Y , Casas M , Cámara MC , Carrasco E , Casas A 
Published: March 2017

Abstract
Background: Patients with HER2-positive ABC, receive anti-HER2 treatment for several months or even years. IV-t is administered weekly or 3-weekly, mandating patients to visit the hospital on a regular basis to receive infusions. This has inconveniences for patients and increase treatment costs. Subcutaneous administration could improve convenience of trastuzumab therapy. This study was designed to evaluate patient's preference for IV-t or SC trastuzumab (SC-t) in ABC patients.
Methods:This is a phase III, open label, multicenter study inpatients with HER2 positive ABC, receiving IV-t for at least 4 months and without evidence of disease progression. Patients received 600 mg of SC-t, either from a vial or from a single injection device (SID), every 3 weeks for 4 cycles. Before starting SC-t, patients received an additional IV-t cycle. Patients were randomized 1:1 to arm A, receiving 2 cycles of SC-t with vial followed by 2 cycles with SID or arm B, receiving the opposite sequence. After cycle 4, patients decided to continue with IV-t or SC-t till disease progression. Stratification criteria were the associated therapy (Chemotherapy, Hormone-therapy or none) and its administration route (IV, oral or none). Patients completed a questionnaire of experiences and preferences at three time points: before starting SC-t, after cycle 2 and after cycle 4. Health Care Professionals completed a satisfaction questionnaire every 5 patients. The primary objective was to evaluate patient´s preference for IV-t or SC-t (after cycle 2) and, secondary objectives were, to evaluate patient´s preference between the two SC-t administrations (vial or SID) after cycle 4, Health Care Professional satisfaction, associated costs of the administration options (Time and Motion pharmacoeconomic study) and safety.
Results: From September-13 to July-15, 166 patients were randomized (81 arm A, 85 arm B) in 26 Spanish sites from GEICAM. Median age was 60 years (35-93), 88% of patients were postmenopausal and 123 and 42 had an ECOG PS of 0 and 1, respectively. The median duration of prior IV-t for ABC was 1.8 years (range: 0.3-14). Patients received a median of 2 previous lines of Chemotherapy and/or Hormone-therapy (range: 1-9). Twenty patients were receiving pertuzumab at inclusion. According to patient questionnaires completed after cycle 2, 137 patients preferred the SC-t (66 arm A, 71 arm B), 11 the IV-t (6 arm A, 5 arm B), 11 didn't have a preference (4 arm A, 7 arm B), and 7 didn't answer (3 progressed, 2 withdrew participation before cycle 2 and 2 unknown reason). Three of the 11 patients choosing IV-t were receiving IV treatment as accompanying therapy; after cycle 4 five of these 11 patients finally continued with SC-t, 5 with IV-t and 1 progressed. From the 11 patients without any preference 7 received SC-t, 2 receive IV-t and 2 progressed; from the 137 patients preferring SC-t, 125 actually received it, 3 received IV-t and 9 progressed.
Conclusions: Our study shows that 82.5% of patients preferred the SC-t over the IV-t. Treatment choice was not influenced by the accompanying therapy.
Citation Format: Ciruelos EM, Montaño Á, Rodríguez CA, González-Flores E, Lluch A, Garrigós L, Quiroga V, Antón A, Malón D, Chacón JI, Velasco M, Gonzalez-Cortijo L, Jolis L, Pascual T, Amigo Y, Casas M, Cámara MC, Carrasco E, Casas A. Phase III trial to evaluate patient´s preference for subcutaneous versus intravenous trastuzumab administration in patients with HER2 positive advanced breast cancer (ABC) under IV trastuzumab (IV-t) treatment for at least 4 months. ChangHER-SC study (GEICAM/2012-07) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-21-16.