Premium
Phase III study to evaluate patient’s preference of subcutaneous versus intravenous trastuzumab in HER2‐positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012‐07)
Author(s) -
Ciruelos Eva M.,
Montaño Alvaro,
Rodríguez César A.,
GonzálezFlores Encarnación,
Lluch Ana,
Garrigós Laia,
Quiroga Vanesa,
Antón Antonio,
Malón Diego,
Chacón Jose I.,
Velasco Montserrat,
GonzalezCortijo Lucía,
Jolis Laura,
Echarri María J.,
Muñoz Montse,
Pascual Tomás,
Amigo Yolanda,
Casas Maribel,
Carrasco Eva,
Casas Ana
Publication year - 2020
Publication title -
european journal of cancer care
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.849
H-Index - 67
eISSN - 1365-2354
pISSN - 0961-5423
DOI - 10.1111/ecc.13253
Subject(s) - medicine , vial , trastuzumab , metastatic breast cancer , adverse effect , breast cancer , cancer , surgery , chemistry
Abstract Objective We compared patients’ preferences for intravenous (IV‐t) versus subcutaneous (SC‐t) trastuzumab administration. Methods Phase III, open‐label, multicentre study in HER2‐positive metastatic breast cancer. Patients were receiving IV‐t for at least 4 months without progression. Randomisation was 1:1 to administer 2 cycles of SC‐t with vial followed by 2 cycles with single injection device (SID) or the reverse sequence (600mg SC‐t every 3 weeks for 4 cycles). Primary objective: patients’ preference for IV‐t versus SC‐t; secondary objectives: patients’ preference for vial versus SID, healthcare professional (HCP) preference and safety. Results We randomised 166 patients in 26 sites. Median number of previous lines of chemotherapy and/or endocrine therapy was 1 (1–7). Median duration of prior IV‐t was 1.8 years (0.3–14). Of the159 patients completing the questionnaires, 86.2% preferred SC‐t, 6.9% preferred IV‐t, and 6.9% had no preference. Patients preferred SID (59.2%) over vial (26.3%). Most (87.2%) HCP preferred SC‐t of whom 51.3% and 28.2% preferred SID and vial respectively. Related adverse events included G1‐2 injection site reactions in 18 patients (10.8%), G1 pain in 8 (4.8%), G1‐2 allergic reaction in 2 (1.2%), one G3 heart failure and 1 G2 ejection fraction decrease. Conclusions SC‐t is preferred with no safety impact.