1. Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study
- Author
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Thomas Bachelot, Alberto Ballestrero, Marco Colleoni, José Valero Alvarez, Amer Sami, Celalettin Camci, Rodrigo Lastra del Prado, Luis De La Cruz Merino, Antonio Bernardo, Peter Barrett-Lee, Yolanda Fernández Pérez, Vladimir Semiglazov, Thierry Petit, Mette Holck Nielsen, C. Langridge, Guillermo López Vivanco, Nik Hauser, Ignacio Porras Quintela, José Manuel Pérez García, Anna-Karin Wennstig, Victoria Dvornichenko, Erik Jakobsen, Guzel Mukhametshina, Heiko Graf, V. Jenkins, Mireille Mousseau, Alfonso Sanchez Muñoz, Pehr Lind, Irina Bulavina, Alexey Manikhas, Bengt Norberg, Xavier Pivot, Per Edlund, Sandeep Sehdev, Valerie Jenkins, Santos Enrech Frances, Nadia Califaretti, V. Müller, G. Curigliano, Duncan Wheatley, Stephen L. Chan, Enrique Espinosa Arranz, S. Osborne, Soeren Linnet, Nana Scotto, J. Gligorov, Volkmar Müller, Tjoung-Won Park-Simon, Karen McAdam, Ann Knoop, Giuseppe Curigliano, X. Pivot, Justine Kilkerr, Georg Heinrich, L. Fallowfield, Francisco Carabantes Ocon, Christopher Wolf, Robert El-Maraghi, Hugues Bourgeois, Christelle Levy, Luca Gianni, Russell Burcombe, Vadim Shirinkin, Huseyin Abali, Etienne Brain, Christoph Tausch, Lidia Perlova-Griff, Claudia Plesse Lefeuvre, Joseph Gligorov, Mikhail Lichinitser, Friedrich Overkamp, S. Verma, Kathryn Monson, Angela Stefania Ribecco, Doris Augustin, Lesley Fallowfield, Saad Tahir, Javier Cassinello Espinosa, Marcus Schmidt, Jacek Jassem, Laurent Zelek, Ruchan Uslu, Richard Simcock, Sherko Kuemmel, Javier Salvador Bofill, A. Knoop, Hervé Bonnefoi, Fikret Arpaci, Silvana Spadafora, Sunil Verma, Hendrik Kroening, and Elżbieta Brewczynska
- Subjects
Adult ,Male ,medicine.medical_specialty ,Receptor, ErbB-2 ,Injections, Subcutaneous ,medicine.medical_treatment ,RC0280.B8 ,Population ,Breast Neoplasms ,Antibodies, Monoclonal, Humanized ,Disease-Free Survival ,HER2/neu ,Cohort Studies ,RC0254 ,RM0147 ,Breast cancer ,Trastuzumab ,Internal medicine ,Clinical endpoint ,medicine ,Humans ,skin and connective tissue diseases ,Infusions, Intravenous ,Adverse effect ,education ,neoplasms ,Aged ,education.field_of_study ,biology ,business.industry ,Hematology ,Middle Aged ,medicine.disease ,Surgery ,Treatment Outcome ,Oncology ,Cohort ,biology.protein ,Female ,business ,Adjuvant ,medicine.drug - Abstract
Patients with HER2-positive early breast cancer (EBC) preferred subcutaneous (s.c.) trastuzumab, delivered via single-use injection device (SID), over the intravenous (i.v.) formulation (Cohort 1 of the PrefHer study: NCT01401166). Here, we report patient preference, healthcare professional satisfaction, and safety data pooled from Cohort 1 and also Cohort 2, where s.c. trastuzumab was delivered via hand-held syringe.Patients were randomized to receive four adjuvant cycles of 600 mg fixed-dose s.c. trastuzumab followed by four cycles of standard i.v. trastuzumab, or vice versa. The primary endpoint was overall preference proportions for s.c. or i.v., assessed by patient interviews in the evaluable ITT population.A total of 245 patients were randomized to receive s.c. followed by i.v. and 243 received i.v. followed by s.c. (evaluable ITT populations: 235 and 232 patients, respectively). s.c. was preferred by 415/467 [88.9%; 95% confidence interval (CI) 85.7-91.6; P0.0001; two-sided test against null hypothesis of 65% s.c. preference]; 45/467 preferred i.v. (9.6%; 95% CI 7-13); 7/467 indicated no preference (1.5%; 95% CI 1-3). Clinician-reported adverse events occurred in 292/479 (61.0%) and 245/478 (51.3%) patients during the pooled s.c. and i.v. periods, respectively (P0.05; 2 × 2 χ(2)); 16 patients (3.3%) in each period experienced grade 3 events; none were grade 4/5.PrefHer revealed compelling and consistent patient preferences for s.c. over i.v. trastuzumab, regardless of SID or hand-held syringe delivery. s.c. was well tolerated and safety was consistent with previous reports, including the HannaH study (NCT00950300). No new safety signals were identified compared with the known i.v. profile in EBC. PrefHer and HannaH confirm that s.c. trastuzumab is a validated and preferred option over i.v. for improving patients' care in HER2-positive breast cancer.NCT01401166.
- Published
- 2014
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