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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

2014; Elsevier BV; Volume: 25; Issue: 10 Linguagem: Inglês

10.1093/annonc/mdu364

1569-8041

Xavier Pivot, Joseph Gligorov, Volkmar Müller, Giuseppe Curigliano, Ann Knoop, Sunil Verma, Valerie Jenkins, Nana Scotto, Stuart Osborne, Lesley Fallowfield, Lesley Fallowfield, Valerie Jenkins, Justine Kilkerr, C. Langridge, Kathryn Monson, Erik Jakobsen, Mette H. Nielsen, Soeren Linnet, Ann Knoop, Xavier Pivot, Hervé Bonnefoi, Mireille Mousseau, Laurent Zelek, Hugues Bourgeois, Claudia Lefeuvre, Thomas Bachelot, Thierry Petit, Étienne Brain, Christelle Lévy, Joseph Gligorov, Doris Augustin, Heiko Graf, Georg Heinrich, Hendrik Kroening, Sherko Küemmel, Volkmar Müller, Friedrich Overkamp, Tjoung‐Won Park‐Simon, Marcus Schmidt, Lidia Perlova-Griff, Christopher Wolf, Marco Colleoni, Alberto Ballestrero, Antônio Bernardo, Angela Stefania Ribecco, Luca Gianni, Giuseppe Curigliano, Elżbieta Brewczyńska, Jacek Jassem, Vadim Shirinkin, Alexey Manikhas, В. В. Дворниченко, Mikhail Lichinitser, Semiglazov Vf, Guzel Mukhametshina, Irina Bulavina, Enrique Espinosa, Francisco Carabantes Ocón, Guillermo López-Vivanco, Javier Salvador Bofill, Ignacio Porras Quintela, Alfonso Sánchez Muñoz, Yolanda Fernández Pérez, Javier Espinosa, Jose Alvarez, Rodrigo Lastra del Prado, LuisLa Cruz De Merino, José Manuel Pérez García, Santos Enrech Francés, Per Edlund, Bengt Norberg, Anna-Karin Wennstig, Pehr Lind, Nik Hauser, Christoph Tausch, Celalettin Camcı, Fikret Arpacı, Hüseyin Abalı, Rüçhan Uslu, Saad Tahir, Duncan Wheatley, Stephen Chan, Peter Barrett‐Lee, Karen McAdam, Richard Simcock, Russell Burcombe, Robert H. El-Maraghi, Nadia Califaretti, Silvana Spadafora, Sandeep Sehdev, Amer Sami, Sunil Verma,

Breast Lesions and Carcinomas

ABSTRACT Background 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 and methods 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. Results 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; P < 0.0001; 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 ( P < 0.05; 2 × 2 χ 2 ); 16 patients (3.3%) in each period experienced grade 3 events; none were grade 4/5. Conclusions 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. Clinicaltrials.gov registration number NCT01401166.