| Title: |
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 |
| Authors: |
Pivot, X.; Gligorov, J.; Müller, V.; Curigliano, G.; Knoop, A.; Verma, S.; Jenkins, V.; Scotto, N.; Osborne, S.; Fallowfield, L.; Fallowfield, Lesley; Jenkins, Valerie; Kilkerr, Justine; Langridge, Carolyn; Monson, Kathryn; Jakobsen, Erik Hugger; Nielsen, Mette Holck; Linnet, Soeren; Knoop, Ann; Pivot, Xavier; Bonnefoi, Herve; Mousseau, Mireille; Zelek, Laurent; Bourgeois, Hugues; Lefeuvre, Claudia Plesse; Bachelot, Thomas; Petit, Thierry; Brain, Etienne; Levy, Christelle; Gligorov, Joseph; Augustin, Doris; Graf, Heiko; Heinrich, Georg; Kroening, Hendrik; Kuemmel, Sherko; Müller, Volkmar; Overkamp, Friedrich; Park-Simon, Tjoung-Won; Schmidt, Marcus; Perlova-Griff, Lidia; Wolf, Christopher; Colleoni, Marco; Ballestrero, Alberto; Bernardo, Antonio; Ribecco, Angela Stefania; Gianni, Luca; Curigliano, Giuseppe; Brewczynska, Elzbieta; Jassem, Jacek; Shirinkin, Vadim; Manikhas, Alexey; Dvornichenko, Victoria; Lichinitser, Mikhail; Semiglazov, Vladimir; Mukhametshina, Guzel; Bulavina, Irina; Arranz, Enrique Espinosa; Ocon, Francisco Carabantes; Vivanco, Guillermo López; Bofill, Javier Salvador; Quintela, Ignacio Porras; Muñoz, Alfonso Sanchez; Pérez, Yolanda Fernández; Espinosa, Javier Cassinello; Alvarez, JoséValero; del Prado, Rodrigo Lastra; Merino, Luis De La Cruz; García, JoséManuel Pérez; Frances, Santos Enrech; Edlund, Per; Norberg, Bengt; Wennstig, Anna-Karin; Lind, Pehr; Hauser, Nik; Tausch, Christoph; Camci, Celalettin; Arpaci, Fikret; Abali, Huseyin; Uslu, Ruchan; Tahir, Saad; Wheatley, Duncan; Chan, Stephen; Barrett-Lee, Peter; McAdam, Karen; Simcock, Richard; Burcombe, Russell; El-Maraghi, Robert; Califaretti, Nadia; Spadafora, Silvana; Sehdev, Sandeep; Sami, Amer; Verma, Sunil; on behalf of the PrefHer Study Group |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2014 |
| Collection: |
HighWire Press (Stanford University) |
| Subject Terms: |
original articles |
| Description: |
BackgroundPatients 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 methodsPatients 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. ResultsA 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 x 2 2); 16 patients (3.3%) in each period experienced grade 3 events; none were grade 4/5. ConclusionsPrefHer 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 ... |
| Document Type: |
text |
| File Description: |
text/html |
| Language: |
English |
| Relation: |
http://annonc.oxfordjournals.org/cgi/content/short/25/10/1979; http://dx.doi.org/10.1093/annonc/mdu364 |
| DOI: |
10.1093/annonc/mdu364 |
| Availability: |
http://annonc.oxfordjournals.org/cgi/content/short/25/10/1979; https://doi.org/10.1093/annonc/mdu364 |
| Rights: |
Copyright (C) 2014, European Society for Medical Oncology |
| Accession Number: |
edsbas.6F7BFC4F |
| Database: |
BASE |