@article{6538fc8f812a4609843e77daef4118e5,
title = "Efficacy and safety of pertuzumab and trastuzumab administered in a single infusion bag, followed by vinorelbine: VELVET cohort 2 final results",
abstract = "Background. Cohort 1 demonstrated the applicability of pertuzumab, trastuzumab, and vinorelbine as an alternative first-line treatment regimen for patients with HER2-positive locally advanced or metastatic breast cancer (MBC) who cannot receive docetaxel. Co-infusion of pertuzumab and trastuzumab may reduce clinic time and medical resource utilization. We report results from Cohort 2, in which pertuzumab and trastuzumab were co-infused, followed by vinorelbine. Patients andMethods. During cycle 1, patients with HER2-positive locally advanced orMBC received loading doses of pertuzumab (840 mg) and trastuzumab (8 mg/kg) on consecutive days, followed by vinorelbine (25 mg/m2) on days two and nine. From cycle 2 onwards, patients received a co-infusion of pertuzumab (420 mg) and trastuzumab (6 mg/kg) on day one, followed by vinorelbine (30–35 mg/m2) on days one and eight (or days two and nine). The primary endpoint was objective response rate (ORR) in patients with measurable disease. Secondary endpoints included progression-free survival (PFS) and safety. Results. Cohort 2 enrolled 107 patients. The ORR was 63.7% (95% confidence interval [CI] 53.0–73.6) in patients with measurable disease (91/107; 85.0%). Median PFS was 11.5 months (95% CI 10.3–15.8). The most common adverse events [AEs] were diarrhea (57.9%), neutropenia (57.0%), and nausea (41.1%). Grade ≥3 AEs occurred in 85 patients (79.4%) and serious AEs in 44 patients (41.1%). Eighteen patients (16.8%) had AEs suggestive of congestive heart failure. Conclusion. These results support the feasibility of pertuzumab and trastuzumab co-infusion from a safety perspective and support Cohort 1 conclusions that vinorelbine offers an alternative chemotherapy companion for pertuzumab and trastuzumab.",
keywords = "HER2-positive, Metastatic breast cancer, Pertuzumab, Trastuzumab, Vinorelbine",
author = "Michael Andersson and L{\'o}pez-Vega, {Jos{\'o} M.} and Thierry Petit and Claudio Zamagni and Valerie Easton and Julia Kamber and Eleonora Restuccia and Perez, {Edith A.}",
note = "Funding Information: This study was funded by F. Hoffmann-la Roche Ltd, Basel, Switzerland. Targos Molecular Pathology GmbH, Kassel, Germany conducted central HER2 testing. Support for third-party writing assistance for this manuscript, furnished by Debbie Briggs, Ph.D., and Katie Wilson, Ph.D., of Health Interactions, was provided by F. Hoffmann-La Roche Ltd. We thank the following VELVET study investigators: Brazil (S. Costa, R. Hegg, M. Mano, J. Nunes), Denmark (M. Andersson, A.H. Jacobsen, S. Linnet), France (S. Delaloge, J. Grenier, A.-C. Hardy Bessard, C. Levy, J. Medioni, C. Moldovan, M. Mousseau, T. Petit, J.-P. Spano, B. You, L. Zelek), Germany (W. Abenhardt, S. Bauer, B. Flath, S. Fuxius, R. Hansen, E. Ladda, L. Mueller, S. Roesel, C. Salat, C. Schulte, U. Soeling, H. Tesch, H.-W. Tessen, J. Wamhoff, J. Wiegand, M. Zaiss), Italy (A. Bottini, M. Cazzaniga, L. Del Mas-tro, A. Falcone, S. Gori, P. Marchetti, F. Roila, S. Spazzapan, C. Zamagni), Spain (N. Batista Lopez, E. Blanco Campanario, Y. Fer-nandez Perez, I. Garau Llinas, L. Gonzalez Cortijo, J.M. L{\'o}pez Vega, R. Perez Carrion, A. Santaballa Bertran), and the U.S. (K. Blackwell, H. Burstein, V. Hansen, R.A. Hirsch, R. Livingston, C. Ma, E. Macrae, E. Mrozek, R.H. Oyola, G. Rodriguez, G. Sledge, J. Specht, E. Tan-Chiu, C. Vaughn, C. Vogel). These analyses have been presented in part by the following: (a) E.A. Perez, J.M. L{\'o}pez-Vega, L. del Mastro, T. Petit, L. Mitchell, C. Pelizon, M. Andersson. Trastuzumab-pertuzumab-vinorelbine for first-line treatment of patients with HER2-positive metastatic breast cancer: a single-arm, two-cohort, phase II study (VELVET). American Society of Clinical Oncology (ASCO) Annual Meeting, 1–5 June 2012, Chicago USA. Trials-in-progress poster TPS653; (b) M. Andersson, J.M. L{\'o}pez-Vega, L. del Mas-tro, T. Petit, L. Mitchell, C. Pelizon, E.A. Perez. Pertuzumab and trastuzumab in combination with vinorelbine for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: a single-arm, two-cohort, Phase II study (VELVET). European Society for Medical Oncology (ESMO), 28 September–2 October 2012, Vienna, Austria. Trials-in-progress Publisher Copyright: {\textcopyright} 2017 The Authors.",
year = "2017",
month = oct,
doi = "10.1634/theoncologist.2017-0079",
language = "English (US)",
volume = "22",
pages = "1160--1168",
journal = "Oncologist",
issn = "1083-7159",
publisher = "AlphaMed Press",
number = "10",
}