{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T20:28:04Z","timestamp":1772224084950,"version":"3.50.1"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2021,11,29]],"date-time":"2021-11-29T00:00:00Z","timestamp":1638144000000},"content-version":"vor","delay-in-days":1636,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007013","name":"F. Hoffmann-la Roche Ltd","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007013","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>VELVET 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients and Methods<\/jats:title>\n                  <jats:p>During cycle 1, patients with HER2-positive locally advanced or MBC 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\u201335 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Cohort 2 enrolled 107 patients. The ORR was 63.7% (95% confidence interval [CI] 53.0\u201373.6) in patients with measurable disease (91\/107; 85.0%). Median PFS was 11.5 months (95% CI 10.3\u201315.8). The most common adverse events [AEs] were diarrhea (57.9%), neutropenia (57.0%), and nausea (41.1%). Grade \u22653 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>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. The Oncologist 2017;22:1160\u20131168<\/jats:p>\n               <\/jats:sec>","DOI":"10.1634\/theoncologist.2017-0079","type":"journal-article","created":{"date-parts":[[2017,6,8]],"date-time":"2017-06-08T00:25:45Z","timestamp":1496881545000},"page":"1160-1168","source":"Crossref","is-referenced-by-count":30,"title":["Efficacy and Safety of Pertuzumab and Trastuzumab Administered in a Single Infusion Bag, Followed by Vinorelbine: VELVET Cohort 2 Final Results"],"prefix":"10.1093","volume":"22","author":[{"given":"Michael","family":"Andersson","sequence":"first","affiliation":[{"name":"Department of Oncology Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jos\u00e9 M.","family":"L\u00f3pez-Vega","sequence":"additional","affiliation":[{"name":"Hospital Universitario Marqu\u00e9s de Valdecilla, Santander, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thierry","family":"Petit","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Paul Strauss Cancer Center and University of Strasbourg, Strasbourg, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudio","family":"Zamagni","sequence":"additional","affiliation":[{"name":"Policlinico S. 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