PMID- 28592618
OWN - NLM
STAT- MEDLINE
DCOM- 20180608
LR  - 20240327
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 22
IP  - 10
DP  - 2017 Oct
TI  - Efficacy and Safety of Pertuzumab and Trastuzumab Administered in a Single 
      Infusion Bag, Followed by Vinorelbine: VELVET Cohort 2 Final Results.
PG  - 1160-1168
LID - 10.1634/theoncologist.2017-0079 [doi]
AB  - BACKGROUND: 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. PATIENTS AND METHODS: 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/m(2)) 
      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/m(2)) 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. The Oncologist 
      2017;22:1160-1168 IMPLICATIONS FOR PRACTICE: Combined treatment with pertuzumab, 
      trastuzumab, and docetaxel is the standard of care for first-line HER2-positive 
      metastatic breast cancer. However, some patients cannot, or choose not to, 
      receive docetaxel. VELVET Cohort 2 results support the results from Cohort 1 that 
      suggest that pertuzumab plus trastuzumab and vinorelbine is a suitable 
      alternative for these patients. In addition to this, results from Cohort 2 
      support the feasibility of administering pertuzumab and trastuzumab together in a 
      single infusion bag, which has the potential to offer greater patient convenience 
      and reduce active health care professional time and medical resource utilization 
      compared with administering them separately.
CI  - (c) 2017 The Authors. The Oncologist published by Wiley Periodicals, Inc. on behalf 
      of AlphaMed Press.
FAU - Andersson, Michael
AU  - Andersson M
AD  - Department of Oncology, Rigshospitalet, Copenhagen, Denmark 
      Michael.Andersson@regionh.dk.
FAU - Lopez-Vega, Jose M
AU  - Lopez-Vega JM
AD  - Hospital Universitario Marques de Valdecilla, Santander, Spain.
FAU - Petit, Thierry
AU  - Petit T
AD  - Department of Medical Oncology, Paul Strauss Cancer Center and University of 
      Strasbourg, Strasbourg, France.
FAU - Zamagni, Claudio
AU  - Zamagni C
AD  - Policlinico S. Orsola-Malpighi Hospital, Bologna, Italy.
FAU - Easton, Valerie
AU  - Easton V
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Kamber, Julia
AU  - Kamber J
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Restuccia, Eleonora
AU  - Restuccia E
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Perez, Edith A
AU  - Perez EA
AD  - Mayo Clinic, Jacksonville, Florida, USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170607
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 5V9KLZ54CY (Vinblastine)
RN  - K16AIQ8CTM (pertuzumab)
RN  - P188ANX8CK (Trastuzumab)
RN  - Q6C979R91Y (Vinorelbine)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/pharmacology/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/pharmacology/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Female
MH  - Humans
MH  - Trastuzumab/pharmacology/*therapeutic use
MH  - Treatment Outcome
MH  - Vinblastine/*analogs & derivatives/pharmacology/therapeutic use
MH  - Vinorelbine
PMC - PMC5634765
OTO - NOTNLM
OT  - HER2-positive
OT  - Metastatic breast cancer
OT  - Pertuzumab
OT  - Trastuzumab
OT  - Vinorelbine
COIS- Disclosures of potential conflicts of interest may be found at the end of this 
      article.
EDAT- 2017/06/09 06:00
MHDA- 2018/06/09 06:00
PMCR- 2018/10/01
CRDT- 2017/06/09 06:00
PHST- 2017/02/10 00:00 [received]
PHST- 2017/04/05 00:00 [accepted]
PHST- 2017/06/09 06:00 [pubmed]
PHST- 2018/06/09 06:00 [medline]
PHST- 2017/06/09 06:00 [entrez]
PHST- 2018/10/01 00:00 [pmc-release]
AID - theoncologist.2017-0079 [pii]
AID - ONCO12171 [pii]
AID - 10.1634/theoncologist.2017-0079 [doi]
PST - ppublish
SO  - Oncologist. 2017 Oct;22(10):1160-1168. doi: 10.1634/theoncologist.2017-0079. Epub 
      2017 Jun 7.