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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1160-1168 |
| Number of pages | 9 |
| Journal | Oncologist |
| Volume | 22 |
| Issue number | 10 |
| DOIs | |
| State | Published - Oct 1 2017 |
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Keywords
- HER2-positive
- Metastatic breast cancer
- Pertuzumab
- Trastuzumab
- Vinorelbine
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
Efficacy and safety of pertuzumab and trastuzumab administered in a single infusion bag, followed by vinorelbine : VELVET cohort 2 final results. / Andersson, Michael; López-Vega, Josó M.; Petit, Thierry; Zamagni, Claudio; Easton, Valerie; Kamber, Julia; Restuccia, Eleonora; Perez, Edith A.
In: Oncologist, Vol. 22, No. 10, 01.10.2017, p. 1160-1168.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Efficacy and safety of pertuzumab and trastuzumab administered in a single infusion bag, followed by vinorelbine
T2 - VELVET cohort 2 final results
AU - Andersson, Michael
AU - López-Vega, Josó M.
AU - Petit, Thierry
AU - Zamagni, Claudio
AU - Easton, Valerie
AU - Kamber, Julia
AU - Restuccia, Eleonora
AU - Perez, Edith A.
PY - 2017/10/1
Y1 - 2017/10/1
N2 - 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.
AB - 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.
KW - HER2-positive
KW - Metastatic breast cancer
KW - Pertuzumab
KW - Trastuzumab
KW - Vinorelbine
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UR - http://www.scopus.com/inward/citedby.url?scp=85034062674&partnerID=8YFLogxK
U2 - 10.1634/theoncologist.2017-0079
DO - 10.1634/theoncologist.2017-0079
M3 - Article
C2 - 28592618
AN - SCOPUS:85034062674
VL - 22
SP - 1160
EP - 1168
JO - Oncologist
JF - Oncologist
SN - 1083-7159
IS - 10
ER -