Efficacy and safety of pertuzumab and trastuzumab administered in a single infusion bag, followed by vinorelbine: VELVET cohort 2 final results

Michael Andersson, Josó M. López-Vega, Thierry Petit, Claudio Zamagni, Valerie Easton, Julia Kamber, Eleonora Restuccia, Edith A. Perez

Research output: Contribution to journalArticle

5 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)1160-1168
Number of pages9
JournalOncologist
Volume22
Issue number10
DOIs
StatePublished - Oct 1 2017

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Safety
docetaxel
Disease-Free Survival
Trastuzumab
vinorelbine
pertuzumab
Confidence Intervals
Neutropenia
Nausea
Diarrhea
Heart Failure
Breast Neoplasms
Drug Therapy

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 journalArticle

Andersson, M, López-Vega, JM, Petit, T, Zamagni, C, Easton, V, Kamber, J, Restuccia, E & Perez, EA 2017, 'Efficacy and safety of pertuzumab and trastuzumab administered in a single infusion bag, followed by vinorelbine: VELVET cohort 2 final results', Oncologist, vol. 22, no. 10, pp. 1160-1168. https://doi.org/10.1634/theoncologist.2017-0079
Andersson, Michael ; López-Vega, Josó M. ; Petit, Thierry ; Zamagni, Claudio ; Easton, Valerie ; Kamber, Julia ; Restuccia, Eleonora ; Perez, Edith A. / Efficacy and safety of pertuzumab and trastuzumab administered in a single infusion bag, followed by vinorelbine : VELVET cohort 2 final results. In: Oncologist. 2017 ; Vol. 22, No. 10. pp. 1160-1168.
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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.",
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AU - Petit, Thierry

AU - Zamagni, Claudio

AU - Easton, Valerie

AU - Kamber, Julia

AU - Restuccia, Eleonora

AU - Perez, Edith A.

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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.

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