Vinorelbine plus 3-weekly trastuzumab in metastatic breast cancer: a single-centre phase 2 trial

Maio, Ermelinda De; Pacilio, Carmen; Gravina, Adriano; Morabito, Alessandro; Rella, Francesca Di; Labonia, V.; Landi, G.; Nuzzo, Francesco; Rossi, Emanuela; Silvestro, P; Botti, Gerardo; Bonito, Maurizio Di; Curcio, Maria Pia; Formichelli, Franca; Vecchia, Franca La; Staiano, Maria; Maurea, Nicola; D’Aiuto, Giuseppe; D’Aiuto, Massimiliano; Thomas, R.; Signoriello, Giuseppe; Perrone, Francesco; Matteis, A. De

doi:10.1186/1471-2407-7-50

Cited by 23 publications

(15 citation statements)

References 28 publications

(20 reference statements)

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“…A separate phase II trial evaluating combination therapy with trastuzumab and vinorelbine reported that two patients (4%) experienced a Ͼ20% reduction from baseline in LVEF and two (4%) experienced a Ͼ10% reduction from baseline in LVEF [26].…”

Section: Nonementioning

confidence: 99%

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Minimizing Cardiotoxicity While Optimizing Treatment Efficacy with Trastuzumab: Review and Expert Recommendations

et al. 2009

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Section editors Gabriel N. Hortobágyi and Kathleen I. Pritchard have disclosed no financial relationships relevant to the content of this article.The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. Target audience:Physicians who wish to advance their current knowledge of clinical cancer medicine in breast cancer. LEARNING OBJECTIVES1. Analyze the clinical trial data for the treatment of breast cancer.2. Evaluate the risk of cardiotoxicity associated with the use of trastuzumab.3. Design and conduct a practical approach to managing patients with trastuzumab-associated cardiotoxicity.This article is available for continuing medical education credit at CME.TheOncologist.com. CME CME ABSTRACTNumerous clinical studies have demonstrated the therapeutic benefit of trastuzumab in women with breast cancer. However, a small but not insignificant proportion of patients have experienced trastuzumab-associated cardiotoxicity during these trials. This phenomenon is generally characterized by an asymptomatic reduction in left ventricular ejection fraction (LVEF) or, less often, congestive heart failure (CHF).

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Section: Nonementioning

confidence: 99%

“…Open-label phase II study (n ϭ 50) [26] T, 8 mg/kg LD, then 6 mg/kg on day 1 ϩ V, 30 mg/m 2 , on days 2 and 8 of 3-week cycles until disease progression LVEF Յ44%; LVEF Ͻ50% with a Ն10% reduction from baseline Grade 1 asymptomatic decline from baseline in LVEF, 4%; grade 2 asymptomatic decline from baseline in LVEF, 4%…”

Section: Nonementioning

confidence: 99%

Minimizing Cardiotoxicity While Optimizing Treatment Efficacy with Trastuzumab: Review and Expert Recommendations

et al. 2009

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“…Two randomized phase II studies confirmed the efficacy and the safety of the combination of trastuzumab with weekly paclitaxel or 3-weekly docetaxel (Marty et al 2005, Gasparini et al 2007). However, due to an increasing use of taxanes in the N Normanno et al: Targeted therapies in breast cancer www.endocrinology-journals.org adjuvant setting, alternative trastuzumab-based combinations were developed, such as combinations with vinorelbine (Burstein et al 2001, Papaldo et al 2006, De Maio et al 2007) and capecitabine (Bartsch et al 2007, Schaller et al 2007. Combinations of trastuzumab with polychemotherapy have been also studied.…”

Section: Trastuzumabmentioning

confidence: 99%

Target-based therapies in breast cancer: current status and future perspectives

Normanno¹,

Morabito²,

Luca³

et al. 2009

Endocrine-Related Cancer

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Identification of molecular alterations in key proteins involved in breast cancer cell proliferation and survival resulted in the development of a new treatment strategy with target-based agents. The anti-ErbB-2 monoclonal antibody (mAb) trastuzumab and the dual epidermal growth factor receptor/ErbB-2 tyrosine kinase inhibitor lapatinib are effective in patients with breast cancer that overexpresses ErbB-2. The anti-vascular endothelial growth factor-A mAb bevacizumab is approved in combination with taxanes for treatment of unselected patients with metastatic breast cancer. In addition, preclinical data suggest that signaling inhibitors can prevent or overcome resistance to endocrine therapy in estrogen receptor positive (ERC) breast cancer. However, the majority of signaling inhibitors explored in breast cancer patients has shown little activity, at least when used as monotherapy; and the results of clinical trials in ERC breast cancer of combinations of signaling inhibitors and endocrine therapies are rather disappointing. Negative findings are likely due to mechanisms of intrinsic or acquired resistance to target-based agents. Breast carcinoma is a complex and heterogeneous disease and several different molecular alterations are involved in its pathogenesis and progression. The redundancy of oncogenic pathways activated in cancer cells, the heterogeneity of the mechanisms of resistance, and the plasticity of tumor cells that are capable to adapt to different growth conditions, significantly hamper the efficacy of each signaling inhibitor in breast cancer. Therefore, a comprehensive approach that takes into account the complexity of the disease is definitely required to improve the efficacy of target-based therapy in breast cancer.

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“…In phase II, the null hypothesis for objective response rate (ORR) in patients with no prior lapatinib was set at 30% and the alternative of interest was set at 55%, based on previously reported data from phase II studies of vinorelbine-trastuzumab [26][27][28]. The sample size was chosen for the study to have a significance level of 0.025 and a power of 95% for no prior lapatinib patients.…”

Section: Statistical Analysesmentioning

confidence: 99%

Safety and efficacy of neratinib (HKI-272) plus vinorelbine in the treatment of patients with ErbB2-positive metastatic breast cancer pretreated with anti-HER2 therapy

et al. 2013

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Results: In phase I (n = 12), neratinib (240 mg) plus vinorelbine (25 mg/m 2 ) was established as the MTD. In phase II, 79 patients with HER2-positive metastatic breast cancer were treated at the MTD. The most common treatment-related adverse events were diarrhea (96%), neutropenia (54%), and nausea (50%). Three patients discontinued treatment due to diarrhea. No clinically important skin side-effects were observed. The OR rate in assessable phase II patients was 41% (no prior lapatinib) and 8% ( prior lapatinib). There was no evidence of pharmacokinetic interaction between neratinib and vinorelbine.Conclusion: Neratinib plus vinorelbine showed promising antitumor activity and no unexpected toxic effects in HER2-positive metastatic breast cancer patients.Trial registration: ClinicalTrials.gov #NCT00706030.

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Vinorelbine plus 3-weekly trastuzumab in metastatic breast cancer: a single-centre phase 2 trial

Abstract: Background: After two studies reporting response rates higher than 70% in HER2-positive metastatic breast cancer with weekly trastuzumab and vinorelbine, we planned a phase 2 study to test activity of the same combination, with trastuzumab given every 3 weeks.

Cited by 23 publications

References 28 publications

Minimizing Cardiotoxicity While Optimizing Treatment Efficacy with Trastuzumab: Review and Expert Recommendations

Minimizing Cardiotoxicity While Optimizing Treatment Efficacy with Trastuzumab: Review and Expert Recommendations

Target-based therapies in breast cancer: current status and future perspectives

Safety and efficacy of neratinib (HKI-272) plus vinorelbine in the treatment of patients with ErbB2-positive metastatic breast cancer pretreated with anti-HER2 therapy

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