SABRE-B: an evaluation of paclitaxel and bevacizumab with or without sunitinib as first-line treatment of metastatic breast cancer

Mayer, EL; Dhakil, S.; Patel, Taral; Sundaram, Srinand; Fabian, CJ; Kozloff, Mark; Qamar, Rubina; Volterra, Fabio; Parmar, Hema; Samant, Meghna; Burstein, Harold J.

doi:10.1093/annonc/mdq260

Cited by 51 publications

(27 citation statements)

References 21 publications

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“…The cardiovascular toxicities are one of the most serious drug-related adverse events necessitating treatment adjustment and/or discontinuation in the clinical trials [20,21]. Though severe cardiovascular toxicities are relatively uncommon, there are currently no methods to predict patients at highest risk and therefore regular monitoring of clinical parameters is warranted.…”

Section: Discussionmentioning

confidence: 99%

Risk of cardiovascular toxicities in patients with solid tumors treated with sunitinib, axitinib, cediranib or regorafenib: An updated systematic review and comparative meta-analysis

Abdel‐Rahman

Fouad

2014

Critical Reviews in Oncology/Hematology

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Section: Discussionmentioning

confidence: 99%

Risk of cardiovascular toxicities in patients with solid tumors treated with sunitinib, axitinib, cediranib or regorafenib: An updated systematic review and comparative meta-analysis

Abdel‐Rahman

Fouad

2014

Critical Reviews in Oncology/Hematology

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“…However, studies combining VEGFR inhibitors and bevacizumab have been fraught with significant toxicity [46, 47]. Metronomic chemotherapy provides an attractive partner in combination with an anti-VEGF biologic given the favorable toxicity profile and activity against endothelial cells.…”

Section: Discussionmentioning

confidence: 99%

Combination antiangiogenic therapy in advanced breast cancer: a phase 1 trial of vandetanib, a VEGFR inhibitor, and metronomic chemotherapy, with correlative platelet proteomics

Mayer

Isakoff

Klement

et al. 2012

Breast Cancer Res Treat

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This phase 1 study evaluated the safety and tolerability of antiangiogenic therapy using vandetanib and metronomic cyclophosphamide and methotrexate in metastatic breast cancer. Eligible patients had metastatic breast cancer with 0–4 prior chemotherapy regimens. All received cyclophosphamide 50 mg daily, methotrexate 2.5 mg days 1–2 weekly, and vandetanib daily in 3 dose-escalation cohorts: 100 mg (C1), 200 mg (C2), and 300 mg (C3). The primary endpoint was safety and tolerability; secondary endpoints included response rate and evaluation of platelet-associated proteins. Twenty three patients were treated and evaluable for toxicity. Common mild toxicities included nausea, vomiting, LFTs abnormalities, fatigue, and rash. Three episodes of dose-limiting toxicity occurred in C3. In all cohorts, 1/3 of patients required vandetanib dose reduction, and 22 % ended therapy for toxicity. Of the 20 response-evaluable patients, 10 % demonstrated partial response and 15 % stable disease ≥24 weeks. Proteomic analyses demonstrated changes in platelet content of angiogenesis regulators, including vascular endothelial growth factor and platelet factor 4, with exposure to therapy. This regimen was tolerable at a maximum vandetanib dose of 200 mg; modest clinical activity was observed in this heavily pretreated population. Changes in the platelet proteome may serve as pharmacodynamic markers of angiogenesis inhibition. Metronomic chemotherapy is an attractive partner with biologics and deserves further study in metastatic breast cancer.

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“…In a randomized phase II trial, paclitaxel and bevacizumab, with or without sunitinib, were given to 46 patients with HER2-negative MBC [49].The study was terminated early due to unacceptable toxicities in patients that received sunitinib. Four patients in the sunitinib arm, compared to none in the arm that did not receive sunitinib, were discontinued from the study due to adverse events.…”

Section: Clinical Data For Antiangiogenic Agents Combined With Cytotomentioning

confidence: 99%

Novel Cytotoxic Agents in the Treatment of Metastatic Breast Cancer

Warsch

Montero

Glück

2012

Curr Breast Cancer Rep

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Breast cancer is the most common cancer affecting women worldwide, comprising approximately 20% of all cancers. Although many advances in the treatment of this disease have been made and mortality of early breast cancer improved over the past three decades, metastatic breast cancer (MBC) remains an incurable disease. Cytotoxic chemotherapy continues to play a major role in the treatment of MBC and has been recently combined with biologic agents such as monoclonal antibodies or kinase inhibitors. Over the past decade, several novel cytotoxic chemotherapies have been evaluated in clinical trials. Encouraging results have been observed with novel anti-microtubule agents, with recent US Food and Drug Administration approval of eribulin in 2010. Other novel cytotoxic agents currently under clinical development include novel anti-microtubule drugs, platinum compounds, and anti-angiogenic agents combined with chemotherapy. Here, we review all the major novel cytotoxic agents that have undergone clinical study over the past 5 years for the treatment of MBC.

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SABRE-B: an evaluation of paclitaxel and bevacizumab with or without sunitinib as first-line treatment of metastatic breast cancer

Abstract: Adding sunitinib to standard doses of bevacizumab plus paclitaxel for metastatic breast cancer is not feasible. Different strategies will be required to evaluate whether there is additional clinical benefit to combining VEGF/VEGFR-targeted agents.

Cited by 51 publications

References 21 publications

Risk of cardiovascular toxicities in patients with solid tumors treated with sunitinib, axitinib, cediranib or regorafenib: An updated systematic review and comparative meta-analysis

Risk of cardiovascular toxicities in patients with solid tumors treated with sunitinib, axitinib, cediranib or regorafenib: An updated systematic review and comparative meta-analysis

Combination antiangiogenic therapy in advanced breast cancer: a phase 1 trial of vandetanib, a VEGFR inhibitor, and metronomic chemotherapy, with correlative platelet proteomics

Novel Cytotoxic Agents in the Treatment of Metastatic Breast Cancer

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