Ramucirumab With Eribulin Versus Eribulin in Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy: A Multicenter, Randomized, Phase II Study

Yardley, Denise A.; Reeves, James A.; Dees, Elizabeth Claire; Osborne, Cynthia R.; Paul, Devchand; Ademuyiwa, Foluso O.; Soliman, Hatem; Guthrie, Troy H.; Andersen, Jay C.; Krekow, Lea; Choksi, J. K.; Daniel, Brooke R.; Danso, Michael A.; Favret, Anne; Oommen, Sanjay P.; Brufsky, Adam; Bromund, Jane; Lin, Yong; Ibrahim, Ayman; Richards, Paul

doi:10.1016/j.clbc.2016.07.005

Cited by 27 publications

(21 citation statements)

References 25 publications

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“…The treatment arms of the screened 28 studies were recorded, yet Dieras’ study, which compared the efficacy between onartuzumab + bevacizumab + CT, bevacizumab + CT + placebo, and onartuzumab + CT + placebo for TNBC patients, was excluded because the treatments did not share common nodes with the others . Finally, 27 RCTs involving 6924 TNBC patients were included and the characteristics of the included trials are displayed in Table …”

Section: Resultsmentioning

confidence: 99%

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A Bayesian network meta‐analysis of the efficacy of targeted therapies and chemotherapy for treatment of triple‐negative breast cancer

et al. 2018

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Triple‐negative breast cancer (TNBC) is a heterogeneous disease with poorer prognosis than other subtypes, yet effective therapies are still not available. We aimed to compare the efficacy of various targeted therapies with chemotherapy (CT) in TNBC patients using a network meta‐analysis. A systematic literature search was performed in PubMed, EMBASE, and the Cochrane Library. A total of 27 randomized controlled trials (RCTs), involving 6924 TNBC patients, were included. Olaparib significantly improved PFS (0.43, 0.29‐0.64) and ORR (2.57, 1.31‐5.09) in comparison with CT. As for bevacizumab + CT, it showed a significant improvement of PFS (0.66, 0.55‐0.80) and ORR (2.15, 1.16‐4.05) compared with CT + placebo. It was also superior to CT alone in PFS (0.48, 0.35‐0.65) and pCR (1.30, 1.13‐1.49 for breast and axillary nodes and 1.26, 1.11‐1.44 for breast). Other targeted agents like iniparib, sorafenib, cetuximab, and ipatasertib combined with CT showed significant superiority in PFS compared with CT alone, and the HRs were 0.75 (0.62‐0.90), 0.44 (0.21‐0.91), 0.67 (0.47‐0.96), and 0.44 (0.24‐0.81), respectively, while some other agents such as sunitinib and cetuximab had the lowest SUCRA in OS, PFS, or ORR without any benefits. In conclusion, our results indicated that the addition of bevacizumab to CT was beneficial for TNBC patients, and olaparib had a great effect in PFS and ORR, especially for those with BRCA mutations. When combined with CT, targeted agents including iniparib, sorafenib, cetuximab, and ipatasertib may have better efficacies for treating TNBC.

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Section: Resultsmentioning

confidence: 99%

“…On the contrary, ramucirumab, another VEGFR-2 antagonist, did not significantly improve the PFS of TNBC patients. 54 It seems that antiangiogenic agents in the treatment of TNBC remain controversial.…”

Section: Discussionmentioning

confidence: 99%

A Bayesian network meta‐analysis of the efficacy of targeted therapies and chemotherapy for treatment of triple‐negative breast cancer

et al. 2018

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“…The safety profile of eribulin means that it is the ideal partner for combination therapies. The results of a few of these combination studies have been reported, and show manageable toxicity profiles, but the majority of these are in small populations (<60 patients) [34,67,[72][73][74][75][76][77][78]. Larger studies of combination therapy are required.…”

Section: Expert Opinionmentioning

confidence: 99%

The safety of eribulin for the treatment of metastatic breast cancer

Peréz-García

Cortés

2019

Expert Opinion on Drug Safety

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Introduction: Eribulin mesylate is a highly potent anticancer agent approved for use in pretreated metastatic breast cancer (MBC). Clinical trials of eribulin in MBC have demonstrated activity against this tumor type, and a phase 3 study in patients with MBC previously treated with an anthracycline and a taxane showed a significant increase in overall survival (OS) with eribulin versus control regimens. Areas covered: This review presents overviews of the development of eribulin, its pharmacology, and its efficacy in MBC. A detailed review of its safety profile is presented, and the safety of eribulin is compared with other agents commonly used to treat MBC. Expert opinion: As eribulin is the only drug shown to improve OS in patients with pretreated MBC, it is an important treatment option for many patients. Eribulin is currently considered a second-line (Europe) or third-line (United States) therapy, and studies have been examining use in the first-line setting. The use of eribulin in combination with other therapies is beginning to be explored because its manageable safety profile makes it an ideal combination-treatment partner. Emerging eribulin combinationtreatment data suggest a manageable toxicity profile, and eribulin is set to be a key drug for the treatment of MBC in the future.

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“…Bevacizumab was investigated in 72 trials 8 – 79 and ramucirumab was investigated in 13 trials. 80 – 92 All of the studies included 21 colorectal cancer, 8 – 26 , 85 , 86 15 breast cancer, 27 – 39 , 87 , 88 16 lung cancer, 40 – 52 , 80 – 82 three renal cell cancer, 53 , 54 two pancreatic cancer, 55 , 56 five ovarian cancer, 57 – 61 six gastric or gastroesophageal junction adenocarcinoma, 62 – 65 , 89 – 91 three glioblastoma, 66 – 68 one lymphoma, 69 one lymphocytic leukemia, 70 two melanoma, 71 , 72 two malignant mesothelioma, 73 , 74 one prostate cancer, 75 one cervical cancer, 76 one leiomyosarcoma, 77 two urothelial carcinoma, 83 , 84 two hepatocellular carcinoma, 78 , 92 and one soft tissue sarcoma. 79 In addition, 35 trials 9 , 10 , 12 – 20 , 22 – 26 , 46 , 49 , 52 , 55 , …”

Section: Resultsmentioning

confidence: 99%

Risk of bleeding associated with antiangiogenic monoclonal antibodies bevacizumab and ramucirumab: a meta-analysis of 85 randomized controlled trials

Xiao¹,

Wang²,

Zhang

2018

OTT

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AimBevacizumab and ramucirumab are antiangiogenic monoclonal antibodies, which target vascular endothelial growth factor-A and vascular endothelial growth factor receptor-2, respectively, used in various cancers. Bleeding events have been described with these two agents. We conducted an up-to-date meta-analysis to determine the relative risk (RR) associated with the use of antiangiogenic monoclonal antibodies, bevacizumab and ramucirumab.MethodsThis meta-analysis of randomized controlled trials was performed after searching PubMed, American Society for Clinical Oncology Abstracts, European Society for Medical Oncology Abstracts, and the proceedings of major conferences for relevant clinical trials. RR and 95% CIs were calculated by random-effects or fixed-effects models for all-grade and high-grade bleeding events related to the angiogenesis inhibitors.ResultsEighty-five randomized controlled trials were selected for the meta-analysis, covering 46,630 patients. The results showed that antiangiogenic monoclonal antibodies significantly increased the risk of all-grade (RR: 2.38, 95% CI: 2.09–2.71, p<0.00001) and high-grade (RR: 1.71, 95% CI: 1.48–1.97, p<0.00001) bleeding compared with control arms. In the subgroup analysis, bevacizumab significantly increased the risk of all-grade (RR: 2.73, 95% CI: 2.24–3.33, p<0.00001) and high-grade bleeding (RR: 1.98, 95% CI: 1.68–2.34, p<0.00001), but ramucirumab only increased the risk of all-grade bleeding (RR: 1.94, 95% CI: 1.76–2.13, p<0.00001) and no difference was observed for the risk of high-grade bleeding (RR: 1.04, 95% CI: 0.78–1.39, p=0.79) compared with the control group. For lung cancer patients, bevacizumab significantly increased the risk of all-grade (RR: 4.72, 95% CI: 1.99–11.19, p=0.0004) and high-grade pulmonary hemorrhage (RR: 3.97, 95% CI: 1.70–9.29, p=0.001), but no significant differences in the risk of all-grade (RR: 1.09, 95% CI: 0.76–1.57, p=0.64) and high-grade (RR: 1.22, 95% CI: 0.35–4.21, p=0.75) pulmonary hemorrhage were observed for ramucirumab. The increased risk of all-grade and high-grade bleeding was also observed in colorectal cancer or non-colorectal tumors and low-dose or high-dose angiogenesis inhibitors.ConclusionAntiangiogenic monoclonal antibodies are associated with a significant increase in the risk of all-grade and high-grade bleeding. Ramucirumab may be different from bevacizumab in terms of the risk of high-grade bleeding and the risk of all-grade and high-grade pulmonary hemorrhage in lung cancer patients.

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Ramucirumab With Eribulin Versus Eribulin in Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy: A Multicenter, Randomized, Phase II Study

Abstract: Ramucirumab combined with eribulin did not significantly improve PFS in advanced MBC.

Cited by 27 publications

References 25 publications

A Bayesian network meta‐analysis of the efficacy of targeted therapies and chemotherapy for treatment of triple‐negative breast cancer

A Bayesian network meta‐analysis of the efficacy of targeted therapies and chemotherapy for treatment of triple‐negative breast cancer

The safety of eribulin for the treatment of metastatic breast cancer

Risk of bleeding associated with antiangiogenic monoclonal antibodies bevacizumab and ramucirumab: a meta-analysis of 85 randomized controlled trials

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