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

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• 作者：Denise A. Yardley¹ ; ^{dyardley@tnonc.com" class="auth_mail" title="E-mail the corresponding author} ; James Reeves² ; E. Claire Dees³ ; Cynthia Osborne⁴ ; Devchand Paul⁵ ; Foluso Ademuyiwa⁶ ; Hatem Soliman⁷ ; Troy Guthrie⁸ ; Jay Andersen⁹ ; Lea Krekow¹⁰ ; Janak Choksi¹¹ ; Brooke Daniel¹² ; Michael Danso¹³ ; Anne Favret¹⁴ ; Sanjay Oommen¹⁵ ; Adam Brufsky¹⁶ ; Jane L. Bromund¹⁷ ; Yong Lin¹⁷ ; Ayman B. Ibrahim¹⁸ ; Paul D. Richards¹⁹
• 关键词：Antiangiogenic therapy ; Brain metastasis ; Targeted agents ; Triple-negative status ; VEGFR-2
• 刊名：Clinical Breast Cancer
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：16
• 期：6
• 页码：471-479.e1
• 全文大小：357 K

文摘

Use of antiangiogenic agents in treatment of metastatic breast cancer (MBC) remains controversial. We evaluated the efficacy and safety of ramucirumab and eribulin versus eribulin alone as third- to fifth-line therapy in women with advanced breast cancer.

Patients and Methods

In this randomized (1:1), open-label, phase II study, US women aged 18 years or older with 2 to 4 previous chemotherapy regimens for locally recurrent or MBC, previous anthracycline and taxane treatment, and Eastern Cooperative Oncology Group performance status of 0 or 1 received ramucirumab with eribulin or eribulin alone in 21-day cycles (eribulin 1.4 mg/m² intravenously on days 1 and 8; ramucirumab 10 mg/kg intravenously on day 1). Randomization was stratified according to previous antiangiogenic therapy and triple-negative status. The primary end point was progression-free survival (PFS) in the intention to treat population.

Results

One hundred forty-one women were randomized to ramucirumab with eribulin (n = 71) or eribulin alone (n = 70). Median PFS for ramucirumab with eribulin was 4.4 months (95% confidence interval [CI], 3.1-6.7) compared with 4.1 months (95% CI, 3.2-5.6) for eribulin (hazard ratio [HR], 0.83; 95% CI, 0.56-1.23; P = .35). Median overall survival in patients who received ramucirumab with eribulin was 13.5 months (95% CI, 10.4-17.9) compared with 11.5 months (95% CI, 9.0-17.3) in patients who received eribulin alone (HR, 0.91; 95% CI, 0.59-1.41; P = .68); objective response rate was 21% (13 of 62 patients) for the combination and 28% (17 of 60 patients) for eribulin alone. No unexpected toxicity was identified for the combination.

Conclusion

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