近期，公布在JCO雜志上的一項研究結(jié)果表明,，將貝伐單抗（阿瓦斯?。┨砑拥綐藴驶熤袑τ谀承┞殉舶┗颊呤怯幸娴摹CEANS試驗的結(jié)果表明,，貝伐單抗添加到標準化療中,，可提高無進展生存期4個月，此外,，可明顯改善客觀反應(yīng)率和緩解時間,。該研究結(jié)果首次在2011年ASCO年會上提出。
在第一次中期分析（2010年9月17,，中位隨訪24個月）時,，有141人死亡；第二次中期分析（2011年8月29日）,，有235人死亡,，大多數(shù)是由疾病進展造成的。在第二次中期分析時,，貝伐單抗組的總體生存期為33.3個月,，只接受化療組為35.2個月。
最終分析評估了后續(xù)治療——對照組的88%患者,，貝伐單抗組84%患者接受后續(xù)的抗癌治療,，包括貝伐單抗（對照組31%，貝伐單抗組15%）,。
主要終點達到
該隊列納入了484名鉑類敏感的復(fù)發(fā)性卵巢癌,，原發(fā)腹腔或輸卵管癌患者，隨機接受吉西他濱和卡鉑加安慰劑或貝伐單抗,。平均化療周期是6,，安慰劑組的平均周期為10，貝伐單抗為12,。持續(xù)治療直到疾病進展,。
主要終點是無進展生存期，次要終點包括客觀緩解率,，緩解時間和安全性,。
中位隨訪24個月,，貝伐單抗組的PFS明顯增加，高于安慰劑組（12.4 vs 8.4個月）,。對照組客觀緩解率為57.4%,，貝伐單抗組為78.5%。緩解時間,，前者是7.4個月,，后者是10.4個月。
沒有出現(xiàn)新的安全性問題,。貝伐單抗組的不良事件發(fā)生率高于對照組,。3級或以上的高血壓在貝伐單抗組更為常見（17.4% vs 0.4%），以及蛋白尿（8.5% vs 0.9%）,。中性粒細胞減少的發(fā)生率兩組類似,，但在貝伐單抗組有2例出現(xiàn)胃腸穿孔，治療后已經(jīng)好轉(zhuǎn),。（生物谷Bioon.com）
doi:10.1200/JCO.2012.42.0505
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OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Carol Aghajanian, Stephanie V. Blank, Barbara A. Goff, Patricia L. Judson, Michael G. Teneriello, Amreen Husain, Mika A. Sovak, Jing Yi and Lawrence R. Nycum
Purpose This randomized, multicenter, blinded, placebo-controlled phase III trial tested the efficacy and safety of bevacizumab (BV) with gemcitabine and carboplatin (GC) compared with GC in platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer (ROC).
Patients and Methods Patients with platinum-sensitive ROC (recurrence ≥ 6 months after front-line platinum-based therapy) and measurable disease were randomly assigned to GC plus either BV or placebo (PL) for six to 10 cycles. BV or PL, respectively, was then continued until disease progression. The primary end point was progression-free survival (PFS) by RECIST; secondary end points were objective response rate, duration of response (DOR), overall survival, and safety.
Results Overall, 484 patients were randomly assigned. PFS for the BV arm was superior to that for the PL arm (hazard ratio [HR], 0.484; 95% CI, 0.388 to 0.605; log-rank P < .0001); median PFS was 12.4 v 8.4 months, respectively. The objective response rate (78.5% v 57.4%; P < .0001) and DOR (10.4 v 7.4 months; HR, 0.534; 95% CI, 0.408 to 0.698) were significantly improved with the addition of BV. No new safety concerns were noted. Grade 3 or higher hypertension (17.4% v < 1%) and proteinuria (8.5% v < 1%) occurred more frequently in the BV arm. The rates of neutropenia and febrile neutropenia were similar in both arms. Two patients in the BV arm experienced GI perforation after study treatment discontinuation.
Conclusion GC plus BV followed by BV until progression resulted in a statistically significant improvement in PFS compared with GC plus PL in platinum-sensitive ROC.
