近期，公布在JCO杂志上的一项研究结果表明，将贝伐单抗（阿瓦斯丁）添加到标准化疗中对于某些卵巢癌患者是有益的。OCEANS试验的结果表明，贝伐单抗添加到标准化疗中，可提高无进展生存期4个月，此外，可明显改善客观反应率和缓解时间。该研究结果首次在2011年ASCO年会上提出。
在第一次中期分析（2010年9月17，中位随访24个月）时，有141人死亡；第二次中期分析（2011年8月29日），有235人死亡，大多数是由疾病进展造成的。在第二次中期分析时，贝伐单抗组的总体生存期为33.3个月，只接受化疗组为35.2个月。
最终分析评估了后续治疗——对照组的88%患者，贝伐单抗组84%患者接受后续的抗癌治疗，包括贝伐单抗（对照组31%，贝伐单抗组15%）。
主要终点达到
该队列纳入了484名铂类敏感的复发性卵巢癌，原发腹腔或输卵管癌患者，随机接受吉西他滨和卡铂加安慰剂或贝伐单抗。平均化疗周期是6，安慰剂组的平均周期为10，贝伐单抗为12。持续治疗直到疾病进展。
主要终点是无进展生存期，次要终点包括客观缓解率，缓解时间和安全性。
中位随访24个月，贝伐单抗组的PFS明显增加，高于安慰剂组（12.4 vs 8.4个月）。对照组客观缓解率为57.4%，贝伐单抗组为78.5%。缓解时间，前者是7.4个月，后者是10.4个月。
没有出现新的安全性问题。贝伐单抗组的不良事件发生率高于对照组。3级或以上的高血压在贝伐单抗组更为常见（17.4% vs 0.4%），以及蛋白尿（8.5% vs 0.9%）。中性粒细胞减少的发生率两组类似，但在贝伐单抗组有2例出现胃肠穿孔，治疗后已经好转。（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.
