Division of Medical Oncology, Princess Margaret Hospital, 5th Floor Room 105, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada.
Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.
Bevacizumab provides clinical benefit in multiple solid tumours, but is associated with some increase in bleeding risk. Thrombotic events necessitating therapeutic anticoagulation (TA) are common in cancer. This report describes the safety of concurrent bevacizumab and TA in three large placebo-controlled clinical studies.
Study 1 (metastatic colorectal cancer (mCRC)), study 2 (mCRC), and study 3 (advanced non-small cell lung cancer) were blinded phase III studies. Eligibility criteria excluded patients on TA. Patients on protocol treatment who developed thrombotic events requiring TA were permitted to continue bevacizumab or placebo under specified conditions. Adverse events in patients who received bevacizumab and TA concurrently were assessed using the NCI-CTCAE scale.
While experience is limited, venous thrombotic events were the most common reason for TA initiation in the three studies. Severe bleeding event rates for patients receiving TA in the bevacizumab-treated groups were similar in frequency to the placebo groups, ranging from 0 to 8% or 0 to 67 events per 100 patient-years. No severe pulmonary bleeding was reported in any of the TA-treated populations.
These data suggest that bevacizumab did not increase the risk of severe bleeding in cancer patients who received TA.
贝伐珠单抗在多种实体瘤中提供了临床获益，但与出血风险增加有关。癌症患者常发生需要治疗性抗凝（TA）的血栓事件。本报告描述了在三项大型安慰剂对照临床研究中同时使用贝伐珠单抗和 TA 的安全性。
研究 1（转移性结直肠癌（mCRC））、研究 2（mCRC）和研究 3（晚期非小细胞肺癌）为双盲 III 期研究。入选标准排除了正在接受 TA 的患者。根据特定条件，接受协议治疗且发生需要 TA 的血栓性事件的患者允许继续使用贝伐珠单抗或安慰剂。使用 NCI-CTCAE 量表评估同时接受贝伐珠单抗和 TA 的患者的不良事件。
尽管经验有限，但在三项研究中，静脉血栓栓塞事件是启动 TA 的最常见原因。接受 TA 的贝伐珠单抗治疗组的严重出血事件发生率与安慰剂组相似，频率范围为 0 至 8%或 0 至 67 例/100 患者-年。在任何接受 TA 的人群中均未报告严重肺出血。
这些数据表明，在接受 TA 的癌症患者中，贝伐珠单抗并未增加严重出血的风险。
