Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Cancer. 2012 Nov 15;118(22):5580-7. doi: 10.1002/cncr.27576. Epub 2012 Apr 27.
The authors performed a phase 2 study of bevacizumab plus pemetrexed and carboplatin followed by maintenance bevacizumab in patients with advanced, nonsquamous nonsmall cell lung cancer.
Previously untreated patients with advanced, nonsquamous nonsmall cell lung cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1 received bevacizumab 15 mg/kg, pemetrexed 500 mg/m(2) and carboplatin at an area under the concentration-time curve of 6 intravenously on day 1 every 21 days. Responding or stable patients who completed 6 cycles then received bevacizumab maintenance every 21 days until disease progression.
In total, 43 patients (40 who were evaluable for response) were entered on the study. Treatment-related grade 3/4 toxicities were low and included febrile neutropenia (2%), neutropenia (28%), anemia (18%), thrombocytopenia (11%), hypertension (7%), epistaxis (5%), venous thrombosis (8%), dyspnea (7%), rectovaginal fistula (2.3%), infusion reaction (2%), and cerebrovascular event (2%). One patient died from complications of venous thromboembolism and cerebrovascular accident after Cycle 2. Minimal clinically significant toxicity occurred during maintenance bevacizumab. Two complete responses (5%) were observed, and 17 patients (42%) had a partial response. Fifteen patients (38%) displayed disease stability. The overall disease control rate was 85%. At a median follow-up of 15.8 months, the median progression-free survival was 7.1 months (95% confidence interval, 5.9-8.3 months), and the median overall survival was 17.1 months (95% confidence interval, 8.8-25.5 months).
Combined bevacizumab, pemetrexed, and carboplatin followed by maintenance bevacizumab was well tolerated and displayed remarkable activity in patients with previously untreated, advanced, nonsquamous nonsmall cell lung cancer.
作者进行了一项贝伐珠单抗联合培美曲塞和顺铂，随后用贝伐珠单抗维持治疗晚期非鳞状非小细胞肺癌患者的 2 期研究。
先前未经治疗的晚期非鳞状非小细胞肺癌患者，东部肿瘤协作组体能状态为 0 或 1 分，接受贝伐珠单抗 15mg/kg、培美曲塞 500mg/m2和卡铂，静脉注射，曲线下面积 6，每 21 天 1 次。完成 6 个周期且有反应或稳定的患者随后每 21 天接受贝伐珠单抗维持治疗，直至疾病进展。
共 43 例患者（40 例可评价疗效）入组该研究。治疗相关的 3/4 级毒性反应较低，包括发热性中性粒细胞减少症（2%）、中性粒细胞减少症（28%）、贫血（18%）、血小板减少症（11%）、高血压（7%）、鼻出血（5%）、静脉血栓形成（8%）、呼吸困难（7%）、直肠阴道瘘（2.3%）、输液反应（2%）和脑血管意外（2%）。1 例患者在第 2 周期后因静脉血栓栓塞和脑血管意外并发症死亡。贝伐珠单抗维持治疗期间出现最小的临床显著毒性。观察到 2 例完全缓解（5%），17 例（42%）患者部分缓解。15 例（38%）患者疾病稳定。总疾病控制率为 85%。中位随访 15.8 个月时，中位无进展生存期为 7.1 个月（95%置信区间，5.9-8.3 个月），中位总生存期为 17.1 个月（95%置信区间，8.8-25.5 个月）。
贝伐珠单抗联合培美曲塞和顺铂，随后用贝伐珠单抗维持治疗，在未经治疗的晚期非鳞状非小细胞肺癌患者中耐受性良好，且具有显著疗效。
