Int J Gynecol Cancer. 2018 May;28(4):729-737. doi: 10.1097/IGC.0000000000001221.
The single-arm ROSiA study explored an extended duration of frontline bevacizumab-containing therapy for ovarian cancer. Post hoc analyses explored safety and efficacy according to age.
After primary debulking surgery, patients with stage IIB-IV or grade 3 stage I-IIA ovarian cancer received 4-8 cycles of paclitaxel [weekly or every 3 weeks (q3w)], carboplatin AUC 5-6 q3w, and bevacizumab 15 (or 7.5) mg/kg q3w, followed by single-agent bevacizumab until progression or for up to 24 months. The primary end point was safety; progression-free survival (PFS) was a secondary end point.
Of 1021 patients treated, 121 (12%) were aged 70 years or older and 44 (4%) were 75 years or older. Compared with younger patients, more patients aged 70 years or older had hypertension at baseline, stage IV disease, and Eastern Cooperative Oncology Group performance status 1 or above. Bevacizumab was continued for more than 15 months in 49% of older versus 53% of younger patients. Older patients experienced higher incidences of all-grade anemia (44% vs 32%), diarrhea (35% vs 25%), and asthenia (22% vs 12%), and grade ≥3 hypertension (41% vs 22%) and thromboembolic events (7% vs 2%) compared with younger patients. Fatal bevacizumab-related adverse events occurred in 1 (0.8%) older versus 5 (0.6%) younger patients. Median PFS was 23.7 (95% confidence interval, 18.6-27.9) versus 25.6 (95% confidence interval, 23.7-28.4) months in patients aged 70 or older versus those younger than 70 years, respectively.
Bevacizumab-treated patients aged 70 years or older had higher incidences of anemia, low-grade diarrhea, and asthenia, and grade ≥3 hypertension and thromboembolic events than those younger than 70 years, but no other relevant increase in toxicity. Median PFS of approximately 2 years is similar to that in younger patients despite the worse prognosis. Older age should not preclude bevacizumab therapy for ovarian cancer in carefully selected patients aged 70 years or older. Given the higher background hypertension prevalence, elderly patients should be monitored more closely while receiving bevacizumab.
ROSiA 单臂研究探索了延长卵巢癌一线贝伐珠单抗治疗时间。事后分析根据年龄探讨了安全性和疗效。
在初次肿瘤细胞减灭术后，ⅡB 期-IV 期或 3 级Ⅰ-ⅡA 期卵巢癌患者接受 4-8 个周期的紫杉醇[每周或每 3 周（q3w）]、卡铂 AUC5-6 q3w 和贝伐珠单抗 15（或 7.5）mg/kg q3w，随后单药贝伐珠单抗治疗，直至疾病进展或最长 24 个月。主要终点为安全性；无进展生存期（PFS）为次要终点。
在 1021 例治疗患者中，121 例（12%）年龄 70 岁或以上，44 例（4%）年龄 75 岁或以上。与年轻患者相比，更多年龄 70 岁或以上的患者基线时患有高血压、IV 期疾病和东部肿瘤协作组体力状态 1 或以上。49%的老年患者贝伐珠单抗用药时间超过 15 个月，而年轻患者为 53%。与年轻患者相比，老年患者更常发生所有级别贫血（44%比 32%）、腹泻（35%比 25%）和乏力（22%比 12%），且更常发生≥3 级高血压（41%比 22%）和血栓栓塞事件（7%比 2%）。与年轻患者相比，1 例（0.8%）老年患者和 5 例（0.6%）年轻患者发生与贝伐珠单抗相关的致死性不良事件。年龄 70 岁或以上患者的中位 PFS 为 23.7（95%置信区间，18.6-27.9）个月，年龄小于 70 岁患者为 25.6（95%置信区间，23.7-28.4）个月。
与年龄小于 70 岁的患者相比，年龄 70 岁或以上的接受贝伐珠单抗治疗的患者贫血、低级别腹泻和乏力的发生率更高，且≥3 级高血压和血栓栓塞事件的发生率更高，但毒性无其他明显增加。尽管预后较差，中位 PFS 约为 2 年，与年轻患者相似。在仔细选择的年龄 70 岁或以上患者中，不应因年龄因素而排除贝伐珠单抗治疗卵巢癌。鉴于较高的背景高血压发生率，在接受贝伐珠单抗治疗期间应更密切监测老年患者。
