Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China; State Key Laboratory of Oncology in South China, Guangzhou, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Department of Internal Medicine, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.
ESMO Open. 2021 Dec;6(6):100313. doi: 10.1016/j.esmoop.2021.100313. Epub 2021 Nov 24.
The value of anti-angiogenesis antibody therapy in recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) remains unknown. We carried out a phase II study to evaluate the addition of bevacizumab to paclitaxel plus carboplatin in R/M NPC.
A total of 80 patients with previously untreated R/M NPC were randomly assigned (1 : 1) to CPB or CP groups to receive carboplatin (area under the curve 6) and paclitaxel (175 mg/m) intravenously every 3 weeks for a maximum of six cycles in combination with or without bevacizumab (7.5 mg/kg), respectively. The primary endpoint was progression-free survival (PFS) as per investigators, and the secondary endpoints were PFS as per independent review committee (IRC), overall survival (OS), objective response rate (ORR), and safety. This study was registered with ClinicalTrials.gov (NCT02250599).
The median PFS as per investigators was 7.5 months [95% confidence interval (CI), 6.53-8.45 months] in the CPB group and 6.5 months (95% CI, 5.53-7.52 months) in the CP group (P = 0.148), which were similar to IRC-assessed PFS. The median OS was also alike between CPB and CP arms (21.0 versus 24.7 months; P = 0.326). ORRs were 87.2% and 72.5%, respectively (P = 0.105). However, the tumor-shrinking rate was higher in the CPB arm than in the CP arm (P = 0.035). No differences in grade 3 or higher adverse events between the groups were observed.
Addition of bevacizumab to paclitaxel plus carboplatin as first-line treatment did not prolong PFS and OS in patients with R/M NPC but improved tumor-shrinking rate. These results indicated that bevacizumab plus chemotherapy might be an optional choice for NPC with heavy tumor load or those pursuing short-term efficacy in neoadjuvant and concurrent chemotherapy.
抗血管生成抗体治疗在复发性或转移性鼻咽癌（R/M NPC）中的价值尚不清楚。我们进行了一项 II 期研究，以评估贝伐珠单抗联合紫杉醇加卡铂在 R/M NPC 中的疗效。
共 80 例未经治疗的 R/M NPC 患者按 1:1 随机分为 CPB 或 CP 组，分别接受卡铂（曲线下面积 6）和紫杉醇（175 mg/m）静脉滴注，每 3 周一次，最多 6 个周期，联合或不联合贝伐珠单抗（7.5 mg/kg）。主要终点为研究者评估的无进展生存期（PFS），次要终点为独立审查委员会（IRC）评估的 PFS、总生存期（OS）、客观缓解率（ORR）和安全性。该研究在 ClinicalTrials.gov 注册（NCT02250599）。
CPB 组和 CP 组的研究者评估的中位 PFS 分别为 7.5 个月（95%CI，6.53-8.45 个月）和 6.5 个月（95%CI，5.53-7.52 个月）（P=0.148），与 IRC 评估的 PFS 相似。CPB 组和 CP 组的中位 OS 也相似（21.0 与 24.7 个月；P=0.326）。ORR 分别为 87.2%和 72.5%（P=0.105）。然而，CPB 组的肿瘤退缩率高于 CP 组（P=0.035）。两组间 3 级或以上不良事件发生率无差异。
贝伐珠单抗联合紫杉醇加卡铂作为一线治疗不能延长 R/M NPC 患者的 PFS 和 OS，但可提高肿瘤退缩率。这些结果表明，贝伐珠单抗联合化疗可能是肿瘤负荷较重或在新辅助和同步化疗中追求短期疗效的 NPC 的一种选择。
