| 张筱婧,楼丽姝,楼寒梅.阿替利珠单抗联合贝伐珠单抗和化疗治疗转移性、持续性或复发性宫颈癌Ⅲ期随机开放标签临床研究 ——BEATcc研究解读[J].肿瘤学杂志,2024,30(5):429-438. |
| 阿替利珠单抗联合贝伐珠单抗和化疗治疗转移性、持续性或复发性宫颈癌Ⅲ期随机开放标签临床研究 ——BEATcc研究解读 |
| Atezolizumab plus Bevacizumab and Chemotherapy for Metastatic， Persistent， or Recurrent Cervical Cancer(BEATcc)： Interpretation of a Randomised， Open-Label， Phase Ⅲ Trial |
| 投稿时间：2024-05-07 |
| DOI：10.11735/j.issn.1671-170X.2024.05.B013 |
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| 中文关键词: 宫颈癌 阿替利珠单抗 一线治疗 Ⅲ期临床研究 生存 |
| 英文关键词:cervical cancer atezolizumab first-line therapy phase Ⅲ clinical trial survival |
| 基金项目: |
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| 中文摘要: |
| 摘 要：GOG240试验确立了贝伐珠单抗联合化疗作为转移性或复发性宫颈癌的标准一线疗法。BEATcc研究旨在评估在标准治疗基础上添加免疫检查点抑制剂的疗效。这项由研究者发起的、随机、开放标签的Ⅲ期临床试验，纳入了来自欧洲、日本和美国92个中心、转移性（ⅣB 期）、持续性或复发性宫颈癌患者，患者具有可测量病灶、未经治疗、不接受根治性手术或放疗，患者以1∶1分层区组随机分配至标准治疗组［顺铂50 mg/m2或卡铂（AUC=5）+紫杉醇175 mg/m2+贝伐珠单抗15 mg/kg，均在每周期第1天进行，3周重复］及试验组（标准治疗联合阿替利珠单抗1 200 mg），持续治疗直至疾病进展、出现不可接受的毒性、患者退出或死亡。分层因素是既往伴随放化疗（是或否）、组织学（鳞状细胞癌与腺癌，包括腺鳞癌）和铂类药物类型（顺铂或卡铂）。主要终点是研究者判断的无进展生存期以及在意向治疗人群中分析的总生存期。2018年10月8日至2021年8月20日期间，519例患者接受入组筛查，410例患者入组。试验组的中位无进展生存期为13.7个月 (95%CI：12.3~16.6个月)，标准治疗组的中位无进展生存期为10.4个月 (95%CI：9.7~11.7)，风险比为0.62 (95%CI：0.49~0.78，P<0.001)。在中期分析中，两组中位总生存期分别为32.1个月 (95%CI：25.3~36.8个月) 和22.8个月 (95%CI：20.3~28.0个月)，HR=0.68(95%CI：0.52~0.88，P=0.004 6)。试验组中79%的患者和标准治疗组中75%的患者发生≥3级的不良事件。阿替利珠单抗导致1~2级腹泻、关节痛、发热和皮疹增加。因此，在转移性、持续性或复发性宫颈癌中，贝伐珠单抗联合铂的标准化疗方案中添加阿替利珠单抗显著改善无进展生存期和总生存期，应作为新的一线治疗方案考虑。 |
| 英文摘要: |
| Abstract： The GOG240 trial has established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial， the addition of an immune checkpoint inhibitor to this standard regime was evaluated. In this investigator-initiated， randomized， open-label phase Ⅲ trial， patients were included from 92 centers in Europe， Japan and the USA. Patients with metastatic (stage ⅣB)， persistent， or recurrent cervical cancer that was measurable， previously untreated， and not amenable to curative surgery or radiation were randomly assigned 1∶1 to receive standard therapy (cisplatin 50 mg/m2 or carboplatin AUC=5， paclitaxel 175 mg/m2， and bevacizumab 15 mg/kg， all on day 1 of every 3-week cycle) with or without atezolizumab 1 200 mg. Treatment was continued until disease progression， unacceptable toxicity， patient withdrawal， or death. Stratification factors were previous concomitant chemoradiation (yes vs no)， histology (squamous cell carcinoma vs adenocarcinoma including adenosquamous carcinoma)， and platinum backbone (cisplatin vs carboplatin). Dual primary endpoints were investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1 and overall survival analyzed in the intention-to-treat population. Between Oct 8， 2018， and Aug 20， 2021， 410 of 519 patients assessed for eligibility were enrolled. Median progression-free survival was 13.7 months (95%CI： 2.3~16.6) with atezolizumab and 10.4 months (95%CI： 9.7~11.7) with standard therapy (HR=0.62， 95%CI： 0.49~0.78， P<0.001). At the interim overall survival analysis， median overall survival was 32.1 months(95%CI： 25.3~36.8) versus 22.8 months (95%CI： 20.3~28.0)， respectively (HR=0.68， 95%CI： 0.52~0.88， P=0.004 6). Grade 3 or worse adverse events occurred in 79% of patients in the trial group and in 75% of patients in the standard group. Grade 1~2 diarrhoea， arthralgia， pyrexia， and rash were increased with atezolizumab. Adding atezolizumab to a standard bevacizumab plus platinum regimen for metastatic， persistent， or recurrent cervical cancer significantly improves progression-free and overall survival and should be considered as a new first-line therapy option. |
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