The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone. In this investigator-initiated, randomised, open-label, phase 3 trial, patients from 92 sites in Europe, Japan, and the USA 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/m or carboplatin area under the curve of 5, paclitaxel 175 mg/m, and bevacizumab 15 mg/kg, all on day 1 of every 3-week cycle) with or without atezolizumab 1200 mg. Treatment was continued until disease progression, unacceptable toxicity, patient withdrawal, or death. Stratification factors were previous concomitant chemoradiation (yes no), histology (squamous cell carcinoma adenocarcinoma including adenosquamous carcinoma), and platinum backbone (cisplatin carboplatin). Dual primary endpoints were investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumours version 1.1 and overall survival analysed in the intention-to-treat population. This study is registered with , , and is ongoing. 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 12·3–16·6) with atezolizumab and 10·4 months (9·7–11·7) with standard therapy (hazard ratio [HR]=0·62 [95% CI 0·49–0·78]; p<0·0001); at the interim overall survival analysis, median overall survival was 32·1 months (95% CI 25·3–36·8) versus 22·8 months (20·3–28·0), respectively (HR 0·68 [95% CI 0·52–0·88]; p=0·0046). Grade 3 or worse adverse events occurred in 79% of patients in the experimental 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. F Hoffmann-La Roche.

中文翻译：

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Atezolizumab 加贝伐单抗和化疗治疗转移性、持续性或复发性宫颈癌 (BEATcc)：一项随机、开放标签 3 期试验

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。在 BEATcc 试验 (ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030) 中，我们旨在评估在此标准骨干中添加免疫检查点抑制剂。在这项由研究者发起的、随机、开放标签的 3 期试验中，来自欧洲、日本和美国 92 个地点的患有转移性（IVB 期）、持续性或复发性宫颈癌的患者，这些患者是可测量的、之前未经治疗且未接受过治疗的患者。适合根治性手术或放疗的患者以 1:1 的比例随机分配接受标准治疗（顺铂 50 mg/m2 或卡铂曲线下面积 5、紫杉醇 175 mg/m2 和贝伐单抗 15 mg/kg，均在每个治疗的第 1 天进行） 3 周周期）加或不加 atezolizumab 1200 mg。持续治疗直至疾病进展、不可接受的毒性、患者退出或死亡。分层因素包括既往伴随放化疗（是、否）、组织学（鳞状细胞癌、腺癌，包括腺鳞癌）和铂骨干（顺铂、卡铂）。双重主要终点是研究者根据实体瘤 1.1 版反应评估标准评估的无进展生存期以及在意向治疗人群中分析的总生存期。这项研究已在 、 、 注册，并且正在进行中。2018年10月8日至2021年8月20日期间，519名接受资格评估的患者中的410名患者入组。阿替利珠单抗组的中位无进展生存期为 13·7 个月 (95% CI 12·3–16·6)，标准治疗组的中位无进展生存期为 10·4 个月 (9·7–11·7)（风险比 [HR]=0· 62 [95% CI 0·49–0·78]；p<0·0001)；在中期总生存分析中，中位总生存期分别为 32·1 个月 (95% CI 25·3–36·8) 和 22·8 个月 (20·3–28·0) (HR 0·68 [95 % CI 0·52–0·88]；p=0·0046）。实验组 79% 的患者和标准组 75% 的患者发生 3 级或更严重的不良事件。阿替利珠单抗导致 1-2 级腹泻、关节痛、发热和皮疹增加。在用于治疗转移性、持续性或复发性宫颈癌的标准贝伐单抗加铂方案中添加阿特珠单抗可显着改善无进展生存期和总生存期，应被视为新的一线治疗选择。F霍夫曼-拉罗氏。