阿替利珠单抗联合贝伐珠单抗与索拉非尼治疗肝细胞癌的反应特征：IMbrave150 试验结果。
Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial.
机构信息
Department of Radiology, Feinberg School of Medicine, Northwestern University, Evanston, IL, USA.
Department of Medical Oncology, City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte, CA, USA.
出版信息
Cancer Med. 2021 Aug;10(16):5437-5447. doi: 10.1002/cam4.4090. Epub 2021 Jun 29.
BACKGROUND
IMbrave150 is a phase III trial that assessed atezolizumab + bevacizumab (ATEZO/BEV) versus sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (HCC) and demonstrated a significant improvement in clinical outcomes. Exploratory analyses characterized objective response rate (ORR), depth (DpR), and duration of response (DoR), and patients with a complete response (CR).
METHODS
Patients were randomized 2:1 to intravenous ATEZO (1200 mg) + BEV (15 mg/kg) every 3 weeks or oral SOR (400 mg) twice daily. Tumors were evaluated using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and HCC-modified RECIST (mRECIST). ORR by prior treatment and largest baseline liver lesion size, DoR, time to response (TTR), and complete response (TTCR) were analyzed.
RESULTS
For both criteria, responses favored ATEZO/BEV versus SOR regardless of prior treatment and in patients with lesions ≥3 cm. Median TTR was 2.8 months per RECIST 1.1 (range: 1.2-12.3 months) and 2.8 months per mRECIST (range: 1.1-12.3 months) with ATEZO/BEV. Patients receiving ATEZO/BEV had a greater DpR, per both criteria, across baseline liver lesion sizes. Characteristics of complete responders were similar to those of the intent-to-treat population. In complete responders receiving ATEZO/BEV per mRECIST versus RECIST 1.1, respectively, median TTCR was shorter (5.5 vs. 7.0 months), mean baseline sum of lesion diameter was longer (5.0 [SD, 5.1] vs. 2.6 [SD, 1.4] cm), and mean largest liver lesion size was larger (4.8 [SD, 4.2] vs. 2.3 [SD, 1.0] cm).
CONCLUSIONS
These data highlight the improved ORR, DpR, and CR rates with ATEZO/BEV in unresectable HCC.
背景
IMbrave150 是一项评估阿替利珠单抗联合贝伐珠单抗（ATEZO/BEV）对比索拉非尼（SOR）用于不可切除肝细胞癌（HCC）患者的 III 期临床试验，结果表明其临床结局显著改善。探索性分析了客观缓解率（ORR）、缓解深度（DpR）和缓解持续时间（DoR）以及完全缓解（CR）患者的特征。
方法
患者按 2:1 随机分组，分别接受静脉注射 ATEZO（1200mg）联合 BEV（15mg/kg）每 3 周 1 次或口服 SOR（400mg）每日 2 次。采用实体瘤反应评价标准 1.1（RECIST 1.1）和 HCC 改良 RECIST（mRECIST）评估肿瘤。分析了既往治疗和最大基线肝脏病变大小的 ORR、DoR、反应时间（TTR）和完全缓解时间（TTCR）。
结果
在 RECIST 1.1 和 mRECIST 标准下，无论既往治疗如何，以及基线肝脏病变≥3cm 的患者，ATEZO/BEV 均优于 SOR。ATEZO/BEV 的 RECIST 1.1 中位 TTR 为 2.8 个月（范围：1.2-12.3 个月），mRECIST 为 2.8 个月（范围：1.1-12.3 个月）。无论基线肝脏病变大小如何，ATEZO/BEV 治疗的 DpR 均更大。完全缓解患者的特征与意向治疗人群相似。mRECIST 下，与 RECIST 1.1 相比，完全缓解患者接受 ATEZO/BEV 的 TTCR 更短（5.5 个月 vs. 7.0 个月），基线时病变直径总和更长（5.0cm[标准差[SD]，5.1cm] vs. 2.6cm[SD，1.4cm]），最大肝脏病变最大径更大（4.8cm[SD，4.2cm] vs. 2.3cm[SD，1.0cm]）。
结论
这些数据突出了阿替利珠单抗联合贝伐珠单抗在不可切除 HCC 中的 ORR、DpR 和 CR 率提高。
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