ANASTASE研究是针对PD-L1阳性转移性三阴性乳腺癌的一项现实世界研究，探究了atezolizumab+nab-紫杉醇作为一线治疗的效果。
Real-world ANASTASE study of atezolizumab+nab-paclitaxel as first-line treatment of PD-L1-positive metastatic triple-negative breast cancer.
发表日期：2023 Sep 08
作者：
Alessandra Fabi, Luisa Carbognin, Andrea Botticelli, Ida Paris, Paolo Fuso, Maria Cristina Savastano, Nicla La Verde, Carla Strina, Rebecca Pedersini, Stefania Guarino, Giuseppe Curigliano, Carmen Criscitiello, Mimma Raffaele, Alessandra Beano, Antonio Franco, Maria Rosaria Valerio, Francesco Verderame, Andrea Fontana, Eva Regina Haspinger, Alessia Caldara, Alba Di Leone, Giampaolo Tortora, Diana Giannarelli, Giovanni Scambia
来源：
npj Breast Cancer
摘要：
基于III期IMpassion130试验的结果，组合使用atezolizumab和nab-紫杉醇已被欧盟推荐作为PD-L1阳性转移性三阴性乳腺癌（mTNBC）的一线治疗。然而，关于这种组合的'真实世界'数据有限。ANASTASE研究（NCT05609903）收集了意大利同情用药计划中PD-L1阳性mTNBC患者接受atezolizumab加nab-紫杉醇治疗的数据。在29个意大利肿瘤中心中进行了一项回顾性分析，纳入了至少完成一周期治疗的患者的数据。共收集了52名患者的数据。其中，21.1%表现为原发性IV期；78.8%曾接受（新辅）助治疗；55.9%患者只有一个转移部位；治疗周期的中位数为5个（IQR：3-8）；客观反应率为42.3%（95%CI：28.9-55.7%）。治疗中止的中位时间为5个月（95%CI：2.8-7.1）；12个月时的临床效益为45.8%。反应持续时间的中位数为12.7个月（95%CI：4.1-21.4）。在中位随访时间为20个月时，无进展生存期的中位数为6.3个月（95%CI：3.9-8.7），下一次治疗或死亡的中位时间为8.1个月（95%CI：5.5-10.7）。12个月和24个月时的总生存率分别为66.3%和49.1%。最常见的免疫相关不良事件包括皮疹（23.1%）、肝炎（11.5%）、甲状腺炎（11.5%）和肺炎（9.6%）。在ANASTASE研究中，接受一线atezolizumab加nab-紫杉醇治疗的PD-L1阳性mTNBC患者达到了IMpassion130研究中报道的PFS和ORR水平，并未出现意外不良事件。© 2023. Springer Nature Limited.
The combination of atezolizumab and nab-paclitaxel is recommended in the EU as first-line treatment for PD-L1-positive metastatic triple-negative breast cancer (mTNBC), based on the results of phase III IMpassion130 trial. However, 'real-world' data on this combination are limited. The ANASTASE study (NCT05609903) collected data on atezolizumab plus nab-paclitaxel in PD-L1-positive mTNBC patients enrolled in the Italian Compassionate Use Program. A retrospective analysis was conducted in 29 Italian oncology centers among patients who completed at least one cycle of treatment. Data from 52 patients were gathered. Among them, 21.1% presented de novo stage IV; 78.8% previously received (neo)adjuvant treatment; 55.8% patients had only one site of metastasis; median number of treatment cycles was five (IQR: 3-8); objective response rate was 42.3% (95% CI: 28.9-55.7%). The median time-to-treatment discontinuation was 5 months (95% CI: 2.8-7.1); clinical benefit at 12 months was 45.8%. The median duration of response was 12.7 months (95% CI: 4.1-21.4). At a median follow-up of 20 months, the median progression-free survival was 6.3 months (95% CI: 3.9-8.7) and the median time to next treatment or death was 8.1 months (95% CI: 5.5-10.7). At 12 months and 24 months, the overall survival rates were 66.3% and 49.1%, respectively. The most common immune-related adverse events included rash (23.1%), hepatitis (11.5%), thyroiditis (11.5%) and pneumonia (9.6%). Within the ANASTASE study, patients with PD-L1-positive mTNBC treated with first-line atezolizumab plus nab-paclitaxel achieved PFS and ORR similar to those reported in the IMpassion130 study, with no unexpected adverse events.© 2023. Springer Nature Limited.