Strati Paolo, Feng Lei, Westin Jason R, Nair Ranjit, Fayad Luis E, Rodriguez Maria A, Chihara Dai, Malpica Luis, Henderson Jared, Gallardo Mariana, Rivera Marissa, Wang Iris, Bolshakova Anastasiia, Radko Anastasia, Kurtz David, Alig Stefan K, Flowers Christopher R, Alizadeh Ash A, Neelapu Sattva S
Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nat Commun. 2025 Aug 7;16(1):7300. doi: 10.1038/s41467-025-62509-z.
This phase II trial aims to determine the efficacy and safety of frontline acalabrutinib, lenalidomide and rituximab for patients with advanced stage follicular lymphoma (FL) and high tumor burden. The primary endpoint was best complete response (CR) rate; the secondary endpoints were overall response rate (ORR), duration of response measured as CR at 30 months (CR30), progression of disease at 24 months (POD24) rate, progression-free survival (PFS), overall survival and safety. Twenty-four patients with previously untreated FL were included in this phase 2 single arm study (NCT04404088). The most common grade 3-4 adverse events were neutropenia (58%) and liver function test elevation (17%). Best ORR was 100% and best CR rate was 92%. CR30 rate was 65% and POD24 rate was 17%. After a median follow-up of 43 months, median PFS and OS were not reached, 2-year PFS rate was 79% and 2-year OS rate was 92%. Here we show that the addition of acalabrutinib to R is a safe and effective frontline regimen for FL patients, and further exploration in larger clinical trials is needed.
这项II期试验旨在确定一线使用阿卡替尼、来那度胺和利妥昔单抗治疗晚期滤泡性淋巴瘤（FL）且肿瘤负荷高的患者的疗效和安全性。主要终点是最佳完全缓解（CR）率；次要终点是总缓解率（ORR）、以30个月时的CR衡量的缓解持续时间（CR30）、24个月时的疾病进展（POD24）率、无进展生存期（PFS）、总生存期和安全性。24例既往未接受治疗的FL患者纳入了这项2期单臂研究（NCT04404088）。最常见的3-4级不良事件是中性粒细胞减少（58%）和肝功能检查升高（17%）。最佳ORR为100%，最佳CR率为92%。CR30率为65%，POD24率为17%。中位随访43个月后，未达到中位PFS和OS，2年PFS率为79%，2年OS率为92%。我们在此表明，在R方案中添加阿卡替尼对FL患者是一种安全有效的一线治疗方案，需要在更大规模的临床试验中进一步探索。
