医学
强的松
弥漫性大B细胞淋巴瘤
淋巴瘤
国际预后指标
耐受性
肿瘤科
内科学
美罗华
总体生存率
人口
无进展生存期
队列
性能状态
探索性分析
护理标准
人口研究
生存分析
外科
临床试验
存活率
化疗
队列研究
回顾性队列研究
随机对照试验
作者
Franck Morschhauser,Gilles Salles,Laurie H. Sehn,Alex F. Herrera,Jonathan W. Friedberg,Marek Trněný,Georg Lenz,Jeff P. Sharman,Charles Herbaux,John M. Burke,Matthew J. Matasar,Graham P. Collins,Neha Mehta–Shah,Lucie Obéric,Adrien Chauchet,Wojciech Jurczak,Yuqin Song,Antonio Pinto,Shinya Rai,Koji Izutsu
摘要
In the POLARIX study (ClinicalTrials.gov identifier: NCT03274492), polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) showed a significant progression-free survival (PFS) benefit versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously untreated intermediate- or high-risk diffuse large B-cell lymphoma (DLBCL; median follow-up: 28 months). In this 5-year update, sustained PFS benefits favoring Pola-R-CHP were observed. In the global intention-to-treat population (N = 879; median follow-up: 64.1 months), Pola-R-CHP demonstrated a significant PFS benefit over R-CHOP (hazard ratio [HR], 0.77 [95% CI, 0.62 to 0.97]), with 5-year PFS rates of 64.9% (95% CI, 59.8 to 70.0) and 59.1% (95% CI, 53.9 to 64.3), respectively. Although not statistically significant, overall survival analysis showed a HR of 0.85 (95% CI, 0.63 to 1.15) at the 5-year data cut compared with 0.94 (95% CI, 0.67 to 1.33) at the 2-year data cut. In the expanded population, 46 and 62 patients had lymphoma-related deaths in the Pola-R-CHP and R-CHOP arms, respectively. Exploratory analyses showed favorable 5-year survival rates with Pola-R-CHP in high-risk subgroups, including activated B-cell DLBCL and International Prognostic Index score 3-5. Long-term tolerability was similar between treatment arms. Findings confirm Pola-R-CHP represents a standard of care for frontline treatment of DLBCL.