Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Massachusetts General Hospital Cancer Center, Boston, MA, USA.
Leuk Lymphoma. 2020 Dec;61(12):2939-2946. doi: 10.1080/10428194.2020.1791850. Epub 2020 Jul 15.
It is difficult to demonstrate an overall survival (OS) benefit in trials of immediate therapy vs observation in follicular lymphoma (FL). (TT2T) may be a preferred endpoint. We identified 584 consecutive patients at our institution with advanced stage FL grade 1-3 A for whom intention was observation ( = 248) or therapy ( = 338). Median time to 1st treatment (TT1T), TT2T, and OS were estimated (subdistribution function). Modified Kendall's tau (mKτ) was used to assess correlation between survival endpoints. Among initially observed patients, median TT1T was 3.3 years, TT2T was 12.1 years, 10-year treatment-free survival was 23%, and 10-year OS was 82%. TT2T was strongly correlated with OS following initial observation (mKτ 0.46, = .004) or therapy (mKτ 0.53, < .0001), while duration of observation was not. TT2T is a potential surrogate for OS. Given the outstanding survival in this population, early intervention trials should focus on identifying high risk patients.
在滤泡性淋巴瘤（FL）的即时治疗与观察试验中，很难证明总体生存（OS）获益。（TT2T）可能是一个更优的终点。我们在机构中确定了 584 例晚期 FL 1-3A 级的连续患者，他们的治疗意图是观察（n=248）或治疗（n=338）。估计了首次治疗（TT1T）、TT2T 和 OS 的中位时间（亚分布函数）。采用改良 Kendall tau（mKτ）评估生存终点之间的相关性。在最初观察的患者中，中位 TT1T 为 3.3 年，TT2T 为 12.1 年，10 年无治疗生存率为 23%，10 年 OS 为 82%。TT2T 与初始观察（mKτ 0.46， = .004）或治疗（mKτ 0.53， < .0001）后的 OS 密切相关，而观察持续时间则没有。TT2T 可能是 OS 的替代指标。鉴于该人群的生存状况良好，早期干预试验应集中于识别高危患者。
