Supplementary Material for: The effect of mind-body intervention on lymphocyte doubling time and treatment free survival in treatment-naïve chronic lymphocytic leukemia patients

Introduction: Mind-Body Intervention (MBI) serves as supportive aid in oncology. We hypothesized that MBI could impact the progression of Chronic Lymphocytic Leukemia (CLL) in the 'watch and wait' (w&w) phase.
Methods: MBI was utilized in a non-randomized prospective controlled study between 02/2020-02/2022 in 76 treatment-naïve CLL patients in the w&w phase (37 intervention and 39 control patients). The primary and secondary endpoints were prolongation of Lymphocyte Doubling Time (LDT) and treatment-free survival (TFS). The prolongation of LDT was compared at 0, 180, 360, and 540 days using paired t-tests. TFS was compared between intervention and control groups using the log-rank test. Cox proportional hazards models were used to calculate the hazard ratio (HR) and 95% confidence interval (CI) for TFS in the intervention group compared to the control, stratified by the study covariates.
Results: MBI prolonged LDT at all time points, including at day 360 (Median of 2.47 years; CI 1.05-3.9; p= 0.001). TFS at 18 months was longer in the intervention group compared to the control group (HR 0.23; CI 0.06-0.79, p=0.01).
Conclusions: MBI was associated with prolonged LDT and TFS in patients with CLL in the w&w phase. These results provide a basis for a larger randomized-control trial.

引言：心身干预（Mind-Body Intervention, MBI）是肿瘤学领域的辅助支持手段。本研究假设，心身干预可对处于观察等待（watch and wait, w&w）阶段的慢性淋巴细胞白血病（Chronic Lymphocytic Leukemia, CLL）患者的疾病进展产生影响。
方法：本研究于2020年2月至2022年2月开展一项非随机前瞻性对照研究，纳入76例处于观察等待阶段的初治慢性淋巴细胞白血病患者，其中干预组37例，对照组39例。本研究的主要终点与次要终点分别为淋巴细胞倍增时间（Lymphocyte Doubling Time, LDT）的延长情况与无治疗生存期（treatment-free survival, TFS）。分别于第0、180、360及540天采用配对t检验比较两组患者的淋巴细胞倍增时间变化；采用对数秩检验对比干预组与对照组的无治疗生存期差异；通过Cox比例风险模型计算干预组相较对照组的无治疗生存期风险比（hazard ratio, HR）及95%置信区间（confidence interval, CI），并按研究协变量进行分层分析。
结果：心身干预在所有观测时间点均能延长患者的淋巴细胞倍增时间，其中第360天时的差异具有统计学意义（中位值2.47年；置信区间1.05~3.9；p=0.001）。干预组18个月时的无治疗生存期显著长于对照组（风险比0.23；置信区间0.06~0.79，p=0.01）。
结论：对于处于观察等待阶段的慢性淋巴细胞白血病患者，心身干预与淋巴细胞倍增时间及无治疗生存期的延长显著相关。本研究结果可为后续开展大规模随机对照试验提供科学依据。