Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, TX.
SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.
JCO Oncol Pract. 2022 Apr;18(4):e442-e451. doi: 10.1200/OP.21.00407. Epub 2021 Oct 4.
Health-related quality of life (HRQOL) is an established prognostic factor for mortality; however, it is unclear if HRQOL is predictive of time to disease progression, a particularly meaningful outcome for patients. We examined the association between HRQOL and progression-free survival (PFS) in SWOG Cancer Research Network clinical trials.
For this secondary analysis, we reviewed all completed SWOG clinical trials to identify those for patients with advanced cancer that incorporated Functional Assessment of Cancer Therapy (FACT) questionnaires at baseline. FACT-Trial Outcome Index (FACT-TOI) was the primary independent variable. Associations between FACT-TOI and other FACT subscores with PFS and overall survival were evaluated via log-rank test and multivariable Cox regression analysis.
Three clinical trials met our inclusion criteria: S0027 and S9509 for advanced non-small-cell lung cancer and S0421 for hormone-refractory prostate cancer. Of the 1,527 enrolled patients, 1,295 (85%) had both HRQOL and survival outcomes data available and were included in this analysis. In univariable analysis, we observed a statistically significant gradient effect in all three trials, with higher baseline FACT-TOI scores corresponding to better PFS (S0027, < .001; S9509, = .02; and S0421, < .001). In multivariable analysis, FACT-TOI was significantly associated with PFS in S0027 (hazard ratio [HR] = 0.64; 95% CI, 0.42 to 1.00) but not in S9509 (HR = 0.77; 95% CI, 0.56 to 1.05) or S042 (HR = 0.86; 95% CI, 0.73 to 1.01). FACT-TOI was significantly associated with overall survival in multivariable analysis ( < .005 in all three trials).
The association between baseline FACT-TOI scores and survival underscores their potential as a stratification factor in clinical trials.
健康相关生活质量（HRQOL）是死亡率的既定预后因素；然而，HRQOL 是否可预测疾病进展时间尚不清楚，而疾病进展时间对于患者来说是一个特别有意义的结果。我们研究了 HRQOL 与 SWOG 癌症研究网络临床试验中无进展生存期（PFS）之间的相关性。
本二次分析研究回顾了所有完成的 SWOG 临床试验，以确定那些纳入基线功能性评估癌症治疗量表（FACT）问卷的晚期癌症患者的临床试验。FACT 试验结局指数（FACT-TOI）是主要的独立变量。通过对数秩检验和多变量 Cox 回归分析评估 FACT-TOI 与其他 FACT 亚量表与 PFS 和总生存期之间的相关性。
有 3 项临床试验符合我们的纳入标准：用于晚期非小细胞肺癌的 S0027 和 S9509 以及用于激素难治性前列腺癌的 S0421。在纳入的 1527 名患者中，有 1295 名（85%）同时具有 HRQOL 和生存结局数据，这些患者被纳入本分析。在单变量分析中，我们观察到这 3 项试验均存在统计学上显著的梯度效应，较高的基线 FACT-TOI 评分与较好的 PFS 相关（S0027，<.001；S9509，=.02；S0421，<.001）。在多变量分析中，FACT-TOI 与 S0027 的 PFS 显著相关（风险比[HR] = 0.64；95%CI，0.42 至 1.00），但与 S9509（HR = 0.77；95%CI，0.56 至 1.05）或 S042（HR = 0.86；95%CI，0.73 至 1.01）无关。FACT-TOI 在多变量分析中与总生存期显著相关（在所有 3 项试验中均<.005）。
基线 FACT-TOI 评分与生存之间的相关性突出了其作为临床试验分层因素的潜力。
