Department of Medicine, Program in Public Health and Chao Family Comprehensive Cancer Center, University of California, Irvine, CA 92697, United States of America.
NRG Oncology Statistics & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States of America.
Gynecol Oncol. 2021 Nov;163(2):392-397. doi: 10.1016/j.ygyno.2021.08.028. Epub 2021 Sep 20.
In a prospective study of platinum-resistant ovarian cancer patients, we examined whether the Disease-related Symptoms-Physical (DRS--P) scale of the NCCN/FACT-Ovarian Cancer Symptom Index-18 (NFOSI-18) is responsive to clinical change in patients estimated by their provider to survive at least six months.
The NFOSI-18, and other FACT measures, was collected at study entry and 3 and 6 months post-enrollment. Measures were compared for those who died or dropped off study prior to 3 months or prior to 6 months (assumed as health deterioration over time), or those who stayed on study through 6 months (presumed as stable disease over time). Statistical analyses included a fitted linear mixed model for estimating the group differences over time, Cox regression to assess the probability of survival with patient-reported outcomes, and effect size.
DRS-P scores of patients who completed only one assessment were significantly lower compared to patients who were able to complete two assessments [5.9 points lower (2.0-9.8); p < 0.01], or three assessments [8.1 points lower (4.8-11.5); p < 0.01]. Measures of abdominal discomfort, functional well-being, emotional well-being, and quality of life were also significant, but treatment side effects were not. Further, in every scale except for neurotoxicity, higher (better) baseline scores were associated with a decreased likelihood of death, after adjusting for age, performance and disease status.
The NFOSI-18 DRS-P scale is responsive to clinical change. It has potential as an indicator of changing health status with ovarian cancer disease progression, distinct from treatment side effects.
在一项铂耐药卵巢癌患者的前瞻性研究中，我们研究了 NCCN/FACT-Ovarian Cancer Symptom Index-18（NFOSI-18）的疾病相关症状-身体（DRS-P）量表是否能反映出患者的临床变化，这些患者的提供者预计他们能至少存活 6 个月。
在研究入组时以及入组后 3 个月和 6 个月时，收集 NFOSI-18 和其他 FACT 量表。将在 3 个月前或 6 个月前死亡或退出研究的患者（假定为随时间恶化的健康状况）与在 6 个月内继续研究的患者（假定为随时间稳定的疾病）的测量结果进行比较。统计分析包括拟合线性混合模型，以估计随时间的组间差异，Cox 回归评估生存概率与患者报告结局的关系，以及效应大小。
仅完成一次评估的患者的 DRS-P 评分明显低于能够完成两次评估的患者[低 5.9 分（2.0-9.8）；p<0.01]，或完成三次评估的患者[低 8.1 分（4.8-11.5）；p<0.01]。腹部不适、功能健康、情绪健康和生活质量的测量也有显著差异，但治疗副作用没有。此外，在除神经毒性以外的每个量表中，较高（更好）的基线评分与调整年龄、表现和疾病状态后死亡可能性降低相关。
NFOSI-18 的 DRS-P 量表能反映临床变化。它有可能成为卵巢癌疾病进展时衡量健康状况变化的指标，与治疗副作用不同。
