目的:已经开发出一种新颖的肺功能成像形式,该形式使用4DCT数据来生成肺通气图像(4DCT-通气)。功能性回避使用4DCT通气来减少对功能性肺的剂量,目的是减少肺副作用。4DCT通风功能避免,第二阶段,多中心临床试验完成.这项工作的目的是量化接受功能回避治疗的患者的患者报告结果(PRO)变化,并确定哪些指标可以预测PRO变化。
方法:接受根治性放疗的局部晚期肺癌患者。每位患者都有使用4DCT数据和图像处理生成的4DCT通气图像。PRO工具包括癌症治疗肺功能评估(FACT-L)问卷,进行预处理,治疗后3、6和12个月。确定了FACT-TOI(试验结果指数)和FACT-LCS(肺癌子量表)临床意义下降(CMD)的百分比。使用线性混合效应模型来确定哪个患者,临床,剂量,剂量-功能指标可预测PRO下降。
结果:59例患者完成了基线PRO调查。83%的患者患有非小细胞肺癌,75%患有III期疾病。中值剂量为60Gy,分30次。CMDFACT-TOI下降46.3%,38.5%,和26.8%,在3、6和12个月时,分别。CMDFACT-LCS下降33.3%,33.3%,和29.3%,在3、6和12个月时,分别。虽然大多数剂量和剂量功能参数的增加与PRO的适度下降有关,结果均不显著(均p>0.053)。
结论:当前的工作提供了功能回避和PRO的创新组合,并且是针对前瞻性4DCT通气功能回避治疗的患者的PRO的第一份报告。大约30%的患者在12个月时有临床上显著的PRO下降。该研究提供了有关4DCT通气功能回避结果的其他数据。
OBJECTIVE: A novel form of lung function imaging has been developed that uses 4-dimensional computed tomography (4DCT) data to generate lung ventilation images (4DCT-ventilation). Functional avoidance uses 4DCT-ventilation to reduce doses to functional lung with the aim of reducing pulmonary side effects. A phase 2, multicenter 4DCT-ventilation functional avoidance clinical
trial was completed. The purpose of this work was to quantify changes in patient-reported outcomes (PROs) for patients treated with functional avoidance and determine which metrics are predictive of PRO changes.
METHODS: Patients with locally advanced lung cancer receiving curative-intent radiation therapy were accrued. Each patient had a 4DCT-ventilation image generated using 4DCT data and image processing. PRO instruments included the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire administered pretreatment; at the end of treatment; and at 3, 6, and 12 months posttreatment. Using the FACT-
Trial Outcome Index and the FACT-Lung Cancer Subscale results, the percentage of clinically meaningful declines (CMDs) were determined. A linear mixed-effects model was used to determine which patient, clinical, dose, and dose-function metrics were predictive of PRO decline.
RESULTS: Of the 59 patients who completed baseline PRO surveys. 83% had non-small cell lung cancer, with 75% having stage 3 disease. The median dose was 60 Gy in 30 fractions. CMD FACT-
Trial Outcome Index decline was 46.3%, 38.5%, and 26.8%, at 3, 6, and 12 months, respectively. CMD FACT-Lung Cancer Subscale decline was 33.3%, 33.3%, and 29.3%, at 3, 6, and 12 months, respectively. Although an increase in most dose and dose-function parameters was associated with a modest decline in PROs, none of the results were significant (all P > .053).
CONCLUSIONS: The current work presents an innovative combination of use of functional avoidance and PRO assessment and is the first report of PROs for patients treated with prospective 4DCT-ventilation functional avoidance. Approximately 30% of patients had clinically significant decline in PROs at 12 months posttreatment. The
study provides additional data on outcomes with 4DCT-ventilation functional avoidance.