Obstructive Sleep Apnea Influences Efficacy of PD-1-Based Immunotherapy Against Non-Small Cell Lung Cancer

Progression-Free Survival (PFS)

PFS was defined as the time from recruitment to the first occurrence of progressive disease(PD) or death due to any cause. PD: at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Overall survival (OS)

OS was defined as the time from the date of enrollment to the date of death due to any cause.

Time frame: From date of randomization until the date of death from any cause, assessed up to 48 months

Compared the baseline sleep monitor results between Group NSCLC and Group OSA+NSCLC.

Record baseline AHI, oxygen desaturation index (ODI), lowest saturation by pulse oximetry (SpO2)\<90%, obstructive apnea index (OAI), central apnea index(CAI), the longest apnea duration, then compare between Group NSCLC and Group OSA+NSCLC.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Factors associated with ORR in NSCLC patients

Cox regression analysis will be used to identify predictors of ORR.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Factors associated with OS and PFS in NSCLC patients

Univariate and multivariate Cox proportional hazards models will be used to identify predictors of PFS and OS.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Compared the baseline level of lymphocytes classification and count between Group NSCLC and Group OSA+NSCLC.

Record baseline lymphocytes classification and count in peripheral blood, then compare between Group NSCLC and Group OSA+NSCLC.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Compared the baseline level of inflammatory biomarkers between Group NSCLC and Group OSA+NSCLC.

Record baseline interleukin 6 (IL-6) and C-reactive Protein (CRP) in peripheral blood, then compare between Group NSCLC and Group OSA+NSCLC.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

The association between OSA and baseline inflammatory biomarkers, peripheral lymphocytes classification and count.

The Spearman correlation test will be used to identify the association between sleep monitor results and the baseline inflammatory biomarkers, peripheral lymphocytes classification and count, including AHI, ODI, lowest SpO2, SpO2\<90%, OAI, CAI, the longest apnea duration

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Compared the baseline gut microbiome between Group NSCLC and Group OSA+NSCLC.

Record baseline gut microbiome by metagenomic shotgun sequencing, then compare between Group NSCLC and Group OSA+NSCLC.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

The association between OSA and the diversity of gut microbiome.

The Spearman correlation test will be used to identify the association between sleep monitor results and the diversity of gut microbiome, including AHI, ODI, lowest SpO2, SpO2\<90%, OAI, CAI, the longest apnea duration.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months