Second, because of the small sample size, the bias observed in the study population may be different from those of larger populations

Second, because of the small sample size, the bias observed in the study population may be different from those of larger populations. and 26 patients were analyzed two and four weeks after nivolumab administration, respectively. The results showed that the NLR after four weeks could predict PFS. The median PFS in 21 patients with NLR 5 after four weeks of nivolumab administration was 95 days (95% confidence interval [CI] 50CNA), while the mPFS in five patients with NLR 5 was 10 days (95% CI 6CNA). NLR 5 showed a hazard ratio of 5.995 (95% CI 1.225C29.35). Conclusion Clarifying NLR four weeks after nivolumab administration may be useful to predict outcomes in nivolumab\treated patients. mutations, rearrangements, and proto\oncogene receptor tyrosine kinase rearrangements, as well as PD\L1 expression status were collected when available. The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Uji\Tokushukai Medical Center (approval date: 29 September 2017; approval number, “type”:”entrez-protein”,”attrs”:”text”:”TGE00856″,”term_id”:”1609359144″,”term_text”:”TGE00856″TGE00856\007). Written informed consent was not required because of the retrospective nature of the study and assured anonymity. Treatment assessment Anti\tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. RECIST evaluation was conducted by chest X\ray and computed tomography (CT), and the treating physicians and radiologists assessed disease progression. The continuation of nivolumab was allowed at the time of RECIST\PD considering the nonconventional response of ICIs, and was SU14813 double bond Z reassessed SU14813 double bond Z by CT within one month. Adverse events were evaluated by Common Terminology Criteria in Adverse Events (CTCAE) version 4.0. Definitions of variables and subpopulations The following markers reflecting the immunological and nutritional status of the host were investigated: mGPS, CAR, NLR, PLR, PNI, and ALI. The mGPS was constructed as a combination of CRP and albumin. Patients with CRP 1 mg/dL were allocated a score of 0, elevated CRP ( 1 mg/dL) a score of 1 1, and those with both elevated CRP and hypoalbuminemia ( 3.5 g/dL) were allocated a score of 2. The CAR was calculated as the ratio of CRP (mg/dL) to albumin (g/dL), and the cutoff value was set at 0.424 or 0.424. The NLR is the ratio of absolute neutrophil count/l to absolute lymphocyte count/l, and the cut\off value was set at 5 or 5. The PLR was calculated as the ratio of the absolute platelet count/L to absolute lymphocyte count/L, and the cutoff values were set at 150, 150C300, and 300. The PNI was calculated using the formula 10 albumin (g/dL) + 0.005 absolute lymphocyte count/L, and the cutoff value was set at 40 or 40. The ALI was calculated using the formula of body mass index at each time point albumin (g/dL) divided by the NLR, and the cutoff value was set at 18 or 18. The cutoff values were Kcnmb1 set based on previous reports. These markers were reassessed two and four weeks after the first cycle of nivolumab. After grouping the cohort by mGPS, CAR, NLR, PLR, and PNI using the abovementioned cutoff values, the PFS in each subgroup was analyzed during the time course of nivolumab treatment in order to clarify whether these markers were associated with PFS. Evaluation of each marker during treatment The abovementioned markers were retrospectively evaluated in each subpopulation at three time points: the initial administration of nivolumab, and two and four weeks later. When disease progression was observed within two or four weeks, subjects were excluded from further analysis. Statistical analysis All statistical analyses were performed using EZR, a graphical user interface for R (R Foundation for Statistical Computing, Vienna, Austria).36 The median PFS (mPFS) with 95% confidence interval (CI) and the objective response rate (ORR) were calculated, and PFS curves were generated according to the KaplanCMeier method. The stratified data of each marker related to mPFS were evaluated by Cox proportional hazards regression analysis. The KaplanCMeier curves of PFS were assessed and compared between subpopulations. Results Baseline patient characteristics The baseline characteristics of the patients are listed in Table ?Table1.1. The median age was 71 years (range: 54C83); 11 patients were female and 19 were male; 24 patients had ECOG PS scores of 0C1 and 6 experienced scores SU14813 double bond Z of 2C3; 26 individuals were current or former smokers, while 4 were by no means smokers; and 21 individuals experienced adenocarcinoma (without any driver oncogenes, except for one mutant patient) and 9 individuals experienced squamous cell carcinoma. Nivolumab SU14813 double bond Z was given as.

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