Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access
Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc
Journal website http://www.jocmr.org

Original Article

Volume 12, Number 5, May 2020, pages 300-306


Treating Japanese Patients With Pembrolizumab for Platinum-Refractory Advanced Urothelial Carcinoma in Real-World Clinical Practice

Figure

Figure 1.
Figure 1. (a) PFS of all cases. (b) OS of all cases. (c) OS according to pembrolizumab treatment line. PFS: progression-free survival; OS: overall survival.

Tables

Table 1. Patients’ Characteristics
 
Characteristic (n = 34)
ECOG-PS: Eastern Cooperative Oncology Group Performance Status; UC: urothelial carcinoma; Hb: hemoglobin; NLR: neutrophil/lymphocyte ratio; LDH: lactate dehydrogenase; CRP: C-reactive protein.
Age (years), median (range)71 (57 - 87)
Male sex, n (%)28 (82)
ECOG-PS score, n (%)
  020 (59)
  ≥ 114 (41)
Primary tumor site, n (%)
  Bladder13 (38)
  Upper urinary tract12 (35)
  Bladder + upper urinary tract9 (27)
Pure UC in histologic testing, n (%)27 (79)
Number of prior chemotherapy regimens
  122 (64)
  26 (18)
  36 (18)
Hb < 10g/dL, n (%)14 (41)
NLR, median (range)2.2 (0.7 - 18.0)
Albumin < 4.1 g/dL, n (%)23 (68)
LDH > 222 U/L, n (%)10 (29)
CRP > 0.14 mg/dL, n (%)26 (76)
Visceral metastases, n (%)27 (79)
  Liver metastases, n (%)11 (32)
Time from previous chemotherapy < 3 months, n (%)27 (79)

 

Table 2. Toxicities in Patients Treated With Pembrolizumab Treatment
 
Any gradeGrade 3
AEs: adverse events.
Treatment-related AEs, n (%)21 (62)8 (24)
  Fatigue62
  Pruritus50
  Fever20
  Hematuria22
  Anorexia21
  Lung infection21
  Pain11
  Anemia11
  Kidney infection11
  Creatinine increased11
  Aspartate and alanine aminotransferase increased11
  Constipation10
  Infusion related reaction10
  Diarrhea10
  Ileus10
  Interstitial pneumonia10
  Hyponatremia10
  Eyelid function disorder10
  Nervous system disorders10

 

Table 3. The Univariate and Multivariate Analyses of the Factors Associated With Overall Survival in Patients Receiving Pembrolizumab Treatment
 
VariableUnivariateMultivariate
HR (95% CI)P valueHR (95% CI)P value
HR: hazard ratio; CI: confidence interval; ECOG-PS: Eastern Cooperative Oncology Group Performance Status; UC: urothelial carcinoma; Hb: hemoglobin; NLR: neutrophil/lymphocyte ratio; LDH: lactate dehydrogenase; CRP: C-reactive protein.
Age0.99 (0.93 - 1.05)0.72
Sex
  Male1
  Female0.91 (0.33 - 2.52)0.86
ECOG -PS
  011
  12.81 (1.13 - 7.29)0.031.61 (0.58 - 4.45)0.36
Primary tumor site
  Bladder1
  Upper urinary tract0.95 (0.34 - 2.70)0.93
  Bladder + upper urinary tract1.69 (0.56 - 5.11)0.35
Histology
  Pure UC1
  Mixed UC2.84 (0.66 - 12.25)0.16
Hb
  ≥ 10 g/dL1
  < 10 g/dL1.50 (0.61 - 3.58)0.37
NLR1.24 (1.03 - 1.46)0.031.07 (0.86 - 1.30)0.50
Albumin
  ≥ 4.1 g/dL1
  < 4.1 g/dL1.57 (0.61 - 4.09)0.34
LDH
  ≤ 222 U/L1
  > 222 U/L3.76 (1.41 - 10.03)0.07
CRP
  ≤ 0.14 mg/dL1
  > 0.14 mg/dL2.04 (0.68 - 6.09)0.20
Liver metastases
  Negative11
  Positive3.61 (1.47 - 8.84)< 0.014.23 (1.48 - 12.08)< 0.01
Time from previous chemotherapy
  < 3 months11
   ≥ 3 months3.59 (1.26 - 10.22)0.025.06 (1.43 - 17.91)0.01