Clinical interest of PD-L1 immuno-histochemistry expression as a predictive factor of Bacillus Calmette Guerin (BCG) efficacy in refractory high-risk non-muscle-invasive bladder cancer (NMIBC)

  • Clara Delcourt
  • Pierre Gemival
  • François Xavier Nouhaud
  • Françoise Gobet
  • Andre Gillibert
  • Sophie Ferlicot
  • Jean Christophe Sabourin
  • Jacques Irani
  • Christian PfisterEmail author
Original Article



To assess PD-L1 expression in tumor (TC) and tumor infiltrating immune cells (IC) as a predictive factor of BCG therapy failure in high-risk NMIBC.

Materials and methods

Patients treated with complete resection followed by bladder BCG instillation for high-risk NMIBC were included. Early recurrence (ER) was defined as tumor recurrence after BCG induction course. The association between ER and immuno-histochemistry PD-L1 (E1L3N clone) expression by tumors cells (TC) and tumor infiltrating immune cells (IC) was investigated using an exact Fisher test variant.


A total of 186 patients were included, of whom 38 (20.4%) were ER, 35 (18.8%) were positive for TC PD-L1 expression and 60 (32.3%) were positive for IC PD-L1. ER was not significantly (p = 0.97) more frequent in the TC PD-L1 ≥ 1% group (n = 7, 20.0%) than in the TC PD-L1-negative group (n = 31, 20.5%). Patients with IC PD-L1 negative had ER in 15 (19.2%) cases and patients with IC PD-L1 ≥ 1% had ER in 23 (21.3%) cases. PD-L1-positive expression for IC (threshold > 1%) was correlated with immune infiltrate density (95.2% dense immune infiltrate vs 47.2% low immune infiltrate, p < 0.05), with increased expression of PD-L1 by IC after BCG therapy (p = 0.006).


No association was observed between immuno-histochemistry PD-L1 positivity and ER after BCG therapy. Nevertheless, the relationship between immune infiltrate and PD-L1 positivity confirmed the interest of assessing the immune infiltrate density to define tumor’s profile.


PD-L1 BCG Bladder cancer 


Author contributions

CD: project development, data collection, manuscript writing. PG: data collection and histological analysis. FXN: project development, data collection. FG: data collection and histological analysis. AG: data collection and statistical analysis. SF: data collection and histological analysis. JCS: data collection and histological analysis. JI: project development, data collection. CP: project development, data collection, manuscript writing and review for important intellectual contents

Compliance with ethical standards

Conflict of interest

The authors declare that they have no competing interests.

Ethical approval

The study protocol was approved by the respective local Ethics Committee.

Informed consent

All patients gave their written informed consent to be included in the study.


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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Clara Delcourt
    • 1
  • Pierre Gemival
    • 2
  • François Xavier Nouhaud
    • 1
  • Françoise Gobet
    • 2
  • Andre Gillibert
    • 3
  • Sophie Ferlicot
    • 4
  • Jean Christophe Sabourin
    • 2
  • Jacques Irani
    • 5
  • Christian Pfister
    • 1
    • 6
    Email author
  1. 1.Department of UrologyCharles Nicolle Rouen University HospitalRouen CedexFrance
  2. 2.Department of PathologyRouen University HospitalRouenFrance
  3. 3.Department of BiostatisticsRouen University HospitalRouenFrance
  4. 4.Department of PathologyKremlin Bicêtre HospitalParisFrance
  5. 5.Department of UrologyKremlin Bicêtre HospitalParisFrance
  6. 6.Clinical Investigation Center, Inserm 6204, Onco-UrologyRouenFrance

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