Purified Protein Derivative Skin test prior to bacillus Calmette-Guérin Therapy May have Therapeutic Impact in Patients with Nonmuscle Invasive Bladder Cancer

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Abstract

Purpose: We investigated the clinical impact of the purified protein derivative skin test prior to bacillus Calmette-Guérin therapy in patients with nonmuscle invasive bladder cancer treated with adjuvant bacillus Calmette-Guérin therapy. Materials and Methods: A total of 498 patients with nonmuscle invasive bladder cancer treated with adjuvant bacillus Calmette-Guérin were included in study, of whom 320 underwent the purified protein derivative skin test 1 to 2 weeks prior to therapy. Oncologic outcomes and the rate of bacillus Calmette-Guérin related side effects were statistically evaluated. Results: The mean ± SD 5-year recurrence-free survival rate in patients who did vs did not undergo the purified protein derivative skin test was 66.6% ± 2.8% and 59.1% ± 4.1%, respectively, which was significantly different (p = 0.048). No significant difference was observed in the progression-free survival rate between patients who did vs did not undergo the test. Multivariate Cox regression analysis revealed that a history of recurrence (HR 1.59, p = 0.02), multiple tumors (HR 1.95, p <0.01), the bacillus Calmette-Guérin Connaught strain (HR 0.71, p = 0.04), 7 or more bacillus Calmette-Guérin instillations (HR 0.70, p = 0.04) and undergoing the purified protein derivative skin test (HR 0.72, p = 0.04) were independently associated with tumor recurrence. Major bacillus Calmette-Guérin related side effects were noted in 77 of the 320 patients (24.1%) who did vs 27 of the 178 (15.2%) who did not undergo the test, which was significantly different (p = 0.02). Conclusions: The purified protein derivative skin test prior to bacillus Calmette-Guérin treatment enhances the therapeutic effects of this treatment and potentially results in a higher incidence of major bacillus Calmette-Guérin related side effects. Combination therapy with bacillus Calmette-Guérin using the purified protein derivative skin test may improve the oncologic outcomes of that therapy.

Original languageEnglish
JournalJournal of Urology
DOIs
Publication statusAccepted/In press - 2018 Jan 1

Fingerprint

Skin Tests
Urinary Bladder Neoplasms
Bacillus
Proteins
Therapeutics
Recurrence
Survival Rate
Therapeutic Uses
Disease-Free Survival
Neoplasms
Regression Analysis
Incidence

Keywords

  • adjuvants
  • adverse effects
  • BCG vaccine
  • immunologic
  • skin tests
  • urinary bladder neoplasms

ASJC Scopus subject areas

  • Urology

Cite this

@article{e7c131fc828f49e6bb3510e2de9b0182,
title = "Purified Protein Derivative Skin test prior to bacillus Calmette-Gu{\'e}rin Therapy May have Therapeutic Impact in Patients with Nonmuscle Invasive Bladder Cancer",
abstract = "Purpose: We investigated the clinical impact of the purified protein derivative skin test prior to bacillus Calmette-Gu{\'e}rin therapy in patients with nonmuscle invasive bladder cancer treated with adjuvant bacillus Calmette-Gu{\'e}rin therapy. Materials and Methods: A total of 498 patients with nonmuscle invasive bladder cancer treated with adjuvant bacillus Calmette-Gu{\'e}rin were included in study, of whom 320 underwent the purified protein derivative skin test 1 to 2 weeks prior to therapy. Oncologic outcomes and the rate of bacillus Calmette-Gu{\'e}rin related side effects were statistically evaluated. Results: The mean ± SD 5-year recurrence-free survival rate in patients who did vs did not undergo the purified protein derivative skin test was 66.6{\%} ± 2.8{\%} and 59.1{\%} ± 4.1{\%}, respectively, which was significantly different (p = 0.048). No significant difference was observed in the progression-free survival rate between patients who did vs did not undergo the test. Multivariate Cox regression analysis revealed that a history of recurrence (HR 1.59, p = 0.02), multiple tumors (HR 1.95, p <0.01), the bacillus Calmette-Gu{\'e}rin Connaught strain (HR 0.71, p = 0.04), 7 or more bacillus Calmette-Gu{\'e}rin instillations (HR 0.70, p = 0.04) and undergoing the purified protein derivative skin test (HR 0.72, p = 0.04) were independently associated with tumor recurrence. Major bacillus Calmette-Gu{\'e}rin related side effects were noted in 77 of the 320 patients (24.1{\%}) who did vs 27 of the 178 (15.2{\%}) who did not undergo the test, which was significantly different (p = 0.02). Conclusions: The purified protein derivative skin test prior to bacillus Calmette-Gu{\'e}rin treatment enhances the therapeutic effects of this treatment and potentially results in a higher incidence of major bacillus Calmette-Gu{\'e}rin related side effects. Combination therapy with bacillus Calmette-Gu{\'e}rin using the purified protein derivative skin test may improve the oncologic outcomes of that therapy.",
keywords = "adjuvants, adverse effects, BCG vaccine, immunologic, skin tests, urinary bladder neoplasms",
author = "Naoya Niwa and Eiji Kikuchi and Kazuhiro Matsumoto and Takeo Kosaka and Ryuichi Mizuno and Mototsugu Oya",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.juro.2017.12.057",
language = "English",
journal = "Journal of Urology",
issn = "0022-5347",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Purified Protein Derivative Skin test prior to bacillus Calmette-Guérin Therapy May have Therapeutic Impact in Patients with Nonmuscle Invasive Bladder Cancer

AU - Niwa, Naoya

AU - Kikuchi, Eiji

AU - Matsumoto, Kazuhiro

AU - Kosaka, Takeo

AU - Mizuno, Ryuichi

AU - Oya, Mototsugu

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Purpose: We investigated the clinical impact of the purified protein derivative skin test prior to bacillus Calmette-Guérin therapy in patients with nonmuscle invasive bladder cancer treated with adjuvant bacillus Calmette-Guérin therapy. Materials and Methods: A total of 498 patients with nonmuscle invasive bladder cancer treated with adjuvant bacillus Calmette-Guérin were included in study, of whom 320 underwent the purified protein derivative skin test 1 to 2 weeks prior to therapy. Oncologic outcomes and the rate of bacillus Calmette-Guérin related side effects were statistically evaluated. Results: The mean ± SD 5-year recurrence-free survival rate in patients who did vs did not undergo the purified protein derivative skin test was 66.6% ± 2.8% and 59.1% ± 4.1%, respectively, which was significantly different (p = 0.048). No significant difference was observed in the progression-free survival rate between patients who did vs did not undergo the test. Multivariate Cox regression analysis revealed that a history of recurrence (HR 1.59, p = 0.02), multiple tumors (HR 1.95, p <0.01), the bacillus Calmette-Guérin Connaught strain (HR 0.71, p = 0.04), 7 or more bacillus Calmette-Guérin instillations (HR 0.70, p = 0.04) and undergoing the purified protein derivative skin test (HR 0.72, p = 0.04) were independently associated with tumor recurrence. Major bacillus Calmette-Guérin related side effects were noted in 77 of the 320 patients (24.1%) who did vs 27 of the 178 (15.2%) who did not undergo the test, which was significantly different (p = 0.02). Conclusions: The purified protein derivative skin test prior to bacillus Calmette-Guérin treatment enhances the therapeutic effects of this treatment and potentially results in a higher incidence of major bacillus Calmette-Guérin related side effects. Combination therapy with bacillus Calmette-Guérin using the purified protein derivative skin test may improve the oncologic outcomes of that therapy.

AB - Purpose: We investigated the clinical impact of the purified protein derivative skin test prior to bacillus Calmette-Guérin therapy in patients with nonmuscle invasive bladder cancer treated with adjuvant bacillus Calmette-Guérin therapy. Materials and Methods: A total of 498 patients with nonmuscle invasive bladder cancer treated with adjuvant bacillus Calmette-Guérin were included in study, of whom 320 underwent the purified protein derivative skin test 1 to 2 weeks prior to therapy. Oncologic outcomes and the rate of bacillus Calmette-Guérin related side effects were statistically evaluated. Results: The mean ± SD 5-year recurrence-free survival rate in patients who did vs did not undergo the purified protein derivative skin test was 66.6% ± 2.8% and 59.1% ± 4.1%, respectively, which was significantly different (p = 0.048). No significant difference was observed in the progression-free survival rate between patients who did vs did not undergo the test. Multivariate Cox regression analysis revealed that a history of recurrence (HR 1.59, p = 0.02), multiple tumors (HR 1.95, p <0.01), the bacillus Calmette-Guérin Connaught strain (HR 0.71, p = 0.04), 7 or more bacillus Calmette-Guérin instillations (HR 0.70, p = 0.04) and undergoing the purified protein derivative skin test (HR 0.72, p = 0.04) were independently associated with tumor recurrence. Major bacillus Calmette-Guérin related side effects were noted in 77 of the 320 patients (24.1%) who did vs 27 of the 178 (15.2%) who did not undergo the test, which was significantly different (p = 0.02). Conclusions: The purified protein derivative skin test prior to bacillus Calmette-Guérin treatment enhances the therapeutic effects of this treatment and potentially results in a higher incidence of major bacillus Calmette-Guérin related side effects. Combination therapy with bacillus Calmette-Guérin using the purified protein derivative skin test may improve the oncologic outcomes of that therapy.

KW - adjuvants

KW - adverse effects

KW - BCG vaccine

KW - immunologic

KW - skin tests

KW - urinary bladder neoplasms

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U2 - 10.1016/j.juro.2017.12.057

DO - 10.1016/j.juro.2017.12.057

M3 - Article

JO - Journal of Urology

JF - Journal of Urology

SN - 0022-5347

ER -