Sustained prophylactic effect of intravesical bacille Calmette- Guérin for superficial bladder cancer: A smoothed hazard analysis in a randomized prospective study

Shiro Hinotsu, Hideyuki Akaza, Shigeo Isaka, Hiroshi Kanetake, Yoshinobu Kubota, Masao Kuroda, Nobuo Shinohara, Toshiaki Shinka, Masaaki Tachibana, Seiji Naito, Yoshihiko Hirao

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Objectives. A previous meta-analysis had revealed that intravesical chemotherapy was effective in reducing the recurrence of superficial bladder cancer only in the early phase, the phase thought to be caused by tumor cell implantation and/or residual tumor cells. To ascertain the sustained prophylactic effect of intravesical bacille Calmette-Guérin (BCG) after transurethral resection of bladder tumor (TURBT), we compared the estimation of the duration of the effect with that of doxorubicin. Methods. Eighty eligible patients with superficial bladder cancer (Stage Ta or T1, grade 1 or 2) were included. Patients were randomly allocated into two groups: the BCG group (six weekly instillations of 80 mg BCG [Tokyo 172 strain]) and the doxorubicin group (17 instillations of 20 mg doxorubicin). A comparison between the smoothed hazards of tumor recurrence was performed using a kernel function method. Results. All 80 patients (40 each in the BCG and doxorubicin groups) were compared. The median follow-up period was 667 days (range 64 to 1607). The risk of recurrence was significantly lower in the BCG group than in the doxorubicin group (P = 0.017, log-rank test). A smoothed hazard curve depicting the reduced risk of recurrence in the BCG group suggested that BCG is not only efficacious in the early phase of recurrence (up to 500 days after TURBT), but also in the late phase, and the latter is thought to include second primary tumors (new tumors). Conclusions. BCG instillation may prevent tumor recurrence caused by both tumor cell implantation and second primary tumors.

Original languageEnglish
Pages (from-to)545-549
Number of pages5
JournalUrology
Volume67
Issue number3
DOIs
Publication statusPublished - Mar 2006
Externally publishedYes

Fingerprint

Urinary Bladder Neoplasms
Prospective Studies
Doxorubicin
Recurrence
Neoplasms
Tokyo
Residual Neoplasm
Meta-Analysis
Drug Therapy

ASJC Scopus subject areas

  • Urology

Cite this

Sustained prophylactic effect of intravesical bacille Calmette- Guérin for superficial bladder cancer : A smoothed hazard analysis in a randomized prospective study. / Hinotsu, Shiro; Akaza, Hideyuki; Isaka, Shigeo; Kanetake, Hiroshi; Kubota, Yoshinobu; Kuroda, Masao; Shinohara, Nobuo; Shinka, Toshiaki; Tachibana, Masaaki; Naito, Seiji; Hirao, Yoshihiko.

In: Urology, Vol. 67, No. 3, 03.2006, p. 545-549.

Research output: Contribution to journalArticle

Hinotsu, S, Akaza, H, Isaka, S, Kanetake, H, Kubota, Y, Kuroda, M, Shinohara, N, Shinka, T, Tachibana, M, Naito, S & Hirao, Y 2006, 'Sustained prophylactic effect of intravesical bacille Calmette- Guérin for superficial bladder cancer: A smoothed hazard analysis in a randomized prospective study', Urology, vol. 67, no. 3, pp. 545-549. https://doi.org/10.1016/j.urology.2005.09.045
Hinotsu, Shiro ; Akaza, Hideyuki ; Isaka, Shigeo ; Kanetake, Hiroshi ; Kubota, Yoshinobu ; Kuroda, Masao ; Shinohara, Nobuo ; Shinka, Toshiaki ; Tachibana, Masaaki ; Naito, Seiji ; Hirao, Yoshihiko. / Sustained prophylactic effect of intravesical bacille Calmette- Guérin for superficial bladder cancer : A smoothed hazard analysis in a randomized prospective study. In: Urology. 2006 ; Vol. 67, No. 3. pp. 545-549.
@article{5e51dd9e0dd3476885c8871ff1da41e3,
title = "Sustained prophylactic effect of intravesical bacille Calmette- Gu{\'e}rin for superficial bladder cancer: A smoothed hazard analysis in a randomized prospective study",
abstract = "Objectives. A previous meta-analysis had revealed that intravesical chemotherapy was effective in reducing the recurrence of superficial bladder cancer only in the early phase, the phase thought to be caused by tumor cell implantation and/or residual tumor cells. To ascertain the sustained prophylactic effect of intravesical bacille Calmette-Gu{\'e}rin (BCG) after transurethral resection of bladder tumor (TURBT), we compared the estimation of the duration of the effect with that of doxorubicin. Methods. Eighty eligible patients with superficial bladder cancer (Stage Ta or T1, grade 1 or 2) were included. Patients were randomly allocated into two groups: the BCG group (six weekly instillations of 80 mg BCG [Tokyo 172 strain]) and the doxorubicin group (17 instillations of 20 mg doxorubicin). A comparison between the smoothed hazards of tumor recurrence was performed using a kernel function method. Results. All 80 patients (40 each in the BCG and doxorubicin groups) were compared. The median follow-up period was 667 days (range 64 to 1607). The risk of recurrence was significantly lower in the BCG group than in the doxorubicin group (P = 0.017, log-rank test). A smoothed hazard curve depicting the reduced risk of recurrence in the BCG group suggested that BCG is not only efficacious in the early phase of recurrence (up to 500 days after TURBT), but also in the late phase, and the latter is thought to include second primary tumors (new tumors). Conclusions. BCG instillation may prevent tumor recurrence caused by both tumor cell implantation and second primary tumors.",
author = "Shiro Hinotsu and Hideyuki Akaza and Shigeo Isaka and Hiroshi Kanetake and Yoshinobu Kubota and Masao Kuroda and Nobuo Shinohara and Toshiaki Shinka and Masaaki Tachibana and Seiji Naito and Yoshihiko Hirao",
year = "2006",
month = "3",
doi = "10.1016/j.urology.2005.09.045",
language = "English",
volume = "67",
pages = "545--549",
journal = "Urology",
issn = "0090-4295",
publisher = "Elsevier Inc.",
number = "3",

}

TY - JOUR

T1 - Sustained prophylactic effect of intravesical bacille Calmette- Guérin for superficial bladder cancer

T2 - A smoothed hazard analysis in a randomized prospective study

AU - Hinotsu, Shiro

AU - Akaza, Hideyuki

AU - Isaka, Shigeo

AU - Kanetake, Hiroshi

AU - Kubota, Yoshinobu

AU - Kuroda, Masao

AU - Shinohara, Nobuo

AU - Shinka, Toshiaki

AU - Tachibana, Masaaki

AU - Naito, Seiji

AU - Hirao, Yoshihiko

PY - 2006/3

Y1 - 2006/3

N2 - Objectives. A previous meta-analysis had revealed that intravesical chemotherapy was effective in reducing the recurrence of superficial bladder cancer only in the early phase, the phase thought to be caused by tumor cell implantation and/or residual tumor cells. To ascertain the sustained prophylactic effect of intravesical bacille Calmette-Guérin (BCG) after transurethral resection of bladder tumor (TURBT), we compared the estimation of the duration of the effect with that of doxorubicin. Methods. Eighty eligible patients with superficial bladder cancer (Stage Ta or T1, grade 1 or 2) were included. Patients were randomly allocated into two groups: the BCG group (six weekly instillations of 80 mg BCG [Tokyo 172 strain]) and the doxorubicin group (17 instillations of 20 mg doxorubicin). A comparison between the smoothed hazards of tumor recurrence was performed using a kernel function method. Results. All 80 patients (40 each in the BCG and doxorubicin groups) were compared. The median follow-up period was 667 days (range 64 to 1607). The risk of recurrence was significantly lower in the BCG group than in the doxorubicin group (P = 0.017, log-rank test). A smoothed hazard curve depicting the reduced risk of recurrence in the BCG group suggested that BCG is not only efficacious in the early phase of recurrence (up to 500 days after TURBT), but also in the late phase, and the latter is thought to include second primary tumors (new tumors). Conclusions. BCG instillation may prevent tumor recurrence caused by both tumor cell implantation and second primary tumors.

AB - Objectives. A previous meta-analysis had revealed that intravesical chemotherapy was effective in reducing the recurrence of superficial bladder cancer only in the early phase, the phase thought to be caused by tumor cell implantation and/or residual tumor cells. To ascertain the sustained prophylactic effect of intravesical bacille Calmette-Guérin (BCG) after transurethral resection of bladder tumor (TURBT), we compared the estimation of the duration of the effect with that of doxorubicin. Methods. Eighty eligible patients with superficial bladder cancer (Stage Ta or T1, grade 1 or 2) were included. Patients were randomly allocated into two groups: the BCG group (six weekly instillations of 80 mg BCG [Tokyo 172 strain]) and the doxorubicin group (17 instillations of 20 mg doxorubicin). A comparison between the smoothed hazards of tumor recurrence was performed using a kernel function method. Results. All 80 patients (40 each in the BCG and doxorubicin groups) were compared. The median follow-up period was 667 days (range 64 to 1607). The risk of recurrence was significantly lower in the BCG group than in the doxorubicin group (P = 0.017, log-rank test). A smoothed hazard curve depicting the reduced risk of recurrence in the BCG group suggested that BCG is not only efficacious in the early phase of recurrence (up to 500 days after TURBT), but also in the late phase, and the latter is thought to include second primary tumors (new tumors). Conclusions. BCG instillation may prevent tumor recurrence caused by both tumor cell implantation and second primary tumors.

UR - http://www.scopus.com/inward/record.url?scp=33644745173&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33644745173&partnerID=8YFLogxK

U2 - 10.1016/j.urology.2005.09.045

DO - 10.1016/j.urology.2005.09.045

M3 - Article

C2 - 16527576

AN - SCOPUS:33644745173

VL - 67

SP - 545

EP - 549

JO - Urology

JF - Urology

SN - 0090-4295

IS - 3

ER -