Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG

Ryan L. Steinberg; Vignesh T. Packiam; Lewis J. Thomas; Nathan Brooks; Andrew Vitale; Sarah L. Mott; Trafford Crump; Jonathan Wang; William C. DeWolf; Donald L. Lamm; Max Kates; M. Eric Hyndman; Ashish M. Kamat; Trinity J. Bivalacqua; Kenneth G. Nepple; Michael A. O'Donnell

doi:10.1016/j.urolonc.2021.03.024

Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG

Ryan L. Steinberg, Vignesh T. Packiam, Lewis J. Thomas, Nathan Brooks, Andrew Vitale, Sarah L. Mott, Trafford Crump, Jonathan Wang, William C. DeWolf, Donald L. Lamm, Max Kates, M. Eric Hyndman, Ashish M. Kamat, Trinity J. Bivalacqua, Kenneth G. Nepple, Michael A. O'Donnell

Urology

Research output: Contribution to journal › Article › peer-review

10 Scopus citations

Abstract

Introduction: Repeat BCG induction remains an option for select non-muscle invasive bladder cancer (NMIBC) patients who fail initial therapy. Alternative salvage intravesical regimens such as Gemcitabine and Docetaxel (Gem/Doce) have been investigated. We aimed to compare the efficacy BCG plus interferon a-2b (BCG/IFN) and Gem/Doce in patients with recurrent NMIBC after a single prior BCG course. Methods: The National Phase II BCG/IFN trial database and multi-institutional Gem/Doce database were queried for patients with recurrent NMIBC after one prior BCG induction course, excluding those with BCG unresponsive disease. Stabilized inverse probability treatment weighted survival curves were estimated using the Kaplan-Meier method and compared. Propensity scores were derived from a logistic regression model. The primary outcome was recurrence free survival (RFS); secondary outcomes were high-grade (HG) RFS and risk factors for treatment failure. Results: We identified 197 BCG/IFN and 93 Gem/Doce patients who met study criteria. Patients receiving Gem/Doce were older and more likely to have HG disease, CIS, and persistent disease following induction BCG (all P < 0.01). After propensity score-based weighting, the adjusted 1- and 2-year RFS was 61% and 53% after BCG/IFN versus 68% and 46% after Gem/Doce (P = 0.95). Adjusted 1- and 2-year HG-RFS was 60% and 51% after BCG/IFN versus 63% and 42% after Gem/Doce (P = 0.68). Multivariable Cox regression revealed that Gem/Doce treatment was not associated with an increased risk of failure (HR = 0.97, P = 0.89) as compared to BCG/IFN. Conclusion: Patients with recurrent NMIBC after a single induction BCG failure and not deemed BCG unresponsive had similar oncologic outcomes with Gem/Doce and BCG/IFN in a post-hoc analysis. Additional prospective studies are needed.

Original language	English (US)
Pages (from-to)	9.e1-9.e7
Journal	Urologic Oncology: Seminars and Original Investigations
Volume	40
Issue number	1
DOIs	https://doi.org/10.1016/j.urolonc.2021.03.024
State	Published - Jan 2022

Keywords

Administration, Intravesical
Chemotherapy
Docetaxel
Gemcitabine
Immunotherapy
Mycobacterium bovis
Urinary bladder neoplasms

ASJC Scopus subject areas

Oncology
Urology

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10.1016/j.urolonc.2021.03.024

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Steinberg, R. L., Packiam, V. T., Thomas, L. J., Brooks, N., Vitale, A., Mott, S. L., Crump, T., Wang, J., DeWolf, W. C., Lamm, D. L., Kates, M., Hyndman, M. E., Kamat, A. M., Bivalacqua, T. J., Nepple, K. G., & O'Donnell, M. A. (2022). Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG. Urologic Oncology: Seminars and Original Investigations, 40(1), 9.e1-9.e7. https://doi.org/10.1016/j.urolonc.2021.03.024

Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG. / Steinberg, Ryan L.; Packiam, Vignesh T.; Thomas, Lewis J. et al.
In: Urologic Oncology: Seminars and Original Investigations, Vol. 40, No. 1, 01.2022, p. 9.e1-9.e7.

Research output: Contribution to journal › Article › peer-review

Steinberg, RL, Packiam, VT, Thomas, LJ, Brooks, N, Vitale, A, Mott, SL, Crump, T, Wang, J, DeWolf, WC, Lamm, DL, Kates, M, Hyndman, ME, Kamat, AM, Bivalacqua, TJ, Nepple, KG & O'Donnell, MA 2022, 'Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG', Urologic Oncology: Seminars and Original Investigations, vol. 40, no. 1, pp. 9.e1-9.e7. https://doi.org/10.1016/j.urolonc.2021.03.024

Steinberg RL, Packiam VT, Thomas LJ, Brooks N, Vitale A, Mott SL et al. Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG. Urologic Oncology: Seminars and Original Investigations. 2022 Jan;40(1):9.e1-9.e7. doi: 10.1016/j.urolonc.2021.03.024

Steinberg, Ryan L. ; Packiam, Vignesh T. ; Thomas, Lewis J. et al. / Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG. In: Urologic Oncology: Seminars and Original Investigations. 2022 ; Vol. 40, No. 1. pp. 9.e1-9.e7.

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abstract = "Introduction: Repeat BCG induction remains an option for select non-muscle invasive bladder cancer (NMIBC) patients who fail initial therapy. Alternative salvage intravesical regimens such as Gemcitabine and Docetaxel (Gem/Doce) have been investigated. We aimed to compare the efficacy BCG plus interferon a-2b (BCG/IFN) and Gem/Doce in patients with recurrent NMIBC after a single prior BCG course. Methods: The National Phase II BCG/IFN trial database and multi-institutional Gem/Doce database were queried for patients with recurrent NMIBC after one prior BCG induction course, excluding those with BCG unresponsive disease. Stabilized inverse probability treatment weighted survival curves were estimated using the Kaplan-Meier method and compared. Propensity scores were derived from a logistic regression model. The primary outcome was recurrence free survival (RFS); secondary outcomes were high-grade (HG) RFS and risk factors for treatment failure. Results: We identified 197 BCG/IFN and 93 Gem/Doce patients who met study criteria. Patients receiving Gem/Doce were older and more likely to have HG disease, CIS, and persistent disease following induction BCG (all P < 0.01). After propensity score-based weighting, the adjusted 1- and 2-year RFS was 61% and 53% after BCG/IFN versus 68% and 46% after Gem/Doce (P = 0.95). Adjusted 1- and 2-year HG-RFS was 60% and 51% after BCG/IFN versus 63% and 42% after Gem/Doce (P = 0.68). Multivariable Cox regression revealed that Gem/Doce treatment was not associated with an increased risk of failure (HR = 0.97, P = 0.89) as compared to BCG/IFN. Conclusion: Patients with recurrent NMIBC after a single induction BCG failure and not deemed BCG unresponsive had similar oncologic outcomes with Gem/Doce and BCG/IFN in a post-hoc analysis. Additional prospective studies are needed.",

keywords = "Administration, Intravesical, Chemotherapy, Docetaxel, Gemcitabine, Immunotherapy, Mycobacterium bovis, Urinary bladder neoplasms",

author = "Steinberg, {Ryan L.} and Packiam, {Vignesh T.} and Thomas, {Lewis J.} and Nathan Brooks and Andrew Vitale and Mott, {Sarah L.} and Trafford Crump and Jonathan Wang and DeWolf, {William C.} and Lamm, {Donald L.} and Max Kates and Hyndman, {M. Eric} and Kamat, {Ashish M.} and Bivalacqua, {Trinity J.} and Nepple, {Kenneth G.} and O'Donnell, {Michael A.}",

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year = "2022",

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doi = "10.1016/j.urolonc.2021.03.024",

language = "English (US)",

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T1 - Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG

AU - Steinberg, Ryan L.

AU - Packiam, Vignesh T.

AU - Thomas, Lewis J.

AU - Brooks, Nathan

AU - Vitale, Andrew

AU - Mott, Sarah L.

AU - Crump, Trafford

AU - Wang, Jonathan

AU - DeWolf, William C.

AU - Lamm, Donald L.

AU - Kates, Max

AU - Hyndman, M. Eric

AU - Kamat, Ashish M.

AU - Bivalacqua, Trinity J.

AU - Nepple, Kenneth G.

AU - O'Donnell, Michael A.

PY - 2022/1

Y1 - 2022/1

N2 - Introduction: Repeat BCG induction remains an option for select non-muscle invasive bladder cancer (NMIBC) patients who fail initial therapy. Alternative salvage intravesical regimens such as Gemcitabine and Docetaxel (Gem/Doce) have been investigated. We aimed to compare the efficacy BCG plus interferon a-2b (BCG/IFN) and Gem/Doce in patients with recurrent NMIBC after a single prior BCG course. Methods: The National Phase II BCG/IFN trial database and multi-institutional Gem/Doce database were queried for patients with recurrent NMIBC after one prior BCG induction course, excluding those with BCG unresponsive disease. Stabilized inverse probability treatment weighted survival curves were estimated using the Kaplan-Meier method and compared. Propensity scores were derived from a logistic regression model. The primary outcome was recurrence free survival (RFS); secondary outcomes were high-grade (HG) RFS and risk factors for treatment failure. Results: We identified 197 BCG/IFN and 93 Gem/Doce patients who met study criteria. Patients receiving Gem/Doce were older and more likely to have HG disease, CIS, and persistent disease following induction BCG (all P < 0.01). After propensity score-based weighting, the adjusted 1- and 2-year RFS was 61% and 53% after BCG/IFN versus 68% and 46% after Gem/Doce (P = 0.95). Adjusted 1- and 2-year HG-RFS was 60% and 51% after BCG/IFN versus 63% and 42% after Gem/Doce (P = 0.68). Multivariable Cox regression revealed that Gem/Doce treatment was not associated with an increased risk of failure (HR = 0.97, P = 0.89) as compared to BCG/IFN. Conclusion: Patients with recurrent NMIBC after a single induction BCG failure and not deemed BCG unresponsive had similar oncologic outcomes with Gem/Doce and BCG/IFN in a post-hoc analysis. Additional prospective studies are needed.

AB - Introduction: Repeat BCG induction remains an option for select non-muscle invasive bladder cancer (NMIBC) patients who fail initial therapy. Alternative salvage intravesical regimens such as Gemcitabine and Docetaxel (Gem/Doce) have been investigated. We aimed to compare the efficacy BCG plus interferon a-2b (BCG/IFN) and Gem/Doce in patients with recurrent NMIBC after a single prior BCG course. Methods: The National Phase II BCG/IFN trial database and multi-institutional Gem/Doce database were queried for patients with recurrent NMIBC after one prior BCG induction course, excluding those with BCG unresponsive disease. Stabilized inverse probability treatment weighted survival curves were estimated using the Kaplan-Meier method and compared. Propensity scores were derived from a logistic regression model. The primary outcome was recurrence free survival (RFS); secondary outcomes were high-grade (HG) RFS and risk factors for treatment failure. Results: We identified 197 BCG/IFN and 93 Gem/Doce patients who met study criteria. Patients receiving Gem/Doce were older and more likely to have HG disease, CIS, and persistent disease following induction BCG (all P < 0.01). After propensity score-based weighting, the adjusted 1- and 2-year RFS was 61% and 53% after BCG/IFN versus 68% and 46% after Gem/Doce (P = 0.95). Adjusted 1- and 2-year HG-RFS was 60% and 51% after BCG/IFN versus 63% and 42% after Gem/Doce (P = 0.68). Multivariable Cox regression revealed that Gem/Doce treatment was not associated with an increased risk of failure (HR = 0.97, P = 0.89) as compared to BCG/IFN. Conclusion: Patients with recurrent NMIBC after a single induction BCG failure and not deemed BCG unresponsive had similar oncologic outcomes with Gem/Doce and BCG/IFN in a post-hoc analysis. Additional prospective studies are needed.

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KW - Chemotherapy

KW - Docetaxel

KW - Gemcitabine

KW - Immunotherapy

KW - Mycobacterium bovis

KW - Urinary bladder neoplasms

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Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG

Abstract

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