Re: Addition of Nintedanib or Placebo to Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Muscle-invasive Bladder Cancer (NEOBLADE): A Double-blind, Randomised, Phase 2 Trial

Michael O'Callaghan; Adelaide Bladder Cancer Research Group; Luke Selth; Matthew Hong; Sina Vatandoust; Dimuth Gunawardane; Luke Grundy; Alexander Jay; Ganessan Kichenadasse

doi:10.1016/j.eururo.2023.05.026

Re: Addition of Nintedanib or Placebo to Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Muscle-invasive Bladder Cancer (NEOBLADE): A Double-blind, Randomised, Phase 2 Trial

Michael O'Callaghan, Adelaide Bladder Cancer Research Group, Luke Selth, Matthew Hong, Sina Vatandoust, Dimuth Gunawardane, Luke Grundy, Alexander Jay, Ganessan Kichenadasse

Research output: Contribution to journal › Comment/debate

Abstract

This phase 2 trial randomised 120 patients with localised muscle-invasive bladder cancer (MIBC) to test if addition of nintedanib to neoadjuvant cisplatin-gemcitabine chemotherapy improved the pathological complete response (pCR) in comparison to chemotherapy plus placebo [1]. There was an a priori option to transform the trial to a phase 3 design if the primary outcome was met. After 33.5 mo of follow-up, the pCR rate did not significantly differ between the two treatment groups (odds ratio [OR] 1.25, 70% confidence interval [CI] 0.84–1.87; p = 0.28). However, a post hoc analysis revealed that overall survival (OS) was better in the nintedanib arm (hazard ratio 0.45, 95% CI 0.21–0.98; p = 0.038).

Original language	English
Pages (from-to)	440-441
Number of pages	2
Journal	European Urology
Volume	84
Issue number	4
Early online date	9 Jun 2023
DOIs	https://doi.org/10.1016/j.eururo.2023.05.026
Publication status	Published - Oct 2023

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Nintedanib
Neoadjuvant Gemcitabine
Cisplatin
locally advanced muscle
NEOBLADE
bladder cancer

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10.1016/j.eururo.2023.05.026Licence: In Copyright

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O'Callaghan, M., Adelaide Bladder Cancer Research Group, Selth, L., Hong, M., Vatandoust, S., Gunawardane, D., Grundy, L., Jay, A., & Kichenadasse, G. (2023). Re: Addition of Nintedanib or Placebo to Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Muscle-invasive Bladder Cancer (NEOBLADE): A Double-blind, Randomised, Phase 2 Trial. European Urology, 84(4), 440-441. https://doi.org/10.1016/j.eururo.2023.05.026

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title = "Re: Addition of Nintedanib or Placebo to Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Muscle-invasive Bladder Cancer (NEOBLADE): A Double-blind, Randomised, Phase 2 Trial",

abstract = "This phase 2 trial randomised 120 patients with localised muscle-invasive bladder cancer (MIBC) to test if addition of nintedanib to neoadjuvant cisplatin-gemcitabine chemotherapy improved the pathological complete response (pCR) in comparison to chemotherapy plus placebo [1]. There was an a priori option to transform the trial to a phase 3 design if the primary outcome was met. After 33.5 mo of follow-up, the pCR rate did not significantly differ between the two treatment groups (odds ratio [OR] 1.25, 70% confidence interval [CI] 0.84–1.87; p = 0.28). However, a post hoc analysis revealed that overall survival (OS) was better in the nintedanib arm (hazard ratio 0.45, 95% CI 0.21–0.98; p = 0.038).",

keywords = "Nintedanib, Neoadjuvant Gemcitabine, Cisplatin, locally advanced muscle, NEOBLADE, bladder cancer",

author = "Michael O'Callaghan and {Adelaide Bladder Cancer Research Group} and Luke Selth and Yoko Tomita and Matthew Hong and Tan, {Thean Hsiang} and Sina Vatandoust and Dimuth Gunawardane and Christopher Hocking and Luke Grundy and Alexander Jay and Ganessan Kichenadasse",

year = "2023",

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doi = "10.1016/j.eururo.2023.05.026",

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volume = "84",

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O'Callaghan, M, Adelaide Bladder Cancer Research Group, Selth, L, Hong, M, Vatandoust, S, Gunawardane, D, Grundy, L, Jay, A & Kichenadasse, G 2023, 'Re: Addition of Nintedanib or Placebo to Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Muscle-invasive Bladder Cancer (NEOBLADE): A Double-blind, Randomised, Phase 2 Trial', European Urology, vol. 84, no. 4, pp. 440-441. https://doi.org/10.1016/j.eururo.2023.05.026

Re: Addition of Nintedanib or Placebo to Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Muscle-invasive Bladder Cancer (NEOBLADE): A Double-blind, Randomised, Phase 2 Trial. / O'Callaghan, Michael; Adelaide Bladder Cancer Research Group ; Selth, Luke et al.
In: European Urology, Vol. 84, No. 4, 10.2023, p. 440-441.

Research output: Contribution to journal › Comment/debate

TY - JOUR

T1 - Re

T2 - Addition of Nintedanib or Placebo to Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Muscle-invasive Bladder Cancer (NEOBLADE): A Double-blind, Randomised, Phase 2 Trial

AU - O'Callaghan, Michael

AU - Adelaide Bladder Cancer Research Group

AU - Selth, Luke

AU - Tomita, Yoko

AU - Hong, Matthew

AU - Tan, Thean Hsiang

AU - Vatandoust, Sina

AU - Gunawardane, Dimuth

AU - Hocking, Christopher

AU - Grundy, Luke

AU - Jay, Alexander

AU - Kichenadasse, Ganessan

PY - 2023/10

Y1 - 2023/10

N2 - This phase 2 trial randomised 120 patients with localised muscle-invasive bladder cancer (MIBC) to test if addition of nintedanib to neoadjuvant cisplatin-gemcitabine chemotherapy improved the pathological complete response (pCR) in comparison to chemotherapy plus placebo [1]. There was an a priori option to transform the trial to a phase 3 design if the primary outcome was met. After 33.5 mo of follow-up, the pCR rate did not significantly differ between the two treatment groups (odds ratio [OR] 1.25, 70% confidence interval [CI] 0.84–1.87; p = 0.28). However, a post hoc analysis revealed that overall survival (OS) was better in the nintedanib arm (hazard ratio 0.45, 95% CI 0.21–0.98; p = 0.038).

AB - This phase 2 trial randomised 120 patients with localised muscle-invasive bladder cancer (MIBC) to test if addition of nintedanib to neoadjuvant cisplatin-gemcitabine chemotherapy improved the pathological complete response (pCR) in comparison to chemotherapy plus placebo [1]. There was an a priori option to transform the trial to a phase 3 design if the primary outcome was met. After 33.5 mo of follow-up, the pCR rate did not significantly differ between the two treatment groups (odds ratio [OR] 1.25, 70% confidence interval [CI] 0.84–1.87; p = 0.28). However, a post hoc analysis revealed that overall survival (OS) was better in the nintedanib arm (hazard ratio 0.45, 95% CI 0.21–0.98; p = 0.038).

KW - Nintedanib

KW - Neoadjuvant Gemcitabine

KW - Cisplatin

KW - locally advanced muscle

KW - NEOBLADE

KW - bladder cancer

UR - http://www.scopus.com/inward/record.url?scp=85161657872&partnerID=8YFLogxK

U2 - 10.1016/j.eururo.2023.05.026

DO - 10.1016/j.eururo.2023.05.026

M3 - Comment/debate

C2 - 37302943

AN - SCOPUS:85161657872

SN - 0302-2838

VL - 84

SP - 440

EP - 441

JO - European Urology

JF - European Urology

IS - 4

ER -

O'Callaghan M, Adelaide Bladder Cancer Research Group, Selth L, Hong M, Vatandoust S, Gunawardane D et al. Re: Addition of Nintedanib or Placebo to Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Muscle-invasive Bladder Cancer (NEOBLADE): A Double-blind, Randomised, Phase 2 Trial. European Urology. 2023 Oct;84(4):440-441. Epub 2023 Jun 9. doi: 10.1016/j.eururo.2023.05.026

Re: Addition of Nintedanib or Placebo to Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Muscle-invasive Bladder Cancer (NEOBLADE): A Double-blind, Randomised, Phase 2 Trial

Abstract

UN SDGs

Keywords

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