TY - JOUR
T1 - Uitkomsten in de dagelijkse praktijk van eerstelijnschemotherapie voor niet-resectabel stadium III en IV urotheelcarcinoom van de blaas
AU - Santeon MIBC-studiegroep
AU - Reesink, Daan J.
AU - van de Garde, Ewoudt M.W.
AU - van der Nat, Paul B.
AU - Los, Maartje
AU - Horenblas, Simon
AU - van Melick, Harm H.E.
AU - Biesma, D. H.
AU - Stijns, P. E.F.
AU - Lavalaye, J.
AU - de Bruin, P. C.
AU - Peters, B. J.M.
AU - Somford, D. M.
AU - Berends, M.
AU - Richardson, R.
AU - Van Andel, G.
AU - Klaver, O. S.
AU - Haberkorn, B. C.M.
AU - Van Rooijen, J. M.
AU - Korthorst, R. A.
AU - Meijer, R. P.
AU - Van der Voort Van Zyp, J. R.N.
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/7
Y1 - 2024/7
N2 - The aim of this study was to evaluate the disparity between the efficacy observed in clinical trials and effectiveness in real-world practice (efficacy-effectiveness gap (EE gap)) in palliative first-line (1L) chemotherapy treatment (CTx) for urothelial carcinoma of the bladder. From seven Dutch teaching hospitals, all patients diagnosed with unresectable stage III (cT2-4aN1-3M0) and IV (cT4b and/or cM1) disease, who received 1L-CTx between 2008 and 2016, were captured. Median overall survival (mOS) of gemcitabine + cisplatin (GemCis)-patients was 10.4 months (95%-CI 7.9–13.0), which was shorter compared to clinical trial findings (range mOS: 12.7–14.3 months) despite comparable clinical characteristics. An EE gap seems present. The mOS of gemcitabine + carboplatin (GemCarbo)-patients was 9.3 months (95%-CI 7.5–11.1). GemCarbo patients had worse prognostic characteristics (higher age, impaired renal function and worse performance status (all p-values < 0.001)) compared to GemCis patients, but survival was not statistically significant different in a multivariable regression analysis (HR 0.90 (95%-CI 0.55–1.47), p-value = 0.674).
AB - The aim of this study was to evaluate the disparity between the efficacy observed in clinical trials and effectiveness in real-world practice (efficacy-effectiveness gap (EE gap)) in palliative first-line (1L) chemotherapy treatment (CTx) for urothelial carcinoma of the bladder. From seven Dutch teaching hospitals, all patients diagnosed with unresectable stage III (cT2-4aN1-3M0) and IV (cT4b and/or cM1) disease, who received 1L-CTx between 2008 and 2016, were captured. Median overall survival (mOS) of gemcitabine + cisplatin (GemCis)-patients was 10.4 months (95%-CI 7.9–13.0), which was shorter compared to clinical trial findings (range mOS: 12.7–14.3 months) despite comparable clinical characteristics. An EE gap seems present. The mOS of gemcitabine + carboplatin (GemCarbo)-patients was 9.3 months (95%-CI 7.5–11.1). GemCarbo patients had worse prognostic characteristics (higher age, impaired renal function and worse performance status (all p-values < 0.001)) compared to GemCis patients, but survival was not statistically significant different in a multivariable regression analysis (HR 0.90 (95%-CI 0.55–1.47), p-value = 0.674).
KW - Bladder cancer
KW - Efficacy-effectiveness gap
KW - First-line chemotherapy
KW - Metastatic
KW - Real-world outcomes
UR - http://www.scopus.com/inward/record.url?scp=85187155797&partnerID=8YFLogxK
U2 - 10.1007/s13629-024-00425-5
DO - 10.1007/s13629-024-00425-5
M3 - Article
AN - SCOPUS:85187155797
SN - 2211-3037
VL - 14
SP - 74
EP - 84
JO - Tijdschrift voor Urologie
JF - Tijdschrift voor Urologie
IS - 4
ER -