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@article{Buti:2021:10.1016/j.ejca.2020.09.033,
author = {Buti, S and Bersanelli, M and Perrone, F and Tiseo, M and Tucci, M and Adamo, V and Stucci, LS and Russo, A and Tanda, ET and Spagnolo, F and Rastelli, F and Pergolesi, F and Santini, D and Russano, M and Anesi, C and Giusti, R and Filetti, M and Marchetti, P and Botticelli, A and Gelibter, A and Occhipinti, MA and Ferrari, M and Vitale, MG and Nicolardi, L and Chiari, R and Rijavec, E and Nigro, O and Tuzi, A and De, Tursi M and Di, Marino P and Conforti, F and Queirolo, P and Bracarda, S and Macrini, S and Gori, S and Zoratto, F and Veltri, E and Di, Cocco B and Mallardo, D and Vitale, MG and Santoni, M and Patruno, L and Porzio, G and Ficorella, C and Pinato, DJ and Ascierto, PA and Cortellini, A},
doi = {10.1016/j.ejca.2020.09.033},
journal = {European Journal of Cancer},
pages = {18--28},
title = {Effect of concomitant medications with immune-modulatory properties on the outcomes of patients with advanced cancer treated with immune checkpoint inhibitors: development and validation of a novel prognostic index},
url = {http://dx.doi.org/10.1016/j.ejca.2020.09.033},
volume = {142},
year = {2021}
}
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TY  - JOUR
AB  - BackgroundConcomitant medications are known to impact on clinical outcomes of patients treated with immune checkpoint inhibitors (ICIs). We aimed weighing the role of different concomitant baseline medications to create a drug-based prognostic score.MethodsWe evaluated concomitant baseline medications at immunotherapy initiation for their impact on objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in a single-institution cohort of patients with advanced cancer treated with ICIs (training cohort, N = 217), and a drug-based prognostic score with the drugs resulting significantly impacting the OS was computed. Secondly, we externally validated the score in a large multicenter external cohort (n = 1012).ResultsIn the training cohort (n = 217), the median age was 69 years (range: 32–89), and the primary tumours were non–small-cell lung cancer (70%), melanoma (14.7%), renal cell carcinoma (9.2%) and others (6%). Among baseline medications, corticosteroids (hazard ratio [HR] = 2.3; 95% confidence interval [CI]: 1.60–3.30), systemic antibiotics (HR = 2.07; 95% CI: 1.31–3.25) and proton-pump inhibitors (PPIs) (HR = 1.57; 95% CI: 1.13–2.18) were significantly associated with OS. The prognostic score was calculated using these three drug classes, defining good, intermediate and poor prognosis patients. Within the training cohort, OS (p < 0.0001), PFS (p < 0.0001) and ORR (p = 0.0297) were significantly distinguished by the score stratification. The prognostic value of the score was also demonstrated in terms of OS (p < 0.0001), PFS (p < 0.0001) and ORR (p = 0.0006) within the external cohort.ConclusionCumulative exposure to corticosteroids, antibiotics and PPIs (three likely microbiota-modulating drugs) leads to progressively worse outcomes after ICI therapy. We propose a simple score that can help stratifying patients in routine practice and clinical trials of ICIs.
AU  - Buti,S
AU  - Bersanelli,M
AU  - Perrone,F
AU  - Tiseo,M
AU  - Tucci,M
AU  - Adamo,V
AU  - Stucci,LS
AU  - Russo,A
AU  - Tanda,ET
AU  - Spagnolo,F
AU  - Rastelli,F
AU  - Pergolesi,F
AU  - Santini,D
AU  - Russano,M
AU  - Anesi,C
AU  - Giusti,R
AU  - Filetti,M
AU  - Marchetti,P
AU  - Botticelli,A
AU  - Gelibter,A
AU  - Occhipinti,MA
AU  - Ferrari,M
AU  - Vitale,MG
AU  - Nicolardi,L
AU  - Chiari,R
AU  - Rijavec,E
AU  - Nigro,O
AU  - Tuzi,A
AU  - De,Tursi M
AU  - Di,Marino P
AU  - Conforti,F
AU  - Queirolo,P
AU  - Bracarda,S
AU  - Macrini,S
AU  - Gori,S
AU  - Zoratto,F
AU  - Veltri,E
AU  - Di,Cocco B
AU  - Mallardo,D
AU  - Vitale,MG
AU  - Santoni,M
AU  - Patruno,L
AU  - Porzio,G
AU  - Ficorella,C
AU  - Pinato,DJ
AU  - Ascierto,PA
AU  - Cortellini,A
DO  - 10.1016/j.ejca.2020.09.033
EP  - 28
PY  - 2021///
SN  - 0959-8049
SP  - 18
TI  - Effect of concomitant medications with immune-modulatory properties on the outcomes of patients with advanced cancer treated with immune checkpoint inhibitors: development and validation of a novel prognostic index
T2  - European Journal of Cancer
UR  - http://dx.doi.org/10.1016/j.ejca.2020.09.033
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000600546100003&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - https://www.sciencedirect.com/science/article/pii/S0959804920310418?via%3Dihub
VL  - 142
ER  -
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