Abstract
Background: Immune checkpoint inhibitors (ICIs) represent an appealing treatment for patients with advanced urothelial cancer (aUC) and a poor performance status (PS). However, the benefit of ICIs for patients with a poor PS remains unknown. It was hypothesized that a poor Eastern Cooperative Oncology Group (ECOG) PS (≥2 vs 0-1) would correlate with shorter overall survival (OS) in patients receiving ICIs. Methods: In this retrospective cohort study, clinicopathologic, treatment, and outcome data were collected for patients with aUC who were treated with ICIs at 18 institutions (2013-2019). The overall response rate (ORR) and OS were compared for patients with an ECOG PS of 0 to 1 and patients with an ECOG PS ≥ 2 at ICI initiation. The association between a new ICI in the last 30 and 90 days of life (DOL) and death location was also tested. Results: Of the 519 patients treated with ICIs, 395 and 384 were included in OS and ORR analyses, respectively, with 26% and 24% having a PS ≥ 2. OS was higher in those with a PS of 0 to 1 than those with a PS ≥ 2 who were treated in the first line (median, 15.2 vs 7.2 months; hazard ratio [HR], 0.62; P =.01) but not in subsequent lines (median, 9.8 vs 8.2 months; HR, 0.78; P =.27). ORRs were similar for patients with a PS of 0 to 1 and patients with a PS ≥ 2 in both lines. Of the 288 patients who died, 10% and 32% started ICIs in the last 30 and 90 DOL, respectively. ICI initiation in the last 30 DOL was associated with increased odds of death in a hospital (odds ratio, 2.89; P =.04). Conclusions: Despite comparable ORRs, ICIs may not overcome the negative prognostic role of a poor PS, particularly in the first-line setting, and the initiation of ICIs in the last 30 DOL was associated with hospital death location.
Original language | English (US) |
---|---|
Pages (from-to) | 1208-1216 |
Number of pages | 9 |
Journal | Cancer |
Volume | 126 |
Issue number | 6 |
DOIs | |
State | Published - Mar 15 2020 |
All Science Journal Classification (ASJC) codes
- Oncology
- Cancer Research
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Impact of performance status on treatment outcomes : A real-world study of advanced urothelial cancer treated with immune checkpoint inhibitors. / Khaki, Ali Raza; Li, Ang; Diamantopoulos, Leonidas N. et al.
In: Cancer, Vol. 126, No. 6, 15.03.2020, p. 1208-1216.Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Impact of performance status on treatment outcomes
T2 - A real-world study of advanced urothelial cancer treated with immune checkpoint inhibitors
AU - Khaki, Ali Raza
AU - Li, Ang
AU - Diamantopoulos, Leonidas N.
AU - Bilen, Mehmet A.
AU - Santos, Victor
AU - Esther, John
AU - Morales-Barrera, Rafael
AU - Devitt, Michael
AU - Nelson, Ariel
AU - Hoimes, Christopher J.
AU - Shreck, Evan
AU - Assi, Hussein
AU - Gartrell, Benjamin A.
AU - Sankin, Alex
AU - Rodriguez-Vida, Alejo
AU - Lythgoe, Mark
AU - Pinato, David J.
AU - Drakaki, Alexandra
AU - Joshi, Monika
AU - Isaacsson Velho, Pedro
AU - Hahn, Noah
AU - Liu, Sandy
AU - Alonso Buznego, Lucia
AU - Duran, Ignacio
AU - Moses, Marcus
AU - Jain, Jayanshu
AU - Murgic, Jure
AU - Baratam, Praneeth
AU - Barata, Pedro
AU - Tripathi, Abhishek
AU - Zakharia, Yousef
AU - Galsky, Matthew D.
AU - Sonpavde, Guru
AU - Yu, Evan Y.
AU - Shankaran, Veena
AU - Lyman, Gary H.
AU - Grivas, Petros
N1 - Funding Information: Ali Raza Khaki was supported by the National Cancer Institute under training grant T32CA009515. Research Electronic Data Capture at the Institute of Translational Health Sciences is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award UL1 TR002319. Evan Y. Yu and Petros Grivas acknowledge the support of the Seattle Translational Tumor Research Program at the Fred Hutchinson Cancer Research Center. David J. Pinato acknowledges support from the Imperial Experimental Cancer Medicine Centre and the Cancer Research UK Imperial Centre and grant funding from the Wellcome Trust Strategic Fund (PS3416). Matthew D. Galsky reports funding from Merck to support the study. Funding Information: Mehmet A. Bilen has served in a consulting or advisory role for Exelixis, Genomic Health, Janssen, Eisai, Nektar, AstraZeneca, EMD/Serono, and Sanofi and has received research funding from Xencor, Bayer, Bristol‐Myers Squibb, Seattle Genetics, Genentech/Roche, Incyte, Eisai, Nektar, AstraZeneca, Tricon Pharmaceuticals, Peleton, and Pfizer. Rafael Morales‐Barrera has served in a consulting or advisory role and/or on speakers bureaus for Sanofi Aventis, Bayer, Janssen, AstraZeneca, Merck Sharp & Dohme, and Asofarma and has received travel accommodations from Roche, Sanofi Aventis, Astellas, Janssen, Merck Sharp & Dohme, Bayer, Pharmacyclics, Clovis Oncology, and Lilly. Michael Devitt has served in an advisory role for Bayer. Christopher J. Hoimes reports research funding from Merck & Co and honoraria for consulting and speakers bureaus from Bristol‐Myers Squibb and Roche/Genentech. Benjamin A. Gartrell reports personal fees from Janssen, Eisai, and Genomic Health. Alex Sankin has served in an advisory role for Genentech and Photocure. Alejo Rodriguez‐Vida has served in an advisory role for Merck Sharp & Dohme, Clovis, Pfizer, Ipsen, Bristol‐Myers Squibb, Astellas, Janssen, Bayer, and Roche; has received lectures fees from Pfizer, Merck Sharp & Dohme, Astellas, Bristol‐Myers Squibb, Janssen, AstraZeneca, Roche, Bayer, and Sanofi Aventis; and has received research funding from Takeda, Pfizer, and Merck Sharp & Dohme. David J. Pinato has received lecture fees from ViiV Healthcare and Bayer, has served in an advisory role for Mina Therapeutics, and has received research funding to his institution from Merck Sharp & Dohme and Bristol‐Myers Squibb. Alexandra Drakaki has served in an advisory role for Bristol‐Myers Squibb, AstraZeneca, Seattle Genetics/Astellas, and Kynan Therapeutics; has received travel accommodations from AstraZeneca, Seattle Genetics/Astellas, and Lilly; has equity in Kynan Pharma, Medicus Data, Urogen, and Allogene; and has received research funding from Kite/Gilead. Monika Joshi has served on advisory boards for Bayer and Sanofi, has received institutional research funds from Pfizer and AstraZeneca, and has received a free drug for a clinical trial from Eisai. Noah Hahn reports grants and personal fees from Bristol‐Myers Squibb, Incyte, Inovio, Merck, Principia Biopharma, Seattle Genetics, Pieris, and AstraZeneca; personal fees from Champions Oncology, CicloMed, Ferring, Genentech, Health Advances, Janssen, Rexahn, TARIS Biomedical, TransMed, Bladder Cancer Academy, and PierView; and grants from Astex. Sandy Liu reports honoraria from Merck and Exelixis. Ignacio Duran has served on advisory boards for Roche, Bristol‐Myers Squibb, Merck Sharp & Dohme, Pharmacyclics, Jansen, Ipsen, and Novartis; has received honoraria from Roche, Bristol‐Myers Squibb, Merck Sharp & Dohme, Jansen, Ipsen, Novartis, and Astellas; has received travel funding from Ipsen and Astra‐Zeneca; has received personal fees from GlaxoSmithKline, Bayer, and Sanofi; and has received institutional research funding from Astra‐Zeneca and Roche. Abhishek Tripathi has served in an advisory role for Foundation Medicine and has received institutional research funding from EMD Serono, Bayer, Clovis Oncology, Aravive, WindMIL Therapeutics, and Corvus Pharmaceuticals. Yousef Zakharia has served on advisory boards for Amgen, Roche Diagnostics, Novartis, Jansen, Eisai, Exelixis, Castle Bioscience, Array, Bayer, and Pfizer; has received grant/research support from NewLink Genetics, Pfizer, Exelixis, and Eisai; and has served on a data and safety monitoring committee for Jansen. Matthew D. Galsky has acted as a consultant for Incyte; has served on advisory boards for Aileron, BioMotiv, Lilly, Janssen, Dendreon, Merck, GlaxoSmithKline, Astellas, Genentech, Bristol‐Myers Squibb, Novartis, Pfizer, EMD Serono, AstraZeneca, Seattle Genetics, Incyte, Aileron, Dracen, Inovio, Numab, and Dragonfly Therapeutics; reports contracted research for Janssen, Dendreon, Novartis Bristol‐Myers Squibb, Merck, Astra Zeneca, and Genentech; and has an ownership interest in Rappta Therapeutics. Guru Sonpavde has served on advisory boards for Bristol‐Myers Squibb, Exelixis, Bayer, Sanofi, Pfizer, Novartis, Eisai, Janssen, Amgen, AstraZeneca, Merck, Genentech, EMD Serono, Astellas, and Seattle Genetics; has received institutional research support from AstraZeneca, Bayer, Amgen, Boehringer‐Ingelheim, Celgene, Janssen, Merck, Sanofi, and Pfizer; is an author for UpToDate; has received personal fees from Clinical Care Options and the National Comprehensive Cancer Network; has served on steering committees for AstraZeneca, Bristol‐Myers Squibb, QED, Astellas, Debiopharm, and Bavarian Nordic; and has been a speaker for OncLive, Research to Practice, and Physicians' Education Resource. Evan Y. Yu reports consulting for Amgen, AstraZeneca, Bayer, Churchill, Dendreon, EMD Serono, Incyte, Janssen, Merck, Pharmacyclics, QED, Seattle Genetics, and Tolmar; institutional research support from Bayer, Daiichi‐Sankyo, Dendreon, Merck, Taiho, and Seattle Genetics; and personal fees from Clovis (last 3 years). Veena Shankaran reports grants from Merck and Bristol‐Myers Squibb. Petros Grivas reports consulting for AstraZeneca, Bayer, Biocept, Bristol‐Myers Squibb, Clovis Oncology, Dendreon, Driver, EMD Serono, Exelixis, Foundation Medicine, GlaxoSmithKline, Roche, Genentech, Genzyme, Heron Therapeutics, Janssen, Merck, Mirati Therapeutics, Pfizer, Seattle Genetics, and QED Therapeutics; participation in educational programs for Bristol‐Myers Squibb and Genentech; and institutional research funding from AstraZeneca, Bayer, Genentech/Roche, Merck, Mirati Therapeutics, Oncogenex, Pfizer, Clovis Oncology, Bavarian Nordic, Immunomedics, Debiopharm, and Bristol‐Myers Squibb (last 3 years). The other authors made no disclosures. Publisher Copyright: © 2019 American Cancer Society
PY - 2020/3/15
Y1 - 2020/3/15
N2 - Background: Immune checkpoint inhibitors (ICIs) represent an appealing treatment for patients with advanced urothelial cancer (aUC) and a poor performance status (PS). However, the benefit of ICIs for patients with a poor PS remains unknown. It was hypothesized that a poor Eastern Cooperative Oncology Group (ECOG) PS (≥2 vs 0-1) would correlate with shorter overall survival (OS) in patients receiving ICIs. Methods: In this retrospective cohort study, clinicopathologic, treatment, and outcome data were collected for patients with aUC who were treated with ICIs at 18 institutions (2013-2019). The overall response rate (ORR) and OS were compared for patients with an ECOG PS of 0 to 1 and patients with an ECOG PS ≥ 2 at ICI initiation. The association between a new ICI in the last 30 and 90 days of life (DOL) and death location was also tested. Results: Of the 519 patients treated with ICIs, 395 and 384 were included in OS and ORR analyses, respectively, with 26% and 24% having a PS ≥ 2. OS was higher in those with a PS of 0 to 1 than those with a PS ≥ 2 who were treated in the first line (median, 15.2 vs 7.2 months; hazard ratio [HR], 0.62; P =.01) but not in subsequent lines (median, 9.8 vs 8.2 months; HR, 0.78; P =.27). ORRs were similar for patients with a PS of 0 to 1 and patients with a PS ≥ 2 in both lines. Of the 288 patients who died, 10% and 32% started ICIs in the last 30 and 90 DOL, respectively. ICI initiation in the last 30 DOL was associated with increased odds of death in a hospital (odds ratio, 2.89; P =.04). Conclusions: Despite comparable ORRs, ICIs may not overcome the negative prognostic role of a poor PS, particularly in the first-line setting, and the initiation of ICIs in the last 30 DOL was associated with hospital death location.
AB - Background: Immune checkpoint inhibitors (ICIs) represent an appealing treatment for patients with advanced urothelial cancer (aUC) and a poor performance status (PS). However, the benefit of ICIs for patients with a poor PS remains unknown. It was hypothesized that a poor Eastern Cooperative Oncology Group (ECOG) PS (≥2 vs 0-1) would correlate with shorter overall survival (OS) in patients receiving ICIs. Methods: In this retrospective cohort study, clinicopathologic, treatment, and outcome data were collected for patients with aUC who were treated with ICIs at 18 institutions (2013-2019). The overall response rate (ORR) and OS were compared for patients with an ECOG PS of 0 to 1 and patients with an ECOG PS ≥ 2 at ICI initiation. The association between a new ICI in the last 30 and 90 days of life (DOL) and death location was also tested. Results: Of the 519 patients treated with ICIs, 395 and 384 were included in OS and ORR analyses, respectively, with 26% and 24% having a PS ≥ 2. OS was higher in those with a PS of 0 to 1 than those with a PS ≥ 2 who were treated in the first line (median, 15.2 vs 7.2 months; hazard ratio [HR], 0.62; P =.01) but not in subsequent lines (median, 9.8 vs 8.2 months; HR, 0.78; P =.27). ORRs were similar for patients with a PS of 0 to 1 and patients with a PS ≥ 2 in both lines. Of the 288 patients who died, 10% and 32% started ICIs in the last 30 and 90 DOL, respectively. ICI initiation in the last 30 DOL was associated with increased odds of death in a hospital (odds ratio, 2.89; P =.04). Conclusions: Despite comparable ORRs, ICIs may not overcome the negative prognostic role of a poor PS, particularly in the first-line setting, and the initiation of ICIs in the last 30 DOL was associated with hospital death location.
UR - http://www.scopus.com/inward/record.url?scp=85076443880&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85076443880&partnerID=8YFLogxK
U2 - 10.1002/cncr.32645
DO - 10.1002/cncr.32645
M3 - Article
C2 - 31829450
AN - SCOPUS:85076443880
VL - 126
SP - 1208
EP - 1216
JO - Cancer
JF - Cancer
SN - 0008-543X
IS - 6
ER -