Publication

Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma

Loriot, Y., Sternberg, C. N., Castellano, D., Oosting, S. F., Dumez, H., Huddart, R., Vianna, K., Alonso Gordoa, T., Skoneczna, I., Fay, A. P., Nolè, F., Massari, F., Brasiuniene, B., Maroto, P., Fear, S., Di Nucci, F., de Ducla, S. & Choy, E., Oct-2020, In : European Journal of Cancer. 138, p. 202-211 10 p.

Research output: Contribution to journalArticleAcademicpeer-review

APA

Loriot, Y., Sternberg, C. N., Castellano, D., Oosting, S. F., Dumez, H., Huddart, R., Vianna, K., Alonso Gordoa, T., Skoneczna, I., Fay, A. P., Nolè, F., Massari, F., Brasiuniene, B., Maroto, P., Fear, S., Di Nucci, F., de Ducla, S., & Choy, E. (2020). Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma. European Journal of Cancer, 138, 202-211. https://doi.org/10.1016/j.ejca.2020.07.023

Author

Loriot, Yohann ; Sternberg, Cora N ; Castellano, Daniel ; Oosting, Sjoukje F ; Dumez, Herlinde ; Huddart, Robert ; Vianna, Karina ; Alonso Gordoa, Teresa ; Skoneczna, Iwona ; Fay, Andre P ; Nolè, Franco ; Massari, Francesco ; Brasiuniene, Birute ; Maroto, Pablo ; Fear, Simon ; Di Nucci, Flavia ; de Ducla, Sabine ; Choy, Ernest. / Safety and efficacy of atezolizumab in patients with autoimmune disease : Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma. In: European Journal of Cancer. 2020 ; Vol. 138. pp. 202-211.

Harvard

Loriot, Y, Sternberg, CN, Castellano, D, Oosting, SF, Dumez, H, Huddart, R, Vianna, K, Alonso Gordoa, T, Skoneczna, I, Fay, AP, Nolè, F, Massari, F, Brasiuniene, B, Maroto, P, Fear, S, Di Nucci, F, de Ducla, S & Choy, E 2020, 'Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma', European Journal of Cancer, vol. 138, pp. 202-211. https://doi.org/10.1016/j.ejca.2020.07.023

Standard

Safety and efficacy of atezolizumab in patients with autoimmune disease : Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma. / Loriot, Yohann; Sternberg, Cora N; Castellano, Daniel; Oosting, Sjoukje F; Dumez, Herlinde; Huddart, Robert; Vianna, Karina; Alonso Gordoa, Teresa; Skoneczna, Iwona; Fay, Andre P; Nolè, Franco; Massari, Francesco; Brasiuniene, Birute; Maroto, Pablo; Fear, Simon; Di Nucci, Flavia; de Ducla, Sabine; Choy, Ernest.

In: European Journal of Cancer, Vol. 138, 10.2020, p. 202-211.

Research output: Contribution to journalArticleAcademicpeer-review

Vancouver

Loriot Y, Sternberg CN, Castellano D, Oosting SF, Dumez H, Huddart R et al. Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma. European Journal of Cancer. 2020 Oct;138:202-211. https://doi.org/10.1016/j.ejca.2020.07.023


BibTeX

@article{d8b21b98b50f41f488a8ce8468886a18,
title = "Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma",
abstract = "Aim: Patients with pre-existing autoimmune disease (AID) are typically excluded from clinical trials of immune checkpoint inhibitors, and there are limited data on outcomes in this population. The single-arm international SAUL study of atezolizumab enrolled a broader {\textquoteleft}real-world{\textquoteright} patient population. We present outcomes in patients with a history of AID. Methods: Patients with locally advanced/metastatic urinary tract carcinoma received atezolizumab 1200 mg every 3 weeks until loss of clinical benefit or unacceptable toxicity. The primary end-point was safety. Overall survival (OS) was a secondary end-point. Subgroup analyses of AID patients were prespecified. Results: Thirty-five of 997 treated patients had AID at baseline, most commonly psoriasis (n = 15). Compared with non-AID patients, AID patients experienced numerically more adverse events (AEs) of special interest (46% versus 30%; grade ≥III 14% versus 6%) and treatment-related grade III/IV AEs (26% versus 12%), but without relevant increases in treatment-related deaths (0% versus 1%) or AEs necessitating treatment discontinuation (9% versus 6%). Pre-existing AID worsened in four patients (11%; two flares in two patients); three of the six flares resolved, one was resolving, and two were unresolved. Efficacy was similar in AID and non-AID patients (median OS, 8.2 versus 8.8 months, respectively; median progression-free survival, 4.4 versus 2.2 months; disease control rate, 51% versus 39%). Conclusions: In 35 atezolizumab-treated patients with pre-existing AID, incidences of special interest and treatment-related AEs appeared acceptable. AEs were manageable, rarely requiring atezolizumab discontinuation. Treating these patients requires caution, but pre-existing AID does not preclude atezolizumab therapy. Trial registration: NCT02928406.",
author = "Yohann Loriot and Sternberg, {Cora N} and Daniel Castellano and Oosting, {Sjoukje F} and Herlinde Dumez and Robert Huddart and Karina Vianna and {Alonso Gordoa}, Teresa and Iwona Skoneczna and Fay, {Andre P} and Franco Nol{\`e} and Francesco Massari and Birute Brasiuniene and Pablo Maroto and Simon Fear and {Di Nucci}, Flavia and {de Ducla}, Sabine and Ernest Choy",
note = "Copyright {\textcopyright} 2020 Elsevier Ltd. All rights reserved.",
year = "2020",
month = oct,
doi = "10.1016/j.ejca.2020.07.023",
language = "English",
volume = "138",
pages = "202--211",
journal = "European Journal of Cancer",
issn = "0959-8049",
publisher = "ELSEVIER SCI LTD",

}

RIS

TY - JOUR

T1 - Safety and efficacy of atezolizumab in patients with autoimmune disease

T2 - Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma

AU - Loriot, Yohann

AU - Sternberg, Cora N

AU - Castellano, Daniel

AU - Oosting, Sjoukje F

AU - Dumez, Herlinde

AU - Huddart, Robert

AU - Vianna, Karina

AU - Alonso Gordoa, Teresa

AU - Skoneczna, Iwona

AU - Fay, Andre P

AU - Nolè, Franco

AU - Massari, Francesco

AU - Brasiuniene, Birute

AU - Maroto, Pablo

AU - Fear, Simon

AU - Di Nucci, Flavia

AU - de Ducla, Sabine

AU - Choy, Ernest

N1 - Copyright © 2020 Elsevier Ltd. All rights reserved.

PY - 2020/10

Y1 - 2020/10

N2 - Aim: Patients with pre-existing autoimmune disease (AID) are typically excluded from clinical trials of immune checkpoint inhibitors, and there are limited data on outcomes in this population. The single-arm international SAUL study of atezolizumab enrolled a broader ‘real-world’ patient population. We present outcomes in patients with a history of AID. Methods: Patients with locally advanced/metastatic urinary tract carcinoma received atezolizumab 1200 mg every 3 weeks until loss of clinical benefit or unacceptable toxicity. The primary end-point was safety. Overall survival (OS) was a secondary end-point. Subgroup analyses of AID patients were prespecified. Results: Thirty-five of 997 treated patients had AID at baseline, most commonly psoriasis (n = 15). Compared with non-AID patients, AID patients experienced numerically more adverse events (AEs) of special interest (46% versus 30%; grade ≥III 14% versus 6%) and treatment-related grade III/IV AEs (26% versus 12%), but without relevant increases in treatment-related deaths (0% versus 1%) or AEs necessitating treatment discontinuation (9% versus 6%). Pre-existing AID worsened in four patients (11%; two flares in two patients); three of the six flares resolved, one was resolving, and two were unresolved. Efficacy was similar in AID and non-AID patients (median OS, 8.2 versus 8.8 months, respectively; median progression-free survival, 4.4 versus 2.2 months; disease control rate, 51% versus 39%). Conclusions: In 35 atezolizumab-treated patients with pre-existing AID, incidences of special interest and treatment-related AEs appeared acceptable. AEs were manageable, rarely requiring atezolizumab discontinuation. Treating these patients requires caution, but pre-existing AID does not preclude atezolizumab therapy. Trial registration: NCT02928406.

AB - Aim: Patients with pre-existing autoimmune disease (AID) are typically excluded from clinical trials of immune checkpoint inhibitors, and there are limited data on outcomes in this population. The single-arm international SAUL study of atezolizumab enrolled a broader ‘real-world’ patient population. We present outcomes in patients with a history of AID. Methods: Patients with locally advanced/metastatic urinary tract carcinoma received atezolizumab 1200 mg every 3 weeks until loss of clinical benefit or unacceptable toxicity. The primary end-point was safety. Overall survival (OS) was a secondary end-point. Subgroup analyses of AID patients were prespecified. Results: Thirty-five of 997 treated patients had AID at baseline, most commonly psoriasis (n = 15). Compared with non-AID patients, AID patients experienced numerically more adverse events (AEs) of special interest (46% versus 30%; grade ≥III 14% versus 6%) and treatment-related grade III/IV AEs (26% versus 12%), but without relevant increases in treatment-related deaths (0% versus 1%) or AEs necessitating treatment discontinuation (9% versus 6%). Pre-existing AID worsened in four patients (11%; two flares in two patients); three of the six flares resolved, one was resolving, and two were unresolved. Efficacy was similar in AID and non-AID patients (median OS, 8.2 versus 8.8 months, respectively; median progression-free survival, 4.4 versus 2.2 months; disease control rate, 51% versus 39%). Conclusions: In 35 atezolizumab-treated patients with pre-existing AID, incidences of special interest and treatment-related AEs appeared acceptable. AEs were manageable, rarely requiring atezolizumab discontinuation. Treating these patients requires caution, but pre-existing AID does not preclude atezolizumab therapy. Trial registration: NCT02928406.

U2 - 10.1016/j.ejca.2020.07.023

DO - 10.1016/j.ejca.2020.07.023

M3 - Article

C2 - 32905959

VL - 138

SP - 202

EP - 211

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

ER -

ID: 135857184