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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 journal › Article › Academic › peer-review
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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 journal › Article › Academic › peer-review
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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