Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma
Por:
Loriot, Y, Sternberg, CN, Castellano, D, Oosting, SF, Dumez, H, Huddart, R, Vianna, K, Gordoa, TA, Skoneczna, I, Fay, AP, Nole, F, Massari, F, Brasiuniene, B, Maroto, P, Fear, S, Di Nucci, F, de Ducla, S, Choy, E
Publicada:
1 oct 2020
Resumen:
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 >= 3 14% versus 6%) and treatment-related grade 3/4 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 preexisting AID does not preclude atezolizumab therapy. (C) 2020 Elsevier Ltd. All rights reserved.
Filiaciones:
Loriot, Y:
Univ Paris Saclay, Univ Paris Sud, Dept Canc Med, Gustave Roussy, Villejuif, France
Univ Paris Saclay, Univ Paris Sud, INSERM U981, Gustave Roussy, Villejuif, France
Sternberg, CN:
San Camillo & Forlanini Hosp, Rome, Italy
Weill Cornell Med, New York, NY USA
Castellano, D:
Hosp Univ 12 Octubre, Med Oncol Serv, Madrid, Spain
Oosting, SF:
Univ Groningen, Univ Med Ctr Groningen, Dept Med Oncol, Groningen, Netherlands
Dumez, H:
Univ Hosp Leuven, Leuven Canc Inst, Dept Gen Med Oncol, Leuven, Belgium
Huddart, R:
Inst Canc Res, Sutton, Surrey, England
Royal Marsden NHS Trust, Sutton, Surrey, England
Vianna, K:
Ctr Integrado Oncol Curitiba CIONC, Curitiba, Parana, Brazil
Gordoa, TA:
Hosp Univ Ramon y Cajal, Med Oncol Dept, Madrid, Spain
Skoneczna, I:
Szpital Biety Mokotowskie Ctr Med, Warsaw, Poland
Fay, AP:
PUCRS Sch Med, Oncoclin Grp, Porto Alegre, RS, Brazil
Nole, F:
European Inst Oncol IRCCS, Med Oncol Div Urogenital & Head & Neck Tumours, IEO, Milan, Italy
Massari, F:
St Orsola Malpighi Hosp, Div Oncol, Bologna, Italy
Brasiuniene, B:
Natl Canc Inst, Vilnius, Lithuania
Maroto, P:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Fear, S:
F Hoffmann La Roche Ltd, Basel, Switzerland
Di Nucci, F:
Genentech Inc, San Francisco, CA 94080 USA
de Ducla, S:
F Hoffmann La Roche Ltd, Basel, Switzerland
Choy, E:
Cardiff Univ, CREATE Ctr, Div Infect & Immun, Sect Rheumatol,Sch Med, Tenovus Bldg,Heath Pk Campus, Cardiff CF14 4XN, Wales
Green Published
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