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.

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  • Safety and efficacy of atezolizumab in patients with autoimmune disease

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  • Yohann Loriot
  • Cora N Sternberg
  • Daniel Castellano
  • Sjoukje F Oosting
  • Herlinde Dumez
  • Robert Huddart
  • Karina Vianna
  • Teresa Alonso Gordoa
  • Iwona Skoneczna
  • Andre P Fay
  • Franco Nolè
  • Francesco Massari
  • Birute Brasiuniene
  • Pablo Maroto
  • Simon Fear
  • Flavia Di Nucci
  • Sabine de Ducla
  • Ernest Choy

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.

Original languageEnglish
Pages (from-to)202-211
Number of pages10
JournalEuropean Journal of Cancer
Publication statusPublished - Oct-2020

ID: 135857184