PMID- 32399958 OWN - NLM STAT- MEDLINE DCOM- 20210818 LR - 20210818 IS - 1424-3997 (Electronic) IS - 0036-7672 (Linking) VI - 150 DP - 2020 May 4 TI - Swiss experience of atezolizumab for platinum-pretreated urinary tract carcinoma: the SAUL study in real-world practice. PG - w20223 LID - Swiss Med Wkly. 2020;150:w20223 [pii] LID - 10.4414/smw.2020.20223 [doi] AB - AIMS OF THE STUDY: Atezolizumab is an approved therapy for urothelial carcinoma based on results from the IMvigor 210 and IMvigor211 phase II and III trials. The global SAUL study evaluated atezolizumab in a broader patient population more representative of real-world populations. Among approximately 1000 patients treated in SAUL, 25 were treated in Swiss oncology centres. We evaluated outcomes in these patients to provide a better understanding of atezolizumab treatment for urinary tract carcinoma in Swiss clinical practice. METHODS: Eligible patients had locally advanced or metastatic urothelial or non-urothelial urinary tract carcinoma that had progressed during or after one to three prior therapies for inoperable, locally advanced or metastatic disease. Patient populations typically excluded from clinical trials (e.g., patients with renal impairment, treated central nervous system [CNS] metastases, stable controlled autoimmune disease or Eastern Cooperative Oncology Group performance status 2) were also eligible. All patients received atezolizumab 1200 mg every 3 weeks until loss of clinical benefit or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included overall survival (OS), overall response rate (ORR) and disease control rate (DCR). RESULTS: All 25 Swiss patients had previously received a gemcitabine/platinum doublet. Disease had progressed within 12 months of platinum-based therapy in all but one patient, and 19 (76%) had received one prior line of therapy for metastatic disease. The median duration of atezolizumab therapy was six cycles (range 1–27) corresponding to 3.6 months. Five patients (20%) had received >20 cycles and four (16%) remained on treatment at the data cut-off. Grade 3 adverse events (AEs) occurred in 13 patients (52%) and were considered to be treatment-related in four patients (16%; liver enzyme increases, musculoskeletal pain, diverticulitis and autoimmune hepatitis). There was one grade 4 AE (hypercalcaemia) and no grade 5 AEs. After median follow-up of 17.3 months, median OS was 7.9 months (95% confidence interval [CI] 5.3–not evaluable), the 1-year OS rate was 47% (95% CI 27–65%), the ORR was 12% (95% CI 3–31%) and the DCR was 40% (95% CI 21–61%). Durable clinical benefit (>1 year on treatment) was observed in seven patients (28%), including one with CNS metastases and one with small-cell carcinoma. CONCLUSIONS: Atezolizumab is an active treatment option for platinum-pretreated urinary tract carcinoma, including patients with conditions that typically exclude them from clinical trials. (Trial registration no.: NCT02928406). FAU - Cathomas, Richard AU - Cathomas R AD - Department of Internal Medicine, Department of Oncology and Haematology, Kantonsspital Graubunden, Chur, Switzerland. FAU - Schardt, Julian AU - Schardt J AD - University Hospital for Medical Oncology, Inselspital Bern, Switzerland. FAU - Pless, Miklos AU - Pless M AD - Department of Medical Oncology, Kantonsspital Winterthur, Switzerland. FAU - Llado, Anna AU - Llado A AD - Istitut Oncologico della Svizzera Italiana, Bellinzona, Switzerland. FAU - Mach, Nicolas AU - Mach N AD - Hopitaux Universitaires Geneve, Geneva, Switzerland. FAU - Riklin, Christian AU - Riklin C AD - Department of Medical Oncology, Luzerner Kantonsspital, Luzern, Switzerland. FAU - Haefeli, Jenny AU - Haefeli J AD - Roche (Schweiz) AG, Reinach, Switzerland. FAU - Fear, Simon AU - Fear S AD - F Hoffmann-La Roche Ltd, Basel, Switzerland. FAU - Stenner, Frank AU - Stenner F AD - Universitatsspital Basel, Basel, Switzerland. LA - eng SI - ClinicalTrials.gov/NCT02928406 PT - Journal Article DEP - 20200504 PL - Switzerland TA - Swiss Med Wkly JT - Swiss medical weekly JID - 100970884 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 49DFR088MY (Platinum) RN - 52CMI0WC3Y (atezolizumab) SB - IM MH - Antibodies, Monoclonal, Humanized MH - *Carcinoma, Transitional Cell MH - Humans MH - Platinum MH - Switzerland MH - *Urinary Bladder Neoplasms EDAT- 2020/05/14 06:00 MHDA- 2021/08/19 06:00 CRDT- 2020/05/14 06:00 PHST- 2020/05/14 06:00 [entrez] PHST- 2020/05/14 06:00 [pubmed] PHST- 2021/08/19 06:00 [medline] AID - Swiss Med Wkly. 2020;150:w20223 [pii] AID - 10.4414/smw.2020.20223 [doi] PST - epublish SO - Swiss Med Wkly. 2020 May 4;150:w20223. doi: 10.4414/smw.2020.20223. eCollection 2020 May 4.