Primary Results from SAUL, a Multinational Single-arm Safety Study of Atezolizumab Therapy for Locally Advanced or Metastatic Urothelial or Nonurothelial Carcinoma of the Urinary Tract

Sternberg, Cora N.; Loriot, Yohann; James, Nicholas D.; Choy, Ernest; Castellano, Daniel; López‐Ríos, Fernando; Banna, Giuseppe Luigi; Giorgi, Ugo De; Masini, Cristina; Bamias, Aristotelis; Muro, Xavier García del; Durán, Ignacio; Powles, Thomas; Gamulin, Marija; Zengerling, Friedemann; Gergely, Lajos; Gedye, Craig; Ducla, Sabine de; Fear, Simon; Merseburger, Axel S.

doi:10.1016/j.eururo.2019.03.015

Cited by 127 publications

(117 citation statements)

References 22 publications

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“…These results confirmed the tolerability of atezolizumab in a real-world, pretreated population, with similar efficacy results to the pivotal clinical trial. 141 Another smaller expanded access study of atezolizumab in patients with pretreated metastatic urothelial carcinoma reached a similar conclusion. 142 In cohort 1 of the previously mentioned IMvigor-210 trial, atezolizumab was evaluated as a first-line therapy in 119 patients with locally advanced or metastatic urothelial carcinoma who were ineligible for cisplatin.…”

Section: Atezolizumabmentioning

confidence: 77%

“…The phase IIIb SAUL study evaluated atezolizumab in 1,004 patients with pretreated, locally advanced or metastatic urothelial or nonurothelial carcinoma of the urinary tract. 141 This study sought to evaluate the safety and efficacy of atezolizumab in patients more similar to the real world population, including those ineligible for IMvigor-211. Median OS was 8.7 months (95% CI, 7.8-9.9), median PFS was 2.2 months (95% CI, 2.1-2.4), and the ORR was 13% (95% CI, 11%-16%).…”

Section: Atezolizumabmentioning

confidence: 99%

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Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Flaig

Spiess

Agarwal

et al. 2020

Journal of the National Comprehensive Cancer Network

491

389

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This selection from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Bladder Cancer focuses on the clinical presentation and workup of suspected bladder cancer, treatment of non–muscle-invasive urothelial bladder cancer, and treatment of metastatic urothelial bladder cancer because important updates have recently been made to these sections. Some important updates include recommendations for optimal treatment of non–muscle-invasive bladder cancer in the event of a bacillus Calmette-Guérin (BCG) shortage and details about biomarker testing for advanced or metastatic disease. The systemic therapy recommendations for second-line or subsequent therapies have also been revised. Treatment and management of muscle-invasive, nonmetastatic disease is covered in the complete version of the NCCN Guidelines for Bladder Cancer available at NCCN.org. Additional topics covered in the complete version include treatment of nonurothelial histologies and recommendations for nonbladder urinary tract cancers such as upper tract urothelial carcinoma, urothelial carcinoma of the prostate, and primary carcinoma of the urethra.

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Section: Atezolizumabmentioning

confidence: 77%

Section: Atezolizumabmentioning

confidence: 99%

Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Flaig

Spiess

Agarwal

et al. 2020

Journal of the National Comprehensive Cancer Network

491

389

View full text Add to dashboard Cite

show abstract

“…The median PFS of the patients in the study of De Giorgi et al, was 4.4 months (95% CI 3.7-6.2). Lastly, the study of Sternberg et al, observed no objective responses in patients with BMs from urothelial and non-urothelial urinary tract carcinoma (UTC), treated with atezolizumab 1200 mg Q3W [45]. The median PFS and OS of the patients in this study were 2.0 months (95% CI 1.5-2.3) and 3.7 months (95% CI 1.5-7.0), respectively.…”

Section: Outcomes Of Immune Checkpoint Inhibitors In Brain Metastasesmentioning

confidence: 46%

The Current Status of Immune Checkpoint Inhibitors in Neuro-Oncology: A Systematic Review

Brahm

Linde

Enting

et al. 2020

Cancers

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The introduction of immune checkpoint inhibitors (ICI), as a novel treatment modality, has transformed the field of oncology with unprecedented successes. However, the efficacy of ICI for patients with glioblastoma or brain metastases (BMs) from any tumor type is under debate. Therefore, we systematically reviewed current literature on the use of ICI in patients with glioblastoma and BMs. Prospective and retrospective studies evaluating the efficacy and survival outcomes of ICI in patients with glioblastoma or BMs, and published between 2006 and November 2019, were considered. A total of 88 studies were identified (n = 8 in glioblastoma and n = 80 in BMs). In glioblastoma, median progression-free (PFS) and overall survival (OS) of all studies were 2.1 and 7.3 months, respectively. In patients with BMs, intracranial responses have been reported in studies with melanoma and non-small-cell lung cancer (NSCLC). The median intracranial and total PFS in these studies were 2.7 and 3.0 months, respectively. The median OS in all studies for patients with brain BMs was 8.0 months. To date, ICI demonstrate limited efficacy in patients with glioblastoma or BMs. Future research should focus on increasing the local and systemic immunological responses in these patients.

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“…Zu den häufigsten behandlungsbedingten Nebenwirkungen ≥ Grad 3 zählten Asthenie, Fatigue, Kolitis und Hypertonie (mit jeweils 1 %). Die Effektivität der Behandlung war im Bereich von früheren Checkpoint-Inhibitor Studien vergleichbar [27].…”

Section: Pd-1/pd-l1-antikörper In Der Zweitlinieein Neuer Therapiestaunclassified

50 Jahre Systemtherapie des Harnblasenkarzinoms

et al. 2019

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ZusammenfassungDieser Übersichtsartikel stellt die Ergebnisse verschiedener Behandlungskonzepte für das metastasierte Urothelkarzinom in den letzten fünf Jahrzehnten zusammen. Mit der Einführung von verschiedenen Kombinations-Chemotherapien wurde ab Mitte der 80er Jahre eine signifikante Überlebensverlängerung und potenzielle Heilbarkeit auch fortgeschrittener Erkrankungsstadien in dieser Tumorentität postuliert. Vor zwei Jahren wurden Studiendaten zur Zweitlinientherapie des metastasierten Urothelkarzinoms mit dem PD1-Antikörper Pembrolizumab publiziert, die erstmals einen Vorteil im Gesamtüberleben gegenüber einer konventionellen Chemotherapie mit Paclitaxel, Docetaxel oder Vinflunin zeigen. Aktuell wird in randomisierten Phase-3-Studien der Einsatz von PD-1/PD-L1 gerichteten Substanzen auch in der Erstlinientherapie des metastasierten Urothelkarzinoms untersucht. Dabei werden verschiedene Therapiestrategien verfolgt: Monotherapien mit PD-1/PD-L1-Inhibitoren sowie deren Kombinationen mit CTLA-4-Inhibitoren oder konventioneller Chemotherapie. Es liegen bereits Daten aus einarmigen Phase-2-Studien zur Monotherapie vor. Erste Daten aus randomisierten Studien werden im Laufe des Jahres 2019 erwartet.

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Primary Results from SAUL, a Multinational Single-arm Safety Study of Atezolizumab Therapy for Locally Advanced or Metastatic Urothelial or Nonurothelial Carcinoma of the Urinary Tract

Cited by 127 publications

References 22 publications

Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

The Current Status of Immune Checkpoint Inhibitors in Neuro-Oncology: A Systematic Review

50 Jahre Systemtherapie des Harnblasenkarzinoms

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