Updated Results of PURE-01 with Preliminary Activity of Neoadjuvant Pembrolizumab in Patients with Muscle-invasive Bladder Carcinoma with Variant Histologies

Necchi, Andrea; Raggi, Daniele; Gallina, Andrea; Madison, Russell; Colecchia, Maurizio; Lucianò, Roberta; Montironi, Rodolfo; Giannatempo, Patrizia; Farè, Elena; Pederzoli, Filippo; Bandini, Marco; Bianchi, Marco; Colombo, Renzo; Gandaglia, Giorgio; Fossati, Nicola; Marandino, Laura; Capitanio, Umberto; Dehò, Federico; Ali, Siraj M.; Chung, Jon; Ross, Jeffrey S.; Salonia, Andrea; Briganti, Alberto; Montorsi, Francesco

doi:10.1016/j.eururo.2019.10.026

Cited by 254 publications

(191 citation statements)

References 23 publications

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“…Recently, Necchi and colleagues [15,26] reported the results from a single-arm phase 2 trial (NCT02736266) evaluating the anti-PD-1 antibody pembrolizumab as neoadjuvant therapy before cystectomy in patients with MIBC. Patients received pembrolizumab 200 mg every 3 wk for up to three doses.…”

Section: Efficacy Of Pembrolizumab In the Presurgical Settingmentioning

confidence: 99%

Rationale and Outcomes for Neoadjuvant Immunotherapy in Urothelial Carcinoma of the Bladder

Rouanne

Bajorin

Hannan

et al. 2020

European Urology Oncology

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Section: Efficacy Of Pembrolizumab In the Presurgical Settingmentioning

confidence: 99%

Rationale and Outcomes for Neoadjuvant Immunotherapy in Urothelial Carcinoma of the Bladder

Rouanne

Bajorin

Hannan

et al. 2020

European Urology Oncology

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“…The third issue regards the importance to not lose the opportunity to undergo definitive RC, the only therapeutic act that has proven to have a healing role in MIBC, because of complications or rapid progression. In the ABACUS trial, 3% of patients could not undergo RC due to immune CPI-related adverse events whereas in the PURE-01 trial, one out of 114 patients (0.9%) did not receive RC due to progression of disease (21,22). Moreover, the preliminary data analysis for 40 evaluable patients enrolled in a phase Ib-II trial (NCT02365766) and treated with NAC + pembrolizumab reported that one patient did not have RC due to AE (27).…”

Section: Discussionmentioning

confidence: 99%

“…Clavien Dindo grade > II postsurgical complications occurred in 15 patients (30%) whereas delayed immune-related AEs including pyrexia in 3 patients (6%), pruritus in 3 patients (6%), and xerostomia in 2 patients (4%) occurred within 2 months post-operatively. This protocol was emended to allow the enrollment of patients with predominant variant histology (VH), usually chemo-resistant and excluded from clinical trials (22). Overall, 114 patients were enrolled and 34 of them (30%) presented with VH, including 19 (17%) with predominant VH.…”

Section: Mono-immunotherapymentioning

confidence: 99%

Current Perspectives on Immunotherapy in the Peri-Operative Setting of Muscle-Infiltrating Bladder Cancer

et al. 2020

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Patients with muscle-infiltrating bladder cancer (MIBC) present a high risk of postoperative recurrence and death from metastatic urothelial cancer despite surgical resection. Before the use of peri-operative chemotherapy, about half (52%) of patients undergoing radical cystectomy had had a relapse of tumor disease within 5 years of surgery. However, when peri-operative cisplatin-based chemotherapy is added to radical cystectomy for patients with MIBC it provides limited benefit in terms of survival, disease recurrence and development of metastases, at the expense of toxic effects. In fact, a significant proportion of patients still recurs and die to metastatic disease. Given the success of immune-oncological drugs in metastatic urothelial cancer, several trials started to test them in patients with non-metastatic MIBC either in neo-adjuvant and adjuvant setting. The preliminary results of these studies in neo-adjuvant setting are showing great promise, confirming the potential benefits of immunotherapy also in patients with non-metastatic MIBC. The aim of this review is to present an overview of developments happening on the introduction of immunotherapy in peri-operative setting in non-metastatic urothelial cancer. Moreover, an analysis of the critical issues regarding how best customize the delivery of immunotherapy to optimize efficacy and minimize the adverse effects, with particular focus on potential prognostic and predictive molecular biomarkers, is done.

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“…Erste Daten zeigten allerdings vielversprechende Ergebnisse. In der Neoadjuvanz vor RC konnte im Rahmen einer Phase II-Studie (PURE-1 Trial) für den PD-1 Inhibitor Pembrolizumab eine hohe Downstagingrate (CR: 42 %) bei guter Verträglichkeit gezeigt werden [85,86]. Auf dem ASCO-GU 2020-Meeting wurden erste Daten aus dem NEODURVARIB-Trial vorgestellt, hierbei wurde für Kombination von Durvalumab plus Olaparib eine CR-Rate von 50 % beschrieben, die Publikation steht noch aus.…”

Section: Immuncheckpoint-therapieunclassified

Nur die Chirurgie? Multimodalkonzepte mit kurativer Intention für das Urothelkarzinom der Harnblase

2020

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ZusammenfassungDie radikale Zystektomie ist der Goldstandard zur Behandlung des muskelinvasiven Urothelkarzinoms. Insbesondere bei Patienten mit fortgeschrittenen Tumoren spielen multimodale, neoadjuvante oder adjuvante Therapiekonzepte eine zunehmend wichtige Rolle für die optimale Patientenversorgung. Zudem sind bei älteren und komorbideren Patienten, die unfit für eine radikale Zystektomie sind, alternative Therapiekonzepte erforderlich. Dieser Artikel fasst die aktuelle Literatur multimodaler Therapien im neoadjuvanten und adjuvanten Setting zusammen und beleuchtet Alternativen zur radikalen Zystektomie mit kurativem Therapieansatz. Ebenfalls werden erste Erkenntnisse über den Einsatz neuer, vielversprechender Therapieoptionen wie der Immuncheckpoint-Blockade im multimodalen Therapieansatz zusammengefasst.

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Updated Results of PURE-01 with Preliminary Activity of Neoadjuvant Pembrolizumab in Patients with Muscle-invasive Bladder Carcinoma with Variant Histologies

Cited by 254 publications

References 23 publications

Rationale and Outcomes for Neoadjuvant Immunotherapy in Urothelial Carcinoma of the Bladder

Rationale and Outcomes for Neoadjuvant Immunotherapy in Urothelial Carcinoma of the Bladder

Current Perspectives on Immunotherapy in the Peri-Operative Setting of Muscle-Infiltrating Bladder Cancer

Nur die Chirurgie? Multimodalkonzepte mit kurativer Intention für das Urothelkarzinom der Harnblase

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