Surgical Safety of Radical Cystectomy and Pelvic Lymph Node Dissection Following Neoadjuvant Pembrolizumab in Patients with Bladder Cancer: Prospective Assessment of Perioperative Outcomes from the PURE-01 Trial

Briganti, Alberto; Gandaglia, Giorgio; Scuderi, Simone; Gallina, Andrea; Colombo, Renzo; Fossati, Nicola; Barletta, Francesco; Pellegrino, Antony; Nocera, Luigi; Montorsi, Francesco; Necchi, Andrea

doi:10.1016/j.eururo.2019.12.019

Cited by 55 publications

(34 citation statements)

References 20 publications

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“…Pathological complete response (pCR; ypT0N0) was achieved in 42 out of 114 patients (37%; 95% confidence interval [CI]: 28-46%). Updated results in a larger cohort, which included 34 tumors with variant histologies (30%), confirmed the activity of neoadjuvant pembrolizumab and its medical safety profile [27]. A substantially lower activity of pembrolizumab was found in patients with variant histologies, as the pT0 rate was 16%.…”

Section: Efficacy Of Pembrolizumab In the Presurgical Settingmentioning

confidence: 64%

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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: 64%

“…Neoadjuvant pembrolizumab did not delay planned surgery, and no new postsurgical complications were observed [27]. After a median follow-up of 23 months (interquartile range: 15-29), 12-and 24-month event-free survival (EFS) was 84.5% (95% CI: 78.5-90.9) and 71.7% (95% CI: 62.7-82).…”

Section: Efficacy Of Pembrolizumab In the Presurgical Settingmentioning

confidence: 98%

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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“…We relied on the population of patients with MIBC enrolled into the single-arm phase 2 PURE-01 study. [4][5][6][7][8][9] This study enrolled 143 consecutive patients who have been treated with 3 cycles of pembrolizumab at a flat dose of 200 mg every 3 weeks before RC. In the PURE-01 study, patients had a predominant urothelial carcinoma histology and a clinical stage up to T3bN0.…”

Section: Methodsmentioning

confidence: 99%

“…3 With the aim to elucidate the relationship between pembrolizumab and the development of AKI and CKD in patients affected by localized bladder cancer, we relied on the population of patients with muscle-invasive bladder cancer (MIBC) enrolled into the PURE-01 study. [4][5][6][7][8][9]…”

Section: Introductionmentioning

confidence: 99%

Renal function outcomes in patients with muscle‐invasive bladder cancer treated with neoadjuvant pembrolizumab and radical cystectomy in the PURE‐01 study

Trevisani

Marco

Raggi

et al. 2021

Intl Journal of Cancer

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The use of pembrolizumab has been largely accepted in several advanced types of cancers. PURE 01 study (NCT02736266) enrolled consecutively 143 patients with muscle‐invasive bladder cancer who received 3 cycles of pembrolizumab 200 mg every 3 weeks before planned radical cystectomy (RC). Clinical, pathological and laboratory data were collected to investigate the relationship between renal function, immunotherapy and cancer‐related outcomes. Serum creatinine and estimated glomerular filtration rate (eGFR) using Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI) creatinine‐equation 2009 were reported at baseline and after every cycle of pembrolizumab; the T stage from clinical classification TNM (cTNM) was stated before the treatment. Our analysis did not demonstrate a significant impairment of eGFR after any cycle of pembrolizumab, neither in the overall cohort nor in subgroups considering the T stages or the CKD G‐categories according to K‐DIGO 2012 classification. In conclusion, in neoadjuvant setting before RC our results suggest that pembrolizumab administration is safe for renal function preservation.

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“…These results seem to suggest that the addition of immunotherapy to standard of care NAC does not result in synergy with respect to pCR rates, however long term OS data is still awaited and phase III trials are underway. Emerging data suggest neoadjuvant CPI do not adversely affect surgical safety of RC [274].…”

Section: Immune Checkpoint Inhibitors (Cpis) and Targeted Therapiesmentioning

confidence: 99%

Current Management of Localized Muscle-Invasive Bladder Cancer: A Consensus Guideline from the Genitourinary Medical Oncologists of Canada

Jiang

North

Canil

et al. 2020

BLC

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BACKGROUND: Despite recent advances in the management of muscle-invasive bladder cancer (MIBC), treatment outcomes remain suboptimal, and variability exists across current practice patterns. OBJECTIVE: To promote standardization of care for MIBC in Canada by developing a consensus guidelines using a multidisciplinary, evidence-based, patient-centered approach who specialize in bladder cancer. METHODS: A comprehensive literature search of PubMed, Medline, and Embase was performed; and most recent guidelines from national and international organizations were reviewed. Recommendations were made based on best available evidence, and strength of recommendations were graded based on quality of the evidence. RESULTS: Overall, 17 recommendations were made covering a broad range of topics including pathology review, staging investigations, systemic therapy, local definitive therapy and surveillance. Of these, 10 (59% ) were level 1 or 2, 7 (41% ) were level 3 or 4 recommendations. There were 2 recommendations which did not reach full consensus, and were based on majority opinion. This guideline also provides guidance for the management of cisplatin-ineligible patients, variant histologies, and bladder-sparing trimodality therapy. Potential biomarkers, ongoing clinical trials, and future directions are highlighted. CONCLUSIONS: This guideline embodies the collaborative expertise from all disciplines involved, and provides guidance to further optimize and standardize the management of MIBC.

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Surgical Safety of Radical Cystectomy and Pelvic Lymph Node Dissection Following Neoadjuvant Pembrolizumab in Patients with Bladder Cancer: Prospective Assessment of Perioperative Outcomes from the PURE-01 Trial

Cited by 55 publications

References 20 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

Renal function outcomes in patients with muscle‐invasive bladder cancer treated with neoadjuvant pembrolizumab and radical cystectomy in the PURE‐01 study

Current Management of Localized Muscle-Invasive Bladder Cancer: A Consensus Guideline from the Genitourinary Medical Oncologists of Canada

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