Multiparametric Magnetic Resonance Imaging as a Noninvasive Assessment of Tumor Response to Neoadjuvant Pembrolizumab in Muscle-invasive Bladder Cancer: Preliminary Findings from the PURE-01 Study

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

doi:10.1016/j.eururo.2019.12.016

Cited by 77 publications

(42 citation statements)

References 23 publications

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“…Although it is relatively novel, a growing body of evidence from both retrospective and prospective studies is becoming available, systematically testing VI-RADS for diagnostic applications both for preoperative risk stratification and assessment of therapeutic response post chemotherapy [ 8 , 11 , 12 ]. Two recent meta-analyses describe the ability of VI-RADS to differentiate between superficial and muscle-invasive disease in a preoperative setting [ 9 , 10 ].…”

Section: Discussionmentioning

confidence: 99%

“…After its introduction in April 2018, two separate meta-analyses have shown excellent overall pooled diagnostic accuracy for VI-RADS score ≥ 3, with Area Under the Curve (AUC) of 0.94 (95% confidence interval [CI], 0.91–0.95) and 0.93 (95% CI 0.91–0.95), respectively [ 9 , 10 ]. As described in the seminal document [ 7 ], the applicability of VI-RADS may extend beyond its intrinsic diagnostic and staging value, leading VI-RADS to act as a predictive tool for several clinical scenarios indicating those non-muscle invasive bladder cancer (NMIBC)’s for secondary resection (Re-TURBT) or as a radiation-free modality to monitor radiological response of MIBC patients eligible for neoadjuvant systemic regimens [ 8 , 11 , 12 ]. One of the most important and underappreciated aspect of VI-RADS is to provide a systematic and standardized approach to define the risk of muscle invasion.…”

Section: Introductionmentioning

confidence: 99%

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Systematic Review and Meta-Analysis of Vesical Imaging-Reporting and Data System (VI-RADS) Inter-Observer Reliability: An Added Value for Muscle Invasive Bladder Cancer Detection

Giudice

Pecoraro

Vargas

et al. 2020

Cancers

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The Vesical Imaging-Reporting and Data System (VI-RADS) has been introduced to provide preoperative bladder cancer staging and has proved to be reliable in assessing the presence of muscle invasion in the pre-TURBT (trans-urethral resection of bladder tumor). We aimed to assess through a systematic review and meta-analysis the inter-reader variability of VI-RADS criteria for discriminating non-muscle vs. muscle invasive bladder cancer (NMIBC, MIBC). PubMed, Web of Science, Cochrane, and Embase were searched up until 30 July 2020. The Quality Appraisal of Diagnostic Reliability (QAREL) checklist was utilized to assess the quality of included studies and a pooled measure of inter-rater reliability (Cohen’s Kappa [κ] and/or Intraclass correlation coefficients (ICCs)) was calculated. Further sensitivity analysis, subgroup analysis, and meta-regression were conducted to investigate the contribution of moderators to heterogeneity. In total, eight studies between 2018 and 2020, which evaluated a total of 1016 patients via 21 interpreting genitourinary (GU) radiologists, met inclusion criteria and were critically examined. No study was considered to be significantly flawed with publication bias. The pooled weighted mean κ estimate was 0.83 (95%CI: 0.78–0.88). Heterogeneity was present among the studies (Q = 185.92, d.f. = 7, p < 0.001; I2 = 92.7%). Meta-regression analyses showed that the relative % of MIBC diagnosis and cumulative reader’s experience to influence the estimated outcome (Coeff: 0.019, SE: 0.007; p= 0.003 and 0.036, SE: 0.009; p = 0.001). In the present study, we confirm excellent pooled inter-reader agreement of VI-RADS to discriminate NMIBC from MIBC underlying the importance that standardization and reproducibility of VI-RADS may confer to multiparametric magnetic resonance (mpMRI) for preoperative BCa staging.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Systematic Review and Meta-Analysis of Vesical Imaging-Reporting and Data System (VI-RADS) Inter-Observer Reliability: An Added Value for Muscle Invasive Bladder Cancer Detection

Giudice

Pecoraro

Vargas

et al. 2020

Cancers

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“…This pattern could theoretically also occur in localized disease, although no cases have been reported to date. Consequently, the use of new radiological techniques, such as multiparametric magnetic resonance imaging [92] and/or positron-emission computed tomography (PET-CT), is important to better assess T-cell response [93] to differentiate between tumour response and progression in these clinical scenarios. Finally, evaluation of ctDNA levels [94] to assess tumour dynamics may also play a role in the future.…”

Section: Surgical Challenges After Neoadjuvant Immunotherapy: New Patmentioning

confidence: 99%

Immunotherapy Moves to the Early-Stage Setting in Non-Small Cell Lung Cancer: Emerging Evidence and the Role of Biomarkers

Mielgo-Rubio

Calvo

Luna³

et al. 2020

Cancers

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Despite numerous advances in targeted therapy and immunotherapy in the last decade, lung cancer continues to present the highest mortality rate of all cancers. Targeted therapy based on specific genomic alterations, together with PD-1 and CTLA-4 axis blocking-based immunotherapy, have significantly improved survival in advanced non-small cell lung cancer (NSCLC) and both therapies are now well-established in this clinical setting. However, it is time for immunotherapy to be applied in patients with early-stage disease, which would be an important qualitative leap in the treatment of lung cancer patients with curative intent. Preliminary data from a multitude of studies are highly promising, but therapeutic decision-making should be guided by an understanding of the molecular features of the tumour and host. In the present review, we discuss the most recently published studies and ongoing clinical trials, controversies, future challenges and the role of biomarkers in the selection of best therapeutic options.

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“…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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Multiparametric Magnetic Resonance Imaging as a Noninvasive Assessment of Tumor Response to Neoadjuvant Pembrolizumab in Muscle-invasive Bladder Cancer: Preliminary Findings from the PURE-01 Study

Cited by 77 publications

References 23 publications

Systematic Review and Meta-Analysis of Vesical Imaging-Reporting and Data System (VI-RADS) Inter-Observer Reliability: An Added Value for Muscle Invasive Bladder Cancer Detection

Systematic Review and Meta-Analysis of Vesical Imaging-Reporting and Data System (VI-RADS) Inter-Observer Reliability: An Added Value for Muscle Invasive Bladder Cancer Detection

Immunotherapy Moves to the Early-Stage Setting in Non-Small Cell Lung Cancer: Emerging Evidence and the Role of Biomarkers

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

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