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Prostate CancerDarolutamide(Nubeqa, BAY1841788)ActiveNot RecruitingArgentinaAustriaBelgiumBrazilCanadaChinaColombiaDenmarkFranceGermanyGreeceItalyJapanRussian FederationSpainTaiwanUnited States 0NCT04122976DAROL
A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described

A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described

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Smoking History as a Predictor of Immunotherapy in Bladder Cancer

KEY TAKEAWAYS

  • The study aimed to investigate the predictive factors influencing ICI efficacy in patients with BC.
  • Smoking history predicts immunotherapy response in bladder cancer, prompting personalized treatment approaches; further investigation is ongoing.

The therapeutic effectiveness of immune checkpoint inhibitors (ICIs) in bladder cancer varies among individuals. Identifying reliable predictors of response to these therapies is crucial for optimizing patient outcomes.

Jianqiu Kong and the team aimed to assess the predictive value of smoking history for immunotherapy outcomes in patients with bladder cancer.

They performed an inclusive analysis of 348 patients with bladder cancer treated with ICIs, supplemented by validation from 248 patients with PD-L1 immunohistochemical staining data. The study examined patient smoking history, clinicopathological characteristics, and immune phenotypes to correlate these factors with immunotherapy outcomes. Multivariate logistic and Cox proportional hazard regressions were employed to adjust for confounders.

About 348 patients with bladder cancer received ICIs showed 116 (33.3%) never smokers, 197 (56.6%) former smokers (median pack-years = 28), and 35 (10.1%) current smokers (median pack-years = 40). Overall survival differences across smoking statuses were not statistically significant (objective response rates: 11.4% current smokers, 17.2% never smokers, and 22.3% former smokers; P = 0.142, 0.410, and 0.281, respectively).

However, a trend suggested better immunotherapy response in former smokers versus current and never smokers. In a validation cohort of 248 patients, PD-L1 expression was notably higher in former smokers (55%) versus current (37%) and never smokers (47%), highlighting smoking history’s potential impact on the tumor microenvironment and ICI responsiveness.

The study concluded that incorporating smoking history is crucial for predicting immunotherapy response in bladder cancer, emphasizing its role in personalized treatment approaches. Further research is recommended to explore lifestyle factors’ comprehensive impact on treatment outcomes.

The study was funded by the National Natural Science Foundation of China, the Guangzhou Municipal Basic Research Program Jointly Funded by City, University, and Enterprise Special Project, and the Natural Science Foundation of Guangdong Province.

Source: https://pubmed.ncbi.nlm.nih.gov/38938564/

Kong J, Zou Y, Zhou H, et al. (2024). “Assessing the predictive value of smoking history for immunotherapy outcomes in bladder cancer patients.” Front Immunol. 2024 Jun 13;15:1404812. doi: 10.3389/fimmu.2024.1404812. PMID: 38938564; PMCID: PMC11208302.

Exploring Transcriptome Changes in Patients With MIBC

KEY TAKEAWAYS

  • The study aimed to investigate the differential transcriptome profiles of patients with MIBC compared to normal subjects.
  • Researchers identified novel molecular pathways, offering potential for defining cancer predisposition factors and exploring therapeutic options.

Bladder cancer (BC) is the most prevalent malignant tumor in the urinary tract, classified mainly into muscle-invasive BC (MIBC) and non-MIBC (NMIBC). Recent studies highlight the important role of changes in transcriptome activity in carcinogenesis, aiding in the identification of additional differentially regulated candidate genes, improving our understanding of the molecular basis of gene regulation in BC.

Pietro Pepe and the team aimed to evaluate the transcriptome of patients with MIBC compared with normal subjects.

They performed an inclusive analysis utilizing mRNA sequencing on the Illumina NovaSeq 6000 Dx system in a case series of 11 subjects with MIBC and 19 age- and sex-matched healthy controls. Functional analysis employed the pathfindR package to comprehensively identify enriched pathways within active subnetworks in omics data.

Our results demonstrated differentiated pathways, including spliceosome activity, oxidative phosphorylation, and chemical carcinogenesis due to reactive oxygen species, in patients with MIBC compared with controls.

The study concluded significant potential for defining cancer predisposition factors and exploring therapeutic options through the identification of novel molecular pathways in patients with MIBC.

No funding information was provided.

Bladder

Source: https://pubmed.ncbi.nlm.nih.gov/38936905/

Pepe P, Salemi M, Marchese G, et al. (2024). “Transcriptome Analysis in Patients With Muscle-invasive Bladder Cancer.” In Vivo. 2024 Jul-Aug;38(4):1660-1664. doi: 10.21873/invivo.13615. PMID: 38936905.

ML Model Predicts LNM in Patients With BUC

KEY TAKEAWAYS

  • The study aimed to investigate ML models for predicting LNM in patients with BUC preoperatively.
  • Researchers noticed that the SVM model with 14 variables was the most effective for predicting LNM.

Lymph node metastasis (LNM) is associated with worse prognosis in patients with bladder urothelial carcinoma (BUC).

Junjie Ji and the team aimed to develop and validate machine learning (ML) models to preoperatively predict LNM in patients with BUC treated with radical cystectomy (RC).

They performed an inclusive analysis by retrospectively collecting demographic, pathological, imaging, and laboratory information of patients with BUC who underwent RC and bilateral lymphadenectomy. Patients were randomly categorized into training and testing sets. Five ML algorithms were utilized to establish prediction models.

The performance of each model was assessed by the area under the receiver operating characteristic curve (AUC) and accuracy. Finally, the corresponding variable coefficients were calculated based on the optimal model to reveal the contribution of each variable to LNM.

About 524 and 131 patients with BUC were finally enrolled into the training set and testing set, respectively. They identified that the support vector machine (SVM) model had the best prediction ability with an AUC of 0.934 (95% confidence interval [CI]: 0.903-0.964) and accuracy of 0.916 in the training set, and an AUC of 0.855 (95% CI: 0.777-0.933) and accuracy of 0.809 in the testing set. The SVM model contained 14 predictors, and positive lymph node imaging contributed the most to the prediction of LNM in patients with BUC.

The study concluded that the developed and validated ML models effectively preoperatively predict LNM in patients with BUC treated with RC, with the SVM model containing 14 variables demonstrating the best performance and high clinical applicability.

This study was partly funded by the Natural Science Foundation of Shandong Province (ZR2021MH354), Medical and health research program of Qingdao (2021-WJZD170).

Source: https://pubmed.ncbi.nlm.nih.gov/38872141/

Ji J, Zhang T, Zhu L, et al. (2024). “Using machine learning to develop preoperative model for lymph node metastasis in patients with bladder urothelial carcinoma.” BMC Cancer. 2024 Jun 13;24(1):725. doi: 10.1186/s12885-024-12467-4. PMID: 38872141; PMCID: PMC11170799.

CEUS: Effective for Differential Diagnosis of nccRCC & ccRCC

CEUS: Effective for Differential Diagnosis of nccRCC & ccRCC

KEY TAKEAWAYS

  • The study aimed to assess the efficacy of CEUS in the diagnosis of pts with nccRCC.
  • Researchers noticed that CEUS offered a better differential diagnosis of nccRCC vs ccRCC.

Non-clear cell renal cell carcinoma (nccRCC) is a rare type of RCC, hard to diagnose with contrast-enhanced ultrasound (CEUS) due to its varied features. Summarizing CEUS characteristics is crucial for differentiating nccRCC from clear cell RCC (ccRCC). Therefore highlighting the manifestation of CEUS is essential for differentiation of nccRCC from ccRCC.

WeiPing Zhang and the team aimed to evaluate the diagnostic qualitative and quantitative efficacy of CEUS in diagnosing nccRCC.

They conducted a retrospective study including 21 patients (pts) with confirmed nccRCC following surgery and assessed the characteristic conventional ultrasound and CEUS imaging features. The paired Wilcoxon signed-rank sum test was employed to compare differences in CEUS time-intensity curve (TIC) parameters between the lesions and the normal renal cortex.

Results revealed that routine ultrasound showed the following primary characteristics in the 21 nccRCC cases: hypoechoic appearance (10/21, 47.6%), absence of liquefaction (18/21, 66.7%), regular shape (19/21, 90.5%), clear boundaries (21/21, 100%), and absence of calcification (17/21, 81%). Color Doppler flow imaging (CDFI) indicated a low blood flow signal, with only 1 case showing grade III.

Qualitative CEUS analysis demonstrated that nccRCC predominantly exhibited slow progression (76.1%), fast washout (57%), uniformity (61.9%), low enhancement (71.5%), and ring enhancement (61.9%). Quantitative CEUS analysis revealed that parameters such as PE, WiAUC, mTTI, WiR, WiPI, WoAUC, WiWoAUC, and WOR in the lesions were significantly lower than those in the normal renal cortex (Z = -3.980, -3.563, -2.427, -3.389, -3.980, -3.493, -3.528, -2.763, P < 0.001, < 0.001, = 0.015, = 0.001, < 0.001, < 0.001, < 0.001, = 0.006). However, there were no significant differences in RT, TTP, FT, or QOF (all P > 0.05).

The study concluded that nccRCC exhibits distinctive characteristics on CEUS, including slow progression, fast washout, low homogeneity enhancement, and ring enhancement, which can aid in distinguishing clinical subgroups of pts with nccRCC from ccRCC.

The study was funded by the Administration of Traditional Chinese Medicine Science and Technology Plan of Jiangxi Province (2021A060) and the Health Commission Science and Technology Plan of Jiangxi Province (202210452).

Source: https://pubmed.ncbi.nlm.nih.gov/38886684/

Zhang W., Wang J., Chen L., et al. (2024). “Qualitative and quantitative assessment of non-clear cell renal cell carcinoma using contrast-enhanced ultrasound.” BMC Urol. 2024 Jun 17;24(1):129. doi: 10.1186/s12894-024-01514-8. PMID: 38886684.

Enhanced RFS With ERBT Over cTURBT in NMIBC

KEY TAKEAWAYS

  • The study aimed to investigate the comparative efficacy and perioperative outcomes of ERBT vs cTURBT in the treatment of patients with NMIBC.
  • Researchers noticed ERBT yielded better or comparable outcomes and improved RFS.

En-Bloc transurethral resection of bladder tumor (ERBT) was clinically used to resect non-muscle-invasive bladder cancer (NMIBC). However, discrepancies persist regarding the comparisons between ERBT and conventional transurethral resection of bladder tumor (cTURBT).

Deng-Xiong Li and the team aimed to assess the overall effectiveness and benefits of ERBT compared to cTURBT in treating NMIBC.

They performed an inclusive analysis by conducting a comprehensive search in PubMed, Embase, Web of Science, Cochrane Database of Systematic Reviews, and manual searches of reference lists to collect and extract data. Data evaluation was carried out using Review Manager 5.4.0, Rx64 4.1.3, and relevant packages.

About 9 eligible meta-analyses and 9 eligible RCTs were included in the study. Patients with NMIBC undergoing ERBT were significantly associated with a lower rate of bladder perforation and obturator nerve reflex compared to those receiving cTURBT. The pooled results indicated that ERBT and cTURBT required similar operation time. Regarding postoperative outcomes, ERBT demonstrated superior performance compared to cTURBT in terms of detrusor muscle presence, catheterization time, and residual tumor.

ERBT exhibited a higher rate of 3-month recurrence-free survival (RFS) compared to those receiving cTURBT (P < 0.05; I2 = 0%). In the bipolar subgroup, ERBT had a significantly better 12-month RFS than cTURBT (P < 0.05; I2 = 0%). Simultaneously, the exclusion of Hybrid Knife data revealed a significant improvement in 12-month RFS associated with ERBT (P < 0.05; I2 = 50%).

The study concluded that, using a combination of umbrella review and meta-analysis, ERBT had better or comparable perioperative outcomes and improved 3 and 12-month RFS compared to cTURBT. ERBT may be a better surgical method for patients with NMIBC.

This study was funded by the Chinese Scholarship Council.

Source: https://pubmed.ncbi.nlm.nih.gov/38819629/

Li DX, Yu QX, Wu RC, et al. (2024). “Efficiency of transurethral en-bloc resection vs. conventional transurethral resection for non-muscle-invasive bladder cancer: An umbrella review.” Cancer Med. 2024 Jun;13(11):e7323. doi: 10.1002/cam4.7323. PMID: 38819629; PMCID: PMC11141332.

Personalized ccRCC Treatment: Genetic Models & RNA Insights

KEY TAKEAWAYS

  • The study aimed to examine ccRCC’s vascularization, immune infiltration, TME roles in disease progression, and treatment outcomes.
  • The results revealed RNA sequencing data is crucial for advancing validation studies and personalized ccRCC therapy.

Clear cell renal cell carcinoma (ccRCC), the prevalent renal cancer in adults, emerges as a highly vascularized and immune-infiltrated solid tumor. The excessive production of vascular endothelial growth factor A fosters unregulated vessel growth and immunosuppression. The tumor microenvironment (TME) significantly influences disease progression, drug targeting, response, and patient outcomes.

Elin Sjöberg and the team aimed to investigate how ccRCC progresses, responds to drugs, and impacts patient outcomes through tumor microenvironment analysis.

The study reviewed experimental models, large-scale omics approaches, and patient prognosis and therapy prediction techniques to understand the endothelium in ccRCC and its interaction with the surrounding TME.

The results revealed that preclinical and clinical studies have unveiled molecular mechanisms of endothelial cross-talk pertinent to disease progression, patient prognosis, and therapy prediction. Despite this, there is a scarcity of representative ccRCC experimental models. Omics approaches have delineated clinically relevant subsets of angiogenic and immune-infiltrated tumors, highlighting distinct molecular signatures and discrete populations of endothelial and immune cells in patients.

The study concluded that recent genetically engineered ccRCC mouse models, along with emerging evidence from single-cell RNA sequencing data, offer opportunities for future validation studies.

These studies, including multiplex imaging of ccRCC patient cohorts, hold significance for enhancing therapy benefits and facilitating personalized treatment approaches for patients with ccRCC.

No funding information was available.

Source: https://pubmed.ncbi.nlm.nih.gov/38863726/

Sjöberg E. (2024). “Molecular mechanisms and clinical relevance of endothelial cell cross-talk in clear cell renal cell carcinoma.” Ups J Med Sci. 2024 May 8;129. doi: 10.48101/ujms.v129.10632. PMID: 38863726; PMCID: PMC11165252.

KIM-1 Predicts Atezo Efficacy in Patients With RCC

KEY TAKEAWAYS

  • The IMmotion010 phase 3 trial aimed to investigate the prognostic and predictive value of circulating KIM-1 levels in determining the benefit of adjuvant atezo in patients with RCC.
  • The primary endpoint was to determine DFS.
  • Researchers noticed that circulating KIM-1 levels may predict RCC recurrence and response to atezolizumab; further investigation is ongoing.

In IMmotion010, adjuvant atezolizumab (atezo) failed to extend investigator-assessed disease-free survival (DFS) compared to placebo (pbo) after resection in patients with renal cell carcinoma (RCC) (HR: 0.93, 95% CI: 0.75, 1.15; P=0.50; Pal Lancet 2023).

Laurence Albiges and the team aimed to explore circulating protein biomarkers to identify high-risk patients with minimal residual disease (MRD) who might derive differential benefits from atezo treatment.

They performed an inclusive analysis by randomizing patients with RCC featuring clear-cell or sarcomatoid components and increased recurrence risk post-nephrectomy to receive either atezo 1200 mg or pbo intravenously every 3 weeks for 16 cycles or 1 year.

A retrospective proteomics analysis was conducted using an affinity-based proximity extension assay (PEA) panel encompassing approximately 3000 analytes to identify circulating proteins exhibiting differential abundance patterns in matched serum samples (baseline versus at recurrence).

Subsequently, a high-sensitivity electrochemiluminescence (ECL) assay was employed to assess levels of KIM-1, a membrane glycoprotein overexpressed in clear-cell and papillary RCC, in all available baseline and post-treatment serum samples. Outcome analyses were performed to compare patients with high (≥86 pg/mL) versus low KIM-1 status at baseline.

Researchers found that in patients with matched PEA samples (n=73), circulating KIM-1 emerged as the most significantly enriched protein at recurrence compared to baseline. Among the 778 patients enrolled in IMmotion010, 752 (97%) had baseline KIM-1 data available, with 300 (40%) classified as KIM-1-high and 452 (60%) as KIM-1-low. KIM-1-high status correlated with reduced DFS, and patients with high KIM-1 levels experienced improved DFS with atezo versus placebo.

Longitudinal analysis of matched samples revealed that in KIM-1-high patients, 9% (12/138) and 26% (36/141) showed a ≥30% increase from baseline in KIM-1 levels at Cycle 4 Day 1 with atezo versus placebo, whereas in KIM-1-low patients, the figures were 16% (34/213) and 12% (25/207), respectively. A ≥30% increase in KIM-1 was associated with worse DFS in both KIM-1-high (atezo HR: 1.68, 95% CI: 0.77-3.69; pbo HR: 3.53, 95% CI: 2.24-5.58) and KIM-1-low (atezo HR: 3.56, 95% CI: 2.21-5.75; pbo HR: 3.22, 95% CI: 1.81-5.70) subgroups. Among patients with matched ECL samples (n=103), median KIM-1 levels were significantly higher (P<0.001) at recurrence (172 pg/mL) than at baseline (79 pg/mL).

The study concluded that high baseline serum KIM-1 levels were linked to poorer prognosis but improved clinical outcomes with atezo compared to placebo. Increased post-treatment KIM-1 levels correlated with worse DFS. These findings suggest that circulating KIM-1 may serve as a non-invasive marker for MRD and disease recurrence, potentially indicating a benefit from atezo in adjuvant RCC. Further investigation into the role of KIM-1 in adjuvant RCC is warranted.

The trial was sponsored by the Hoffmann-La Roche.

Source: https://meetings.asco.org/abstracts-presentations/231606

Clinical Trial: https://clinicaltrials.gov/study/NCT03024996

Albiges L, Bex A, Suárez C, et al. (2024). “Circulating kidney injury molecule-1 (KIM-1) biomarker analysis in IMmotion010: A randomized phase 3 study of adjuvant (adj) atezolizumab (atezo) vs placebo (pbo) in patients (pts) with renal cell carcinoma (RCC) at increased risk of recurrence after resection.” Presented at ASCO 2024. J Clin Oncol 42, 2024 (suppl 16; abstr 4506), 10.1200/JCO.2024.42.16_suppl.4506

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