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  • 1
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    Online Resource
    Inflammatory markers to predict prognosis in renal cell carcinoma (RCC) patients treated with immune checkpoint inhibitors (ICIs).
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 6_suppl ( 2020-02-20), p. 757-757
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 6_suppl ( 2020-02-20), p. 757-757
    Abstract: 757 Background: Immune checkpoint inhibitors have increased survival in mRCC across all risk groups. In this new treatment paradigm, inflammatory markers could add prognostic information to the International metastatic Renal Cell Carcinoma Database Consortium (IMDC) model in patients treated with ICI. Methods: We conducted a multicenter retrospective analysis of mRCC patients treated with ICI from 2013 to 2019. Clinical, pathological and laboratory data including blood cell counts were collected. Multivariate Cox-regression models were performed to evaluate the independent prognostic significance of the IMDC score, the derived neutrophil to lymphocyte ratio (dNLR) and LDH at baseline, as well as the inflammatory prognostic index (IPI). Results: A total of 104 patients were included. Of these, 19% were treatment-naïve, 34% had received one previous line of treatment and 47% had received two or more previous lines of treatment. Distribution of IMDC model for favorable, intermediate and poor risk was 23%,57% and 20%. Median OS was 15 months and the disease control rate (DCR) was 51%. The multivariate analysis identified the IMDC risk score, the dNLR and the IPI as independent predictors of OS. In addition, both inflammatory markers, the IPI and the dNLR, were able to improve the prognostic value of the IMDC risk score (p = 0.01 and p = 0.006, respectively). Specifically, in patients with 0 or 1 IMDC risk factors, both the IPI and the dNLR were able to subclassify additional prognostic subgroups (i.e. dNLR 〉 3 vs ≤3 HR = 3,16; 95% CI; 1.71-5.76). Conclusions: Adding IPI and/or dNLR may add further information about the benefit of ICIs in mRCC patients with 0 or 1 IMDC risk factors. Inflammatory systemic markers may improve the prognostic performance of the IMDC model.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.6_suppl.757
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 2
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    Online Resource
    Genomic Landscape of Vinflunine Response in Metastatic Urothelial Cancer
    MDPI AG ; 2022
    In:  Cancers Vol. 14, No. 2 ( 2022-01-13), p. 378-
    Details
    In: Cancers, MDPI AG, Vol. 14, No. 2 ( 2022-01-13), p. 378-
    Abstract: Background and Aims: Metastatic urothelial carcinoma (mUC) remains an incurable disease with limited treatment options after platinum-based chemotherapy and immune checkpoint blockade (ICB). Vinflunine has shown a modest increase in overall survival and remains a therapeutic option for chemo- and immunotherapy refractory tumours. However, biomarkers that could identify responding patients to vinflunine and possible alternative therapies after failure to treatment are still missing. In this study, we aimed to identify potential genomic biomarkers of vinflunine response in mUC patient samples and potential management alternatives. Methods: Formalin-fixed paraffin-embedded samples of mUC patients (n = 23) from three university hospitals in Spain were used for genomic targeted-sequencing and transcriptome (using the Immune Profile panel by NanoString) analyses. Patients who received vinflunine after platinum-based chemotherapy failure were classified in non-responders (NR: progressive disease ≤ 3 months; n= 11) or responders (R: response ≥ 6 months; n = 12). Results: Genomic characterization revealed that the most common alteration, TP53 mutations, had comparable frequency in R (6/12; 50%) and NR (4/11; 36%). Non-synonymous mutations in KTM2C (4/12; 33.3%), PIK3CA (3/12; 25%) and ARID2 (3/12; 25%) were predominantly associated with response. No significant difference was observed in tumour mutational burden (TMB) between R and NR patients. The NR tumours showed increased expression of diverse immune-related genes and pathways, including various interferon gamma-related genes. We also identified increased MAGEA4 expression as a potential biomarker of non-responding tumours to vinflunine treatment. Conclusions: Our data may help to identify potential genomic biomarkers of response to vinflunine. Moreover, tumours refractory to vinflunine showed immune signatures potentially associated with response to ICB. Extensive validation studies, including longitudinal series, are needed to corroborate these findings.
    Type of Medium: Online Resource
    ISSN: 2072-6694
    URL: Article
    DOI: 10.3390/cancers14020378
    Language: English
    Publisher: MDPI AG
    Publication Date: 2022
    detail.hit.zdb_id: 2527080-1
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  • 3
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    Online Resource
    Immunotherapy maintenance therapy for advanced urothelial carcinoma (aUC): a comprehensive review
    Springer Science and Business Media LLC ; 2022
    In:  Journal of Cancer Research and Clinical Oncology Vol. 148, No. 5 ( 2022-05), p. 1097-1105
    Details
    In: Journal of Cancer Research and Clinical Oncology, Springer Science and Business Media LLC, Vol. 148, No. 5 ( 2022-05), p. 1097-1105
    Type of Medium: Online Resource
    ISSN: 0171-5216 , 1432-1335
    URL: Article
    DOI: 10.1007/s00432-021-03882-2
    RVK:
    XA 52301
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 1459285-X
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  • 4
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    Online Resource
    Immune checkpoint inhibitors plus tyrosine kinase inhibitors combination in the first-line setting of metastatic clear cell renal cell carcinoma: A meta-analysis of randomized clinical trials.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 6_suppl ( 2020-02-20), p. 704-704
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 6_suppl ( 2020-02-20), p. 704-704
    Abstract: 704 Background: ICIs + TKIs have shown to improve outcomes in treatment-naïve metastatic clear-cell renal cell carcinoma (ccRCC). We aimed to analize the efficacy of all combinations published including the subgroup analysis based on age, sex and IMDC prognostic factors score. Methods: We searched published RCTs in MEDLINE and EMBASE comparing ICIs + TKIs vs TKIs in 1L metastatic ccRCC. Outcomes selected to assess efficacy were progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) in the intent-to-treat population. Hazard ratios (HR) for PFS and OS, and relative risk (RR) for ORR with 95% confidence intervals (CI) were used as efficacy measures. Subgroup-based meta-analysis was afterwards performed according to randomized-effect model. Results: We identified two eligible RCTs of ICIs + TKIs (avelumab [avelu] or pembrolizumab [pembro] + axitinib [axi]) versus TKIs (sunitinib). Combined sample size was 1,747 patients (avelu + axi arm 442 patients; pembro + axi arm 432 patients; sunitinib arm 873 patients). Globally, three outcomes favored the combination. Improved HRs for PFS (0.69), OS (0.64) and ORR (1.81) were found for combination (Table). Regarding subgroup analysis HRs for PFS were favorable for combination in male (0.665) and female (0.66). Benefit in combination arms was confirmed in terms of age 〈 65 years (0.68) and ≥ 65 years (0.66). Intermediate and poor IMDC subgroups showed statistically significant benefit for combination (HR 0.68 and 0.56), whereas PFS in favorable group (0.68) was not statistically significant. Conclusions: ICIs + TKIs combination therapy has consistently demonstrated to be superior in terms of OS, PFS and ORR in 1L ccRCC to TKIs alone. We hereby confirm statistically significant benefit per subgroups except for favorable IMDC subgroup.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.6_suppl.704
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 5
    Online Resource
    Online Resource
    Impact of age in advanced renal cell carcinoma treated with immune checkpoint inhibitors.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 6_suppl ( 2020-02-20), p. 702-702
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 6_suppl ( 2020-02-20), p. 702-702
    Abstract: 702 Background: Immune checkpoint inhibitors (ICIs) are beneficial in a subset of metastatic renal cell carcinoma (mRCC) patients. Elderly patients are usually under-represented in pivotal trials. Importantly, aging has been pointed as a potential detrimental factor for the benefit with ICIs as a consequence of the “immunosenescence” which could decrease the efficacy of these treatments. Methods: We assessed the potential role of aging according to Cochrane Collaboration's Guidelines. Search of randomized clinical trials (RCTs) comparing ICIs (monotherapy or in combination with other therapies) to standard of care (SoC) in mRCC patients was performed. Trials must have included subgroup analysis evaluating the selected outcome (overall survival-OS-) in different subsets of patients according to age. Additionally, a retrospective series of mRCC patients treated with ICIs from our institution was also reviewed to assess the impact of age. Results: A total of 3415 patients (4 studies) were included in the meta-analysis (ICIs arm: 1709 patients; SoC arm: 1706 patients). Altogether, OS results favored ICIs. Older patients (aged more than 75 years-old) seem to present a less clear benefit with ICIs compared to SoC in comparison with younger patients (aged up to 75 years-old; p-value for difference between subgroups: 0.006) (Table). No differences between subgroups were found when considering 65 years-old as the borderline (p-value: 0.179). A similar trend was found in our series, with a numerically better median OS in patients younger than 65 years-old compared to those older than 65 years-old (31,6 vs. 23,6 months); the effect of age on outcomes was maintained along all International Metastatic RCC Database Consortium (IMDC) score subgroups. Conclusions: Elderly patients with mRCC, particularly older than 75 years-old, could benefit to a lesser extent compared to younger counterparts from receiving ICIs.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.6_suppl.702
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 6
    Online Resource
    Online Resource
    Atezolizumab + intravesical BCG (Bacillus Calmette-Guerin) in high-risk non-muscle invasive bladder cancer (NMIBC) patients: Institutional clinical and translational study (BladderGATE).
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 6_suppl ( 2020-02-20), p. TPS598-TPS598
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 6_suppl ( 2020-02-20), p. TPS598-TPS598
    Abstract: TPS598 Background: Intravesical Bacillus Calmette-Guerin (BCG) induction + BCG maintenance after transurethral resection (TURBT) is the current standard of care for patients (pt) with high-risk non-muscle invasive bladder cancer (NMIBC). Recurrence rate at 2 years is around 30%, which is clearly unsatisfactory. Programmed death ligand 1 (PD-L1) is a surface glycoprotein that functions as an inhibitor of T-cells and plays a crucial role in suppression of cellular immune response. Atezolizumab is a humanized IgG1 monoclonal antibody targeting PD-L1 and is associated with long-term durable remissions in pts with metastatic urothelial cancer (Powles T. Lancet. 2018). Atezolizumab in combination with standard BCG could be beneficial in pts with NMIBC. BladderGATE (NCT04134000) is a phase Ib-II study aims to evaluate the clinical impact and safety of the combination of Atezolizumab + intravesical BGC (medac strain), including a translational study (microbioma and urobioma) in pts with NMIBC. Methods: Eligible pt have confirmed histopathology of NMIBC, BCG naïve or stopped 〉 3 years ago, WHO PS 0-1, no prior radiation to bladder and adequate hematologic and end-organ function. We propose a de-escalation design to enroll patients to identify DLT and MTD proposed to safety and efficacy expansion cohort. Pt will receive induction BCG, 1 instillation every week (qw) (dose level 0) or BCG, 1/2 instillation qw (dose level -1) + intravenously atezolizumab 1200 mg every 3 w (q3w), during 6 w. After induction, BCG will be administered as maintenance treatment at weeks 12, 24 and 48 and atezolizumab 1200 mg q3w up to 1 year. Pt will be accrued to each dose level in cohorts of 10 pt until the MTD is achieved (the highest dose at which 〈 4 out of 10 pt experience DLT). DLT will be evaluated during induction treatment. Additional pt will be included in the expansion cohort up to 40 pt. DLT and safety profile will be evaluated according to NCI-CTCAE v 5.0 criteria. Recurrence-free survival will be assessed per RECIST 1.1. Tissue, plasma and urine sample will be collected for translational study. Clinical trial information: NCT04134000.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.6_suppl.TPS598
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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