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  • 1
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    Cctg BL12: Randomized phase II trial comparing nab-paclitaxel (Nab-P) to paclitaxel (P) in patients (pts) with advanced urothelial cancer progressing on or after a platinum containing regimen (NCT02033993).
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 15_suppl ( 2018-05-20), p. 4505-4505
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 15_suppl ( 2018-05-20), p. 4505-4505
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2018.36.15_suppl.4505
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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  • 2
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    Time trends of drug specific adverse events among patients on androgen receptor antagonists: Implications for remote monitoring.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 6_suppl ( 2021-02-20), p. 40-40
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 6_suppl ( 2021-02-20), p. 40-40
    Abstract: 40 Background: In light of the global pandemic, reducing patient exposure via remote monitoring is desirable. Currently, advanced prostate cancer patients prescribed Abiraterone or Enzalutamide are scheduled for an in-person appointment monthly, to screen for adverse events (AEs). We set out to determine time trends of drug specific AEs in order to determine whether reducing in-person visits for patients taking either Abiraterone or Enzalutamide is feasible. Methods: This chart review was conducted on 667 unique advanced prostate cancer patients, being either metastatic hormone sensitive or castration resistant and utilizing Abiraterone or Enzalutamide. Patients who switched courses of treatment and received both drugs were included twice in the data, resulting in 828 “subjects” overall. Data were collected via accessing electronic patient records, to determine the first sign of an AE related to either Abiraterone or Enzalutamide. These AEs include; hypertension, elevated liver enzymes (bilirubin, AST, ALT) or hypokalemia. Survival analysis was used to determine the time to adverse event. All grade AEs are included in this analysis. Results: In this study, 425 and 403 patients received Enzalutamide and Abiraterone, respectively. In total, 36.3% of those who took Enzalutamide experienced an AE, compared to 43.4% of patients on Abiraterone. For patients utilizing Abiraterone, cumulative incidence of AEs at 3,6,9 and 12 months were: 65.0%, 81.2%, 90.9% and 93.9%, respectively. Among Enzalutamide users, cumulative incidence of AEs at 3,6,9 and 12 months were: 46.8%, 67.5%, 81.2% and 88.3%, respectively. The primary first AEs associated with Enzalutamide consumption were hypertension and liver dysfunction (77.48% and 22.52%). In the Abiraterone group, the first associated AEs were liver dysfunction (48.78%), hypertension (46.34%), and hypokalemia (4.88%). Conclusions: These data suggest that the likelihood of attaining AEs associated with Abiraterone or Enzalutamide utilization decreases over time and tend to occur within the first 6 months of therapy. Furthermore, the vast majority of these AEs can be remotely monitored via outside laboratories and remote blood pressure monitoring. In light of the COVID-19 crisis, remote monitoring after 6 months of taking Abiraterone or Enzalutamide would appear appropriate. Efforts to further safely reduce in person visits should be explored.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.6_suppl.40
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 3
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    The 2014 CUA-CUOG Guidelines for the Management of Castration Resistant Prostate Cancer (CRPC)
    Canadian Urological Association Journal ; 2015
    In:  Canadian Urological Association Journal Vol. 9, No. 3-4 ( 2015-04-13), p. 90-
    Details
    In: Canadian Urological Association Journal, Canadian Urological Association Journal, Vol. 9, No. 3-4 ( 2015-04-13), p. 90-
    Type of Medium: Online Resource
    ISSN: 1920-1214 , 1911-6470
    URL: Article
    DOI: 10.5489/cuaj.2526
    Language: Unknown
    Publisher: Canadian Urological Association Journal
    Publication Date: 2015
    detail.hit.zdb_id: 2431403-1
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  • 4
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    5α-reductase inhibitors and the risk of grade reclassification for men with long-term follow-up on active surveillance for prostate cancer.
    American Society of Clinical Oncology (ASCO) ; 2016
    In:  Journal of Clinical Oncology Vol. 34, No. 2_suppl ( 2016-01-10), p. 92-92
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 2_suppl ( 2016-01-10), p. 92-92
    Abstract: 92 Background: The role of 5α-reductase inhibitors (5-ARIs) in prostatic diseases remains controversial because of an FDA black box label. We have previously published on the impact of 5-ARIs in men managed with active surveillance (AS), demonstrating their protective effect against progression. However, the long-term safety of 5-ARIs in the setting of AS has never been described, thus we sought to assess this. Methods: This is a single-institution, prospectively maintained, retrospective cohort study comparing men taking a 5-ARI versus no 5-ARI while on AS for PCa. Pathologic progression was evaluated and defined as Gleason score 〉 6, maximum core involvement 〉 50%, or more than 3 cores positive on a follow-up prostate biopsy. Time dependent covariate analysis to account for time on AS but not on 5-ARI was conducted to diminish the likelihood of overestimating the benefit. To account for differences in prostate volume at baseline between 5-ARI and non-5-ARI groups sensitivity analyses were performed, restricting men in the non-5-ARI group to those with larger glands (volume 〉 40 ml). Kaplan-Meier analyses were conducted along with multivariable Cox proportional hazard regression modeling for predictors of pathologic progression. Results: The original cohort of 288 men on AS were analyzed. The median follow-up was 61.2 months (IQR: 29.8-95.24) with 124 men (43%) experiencing pathologic progression and 119 men (41.3%) abandoning AS. Men taking a 5-ARI experienced a lower rate of pathologic progression (24.3% vs 49.1%; p 〈 0.001) and were less likely to abandon AS (25.7% vs 46.3%; p = 0.002). On multivariable Cox proportional hazards analysis, lack of 5-ARI use was most strongly associated with pathologic progression (HR: 2.56; 95% confidence interval, 1.32-5.02). Sensitivity analyses done to account for gland size demonstrated that lack of 5-ARI use was still predictive of progression (HR: 2.76; CI, 1.45–5.25; p = 0.002). Importantly, 5-ARI use was not associated with increased risk of high-grade prostate cancer. Conclusions: 5-ARIs were associated with a significantly lower rate of pathologic progression and abandonment of AS in men with median follow-up of 5 years.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2016.34.2_suppl.92
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2016
    detail.hit.zdb_id: 2005181-5
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  • 5
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    Are we systemically under treating cisplatin-eligible patients with muscle invasive bladder cancer (MIBC) who are undergoing bladder preservation by chemoradiotherapy?
    American Society of Clinical Oncology (ASCO) ; 2016
    In:  Journal of Clinical Oncology Vol. 34, No. 2_suppl ( 2016-01-10), p. 417-417
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 2_suppl ( 2016-01-10), p. 417-417
    Abstract: 417 Background: Neoadjuvant chemotherapy (NC) improves survival in MIBC pts regardless of local management-cystectomy or chemoradiation. NC use with chemoradiation has been limited as these pts are often elderly, frail and cisplatin-ineligible. But, as more fit, cisplatin-eligible pts opt for chemoradiation it is critical that we re-evaluate the feasibility and outcomes of giving NC followed by chemoradiation. Methods: We reviewed 25 MIBC pts with cT 2-4 N 0-1 M 0 , undergoing chemoradiation between 2008-2014 at the Princess Margaret and Durham Regional Cancer Centers. All pts received NC with gemcitabine-cisplatin (2-4 cycles) then external beam radiation (median dose 60Gy) with concurrent cisplatin. Toxicities were recorded using CTCAE v 3.0. Response and outcomes were assessed by cystoscopy and imaging. Median follow-up was 29.7 mos and 6 pts had 〈 2 yrs of follow-up. Kaplan Meier analysis was used for survival. Results: Main reasons for a chemoradiation approach were pt preference 15/25 (60%) and comorbidities 10/25(40%). At diagnosis, median age was 69 (49-85), 76% were male, all were ECOG PS 0/1, median CrCl was 58.5 ml/min and 7/25 (28%) had hydronephrosis. CIS was seen in 10/25 (40%), LVI in 3/25 (12%) and node positivity in 2/25 (8%). All but 1 patient completed planned NC, where main Grade 3/4 toxicities as expected were neutropenia and infection. All planned radiotherapy and 83% of planned concurrent chemotherapy was given. Maximal TURBT was done in 76%. Cystoscopically post NC, 12/15 (80%) had a CR, 1/15 (7%) had CIS, and 2/15 (13%) had residual disease. Of the 12 pts with a CR, radiologically 4/12 had a CR, 2/12 had a PR and 6/12 had SD. Four pts required salvage cystectomy for local recurrence, 4 pts developed metastases and have died. Median OS was not reached, but the 2 yr OS rate was 73.8% (95% CI 50.3-87.4%). Conclusions: NC followed by chemoradiation, showed cystoscopic CR rates of 80% post NC and 2 yr OS rates of 73.8% suggesting this approach should be considered in cisplatin-eligible MIBC pts undergoing chemoradiation. Comparing outcomes between matched MIBC pts receiving NC and then chemoradiation or cystectomy also appears warranted.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2016.34.2_suppl.417
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2016
    detail.hit.zdb_id: 2005181-5
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  • 6
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    Use of microRNA signature to distinguish early from late biochemical failure in prostate cancer.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 6_suppl ( 2013-02-20), p. 194-194
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 6_suppl ( 2013-02-20), p. 194-194
    Abstract: 194 Background: With the introduction of PSA testing, the problem of over-treatment emerged in prostate cancer. Only a small subset of prostate cancer patients will require more intensive adjuvant therapy. There is currently no biomarker that can predict disease aggressiveness at the time of surgery. Methods: We analyzed miRNA expression in 41 patients (the discovery set) which were dichotomized into; 'high risk'- experienced biochemical failure within 24 months after radical prostatectomy (n=26) and 'low risk' who did not have biochemical failure for at least 35 months (n=15). The validation set consisted of 72 cases. Total RNA was isolated from FFPE cores. cDNA was prepared for each patients and expression miRNA expression was screened by qRT-PCR –based panel. miRNAs were ranked by non-parametric tests. Linear regression models were built to predict biochemical failure. We used TargetScan for miRNA target prediction. Targets were validated by transient transfection of synthetic miRNA precursors followed by qRT-PCR quantification of the targets. Proliferation was assessed by measuring cell viability. Results: We compared the expression of 754 mature human miRNAs in patients with ‘high’ or ‘low’ risk for biochemical failure. We identified 24 miRNAs that were differentially expressed between the risk groups. We developed three logistic regression models, based on the expression of 2-3 miRNAs (PPV=100% and NPV ranges 86.4-100%). We confirmed the differential expression on the study set and on a larger, independent set of PCa pateints. We also validated one model on an independent set of patients. Further, we show that transfection of miR-152 and miR-331-3p, featured in the logistic regression models, altered proliferation of PCa3 and DU145 cells. Target prediction indicated Erbb3 and Erbb2 as potential direct targets and their mRNA expression significantly reduced when miR-152 and miR-331-3p were overexpressed. Conclusions: Altered miR-331-3p and miR-152 expression represent a potential tool for assessing the risk of early biochemical failure. These miRNAs may act through the Erbb family to induce an alternative way of AR activation.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.6_suppl.194
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 7
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    A phase I pilot study of preoperative radiotherapy for prostate cancer: Long-term toxicity and oncologic outcomes.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 7_suppl ( 2019-03-01), p. 60-60
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 7_suppl ( 2019-03-01), p. 60-60
    Abstract: 60 Background: Pre-operative radiotherapy (PreORT) improves local control in various cancer types, and has become an established oncologic treatment strategy. During 2001-2004, we conducted a phase I pilot study assessing the role of short-course PreORT for men with unfavourable intermediate- and high-risk localized prostate cancer (PCa). We present long-term follow-up toxicity and oncologic outcomes. Methods: Eligible patients had histologically proven PCa, cT1-T2N0M0, PSA 〉 15-35 ng/ml with any Gleason score, or PSA 10-15 ng/ml with Gleason score ≥7. Patients received 25 Gy in five consecutive daily fractions to the prostate, followed by radical prostatectomy (RadP) within 14 days after RT completion. Primary outcomes were intra-operative morbidity, and late genitourinary (GU) and gastrointestinal (GI) toxicities. Acute toxicity was assessed during radiotherapy treatment on daily basis using RTOG grade scoring scale. Patients were assessed post-RadP clinically and with PSA at 1 and 6 months, and every 6 months. Intra- and Post-RadP toxicity was documented prospectively and scored as per Common Terminology Criteria for Adverse Events v4.0. Biochemical failure (BF) was determined based on two consecutive post-RadP PSA 〉 0.2 ng/ml. Results: Fifteen patients were enrolled; 14 patients completed PreORT followed by RadP, which also included bilateral lymph node dissections in 13 cases. Median follow-up was 12.2 years (range 6.7-16.3 years). Late GU toxicity was common, with 2 patients (14.3%) experiencing G2 toxicity, and 6 patients (42.8%) G3 toxicity. There were no G4-5 late GU toxicity. Late GI toxicity was infrequent, with only 1 patient (7.1%) experiencing transient G2 proctitis. At last follow-up, 8 (57.1%) and 6 (42.8%) patients experienced BF and metastatic disease recurrence, respectively. Conclusions: The use of PreORT in men with high-risk PCa is associated with unexpected high-rates of late GU toxicity. Future studies examining the role of RT pre-RadP must cautiously select RT technique and dose schedule. Importantly, long-term follow-up data is essential to fully determine the therapeutic index of PreORT in the management of localized PCa. Clinical trial information: NCT00252447.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.7_suppl.60
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 8
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    Metformin use and all-cause and prostate-cancer-specific mortality among diabetic men.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 5007-5007
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 5007-5007
    Abstract: 5007 Background: To evaluate the association between cumulative duration of metformin use after prostate cancer diagnosis and all-cause and prostate cancer-specific mortality among diabetic patients. Methods: We used a population-based retrospective cohort design. Data were obtained from several Ontario health care administrative databases. Within a cohort of men over the age of 66 with incident diabetes who subsequently developed prostate cancer, we examined the effect of duration of anti-diabetic medication exposure, after prostate cancer diagnosis, on all-cause and prostate cancer-specific mortality. Crude and adjusted hazard ratios were calculated using a time-varying Cox proportional hazard model to estimate effects. Results: The cohort consisted of 3,837 patients. Median age (interquartile range IQR) at diagnosis of prostate cancer was 75 (72-79) years. During a median (IQR) follow up of 4.64 (2.7-7.1) years, 1,343 (35%) died, and 291 patients died of prostate cancer (7.6%). Cumulative duration of metformin treatment, after prostate cancer diagnosis, was associated with a significant decreased risk of prostate cancer-specific and all-cause mortality in a dose-dependent fashion. The adjusted hazard ratio, for prostate cancer-specific mortality was 0.76 (95% confidence interval, 0.64-0.89) for each additional six months of metformin use. The association with all-cause mortality was also significant but declined over-time from a HR of 0.76 in the first 6 months to 0.93 between 24-30 months. There was no relationship between cumulative use of other anti-diabetic drugs and either outcome. Conclusions: Increased cumulative duration of metformin exposure after prostate cancer diagnosis was associated with decreases in both all-cause and prostate-cancer-specific mortality among diabetic men.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.5007
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 9
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    Online Resource
    Final results of a phase II study of neoadjuvant metformin in prostatic carcinoma.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 5070-5070
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 5070-5070
    Abstract: 5070 Background: Metformin is an inhibitor of the complex 1 in the respiratory chain, and is widely used in diabetes due to its effect on reducing insulin resistance. It has also been recently described to have effects via AMPK on inhibiting the mTOR kinase. Significant preclinical and epidemiological studies suggest its role in chemoprevention. These actions provide significant rationale to evaluate its utility in prostate cancer. Methods: Men were required to have histologically confirmed prostate cancer involving at least 20% of at least 1 unfragmented biopsy core. Exclusion criteria included patients who were found to be on treatment with any drug used for the treatment of any form of diabetes, or patients that began treatment for any form of diabetes during the course of the study. Pts were treated with up to 500mg tid of metformin. The primary objectives were to demonstrate safety and tolerability of neoadjuvant metformin administration in men with prostate cancer and to document changes in phospho-AKT signalling indices. Results: 24 patients were enrolled with 21 patients evaluable; median age was 64 yrs (range, 45-70 yrs). Baseline characteristics included median PSA 6 ng/mL (range, 3.22-36.11ng/mL). Median duration of drug treatment was 41 days (range 18-81). No grade 3 adverse events were reported during treatment or radical prostatectomy that were related to metformin. Significant pre-and post changes were noted in serum IGF1 (p=0.02), fasting glucose (p=0.03), BMI (p 〈 0.01) and waist/hip ratio (p 〈 0.01). There was a trend for a PSA reduction (p=0.08). There were no correlations between any metabolic, morphometric or cancer-related serum indices. On a per patient analyses, metformin reduced a computerised relative ki67 proliferation index by an average of 29% (absolute difference of 1.4%) compared to the baseline biopsy (p=0.006). P-4eBP1 staining was also reduced as assessed by H-score (p 〈 0.01) consistent with the ability of metformin to inhibit mTOR. Conclusions: Neoadjuvant metformin is well tolerated prior to radical prostatectomy and shows promising effects on proliferation and signaling indices. Further research is needed to define the clinical utility of metformin in prostate cancer. Clinical trial information: NCT00881725.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.5070
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 10
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    Online Resource
    RNA-sequencing to identify three different molecular grades and immune checkpoint cascades with distinct clinical behaviour in NMIBC.
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 6_suppl ( 2018-02-20), p. 412-412
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 6_suppl ( 2018-02-20), p. 412-412
    Abstract: 412 Background: NMIBC has a highly variable clinical behavior not adequately predicted by histological grade or clinical parameters. Some are indolent; others quickly progress to MIBC. Discrepancies between phenotype and genotype is compounded further by interobserver variability in pathological grading. There is an unmet need to improve the prediction of NMIBC. Methods: Whole transcriptomic analysis of 178 bladder tumors (158 NMIBC, 20 MIBC/metastatic) was performed from FFPE tissue incorporating messenger RNA expression, splice variants, gene fusion, mutation detection and immune checkpoint inhibitor cascades. CTLA, PD-1, LAG3, TIM3, TIGIT and B7 were compiled as an index including all major cascade genes. Data were integrated and tested for correlations with pathological grading and clinical outcomes. Conventional pathological grading for WHO 1973 (Grade 1, 2, 3) and 2004 (LG vs HG) classifications was reviewed by 3 expert uro-pathologists. Kappa statistic for interobserver variability was calculated. For validation we used an independent RNA-seq dataset (n = 209, Hedegaard et al. 2016 Cancer Cell). Results: Unsupervised clustering of RNA-Seq data distinguished 3 molecular subtypes of NMIBC; Molecular Grade Related Index (MGRI) 1, MGRI2, MGRI3. MGRI1 comprised of almost exclusively LG tumors. MGRI3 clustered with HG MIBC. Kappa for interobserver variability of expert pathologists was 0.40 and 0.78 in 1973 and 2004 WHO classification, respectively. FGFR3 mutations, FGFR3::TACC3 fusion events and MGRI1 genes were associated with components of xenobiotic metabolism (p = 2.51x10 -09 ) signalling systems, in particular, GTPase regulation (p = 0.002), respiratory cycle genes (p = 0.004), HOX cluster (p = 0.005). MGRI independently predicted progression to MIBC (n = 138, HR = 2.96, 95%CI = 1.70-5.13, p = 1.20x10 -04 ). 5-year PFS in a combined data set (n = 347) differed significantly for MGRI1 (100%) vs MGRI2 (92.2%) vs MGRI3 (73.5%, p = 1.99x10 -05 , Gray’s test). PD-1 ICC independently predicted progression (OR = 2.85, p 〈 0.05). Conclusions: RNA-seq delineates 3 molecular classes of NMIBC with different risks of progression to MIBC compared to conventional histologic grading.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2018.36.6_suppl.412
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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