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178 Abstracts

  • Introduction & Objectives

    Heat shock protein 27 (Hsp27) is over-expressed in bladder cancer (BC) and postulated to increase tumour growth, metastasis, and chemotherapy resistance. Apatorsen (A; OGX-427), a novel antisense oligonucleotide, inhibits Hsp27 production and can potentially enhance the efficacy of chemotherapy. This trial was designed to evaluate efficacy and safety of A in combination with gemcitabine and cisplatin (GC) in patients with advanced BC.

    Material & Methods

    Chemotherapy naïve patients with advanced BC were randomized to GC+A 600 mg, GC+A 1000 mg, or GC + placebo. Patients were stratified by Karnofsky performance status (KPS) and visceral disease. The primary endpoint was overall survival (OS). Prognostic sub-groups were retrospectively evaluated using multiple variable modelling and hierarchical step down. A post hoc analysis was performed to explore the hypothesis that Hsp27 inhibition might be relevant to OS in poor prognosis disease.

    Results

    A total of 179 patients were randomized/treated. Median OS was 15.2 months (m). When compared to GC + placebo, GC+A 600 demonstrated improved OS and PFS (OS HR = 0.856 and PFS HR = 0.830) versus GC+A 1000 (OS HR = 0.898; PFS HR = 0.927). Results from the post hoc model revealed that KPS, liver metastasis, alkaline phosphatase, and hemoglobin were prognostic. A median prognostic score dichotomized patients into poor and good prognosis groups (50% each group). Patients with poor prognosis treated with GC+A 600 had a greater reduction in risk of death (HR = 0.717) than patients with good prognosis (HR = 1.44). The most significant prognostic factor was KPS ≤80% (35% pts in GC+A 600 vs GC) resulting in HR = 0.50 in favour of GC+A 600. Overall treatment was well tolerated. Most common Grade ≥3 adverse events (AEs) were neutropenia, anemia, thrombocytopenia and hypertension. Frequency of ≥3 Grade toxicities were: 89% (GC), 93% (GC+A 600) and 95% (GC+A 1000). GC+A 1000 had a higher treatment discontinuation rate due to AEs.

    Conclusions

    Advanced BC patients with poor prognosis benefited from apatorsen 600mg combined with first line GC. Apatorsen may be impacting the intrinsic biology of patients with poor risk factors. Further evaluation is warranted in this patient population.

    Session: Oral presentations of the best abstracts

    Location: Saturday, 14 November 2015, 08:50 - 09:30, Auditorium

  • Introduction & Objectives

    The standard of care regarding the timing of chemotherapy (ct) for locally advanced bladder cancer (BC) remains controversial, as only few randomized studies compared adjuvant versus neoadjuvant ct. The level one evidence supports the use of neoadjuvant ct. We compared patients (pts) outcomes following neoadjuvant or adjuvant ct in unselected pts treated in a routine clinical practice.

    Material & Methods

    Data from population based cancer registry of Slovenia was used to select a cohort of 116 pts with locally advanced (M0) bladder cancer (BC) consecutively treated between years 2004 through 2008. Patients with  metastatic disease (M1) were excluded. Among them, 83 pts were treated with perioperative platinum based ct and radical cystectomy, 18 received radiochemotherapy and 15 had an unexplained early termination of treatment. Clinical data and treatment characteristics were retrospectively collected from medical charts.

    Results

    Characteristics  of pts were as follows: median age: 63 years (range 39-78); stage: II and III 43 (37.1 %), IV (M0) 40 (34.5%); histology: Pure transitional cell carcinoma (TCC) 98 (85%), TCC with aberrant differentation 10 (8%), other 7 (6%). Thirty nine of pts (33.6 %) received neoadjuvant and 44 (37.9%) adjuvant ct, most of them cisplatin (cisplatin/gemcitabine or methotrexate/vinblastine/cisplatin) based regimen (adjuvant: 81.8%, neoadjuvant: 90.9%). Median follow-up was 7.4 years. Five-years DFS for the entire group was 59.8%, mOS 4.7 years (95% CI 2.72-6.81). There was no significant difference in DFS  (p=0.68) nor OS (p=0.45) between pts treated with neoadjuvant adjuvant ct.

    Conclusions

    In our analysis there was no statistically significant difference in survival between pts receiving neoadjuvant versus adjuvant systemic platinum-based ct for locally advanced BC.

  • Introduction & Objectives

    Nerve-sparing radical prostatectomy (NS-RP) is widely performed in patients with localized prostate cancer in an effort to retain erectile function and possibly urinary continence after surgery. It remains unclear in which patients NS-RP is oncologically safe and in which patients NS-RP should be performed for optimal functional outcome. Present Dutch guidelines and the guidelines of the EAU do not give clear recommendations on the criteria to perform NS-RP.

    Material & Methods

    Through this study, we wanted to evaluate the considerations and clinical criteria that urologists use to select patients for NS-RP.
    We conducted an online survey, to determine how urologists performing RP make this assessment. Eighty-nine urologists were invited to fill in the questionnaire on NS-RP.
    Questions were subdivided in the following categories: general patient characteristics, clinical prognostic parameters, radiological criteria with a specific focus on multiparametric MRI (mpMRI), pathological prognostic criteria. Furthermore,  patient-related expectations were accounted for.

    Results

    The survey was completed by 72 urologists (80.9% of total), of which 68.1% (49 urologists) perform radical prostatectomy (16.3% open, 18.4% laparoscopic, 73.5% RALP as a first surgeon), and almost all 98.0% (48 urologists) perform NS-RP.
    See table 1 for an overview of the percentage of urologists who use one of the parameters as decision points for NS-RP.

    Table 1. Percentage of urologists that uses one of the parameters as decision points for NS-RP

    Parameter % urologists using parameter to determine side of NS-RP
    Validated sexual function questionnaire pre-operatively (SHIM or IIEF) 55.1%
    Clinical
    -          cT3
    -          Age

    59.2%
    65.3%
    Radiology
    -          mpMRI

    28.1%
    Pathological
    -          Gleason score ≥8
    -          Tumor volume
     
    95.9%
    90.0%
    Shared decision making 93.8%
    Nomograms 59.2%

    Conclusions

    Clear recommendation to perform NS-RP do yet not exist. In our survey, different poor prognostic clinical, radiological, and pathological prognostic parameters had influence on the decision of the urologists to perform NS-RP. As of yet, the decision to NS-RP remains largely one that is taken by the urologist based on his or her own interpretation of a wide set of clinical, radiological, and pathological prognostic parameters.

  • Introduction & Objectives

    Renal cell carcinoma (RCC), which constitutes the majority of malignant renal masses, is a biologically, histologically and clinically heterogeneous disease. Its incidence has been increasing worldwide across all age groups, being twice more frequent in males. Several studies have showed different clinicopathological features according to gender and age, with women and younger patients presenting with smaller, lower stage RCCs. Our objective was to describe the characteristics of treated solid renal masses and to assess whether there were gender and age-specific differences in pathological parameters.

    Material & Methods

    Between January 2010 and February 2015 a total of 467 patients were submitted to nephrectomy at our institution. Baseline demographic and tumour characteristics were collected and compared for identification of differences between gender and age groups (<50, 50-70 and >70 years). Chi-square tests were used for dichotomous variables and t tests for continuous variables.

    Results

    The age of the cohort was 63.5±12.6 years (13.7% <50, 52.7% 50-70, 33.8% >70 years) and 43.4% were female.
    16.3% of the renal masses were benign (11.1% oncocytomas, 3.2% angiomyolipomas, 1.9% other benign conditions) and had smaller dimensions than cancers (Comparisons of the pathological features by gender showed that women had a higher percentage of benign pathology (23.3% vs. 10.9%, p<0.001) and a significantly higher proportion of cromophobe RCCs (27.1% vs. 16.5%), a lower proportion of clear cell RCCs (53.5% vs. 65.7%, p=0.025) and less tumour necrosis (16.2% vs. 29.7%, p=0.003).
    Considering the 3 age groups, younger patients had lower stage tumours (84.0% vs. 77.3% vs. 63.5%, p=0.001) and a higher proportion of cromophobe RCCs (30.0% vs. 21.7% vs. 18.3%, p=0.044). Amongst patients with clear cell RCCs, younger patients had lower stages (81.8% vs. 78.0% vs. 60.9%, p=0.005), lower nuclear grades (78.8% vs. 61.0% vs. 56.3%, p=0.041) and less lymphovascular invasion (9.1% vs. 22.9% vs. 27.6%, p=0.045).

    Conclusions

    Females had more benign lesions and a higher proportion of cromophobe RCCs than males. Younger patients had tumours with lower stages, more cromophobe RCCs and their clear cell RCCs had lower stages, lower nuclear grades and less lymphovascular invasion than those of older patients. These pathologic features have been associated with less aggressive tumours, suggesting an overall better prognosis for both groups.

  • Introduction & Objectives

    Most men diagnosed with prostate cancer in the United States are found to have low-grade tumours. While many of these men are candidates for active surveillance, a proportion may have a bad outcome owing to aggressive prostate cancer that was missed on initial biopsy. A recent prospective study confirmed the 4Kscore® Test accurately predicts the risk of aggressive cancer on prostate biopsy. The purpose of this study was to analyse if the 4Kscore could predict the presence of Gleason ≥7 in a cohort of men with low-grade tumours on prostate biopsy who underwent radical prostatectomy.

    Material & Methods

    A recent large, US multi-center prospective trial enrolled 1312 men referred for prostate biopsy for suspicion of prostate cancer regardless of age, PSA, digital rectal exam findings or prior biopsy status. Prior to TRUS-guided prostate biopsy, blood was collected for a 4Kscore test. The 4Kscore calculates the risk of high-grade (Gleason ≥7) prostate cancer on prostate biopsy by a blood test that measures levels of four kallikrein biomarkers (total PSA, free PSA, intact PSA, and human kallikrein-2) plus age, DRE findings, and prior biopsy status. We used all men who were found to have low-grade (Gleason 6) cancer on biopsy and underwent radical prostatectomy (RP) for this analysis. We assessed the association of the 4Kscore test with the risk of tumour upgrading found in the surgical specimen. Chi squared test was used to evaluate the association.

    Results

    Among the 1312 men enrolled in this trial, 144 men were found to have prostate cancer and underwent radical prostatectomy. Of these men who elected to undergo surgical extirpation, 50 men had Gleason 6 cancer on prostate biopsy, of which the RP pathology revealed 42% (21) men had Gleason ≤6 prostate cancer, 52% (26) men had Gleason 7 prostate cancer, and 4% (2) men had Gleason ≥8 cancer. One patient was found not to have cancer at surgery. Using a 4Kscore cut off of 7.5%, tumour upgrading occurred in significantly more men with a 4Kscore ≥ 7.5% vs. men with a 4Kscore < 7.5% (67% vs. 35%, p=0.034). For a 4Kscore cut off of 20%, tumour upgrading occurred in 85% (11/13) men with a 4Kscore ≥20%, significantly more than tumour upgrading in men with a 4Kscore < 20% (p=0.016).

    Conclusions

    In men who had Gleason 6 disease on biopsy and underwent RP, higher 4Kscores were associated with tumour upgrading at surgery. Men with 4Kscores >20% and Gleason 6 prostate cancer on biopsy have the highest likelihood of harbouring Gleason ≥7 disease and as such these men may not be suitable candidates for active surveillance protocols.

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