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168 Abstracts

  • Introduction & Objectives

    Selective Internal Radiation Therapy (SIRT) is an interventional procedure used for unresectable liver tumours, and has properties that make it potentially useful for primary Renal Cell Carcinoma (RCC) that is unsuitable for nephrectomy. RESIRT is the first-in-human study to evaluate safety and feasibility of SIRT for primary RCC.

    Material & Methods

    Patients (pts) not amenable for or who declined conventional therapy were eligible. A single transfemoral microcatheter administration of Yttrium-90 (Y-90) resin microspheres (SIR-Spheres; Sirtex, Australia) was delivered super-selectively via the renal artery to the tumour at intended radiation doses of 75, 100, 150, 200, 300 Gray and a final cohort with a procedural endpoint of imminent stasis, in a dose-escalation design. Post-SIRT follow-up was 12 months. The primary endpoint was safety and toxicity 30 days post-SIRT. Secondary endpoints included tumour response (RECIST v1.1).

    Results

    The study enrolled 21 pts with RCC (33% left and 67% right kidney), mean age 75.0 years (SD: 9.3; range 48–86) and WHO performance status of 0 (81%) or 1 (19%); gender was 6 (29%) female and 15 (71%) male. Eight pts (38%) had metastatic RCC. Seven pts (33%) had previously undergone total nephrectomy of the contralateral kidney, 1 (5%) received prior chemotherapy and 1 (5%) progressed after cryotherapy to the target organ. Three patients were re-treated within the RESIRT study at a higher Y-90 dose, after at least a 12-month interval from their previous SIRT treatment. Median follow-up was 12.0 months (95% CI 11.9–12.1). Sum of longest diameters for the target lesion was median 45 mm (range 23‒123 mm). The intended Y-90 doses were delivered without any dose-limiting toxicity.  Imminent stasis was reached in 11 (52%) pts. 18 (86%) pts experienced 70 adverse events (AEs) at any time to 12 months, with 8 (38%) pts experiencing 18 SAEs; 4 (19%) pts experienced 5 SAEs within 30 days post-SIRT, all determined as not related to SIRT. Ten (48%) pts had 24 AEs grade ≥3 at any time point to 12 months and all were considered unrelated to SIRT; 9 pts (43%) had 16 AEs that were related to SIRT (all grade 1–2, no SAEs), of which 2 occurred pre SIRT. Treatment-related AEs were fatigue/tiredness/lethargy, pain, hypertension, lack of appetite, nausea, ‘heaviness’, bruised groin andhypomagnesemia. Best overall tumour responses were Partial Response [PR] 1/18 (6%), stable disease [SD] 16/18 (89%) and progressive disease 1/18 (6%), with SD in 2 further patients with on-going follow-up.

    Conclusions

    This pilot study demonstrates good tolerability of SIRT at all dose levels including imminent stasis in treating primary tumours in RCC pts otherwise unsuitable for conventional therapy.

    Session: Oral presentations of the 6 best abstracts

    Location: Saturday, 26 November 2016, 11:15 - 11:55, Auditorium

  • Introduction & Objectives

    This study aims to clarify the clinicopathologic features of long-term survivors after radical cystectomy in muscle invasive bladder cancer patients with lymph nodes metastasis.

    Material & Methods

    We analyzed data on 269 patients at two institutions who underwent radical cystectomy and urinary diversion for bladder cancer between 2006 and 2015 and were observed at least 2 year postoperatively.

    Results

    The incidence of lymph nodes metastasis was 25.2% (68 patients). Urinary diversion was orthotopic bladder substitutions in 16, ileal conduit in 22, ureterocutaneoustomy in 30 patients. Clinicopathologic features associated with above 2-year recurrence free survivors included low grade (p=0.001), no ureteral invasion (p=0.001), adjuvant chemotherapy (p=0.010) (Table 1).

    Conclusions

    This study shows that long-term recurrence-free survival above 2-years after radical cystectomy with pelvic lymphadenectomy can be achieved in patients with favorable tumor characteristics. In addition, ureteral status and adjuvant chemotherapy was reliable predictor of above 2-year recurrence free survivors.

  • Introduction & Objectives

    Circulating Tumor Cells (CTC) are promising biomarkers in advanced prostate cancer. Since they are seeded from metastases they may also serve as liquid biopsies for skeletal metastases that are difficult to sample. The aim of the present study was to evaluate to which extent CTCs reflect the phenotype of skeletal metastases, and thereby their potential to serve as a clinical tool in individualizing treatment of metastatic prostate cancer.

    Material & Methods

    CTC and tissue from skeletal metastases were sampled from 17 patients (5 castration naïve and 12 castration resistant) during surgery for spinal cord compression symptoms. CTCs were sampled prior to removal of metastatic tissue, and isolated with AdnaTest ProstateCancerSelect/Detect (Qiagen). Resulting cDNA was pre-amplified in a multiplex reaction and analysed for expression of 48 genes related to prostate cancer progression and metastasis with qPCR. RNA was extracted from the metastatic tissue with RNeasy Plus Universal Mini kit (Qiagen), and gene expression was assessed in the same way as for CTCs. EpCAM expression level was used as internal control to enable normalization to epithelial content (CTCs or tumor tissue) of the samples. Correlation of detected signals between matched CTC and tissue was calculated with Pearson correlations.

    Results

    In 10 of the 17 patient samples (59%) there was a statistically significant correlation between the gene expression profile of CTCs and the sampled metastatic tissue. In the castration naïve group, 80% of the patients had correlating gene expression in CTC and the metastatic sample, while only 50 % of CRPC patients displayed such correlation. The genes that contributed most to the correlations were AGR2, AKR1C3, FOLH1 (PSMA), CDH1 (E-cadherin) and TACSTD2 (TROP2).

    Conclusions

    This study shows that gene expression patterns in CTC can reflect those of metastases. The high ratio of correlation between CTC and a single metastatic sample in the castration naïve patients may be due to a limited metastatic heterogeneity. Thus, one interpretation of the decreased correlation ratio in CRPC patients is that CTCs reflect the total heterogenic tumor burden rather than the single sample used the present study. Taken together, the results imply that CTC phenotyping is a promising tool for individualized therapy in metastatic prostate cancer.

  • Introduction & Objectives

    Extreme hypofractionated image guided radiotherapy or hypofractionated Stereotactic Body Radiation Therapy (SBRT) in prostate cancer is a novel precise strategy to reduce total treatment time and increase effective doses to the prostatic tumor taking into account prostate cancer and organs at risk radiosenstivity. 1) To evaluate the feasibility and toxicity of two regimens of hypofractionated Stereotactic Body Radiation Therapy (SBRT). 2) To obtain patients self-reported Quality Of Life (QOL) measures in two cohorts of SBRT and to compare with a LDR (Low Dose Rate)-brachytherapy for intermediate risk prostate cancer and HDR (High Dose Rate)- brachytherapy boost after 60Gy of external radiation EBRT for high risk patients.

    Material & Methods

    Two prospective phase I-II studies were approved by our institutional review and ethics board. Inclusion criteria were: Trial1) T1-2N0M0, Gleason Score 6-7, PSA< 20 ng/mL, and IPSS 0-7. Trial 2) T3aN0M0 Gleason score 8 or less (N+risk<25%) and IPSS <13. Hormonal-therapy was prescribed according to risk classification. Image Guided RT with Cone Beam CT was mandatory. Dose SBRT was delivered at a prescribed Planning Target Volume (PTV) 35 Gy in five fractions in 5 alternative days or 9 Gy after 60 Gy 2 Gy per fraction in 30 days, using with RapidArc IMAT, with 6 MV FFF photons. CTCAE v4.0 morbidity scores were used to assess toxicities. Health-related quality of life questionnaire, such as EPIC, was administered centrally by telephone interview before treatment and during follow-up (at 3, 6 and 12 months). Comparison of QLQ values by confidence intervals was done between Trial 1 patients and a cohort of 280 LDR-brachytherapy patients and external radiation combined plus HDR-brachytherapy 9 Gy boost in 88 patients vs Trial 2 patients. This work was supported by a grant from the Fundación Mutua-Madrileña (AP87652011).

    Results

    Thirty-one patients have been recruited. Mean age was 70.6 years. Nineteen patients were included in trial 1 and 12 in trial 2. According to D'Amico risk classification for trial 1), 3/19 patients were low-risk and 16/19 were intermediate risk, for trial 2) 12 patients were high risk. All patients completed the treatment as programmed with good tolerance. No toxicity greater than grade 2 was observed. Acute GU and rectal toxicities were seen in 20/31 (64.5%) and 17/31 (54.8%) patients respectively. Both GU and rectal late toxicities G 2 were: 2/31 (6.4%) and 1/31 (3.2%). EPIC urinary values were significantly better at 3 and 6 moths for SBRT (5x7) vs LDR-brachytherapy and EPIC hormonal was higher at 3, 6 and 12 months in LDR-brachytherapy group, whereas in 9 Gy boost patients EPIC hormonal was lower at baseline and 3 months in SBRT group. Values on both bowel and sexual did not showed differences.

    Conclusions

    Early findings indicate that both SBRT regimes with IMAT and FFF beams for low-intermediate-risk prostate cancer and high risk are feasible and well tolerated in selected patients. Although EPIC hormonal QLQ measures are worse than brachytherapy cohorts, EPIC values related to radiation treatment are not different. Long-term follow-up is needed for assessment of late toxicity and outcomes.

  • Introduction & Objectives

    Penile cancer (NP) is a rare neoplasm, accounting for <1% of the tumors in man. The reduced incidence of this condition results in a limited number of randomized trials and low evidence for the best therapeutic approach. We describe a 15-year single center experience in the management of patients with PC.

    Material & Methods

    Retrospective analysis of 55 patients with PC, between 2000 and 2014. The association between categorical variables was evaluated by chi-square test or Fisher's exact test. The survival analysis was performed using the Kaplan-Meier method and log-rank test to compare groups.

    Results

    55 patients with a mean age of 61.1 ±12.2 years [34.0 to 84.0]. 80.9% of the patients presented risk factors for PC (previous STDs 44.7%, phimosis 37,8% and balanitis 28.9%). Most patients presented a single (86.7%), vegetating lesion (56.3%) with an average duration of 12.9 ±15,9 months [2-60] and an average diameter of 31.7 ± 20,9mm [10.0 to 100.0]. 37,5% of the lesions were located in the glans (37.5%), followed by the sulcus (25%) and penile shaft (20.8%). Palpable lymph nodes were reported in 43.2% of patients, predominantly bilateral (50.0%) and mobile (62.5%). Squamous cell carcinoma was diagnosed in 98.0% of the cases, mostly well and moderately differentiated (45.2 and 40.5%, respectively), with lymphovascular invasion in 14.6%. The main surgical intervention was partial penectomy (69,1%), followed by wide excision of the lesion (16.4%) and glansectomy (5.5%). 8.6% of patients had previously undergone topical treatment. In terms of pathological staging, 10.7% had noninvasive disease (CIS / pTa), 27.6% pT1, 31.9% pT2, 27,7% pT3 and 2.1% pT4. Negative lymph node staging (cN0 and pN0) in 74.4% of the patients, N2 in 17.0% and N3 in 8.5%. Radical inguinal lymphadenectomy was performed in 30.6% of patients, with a mean number of nodes removed of 15.3 ±5.6 [1-25]. Pelvic lymphadenectomy was performed in 12.2% of the patients. 18.0% of patients had recurrence after surgical treatment, with a time interval between treatment-recurrence of 5.5 ± 3,9meses [1.0 to 12.0]. The correlation of several clinical and pathological variables with the risk of recurrence, lymph node involvement (N +) or metastatic disease (M +), showed a clinically significant association between greater diameter of the lesion and higher risk of recurrence (p = 0.027), and between palpable lymph nodes and greater risk of inguinal N+ (p = 0.004) and M+ (p = 0.026). Differential survival analysis, according to pT stage, lymph node involvement (N) or metastatic (M0/M +) confirmed lower survival rate of the most advanced stages. We register an overall mortality rate of 29.8%, for a mean follow-up of 41.2 months ± 32.8 [1.0 to 123.0].

    Conclusions

    The described cohort shows aggressive characteristics, with a high percentage of lesions in penile shaft (20.8%), ≥pT2 staging (61.7%), nodal involvement (25.5%) and metastatic disease (12.5%). This factor was reflected in a higher rate of radical surgical approaches and inguinal lymphadenectomy. In the series presented the diameter of the lesion was correlated with higher risk of recurrence and the presence of palpable lymph nodes with increased risk of N+ and M+. Survival curves reflect more aggressive disease at advanced stages.

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