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178 Abstracts

  • Introduction & Objectives

    New post-docetaxel treatment options, such as cabazitaxel, abiraterone, enzalutamide and radium-223, improve health outcomes in mCRPC patients. The objective of this study was to evaluate whether variation exists in the prescription rate of the first post-docetaxel treatment (regardless of specific therapies) and overall survival (OS) in mCRPC patients and to explore the role of structural hospital characteristics.

    Material & Methods

    CAPRI is an observational study in 20 hospitals in the Netherlands. Patients who have been diagnosed with mCRPC in the period 2010 to 2013 and received docetaxel before 1-1-2014 were selected from the registry. Structural hospital characteristics were assessed based on annual volume of mCRPC diagnoses, hospital type, participation in  mCRPC trials, hospital region and referral time from diagnosis to first consultation of medical oncologist. The outcomes prescription rate and OS were adjusted for known prognostic factors: age, ECOG performance status, opioid analgesic use, disease site, PSA, alkaline phosphatase (ALP), hemoglobin and lactate dehydrogenase (LDH).

    Results

    We identified 653 patients treated with docetaxel. The median percentage of patients who received any post-docetaxel treatment was 61% and varied between hospitals from 35% to 87% (figure 1). The odds of receiving this treatment were significantly higher in semi-specialized (OR 1.875, p=0.026) or specialized hospitals (OR 1.692, p=0.026) as compared to general hospitals. However, this difference was not retained after case-mix correction. We observed no association between prescription rates and the other hospital characteristics. Median OS adjusted for case-mix was 17 months for patients who received any post-docetaxel treatment as compared to 9 months for patients who did not. The median OS per hospital was not significantly related to the first post-docetaxel prescription rate.

    Figure 1: Funnel plot of percentage of patients who received any post-docetaxel treatment per hospital type (specialized, semi-special or general hospital) and median overall survival per hospital type in months.


    This study shows that variation exists in prescribing the first post-docetaxel treatments between Dutch hospitals, which cannot be explained by structural hospital characteristics after adjustment for case-mix. mCRPC patients treated with any post-docetaxel treatment had a significantly higher survival. However, variation in prescription rate of the first post-docetaxel treatment between Dutch hospitals does not seem to affect the median OS.

  • Introduction & Objectives

    This study aimed to evaluate the behavior of non-muscle-invasive bladder cancer (NMIBC) in patients submitted to transurethral bladder resection (TURB) comparing subjects in chronic therapy with aspirin, statins, or both drugs to untreated ones.

    Material & Methods

    This retrospective study was conducted on 564 patients diagnosed with NMIBC who underwent TURB between March 2008 and April 2013. The study population was divided into two main groups: treated (aspirin and/or statins) and untreated. The treated group was further divided into three therapeutic subgroups: Group A (100 mg of aspirin, daily for at least two years); Group B (20 mg or more of statins, daily for at least two years); and Group C (100 mg of aspirin and 20 mg of statins together).

    Results

    More resections (2,073) and a higher rate of recurrence (54%), number of recurrences (1,073), and number of lesions in recurrence (mean, 2.44) were observed in the treated group than in the untreated group (p < 0.05). In the treatment subgroups,  significantly fewer resections, recurrences, and number of lesions in recurrence, as well as a lower percentage of patients with recurrences, were found in Group A than in Groups B and C (p < 0.05).

    Conclusions

    A statistical significance in terms of number of bladder resections was found in those patients treated with aspirin and/or statins compared to those not treated with either drug group (p = 0.032). Further evidence is given by the greater number of patients with relapse of tumor (54%), defined as those who have required at least a second TURB, as well as the mean number of recurrences per patient, which was significantly greater in the treated patients (p = 0.033).The higher number of lesions in recurrence represents another important result in the treated group compared to the untreated group (p = 0.021). In this analysis, which did not distinguish between different treatment subgroups, the prognosis of NMIBC for treated patients was worse than that for untreated patients. In a more detailed analysis, patients treated with aspirin received significantly fewer resections than did the entire population, which is statistically significant when compared to the untreated group (p = 0.042).
    Group A also had fewer patients with recurrence (42.9%), fewer recurrences (0.585), and fewer lesions in recurrence (1.14) than did patients in the other treated groups and in the untreated group (p values < 0.05). This is the first study that investigated the effects of combined aspirin and statin use on the behavior and progression of NMIBC. The results of Group C have demonstrated a statistically increased number of resections (2,143), rate of relapsing patients (57,1%), number of recurrences (1,143), and number of lesions in relapse(2,57)compared with those outcomes in the untreated group and, especially,in aspirin Group.We conclude that long-term treatment with aspirin in patients with NMIBC can reduce the risk of tumor recurrence, the average number of resections, and the number of lesions in recurrence. In contrast, treatment with statins does not result in similar reductions and may reduce the beneficial effect of aspirin.

  • Introduction & Objectives

    Intraoperative imaging can provide valuable information about tumour localization and may improve complete tumour resection. Girentuximab may be used as a tumour-targeting agent to image clear cell renal cell carcinoma (ccRCC). It targets carbonic anhydrase IX (CAIX), which is expressed in 95% of ccRCC. Labeled with both a near-infrared fluorescent dye (IRdye 800CW) and a radionuclide (Indium-111), girentuximab can be used to perform intraoperative dual-modality imaging. This study aimed to assess the feasibility of dual-modality imaging in ccRCC using ex vivo perfusion of human tumorous kidneys with dual-labeled girentuximab.

    Material & Methods

    After informed consent six kidneys were obtained from patients who underwent a radical tumour nephrectomy. After nephrectomy the renal artery was connected to a pump via a catheter. Five kidneys were perfused during 10-15 h with 111In-girentuximab-IRdye 800CW (1.2 mg, 3.6–5.2 MBq) in 350 ml Ringer’s lactate (4 °C). To demonstrate selective binding of girentuximab one specimen was perfused with a mixture of two dual-labeled antibodies; 131I-girentuximab-IRdye 800CW and an irrelevant control antibody (IgG) 125I-IgG-IRdye 800CW. Next, the kidneys were perfused with Ringer’s lactate (2.5–4 h) to wash out unbound antibody. Then, a 5-mm thick slice of the kidney was analyzed by autoradiography and fluorescence imaging. Antibody accumulation was determined quantitatively by measuring the activity in 1 cm3 cubes of tumour and normal tissue in a gamma counter. These were subsequently analyzed (immuno)histochemically.

    Results

    Accumulation of dual-labeled girentuximab in tumour tissue was clearly visualized by autoradiography and fluorescence imaging. The match between the radioactive/fluorescent signal and CAIX expression was excellent. Maximum tumour uptake of girentuximab was 0.33 % of the injected dose per gram (mean 0.12 %ID/g) versus 0.04 %ID/g (mean 0.02 %ID/g) in normal kidney tissue. Perfusion with the mixture of two dual-labeled antibodies resulted in a mean tumour uptake of  0.01 %ID/g of 125I-IgG-IRdye 800CW, which was significantly lower than the uptake of 131I-girentuximab-IRdye 800CW (0.08 %ID/g, p<0.05).

    Conclusions

    Dual-labeled girentuximab accumulated specifically in ccRCC tissue indicating the feasibility of dual-modality imaging to detect ccRCC intraoperatively. A clinical study to evaluate intraoperative dual-modality imaging in ccRCC patients has been initiated.

  • Introduction & Objectives

    [11C]choline PET/CT has been established as a diagnostic tool in re-staging patients with biochemical failure after radical treatment for prostate cancer in particular for its capability to detect the presence of lymph node and bone metastases.
    The knowledge of the anatomical site of recurrence may be useful to refer patients to the specific tailored therapy, in addition to the conventional anti-hormonal therapy.
    We investigated the role of [11C]choline PET/CT as an image method for target volume definition  and delineation  in patients with oligometastatic prostate cancer  for Cyberknife stereotactic tailored therapy.

    Material & Methods

    Between March 2009 and march 2013 a cohort of 30 patients with up to 3 synchronous lymph node prostate oligometastases staged with [11C]choline PET/CT (47 lesions, median volume 12,92 cc, range 0,39 -111,67), following biochemical recurrence after local curative treatment were treated with Cyberknife Stereotactic Body Radiotherapy (SBRT) in our Center. In all patients [11C]choline PET/CT images was used to select and to delineate target volumes at lymph node recurrent sites. The mean age of patients population at the time of the Cyberknife treatment was 68 years (range 55-84). Cyberknife prescription doses were 3000-3600 cGy delivered in 3 consecutive fractions of 1000-1200 cGy. In 14 lesions (37%) SBRT was performed as re-irradiation (the recurrent lesion was situated in the previously irradiated volume).

    Results

    The Cyberknife treatment was well tolerated without any acute or late toxicity at all. There were no in field recurrence, resulting in a local control of 100%. Eleven and 3 patients, respectively required a second and third salvage treatment for metachronous metastatic disease. The median time to clinical progression was 14 months (range 3-54). After a median follow up of 33 months (range 13-73) 16 patients started with Androgen Deprivation Therapy (ADT) because of polymetastatic disease resulting in an ADT-FS of 80% at 1 year and 65% at 2 years. The median time ADT was deferred resulted of 26 months (range 4-56).

    Conclusions

    The recent evidence of the potential toxic nature of ADT suggest that effective local therapy might reduce the burden of systemic therapies usually given to patients with metastatic prostate cancer. Although there are not literature data that support the use of [11C]choline PET/CT to plan target volume at lymph nodal level our preliminary results are promising, showing that the treatment is well tolerated with excellent rate of local control and suggest a potential role of [11C]choline PET/CT to select and refer patients to specific treatment strategies.

  • Introduction & Objectives

    To investigate the dose-response relationship for late rectal bleeding (LRB) after radical radiotherapy (RT) for prostate cancer, in a pooled population resulting from two large prospective multicenter trials: AIROPROS0102  (Fellin et al. R&O 2014) and TOG 03.04 RADAR (Ebert et al. IJROBP 2015).

    Material & Methods

    Both trials included patients (pts) treated with conventional fractionation 3DConformal-RT. Dose range was between 66-74 Gy. Planning data were available for all pts and the toxicity (tox) was prospectively scored using the SOMA/LENT scale, with a minimum follow-up of 3 years. Grade2-3 LRB and grade3 LRB were considered as separated endpoints. The relationship between LRB incidence at 3 years and rectal dosimetry was estimated through the Equivalent Uniform Dose (EUD) calculated using the volume parameter n as derived by 3 previous studies: n=0.23 (EUD023, Rancati et al. R&O 2004), n=0.09 (Michalski et al. IJROBP 2010) and n=0.03 (Rancati et al.R&O 2011). All EUDs were included into logistic models. The presence of grade2-3 acute tox was also considered as a potential clinical predictor and inserted into multivariable models together with EUD. The performance of the models was assessed through discriminative power (AUC, sensitivity, specificity) and calibration plot (slope (m) and R^2 for plot fitting).

    Results

    1264 pts were available: 656 AIROPROS0102 and 608 Trog 03.04 RADAR.  Grade2-3 LRB was registered in 192 pts (15.2%), while grade3 LBR was present in 80 pts (6.3%).  EUD023 was the best predictor of grade2-3 LRB: OR=1.09, AUC=0.65, m=1.01 and R^2=0.9, indicating moderate discrimination and very good calibration. Coupling EUD023 with presence of acute tox highlighted an important role of consequential injury (OR for acute tox=1.3) and resulted in improved specificity (0.65 vs 0.6 for a fixed sensitivity of 0.6, AUC=0.65, m=1.0, R^2=0.88).  EUD023 was also the best predictor for grade3 LRB: OR=1.08, AUC=0.64, m=0.99 and R^2=0.67. Even in this case acute tox played an important role (OR=2.5, AUC=0.64, m=1.03, R^2=0.67).
    Figure 1 shows LRB probability as a function of EUD023 and of the presence of acute GI tox.

    Conclusions

    EUD calculated with a volume parameter n=0.23 was predictive of LRB in the pooled population. This dose metric highlights the importance of the medium-high doses (“dose bath”, range: 50-75Gy). Including presence of acute GI tox allowed improvement in specificity, thus underlining once more the importance of the consequential effect between acute and late phases of radioinduced toxicities.
     
    The study was funded by: AIRC IG16087, Fondazione I.Monzino and NHMRC (300705, 455521, 1006447).

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