Cost‑effectiveness analysis of hexaminolevulinate (Hexvix®) guided cystoscopy in Non‑Muscle Invasive Bladder Cancer patients (NMIBC) in Italy

OBJECTIVE: To estimate the incremental cost‑effectiveness of hexaminolevulinate (Hexvix®) + Blue Light (H+BL) cystoscopy (compared to white light cystoscopy only) when used at initial transurethral resection of the bladder tumour (TURBT) for patients diagnosed with non‑muscle invasive bladder cancer (NMIBC) in Italy.METHODS: A cost‑effectiveness model has been developed to estimate the incremental cost‑effectiveness of introducing H+BL at initial TURBT for patients diagnosed with NMIBC in Italy. The model consists of two parts: 1) a short term decision tree which estimates the outcome of the initial diagnostic procedure, and 2) a Markov cohort model which is used to estimate long term outcomes through extrapolation based on data and assumptions about patient management, the natural history of the disease and the empirical efficacy of H+BL in improving diagnosis detection and reducing recurrence. Cost‑effectiveness results are expressed as incremental costs per QALY gained. Univariate and probabilistic sensitivity analyses are conducted to test the robustness of the model to changes in inputs and assumptions.RESULTS: Base case results suggest that Hexvix® is a dominant strategy when used in the resection of NMIBC. Hexvix® is expected to be associated with 0.070 incremental QALYs, with cost savings of € 435 per patient. Sensitivity analyses suggest that the cost of Hexvix® and the relative risk of recurrence in intermediate and low risk groups are key drivers in the model. Probabilistic analyses indicate that Hexvix® is expected to be cost‑effective in >99% of iterations, assuming a willingness to pay threshold of € 25,000 per QALY.CONCLUSION: In conclusion, Hexvix® is expected to be a cost‑effective strategy when used in the resection of NMIBC in Italy.

U-CHANGE Project: a multidimensional consensus on how clinicians, patients and caregivers may approach together the new urothelial cancer scenario

IntroductionAdvanced urothelial carcinoma remains aggressive and very hard to cure, while new treatments will pose a challenge for clinicians and healthcare funding policymakers alike. The U-CHANGE Project aimed to redesign the current model of care for advanced urothelial carcinoma patients to identify limitations (“as is” scenario) and recommend future actions (“to be” scenario).MethodsTwenty-three subject-matter experts, divided into three groups, analyzed the two scenarios as part of a multidimensional consensus process, developing statements for specific domains of the disease, and a simplified Delphi methodology was used to establish consensus among the experts.ResultsRecommended actions included increasing awareness of the disease, increased training of healthcare professionals, improvement of screening strategies and care pathways, increased support for patients and caregivers and relevant recommendations from molecular tumor boards when comprehensive genomic profiling has to be provided for appropriate patient selection to ad hoc targeted therapies.DiscussionWhile the innovative new targeted agents have the potential to significantly alter the clinical approach to this highly aggressive disease, the U-CHANGE Project experience shows that the use of these new agents will require a radical shift in the entire model of care, implementing sustainable changes which anticipate the benefits of future treatments, capable of targeting the right patient with the right agent at different stages of the disease

Monitoring Patients with Metastatic Hormone-Sensitive and Metastatic Castration-Resistant Prostate Cancer: A Multidisciplinary Consensus Document

Background: The availability of a number of agents that are efficacious in patients with metastatic prostate cancer (mPC) has led to them being used sequentially, and this has prolonged patient survival. However, in order to maximize their efficacy, clinicians need to be able to obtain a reliable picture of disease evolution by means of monitoring procedures. Methods: As the intensive monitoring protocols used in pivotal trials cannot be adopted in everyday clinical practice and there is no agreement among the available guidelines, a multidisciplinary panel of Italian experts met to develop recommendations for monitoring mPC patients using a modified Delphi method. Results: The consensus project considered methods of clinically, radiographically, and biochemically monitoring patients with metastatic hormone-sensitive and metastatic castration-resistant prostate cancer undergoing chemotherapy and/or hormonal treatment. The panelists also considered the methods and timing of monitoring castration levels, bone health, and the metabolic syndrome during androgen deprivation therapy. Conclusions: The recommendations, which were drawn up by experts following a formal and validated consensus procedure, will help clinicians face the everyday challenges of monitoring metastatic prostate cancer patients

MATCHING BRCA AND PROSTATE CANCER IN A PUBLIC HEALTH SYSTEM: REPORT OF THE ITALIAN SOCIETY FOR URO-ONCOLOGY (SIUrO) CONSENSUS PROJECT

: The recent approval of PARP inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC) patients with BRCA mutations firstly introduced the possibility of proposing a targeted treatment in this disease. However, the availability of this therapeutic option raises a number of questions concerning the management of prostate cancer in everyday clinical practice: the timing and method of detecting BRCA mutations, the therapeutic implications of the detection, and the screening of the members of the family of a prostate cancer patient with a BRCA alteration. These challenging issues led the Italian Society for Uro-Oncology (SIUrO) to organise a Consensus Conference aimed to develop suggestions capable of supporting clinicians managing prostate cancer patients. The present paper described the development of the statements discussed during the consensus, which involved all of the most important Italian scientific societies engaged in the multi-disciplinary and multi-professional management of the disease

Impact of Surgical Approach on Patient-Reported Outcomes after Radical Prostatectomy: A Propensity Score-Weighted Analysis from a Multicenter, Prospective, Observational Study (The Pros-IT CNR Study)

18noBACKGROUND: To report health-related quality of life outcomes as assessed by validated patient-reported outcome measures (PROMs) after radical prostatectomy (RP). -Methods: This study analyzed patients treated with RP within The PROState cancer monitoring in Italy, from the National Research Council (Pros-IT CNR). Italian versions of Short-Form Heath Survey and university of California los Angeles-prostate cancer index questionnaires were administered. PROMs were physical composite scores, mental composite scores and urinary, bowel, sexual functions and bothers (UF/B, BF/B, SF/B). Baseline unbalances were controlled with propensity scores and stabilized inverse weights; differences in PROMs between different RP approaches were estimated by mixed models. RESULTS: Of 541 patients treated with RP, 115 (21%) received open RP (ORP), 90 (17%) laparoscopic RP (LRP) and 336 (61%) robot-assisted RP (RARP). At head-to-head -comparisons, RARP showed higher 12-month UF vs. LRP (interaction treatment * time p = 0.03) and 6-month SF vs. ORP (p < 0.001). At 12-month from surgery, 67, 73 and 79% of patients used no pad for urinary loss in ORP, LRP and RARP respectively (no differences for each comparison). Conversely, 16, 27 and 40% of patients declared erections firm enough for sexual intercourse in ORP, LRP and RARP respectively (only significant difference for ORP vs. RARP, p = 0.0004). CONCLUSIONS: Different RP approaches lead to significant variations in urinary and sexual PROMs, with a general trend in favour of RARP. However, their clinical significance seems limited.nonenoneAntonelli, Alessandro; Palumbo, Carlotta; Noale, Marianna; Porreca, Angelo; Maggi, Stefania; Simeone, Claudio; Bassi, Pierfrancesco; Bertoni, Filippo; Bracarda, Sergio; Buglione, Michela; Conti, Giario Natale; Corvò, Renzo; Gacci, Mauro; Mirone, Vincenzo; Montironi, Rodolfo; Triggiani, Luca; Tubaro, Andrea; Artibani, WalterAntonelli, Alessandro; Palumbo, Carlotta; Noale, Marianna; Porreca, Angelo; Maggi, Stefania; Simeone, Claudio; Bassi, Pierfrancesco; Bertoni, Filippo; Bracarda, Sergio; Buglione, Michela; Conti, Giario Natale; Corvò, Renzo; Gacci, Mauro; Mirone, Vincenzo; Montironi, Rodolfo; Triggiani, Luca; Tubaro, Andrea; Artibani, Walte

Impact of Gastrointestinal Side Effects on Patients' Reported Quality of Life Trajectories after Radiotherapy for Prostate Cancer: Data from the Prospective, Observational Pros-IT CNR Study

Simple SummaryThe analyses presented, based on data from the PROState cancer monitoring in ITaly from the National Research Council (Pros-IT CNR) study, evaluated patients' reported quality of life outcomes related to bowel function and bother over a 2-year period from the diagnosis. Growth mixture models were considered for patients who underwent radiotherapy, including treatments that were associated or not associated with androgen deprivation therapy. Our data revealed that the proportion of patients that were radiotherapy-treated with persisting significant bowel worsening at the 24 months interval is very limited. The absence of comorbidities and the use of intensity or volumetric radiotherapy techniques with image guidance were found to be related with a better tolerance to radiotherapy in terms of bowel side effects. These findings could be relevant for treatment selection and accurate patient information.Radiotherapy (RT) represents an important therapeutic option for the treatment of localized prostate cancer. The aim of the current study is to examine trajectories in patients' reported quality of life (QoL) aspects related to bowel function and bother, considering data from the PROState cancer monitoring in ITaly from the National Research Council (Pros-IT CNR) study, analyzed with growth mixture models. Data for patients who underwent RT, either associated or not associated with androgen deprivation therapy, were considered. QoL outcomes were assessed over a 2-year period from the diagnosis, using the Italian version of the University of California Los Angeles-Prostate Cancer Index (Italian-UCLA-PCI). Three trajectories were identified for the bowel function; having three or more comorbidities and the use of 3D-CRT technique for RT were associated with the worst trajectory (OR = 3.80, 95% CI 2.04-7.08; OR = 2.17, 95% CI 1.22-3.87, respectively). Two trajectories were identified for the bowel bother scores; diabetes and the non-Image guided RT method were associated with being in the worst bowel bother trajectory group (OR = 1.69, 95% CI 1.06-2.67; OR = 2.57, 95% CI 1.70-3.86, respectively). The findings from this study suggest that the absence of comorbidities and the use of intensity modulated RT techniques with image guidance are related with a better tolerance to RT in terms of bowel side effects

Disease-specific and general health-related quality of life in newly diagnosed prostate cancer patients: the Pros-IT CNR study

The National Research Council (CNR) prostate cancer monitoring project in Italy (Pros-IT CNR) is an observational, prospective, ongoing, multicentre study aiming to monitor a sample of Italian males diagnosed as new cases of prostate cancer. The present study aims to present data on the quality of life at time prostate cancer is diagnosed