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BACKGROUND: The search for factors beyond the radiotherapy dose that could identify patients more at risk of developing radio-induced toxicity is essential to establish personalised treatment protocols for improving the quality-of-life of survivors. To investigate the role of the intestinal microbiota in the development of radiotherapy-induced gastrointestinal toxicity, the MicroLearner observational cohort study characterised the intestinal microbiota of 136 (discovery) and 79 (validation) consecutive prostate cancer patients at baseline radiotherapy. METHODS: Gastrointestinal toxicity was assessed weekly during RT using CTCAE. An average grade >1.3 over time points was used to identify patients suffering from persistent acute toxicity (endpoint). The microbiota of patients was quantified from the baseline faecal samples using 16S rRNA gene sequencing technology and the Ion Reporter metagenomic pipeline. Statistical techniques and computational and machine learning tools were used to extract, functionally characterise, and predict core features of the bacterial communities of patients who developed acute gastrointestinal toxicity. FINDINGS: Analysis of the core bacterial composition in the discovery cohort revealed a cluster of patients significantly enriched for toxicity, displaying a toxicity rate of 60%. Based on selected high-risk microbiota compositional features, we developed a clinical decision tree that could effectively predict the risk of toxicity based on the relative abundance of genera Faecalibacterium, Bacteroides, Parabacteroides, Alistipes, Prevotella and Phascolarctobacterium both in internal and external validation cohorts. INTERPRETATION: We provide evidence showing that intestinal bacteria profiling from baseline faecal samples can be effectively used in the clinic to improve the pre-radiotherapy assessment of gastrointestinal toxicity risk in prostate cancer patients. FUNDING: Italian Ministry of Health (Promotion of Institutional Research INT-year 2016, 5 × 1000, Ricerca Corrente funds). Fondazione Regionale per la Ricerca Biomedica (ID 2721017). AIRC (IG 21479).
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Microbioma Gastrointestinal , Neoplasias da Próstata , Lesões por Radiação , Humanos , Masculino , Microbioma Gastrointestinal/efeitos da radiação , Neoplasias da Próstata/radioterapia , Idoso , Lesões por Radiação/etiologia , Lesões por Radiação/microbiologia , Lesões por Radiação/diagnóstico , Pessoa de Meia-Idade , Metagenômica/métodos , Fezes/microbiologia , RNA Ribossômico 16S/genética , Radioterapia/efeitos adversos , Bactérias/classificação , Bactérias/genética , Bactérias/efeitos da radiação , Gastroenteropatias/etiologia , Gastroenteropatias/microbiologia , MetagenomaRESUMO
PURPOSE: The purpose of this study is to study the evolution of quality of life (QoL) in the first 5 years following Intensity-modulated radiation therapy (IMRT) for prostate cancer (PCa) and to determine possible associations with clinical/treatment data. MATERIAL AND METHODS: Patients were enrolled in a prospective multicentre observational trial in 2010-2014 and treated with conventional (74-80 Gy, 1.8-2 Gy/fr) or moderately hypofractionated IMRT (65-75.2 Gy, 2.2-2.7 Gy/fr). QoL was evaluated by means of EORTC QLQ-C30 at baseline, at radiation therapy (RT) end, and every 6 months up to 5 years after IMRT end. Fourteen QoL dimensions were investigated separately. The longitudinal evaluation of QoL was analysed by means of Analysis of variances (ANOVA) for multiple measures. RESULTS: A total of 391 patients with complete sets of questionnaires across 5 years were available. The longitudinal analysis showed a trend toward the significant worsening of QoL at RT end for global health, physical and role functioning, fatigue, appetite loss, diarrhoea, and pain. QoL worsening was recovered within 6 months from RT end, with the only exception being physical functioning. Based on ANOVA, the most impaired time point was RT end. QoL dimension analysis at this time indicated that acute Grade ≥ 2 gastrointestinal (GI) toxicity significantly impacted global health, physical and role functioning, fatigue, appetite loss, diarrhoea, and pain. Acute Grade ≥ 2 genitourinary (GU) toxicity resulted in lower role functioning and higher pain. Prophylactic lymph-nodal irradiation (WPRT) resulted in significantly lower QoL for global health, fatigue, appetite loss, and diarrhoea; lower pain with the use of neoadjuvant/concomitant hormonal therapy; and lower fatigue with the use of an anti-androgen. CONCLUSIONS: In this prospective, longitudinal, observational study, high radiation IMRT doses delivered for PCa led to a temporary worsening of QoL, which tended to be completely resolved at six months. Such transient worsening was mostly associated with acute GI/GU toxicity, WPRT, and higher prescription doses.
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Neoplasias da Próstata , Radioterapia de Intensidade Modulada , Masculino , Humanos , Radioterapia de Intensidade Modulada/efeitos adversos , Radioterapia de Intensidade Modulada/métodos , Qualidade de Vida , Estudos Prospectivos , Neoplasias da Próstata/tratamento farmacológico , Dor/etiologia , Diarreia , Fadiga/etiologiaRESUMO
Stability analysis remains a fundamental step in developing a successful imaging biomarker to personalize oncological strategies. This study proposes an in silico contour generation method for simulating segmentation variations to identify stable radiomic features. Ground-truth annotation provided for the whole prostate gland on the multi-parametric MRI sequences (T2w, ADC, and SUB-DCE) were perturbed to mimic segmentation differences observed among human annotators. In total, we generated 15 synthetic contours for a given image-segmentation pair. One thousand two hundred twenty-four unfiltered/filtered radiomic features were extracted applying Pyradiomics, followed by stability assessment using ICC(1,1). Stable features identified in the internal population were then compared with an external population to discover and report robust features. Finally, we also investigated the impact of a wide range of filtering strategies on the stability of features. The percentage of unfiltered (filtered) features that remained robust subjected to segmentation variations were T2w-36% (81%), ADC-36% (94%), and SUB-43% (93%). Our findings suggest that segmentation variations can significantly impact radiomic feature stability but can be mitigated by including pre-filtering strategies as part of the feature extraction pipeline.
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BACKGROUND: Men diagnosed with localized prostate cancer (PCa) on active surveillance (AS) have shown to cope with anxiety caused by living with an 'untreated cancer' and different factors can influence the tolerance level for anxiety in these patients. The present study analyzes Italian (Milan) and Dutch (Rotterdam) men prospectively included in the Prostate cancer International Active Surveillance (PRIAS) trial, aiming to explore whether socio-demographic factors (i.e. age, relationship status, education, nationality) may be relevant factors in conditioning the level of anxiety at AS entry and over time. METHODS: Italian and Dutch men participating in the IRB-approved PRIAS study, after signing an informed consent, filled in the Memorial Anxiety Scale for PCa (MAX-PC) at multiple time points after diagnosis. A linear mixed model was used to assess the relationship between the level of patient's anxiety and time spent on AS, country of origin, the interaction between country and time on AS, patients' relationship status and education, on PCa anxiety during AS. RESULTS: 823 MAX-PC questionnaires were available for Italian and 307 for Dutch men, respectively. Median age at diagnosis was 64 years (IQR 60-70 years) and did not differ between countries. On average, Dutch men had a higher total MAX-PC score than Italian men. However, the level of their anxiety decreased over time. Dutch men on average had a higher score on the PCa anxiety sub-domain, which did not decrease over time. Minimal differences were observed in the sub-domains PSA anxiety and fear of recurrence. CONCLUSION: Significant differences in PCa anxiety between the Italian and Dutch cohorts were observed, the latter group of men showing higher overall levels of anxiety. These differences were not related to the socio-demographic factors we studied. Although both PRIAS-centers are dedicated AS-centers, differences in PCa-care organization (e.g. having a multidisciplinary team) may have contributed to the observed different level of anxiety at the start and during AS. Trial registration This study is registered in the Dutch Trial Registry ( www.trialregister.nl ) under NL1622 (registration date 11-03-2009), 'PRIAS: Prostate cancer Research International: Active Surveillance-guideline and study for the expectant management of localized prostate cancer with curative intent'.
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Neoplasias da Próstata , Conduta Expectante , Ansiedade/epidemiologia , Ansiedade/etiologia , Comparação Transcultural , Etnicidade , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias da Próstata/diagnósticoRESUMO
Our aim was to analyse, on a population level, the year-long decline in cancer diagnoses in the region of Lombardy (Italy), and to characterise the tumours with the greatest reduction in diagnosis by patient age, sex and tumour stage at diagnosis. We used the health care utilisation databases of the Lombardy region to identify cancer patients' characteristics (eg, sex, age) and cancer-related information (eg, cancer site, stage at diagnosis). The frequency of new cancer diagnoses in 2019 and 2020 were compared in terms of percentage differences in undiagnosed cases. We observed two peaks in the decline in cancer diagnoses: March to May 2020 (-37%) and October to December 2020 (-19%). The decline persisted over the course of 2020 and was higher in males and patients aged 74+. Diagnoses of all four common cancers analysed (female breast, lung, colorectal and prostate) remained below pre-pandemic levels. For breast and colorectal cancers, the decline in diagnoses was high in the age groups targeted by population-based screening programmes. We observed a reduction in localised stage cancer diagnoses for all four cancers. Our data confirm that timely monitoring of cancer diagnoses and interventions to prevent disruption of routine diagnostic services are needed to mitigate the impact of emergencies on cancer patients.
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COVID-19 , Neoplasias , COVID-19/diagnóstico , COVID-19/epidemiologia , Bases de Dados Factuais , Feminino , Humanos , Masculino , Programas de Rastreamento , Neoplasias/diagnóstico , Neoplasias/epidemiologia , PandemiasRESUMO
Active surveillance (AS) has evolved as a strategy alternative to radical treatments for very low risk and low-risk prostate cancer (PCa). However, current criteria for selecting AS patients are still suboptimal. Here, we performed an unprecedented analysis of the circulating miRNome to investigate whether specific miRNAs associated with disease reclassification can provide risk refinement to standard clinicopathological features for improving patient selection. The global miRNA expression profiles were assessed in plasma samples prospectively collected at baseline from 386 patients on AS included in three independent mono-institutional cohorts (training, testing and validation sets). A three-miRNA signature (miR-511-5p, miR-598-3p and miR-199a-5p) was found to predict reclassification in all patient cohorts (training set: AUC 0.74, 95% CI 0.60-0.87, testing set: AUC 0.65, 95% CI 0.51-0.80, validation set: AUC 0.68, 95% CI 0.56-0.80). Importantly, the addition of the three-miRNA signature improved the performance of the clinical model including clinicopathological variables only (AUC 0.70, 95% CI 0.61-0.78 vs. 0.76, 95% CI 0.68-0.84). Overall, we trained, tested and validated a three-miRNA signature which, combined with selected clinicopathological variables, may represent a promising biomarker to improve on currently available clinicopathological risk stratification tools for a better selection of truly indolent PCa patients suitable for AS.
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BACKGROUND: Physical activity (PA) is associated with favorable outcomes in prostate cancer (PCa) patients. We assessed its effect on the risk of PCa reclassification (PCaR) during active surveillance. METHODS: Anthropometric, demographic, and clinical data concerning men diagnosed with a low-risk PCa and initially managed with active surveillance at the two participating institutions were retrospectively collected. The Physical Activity Scale for the Elderly (PASE) was used for patients' self-assessment of their daily exercise and their consequent stratification into three groups: sedentary (PASE ≤ 65), moderately active (65 < PASE < 125), active (PASE ≥ 125). Kaplan-Meier model was used to evaluate the predictive role of PA on PCaR, computed at 2, 5, 10 years after diagnosis; differences between lifestyle groups were assessed using the log-rank and uni-/multivariable Cox analyses applied to identify predictors of reclassification. RESULTS: Eighty-five patients were included in the analysis, with a median age of 66 years (IQR: 59-70); 16% were active, 45% were former smokers, and 3 presented with metabolic syndrome (MetS). Prostate-specific antigen (PSA) density was 0.12 (IQR: 0.07-0.15); 34 men showed a PSA doubling time <10 years. The Median PASE score was 86 (IQR: 61.5-115.8): 24 patients were sedentary, 46 moderately active, and 15 active. At a median follow-up of 37 months (IQR: 14-53), 25% of patients experienced PCaR. These were less physically active (PASE score 69.3 vs 87.8; p = 0.056) and presented with significantly smaller prostates (46 ml vs 50.7 ml; p = 0.001) and a higher PSAD (0.14 vs 0.10; p = 0.019). At 2 years, the risk of reclassification was 25 ± 5%, while it was 38 ± 7% at both 5 and 10 years. The risk was significantly different in the three PA groups (Log Rank p = 0.033). PASE score was the only independent predictor of PCaR (HR: 0.987; 95%CI: 0.977-0.998; p = 0.016). CONCLUSIONS: PA influences PCa evolution, as increasing levels are associated with a significantly reduced risk of tumor reclassification among patients undergoing active surveillance.
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Exercício Físico , Neoplasias da Próstata/patologia , Neoplasias da Próstata/prevenção & controle , Conduta Expectante , Idoso , Progressão da Doença , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de RiscoRESUMO
PURPOSE: In 2003, the German Cancer Society (Deutsche Krebsgesellschaft, DKG) launched a certification program aimed at improving the quality of cancer care. The purpose of this article is to describe the experience of the Prostate Cancer Unit (PCU) at Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, in the process towards DKG certification. METHODS: In 2018, PCU decided to apply for certification by adopting DKG catalogue of requirements (CoR) and quality indicators. A multiprofessional working group was established with the aim of acting the necessary steps to meet DKG standards. RESULTS: Our organizational setting (procedures, personnel) and activities were accurately analyzed, thus outlining strengths and weaknesses, and modified to comply with DKG CoR and indicators. As examples, (1) a quality management plan was developed; (2) measures were taken to strengthen the surgical expertise; (3) cases evaluated in weekly tumor boards were expanded to include surgical cases with pathological risk factors, metastatic, relapsed and castration-resistant patients; (4) a survey was added to the patient-dedicated initiatives already scheduled; (5) the TuDoc software became the tool to register all new cases of prostate cancer patients referred to PCU. CONCLUSIONS: The process of certification requires many efforts but represents a unique opportunity of improving quality of care of prostate cancer patients, making it comparable on an international scale.
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Neoplasias da Próstata/terapia , Garantia da Qualidade dos Cuidados de Saúde/normas , Idoso , Idoso de 80 Anos ou mais , Certificação , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
OBJECTIVE: To investigate whether prostate cancer (PCa) patients' coping strategies (i.e., fighting spirit, anxious preoccupation, fatalism, helplessness/hopelessness, and avoidance) significantly change during the first 3-year follow-up period of active surveillance (AS). MATERIALS AND METHODS: Altogether, 104 patients on AS completed the Mini-Mental Adjustment to Cancer (Mini-MAC) at baseline (T0), at 10 and 12 months after diagnostic biopsy (T1 and T2, respectively) and then at 24- (T3) and 36-month (T4) follow-up. Paired samples T test was used to detect statistically significant changes over time. Changes ≥ 1 point (or ≤ - 1) were hypothesized to be clinically relevant. RESULTS: During the first 3 years on AS, men experienced decreased anxiety, avoidance thoughts/behaviors, and fight-against-cancer attitudes, and these changes were found to be statistically significant. When considering clinically significant changes between inclusion in AS (T0) and 3-year follow-up (T4), avoidance decreased in 19% of patients. CONCLUSIONS: Most patients were observed to have adopted functional coping strategies at baseline, which were maintained through the first 3 years on AS. Overall, men on AS may perceive increasing control over their cancer and comfort with the AS protocol over time and experience slight decreases in anxious preoccupation, cancer-related avoidance thoughts and behaviors, and fight-against-cancer reactions. For those men who find it difficult to cope with AS, psychological monitoring and interventions could be helpful throughout the monitoring journey.
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Adaptação Psicológica , Neoplasias da Próstata/psicologia , Adulto , Idoso , Ansiedade/psicologia , Emoções , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Neoplasias da Próstata/diagnóstico , Autoimagem , Conduta ExpectanteRESUMO
BACKGROUND: The psychological burden possibly deriving from not immediately undergoing radical treatment for prostate cancer (PCa) could be a potential disadvantage of active surveillance (AS), especially in the eve of some relevant clinical exams [i.e., re-biopsy, prostate-specific antigen (PSA) test, and medical examination]. Even if it is known from the literature that the majority of PCa men in AS do not report heightened anxiety, there is a minority of patients who show clinically significant levels of anxiety after diagnosis. The present study aimed to investigate if demographic, clinical, and psychological variables at the entrance in AS (T0) were associated with the risk of developing clinically significant PCa-related anxiety 2 months before the first re-biopsy (T1) and to offer psychological support to improve quality of life (QoL). MATERIALS AND METHODS: A total of 236 patients participated in the PCa Research International: AS (PRIAS) protocol and in PRIAS-QoL study. Demographic/clinical features, health-related QoL domains, coping with cancer, PCa-related anxiety [Memorial Anxiety Scale for PCa (MAX-PC)], personality traits, and decision-making-related factors were assessed at T0. MAX-PC was also administered at T1. PCa-related anxiety at T1 was considered to be of clinical significance if the MAX-PC score was ≥1.5. Multivariable logistic regression coupled to bootstrap was used to detect factors associated with high levels of anxiety. RESULTS: The median age was 64.4 years. Fifty-six patients (24%) reported MAX-PC total score above the cutoff. Three factors were associated with a high level of PCa anxiety at T1: anxious preoccupation [odds ratio (OR) = 4.36], extraversion (OR = 1.9), and prostate-related symptoms (median OR = 0.46). Physical well-being was associated with a low PCa anxiety subscale (median OR = 0.15); neuroticism and functional well-being were associated with PSA anxiety (median OR = 7.05 and 0.73, respectively). Neuroticism and helplessness/hopelessness were associated with fear of progression (median OR = 18.1 and 5.8, respectively). CONCLUSION: Only a partial portion of the sample experienced significant levels of anxiety after 10 months. Psychological assessment should be routinely conducted to detect risk factors (i.e., anxious preoccupation, extraversion) for increased anxiety, offering tailored psychological interventions aimed at promoting interpersonal awareness and emotional well-being.
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PURPOSE: The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) is a self-report questionnaire that was developed in English to assess prostate cancer (PCa)-related anxiety. The aim of this study was to perform a cultural adaptation for the tool to be used in a population of Italian men on active surveillance (AS). METHODS: A total of 222 patients with localized PCa who were recruited for the Prostate Cancer Research International: Active Surveillance (PRIAS) protocol completed the MAX-PC. Psychometric analysis was performed to assess reliability indexes. A Spearman rank correlation was used to test the association between MAX-PC scales and other questionnaires and was used for longitudinal analysis. RESULTS: Cronbach coefficients and item to total correlation demonstrated good internal consistency. Some items related to the repetition of the PSA test showed a large floor effect and thus were poorly effective in measuring anxiety for PSA testing in patients on AS. Confirmatory factor analysis partly failed to reproduce the structure of the original version. A modified version of MAX-PC, excluding the items with a large floor effect, was thus considered for AS patients. Factor analysis on this version demonstrated considerable consistency with the presence of 3 subscales: anxiety related to PCa, anxiety related to PSA testing, and anxiety related to the fear of tumor progression. Longitudinal analysis showed an acceptable validity over time. The MAX-PC was correlated with the anxious preoccupation subscale of the Mini-Mental Adjustment to Cancer scale. CONCLUSIONS: A slightly modified version of the MAX-PC was developed for use in Italian men on AS. This instrument appears to be a valid and reliable tool that measures anxiety in men with PCa who are enrolled in AS programs.
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Adaptação Fisiológica/fisiologia , Ansiedade/genética , Ansiedade/psicologia , Neoplasias da Próstata/complicações , Neoplasias da Próstata/psicologia , Progressão da Doença , Medo/psicologia , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Psicometria/métodos , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
BACKGROUND AND PURPOSE: Intestinal toxicity is commonly experienced during whole-pelvis intensity-modulated radiotherapy (WPRT) for prostate cancer. The aim of the current study was to assess bowel dose-volume relationships for acute patient-reported intestinal symptoms of patients treated with WPRT for prostate cancer. MATERIALS AND METHODS: Complete data of 206 patients were available; the median dose to pelvic nodes was 51.8Gy (range 50.4-54.4, 1.7-2Gy/fr). Intestinal symptoms were assessed as changes in the Inflammatory Bowel Disease Questionnaire scores relative to the Bowel Domain (IBDQ-B) between baseline and radiotherapy mid-point/end. The 25th percentiles of the most severe worsening from baseline (ΔIBDQ-B) were set as end-points. The impact of bowel loops and sigmoid colon dose-volume/surface parameters as well as selected clinical parameters were investigated using multivariate logistic regression. RESULTS: Analyses were focused on the four questions showing a median ΔIBDQ-B>0. No dose volume/surface parameters were predictive, other than ΔIBDQ5≥3 (loose stools): when grouping patients according to bowel DVHs (high risk: V20>470cc, V30>245cc, V42>110cc; low risk: all the remaining patients), a two-variable model including high-risk DVH-shape (OR: 9.3) and age (protective, OR: 0.94) was assessed. The model showed good calibration (slope: 1.003, R2=0.92) and was found to be robust after bootstrap-based internal validation. CONCLUSIONS: Constraining the bowel loops may reduce the risk of loose stools. The risk is higher for younger patients.
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Enteropatias/etiologia , Intestinos/efeitos da radiação , Lesões por Radiação/etiologia , Idoso , Idoso de 80 Anos ou mais , Diarreia/diagnóstico , Diarreia/etiologia , Relação Dose-Resposta à Radiação , Humanos , Enteropatias/diagnóstico , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Pelve/efeitos da radiação , Neoplasias da Próstata/radioterapia , Lesões por Radiação/diagnóstico , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador/métodos , Radioterapia de Intensidade Modulada/efeitos adversos , Inquéritos e QuestionáriosRESUMO
PURPOSE: To evaluate the outcomes of active surveillance (AS) on patients with low-risk prostate cancer (PCa) and to identify predictors of disease reclassification. METHODS: In 2005, we defined an institutional AS protocol (Sorveglianza Attiva Istituto Nazionale Tumori [SAINT]), and we joined the Prostate Cancer Research International: Active Surveillance (PRIAS) study in 2007. Eligibility criteria included clinical stage ≤T2a, initial prostate-specific antigen (PSA) <10 ng/mL, and Gleason Pattern Score (GPS) ≤3 + 3 (both protocols); ≤25% positive cores with a maximum core length containing cancer ≤50% (SAINT); and ≤2 positive cores and PSA density <0.2 ng/mL/cm3 (PRIAS). Switching to active treatment was advised for a worsening of GPS, increased positive cores, or PSA doubling time <3 years. Active treatment-free survival (ATFS) was assessed using the Kaplan-Meier method. Factors associated with ATFS were evaluated with a multivariate Cox proportional hazards model. RESULTS: A total of 818 patients were included: 200 in SAINT, 530 in PRIAS, and 88 in personalized AS monitoring. Active treatment-free survival was 50% after a median follow-up of 60 months. A total of 404/818 patients (49.4%) discontinued AS: 274 for biopsy-related reclassification, 121/404 (30%) for off-protocol reasons, 9/404 (2.2%) because of anxiety. Biopsy reclassification was associated with PSA density (hazard ratio [HR] 1.8), maximum percentage of core involvement (HR 1.5), positive cores at diagnostic biopsy (HR 1.6), older age (HR 1.5), and prostate volume (HR 0.6) (all p<0.01). Patients from SAINT were significantly more likely to discontinue AS than were the patients from PRIAS (HR 1.65, p<0.0001). CONCLUSIONS: Five years after diagnosis, 50% of patients with early PCa were spared from active treatment. Wide inclusion criteria are associated with lower ATFS. However, at preliminary analysis, this does not seem to affect the probability of unfavorable pathology.
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Progressão da Doença , Neoplasias da Próstata/epidemiologia , Neoplasias da Próstata/patologia , Idoso , Biópsia , Intervalo Livre de Doença , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Modelos de Riscos Proporcionais , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangueRESUMO
PURPOSE: To investigate the presence of regret in patients about having followed an active surveillance (AS) protocol. The secondary aim was to identify variables that influence regret. METHODS: From February 2006 to May 2014, 204 patients discontinued the AS protocols and were invited to enter the study. Sociodemographic variables were collected at AS enrollment, together with health-related quality of life (Functional Assessment of Cancer Therapy-Prostate version [FACT-P]) and coping (Mini-Mental Adjustment to Cancer). Patients were asked to complete a Treatment Regret Scale as well as the FACT-P questionnaire. Clinical data were gathered, as well as time of stay within the AS protocol, reason for discontinuing AS, kind of post-AS treatment, and time elapsed since AS discontinuation. Questionnaires were completed by 105 patients (51.5% of those who had been invited to enter the study). RESULTS: Most of the patients had a low or null degree of regret on the Treatment Regret Scale from 0 to 100 (82/105 patients [78.1%] obtained a score <30, and about 30% of the sample had a score equal to zero). Only 5 patients (4.7%) scored 60 or more, indicating some degree of regret. None of the statistical tests between regret scores and a number of analyzed variables reached significance. CONCLUSIONS: These results show that the degree of regret about following an AS protocol and after its discontinuation because of entering active treatment was very low. The regret after AS was not related to sociodemographic or clinical factors.
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Tomada de Decisões , Emoções , Neoplasias da Próstata/epidemiologia , Neoplasias da Próstata/psicologia , Idoso , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias da Próstata/terapia , Fatores Socioeconômicos , Inquéritos e QuestionáriosRESUMO
AIM: To assess the predictors of the onset of impotence 1 year after radiotherapy for prostate cancer. PATIENTS AND METHODS: In a multi-centric prospective study, the International Index of Erectile Function (IIEF) questionnaire-based potency of 91 hormone-naïve and potent patients (IIEF1-5 > 11 before radiotherapy) was assessed. At the time of this analysis, information on potency 1 year after treatment was available for 62 of 91 patients (42 treated with hypofractionation: 2.35-2.65 Gy/fr, 70-74.2 Gy; 20 with conventional fractionation: 74-78 Gy). Prospectively collected individual information and Dmax/Dmean to the penile bulb were available; the corresponding 2 Gy-equivalent values (EQD2_max/EQD2_mean) were also considered. Predictors of 1year impotency were assessed through uni- and multi-variable backward logistic regression: The best cut-off values discriminating between potent and impotent patients were assessed by ROC analyses. The discriminative power of the models and goodness-of-fit were measured by AUC analysis and the Hosmer-Lemeshow (H&L) test. RESULTS: At 1year follow-up, 26 of 62 patients (42 %) became impotent. The only predictive variables were baseline IIEF1-5 values (best cut-off baseline IIEF1-5 ≥ 19), Dmax ≥ 68.5 Gy and EQD2_max ≥ 74.2 Gy. The risk of 1year impotence may be predicted by a two-variable model including baseline IIEF1-5 (OR: 0.80, p = 0.003) and EQD2_max ≥ 74.2 Gy (OR: 4.1, p = 0.022). The AUC of the model was 0.77 (95% CI: 0.64-0.87, p = 0.0007, H&L: p = 0.62). The 1year risk of impotency after high-dose radiotherapy in potent men depends on the EQD2_max to the penile bulb and on baseline IIEF1-5 values. CONCLUSION: A significant reduction in the risk may be expected mainly when sparing the bulb in patients with no/mild baseline impotency (IIEF1-5 > 17).