Andrea Roncadori

Objective: Surgical intervention is frequently considered for drug‐resistant focal structural epilepsy. However, the impact of early surgery on seizure control, cognitive performance, and quality of life (QoL) across drug‐sensitive and drug‐resistant patients remains incompletely characterized. Methods: We conducted a prospective–retrospective study on 214 patients with age > 6 years with focal structural epilepsy (focal cortical dysplasia type II, hippocampal sclerosis, low‐grade epilepsy‐associated tumors) stratified as: drug‐sensitive (DS, n = 72) and drug‐resistant (DR, n = 112) patients undergoing surgery, and drug‐resistant patients on pharmacological treatment (DRT, n = 30). Cognitive function (including language, verbal and visuospatial memory, attention/executive functions) and QoL (using the Quality of Life in Epilepsy Inventory [QOLIE] and 36‐Item Short Form Survey [SF‐36] questionnaires) were assessed at baseline and 1‐year follow‐up in patient subgroups. Statistical analyses included chi‐square tests, t tests, analysis of variance (ANOVA), and multivariable regression models; p < .05 was considered statistically significant. Results: The DS patients demonstrated superior rates of complete seizure freedom (86%) compared with DR patients (69%, p = .009). At baseline, DS patients exhibited significantly fewer cognitive deficits compared with DR and DRT patients ( p < .05). At the 1‐year follow‐up, no significant changes in neuropsychological performance were observed in any group, although a mild decline in verbal and/or visuospatial memory performance was observed in DRT patients. In a subset of patients ( n = 59 adults) at baseline, DR and DRT patients reported significantly worse overall subjective QoL compared with DS patients ( p = .047 and p = .036, respectively). Longitudinal analysis revealed significant improvements in QoL among surgically treated patients. Significance: Early epilepsy surgery in symptomatic focal epilepsy yields excellent seizure outcomes, particularly in DS patients. Baseline preservation of cognitive function and QoL, together with the stability of these measures after surgery, suggests that timely surgery may help prevent deterioration in cognitive and psychosocial functioning. These findings support early referral for surgical evaluation in selected patients and highlight the need for larger studies with extended follow‐up, to confirm surgical outcome, long‐term neuropsychological, and patient‐reported benefits.

Background and Objectives: Effective palliative care relies on accurate identification and management of symptoms, especially in patients referred for palliative radiotherapy (PRT). This study aimed to identify symptom clusters (SCs)—defined as ≥2 interrelated symptoms—in patients evaluated at a multidisciplinary Radiotherapy and Palliative Care (RaP) outpatient clinic, using the Edmonton Symptom Assessment System (ESAS). Materials and Methods: We retrospectively analyzed data from patients referred to the RaP clinic between February 2017 and April 2020. Demographic and clinical characteristics, including ESAS scores at first visit, were collected. SCs were identified with principal component analysis (PCA) and unsupervised k-means clustering (KMC), determining the number of SCs based on the maximum gap statistic and interpretability. Associations with ECOG performance status (PS), primary tumor and metastases site, and PRT administration were analyzed. Exploratory survival analyses were performed. Results: Among 215 patients (median age = 71 years; 53% male), the mean total ESAS score was 24.03 (SD = 15.28). PCA identified four SCs: SC_PCA1 (tiredness, drowsiness, dyspnea, malaise), SC_PCA2 (depression, anxiety), SC_PCA3 (nausea, loss of appetite) and SC_PCA4 (pain). KMC revealed three SCs: SC_KMC1 (pain, tiredness, drowsiness, malaise), SC_KMC2 (nausea, loss of appetite, dyspnea), and SC_KMC3 (depression, anxiety). Worse ECOG PS correlated with physical SCs (p < 0.05). Psychological SCs were associated with lower likelihood of receiving PRT (OR_PCA2 = 0.26, CI: 0.07–0.80, OR_kmc3 = 0.19, CI: 0.02–0.85, p < 0.05), but when associated with pain/systemic clusters correlated with greater PRT use. A trend toward shorter survival was seen in SC_KMC2. Conclusions: SC analysis could improve personalized symptom management and clinical decision-making in the PRT setting.

Background: Treatment for advanced non-small-cell lung cancer (NSCLC) has evolved substantially over the past decade, necessitating evaluation of real-world treatment patterns and effectiveness before and after the introduction of newer therapies. Methods: This retrospective cohort study included adult patients initiating a non-curative first-line therapy for advanced NSCLC between 2014 and 2021 at the IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST), with follow-up through 2022. Overall survival (OS) and real-world progression-free survival from the start date of the first line of therapy for advanced NSCLC were estimated using Kaplan–Meier methods. Results: Overall, 910 patients were included; at diagnosis, 83% had a de novo diagnosis and 17% had recurrent disease. During the study, 41% of patients received platinum-based chemotherapy alone; 22% received non-platinum-based chemotherapy alone; 21% received anti-programmed death (PD)-(ligand [L])1 immune checkpoint inhibitors (ICIs), alone or with chemotherapy; and 16% received targeted therapy (single-agent tyrosine kinase inhibitors) as first-line therapy for advanced disease. From 2014 to 2021, the proportion of patients receiving first-line anti-PD-(L)1 ICIs increased from 0% to 58% and the proportion of those receiving first-line platinum-based chemotherapy decreased from 65% to 6%. Median (95% CI) OS was 8.2 (7.5–9.2) months; the minimum-to-maximum range of median OS was 6.0–7.4 months from 2014 to 2017 and 8.4–15.9 months from 2018 to 2021. Median OS was numerically longer in patients with recurrent disease versus a de novo diagnosis, first-line targeted versus other therapy, high versus low PD-L1 expression, and non-squamous/other versus squamous histology. Conclusions: This study provides real-world data further supporting (i) the benefits of precision targeted therapy for patients with advanced NSCLC and actionable genomic alterations and (ii) the positive impact of immunotherapy approvals on the treatment paradigm for advanced NSCLC.

Background/Objectives: Management of cancer treatment-induced bone loss (CTIBL) is essential for preserving quality of life among breast cancer (BC) patients receiving endocrine therapy. However, bone-modifying agents (BMAs) remain underused and delayed. In 2014, IRST launched the first bone health outpatient service in Romagna (the eastern area of the Emilia-Romagna region). A multi-centre, retrospective observational study with propensity score matching (PSM) was conducted to evaluate the impact of the IRST organisational model on bone health. Methods: The PSM matched the Emilia-Romagna patients who underwent BC surgery between 2014 and 2022 and were in follow-up in the Romagna area. Patients were grouped as follows: (1) IRST and (2) other Romagna hospitals (without bone health service, i.e., the control group). The matching was based on age, in situ/invasive cancer, and type of early-stage treatment (hormone treatment vs. chemotherapy). Logistic regression and Cox proportional-hazard models assessed factors associated with bone care treatment initiation and timings, respectively. Results: After PSM, we matched 3112 of the 8021 eligible patients into the two cohorts. IRST patients were 39% more likely to receive BMAs (OR: 1.393; 95% CI: 1.236–1.571) and initiated treatment approximately 12 months earlier. We observed that patients with invasive tumours were 77% more likely to initiate bone therapy than those with in situ tumours (OR: 1.766; 95% CI: 1.237–2.585). The early initiation of bone health therapy was influenced by age (p < 0.001) and neoadjuvant chemotherapy treatment (p < 0.001). Conclusions: The IRST model demonstrates responsiveness to bone health needs in BC patients and may be implemented elsewhere to support integrated CTIBL care.

Background/Objectives: Effective palliative care relies on accurate identification and management of symptoms, especially in patients referred for palliative radiotherapy (PRT). This study aimed to identify symptom clusters (SCs)—defined as ≥2 interrelated symptoms—in patients evaluated at a multidisciplinary Radiotherapy and Palliative Care (RaP) outpatient clinic, using the Edmonton Symptom Assessment System (ESAS). Methods: We retrospectively analyzed data from patients referred to the RaP clinic between February 2017 and April 2020. Demographic and clinical characteristics, including ESAS scores at first visit, were collected. Principal component analysis (PCA) and unsupervised K-means clustering (KMC) were used to identify SCs. Associations with ECOG performance status (PS), primary tumor site, metastases site and PRT administration were analyzed. Exploratory survival analyses were performed.Results: Among 215 patients (median age 71 years; 53% male), the mean total ESAS score was 24.03 ± 15.28. PCA identified four SCs: SCPCA1 (tiredness, drowsiness, dyspnea, malaise), SCPCA2 (depression, anxiety), SCPCA3 (nausea, loss of appetite) and SCPCA4 (pain). KMC revealed three SCs: SCKMC1 (pain, tiredness, drowsiness, malaise), SCKMC2 (nausea, loss of appetite, dyspnea), SCKMC3 (depression, anxiety). Worse ECOG PS correlated significantly with physical SCs (p < 0.05). A trend linked SCKMC1 with greater PRT use. Psychological SCs (SCPCA2, SCKMC3) were significantly associated with a lower likelihood of receiving PRT. A trend toward shorter survival was observed among patients belonging to SCKMC2. Conclusions: SC analysis could improve clinical decision-making in the PRT setting. SC profiles reflect patient complexity and may guide personalized symptom management and treatment selection in advanced cancer.

Objectives: The aim of this study was to investigate the treatment patterns and outcomes in two propensity score-matched cohorts of patients with neuroendocrine tumours (NETs) treated with first-line somatostatin analogue (SSA). Methods: Metastatic NET patients treated with first-line SSA (2009–2022) were retrospectively examined. First-line lanreotide vs. octreotide cohorts were matched 1:1 by propensity scores for demographics, tumour characteristics, and diagnosis year. Progression-free survival (PFS) and overall survival (OS) were analysed using Kaplan–Meier analysis and the Cox proportional hazards model. Results: Among 441 patients, 310 were matched (155 in both the octreotide and lanreotide groups). First-line SSA was monotherapy (63.5%) or combination with other medications (36.5%). A total of 77% of second-line patients (188/244) maintained their initial SSA medication in combination with other therapies. Radioligand therapy with lanreotide (N = 72; 29.5%) or octreotide (N = 70; 28.7%) was the most common second-line treatment. First-line lanreotide and octreotide cohorts had similar median PFS (15.5; 95% CI: 13.6–19.1 vs. 14.0; 95% CI: 12.0–15.8 months), despite octreotide having a 36% higher likelihood of moving to the second line than lanreotide (95% CI: 1.05–1.76, p = 0.018). Multiple metastases (HR = 1.45; p = 0.004, 95% CI: 1.13–1.87) and Ki-67 > 20% (HR = 2.34; p < 0.001, 95% CI: 1.43–3.83) were significantly associated with the worst PFS. First-line lanreotide patients had a median OS of 10.4 years (95% CI: 7.5-NA) and octreotide 9.2 years (95% CI: 7.3-NA) (p = 0.537). Bone metastases increased death risk by 91% (p = 0.014; 95% CI: 1.14–3.20). Conclusions: SSA monotherapy is the main first-line treatment and most subsequent treatments include SSA with additional medications. Cohorts had similar PFS/OS, but octreotide demonstrated a 36% significantly higher likelihood of moving to the second-line treatment.

Background: Cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors have changed the therapeutic management of hormone receptor-positive (HR+) metastatic breast cancer (mBC) by targeting the cell cycle machinery and overcoming endocrine resistance. However, a large number of patients present disease progression due to cancer cells resisting CDK4/6 inhibitors. Our research considers which clinicopathological characteristics could be useful in identifying patients who might respond to CDK4/6 inhibitors by analyzing a retrospective case series of patients with HR+ mBC who were treated with hormone therapy plus CDK4/6 inhibitors. Methods: Approximately 177 mBC patients were enrolled, of whom 66 were treated with CD4/6 inhibitors plus letrozole and 111 were treated with CDK4/6 inhibitors and fulvestrant. A multistate model was used. Results: A low body surface area and older age were associated with an increased risk of developing neutropenia. A high Ki67 index, the presence of visceral metastases, and not having previously undergone adjuvant chemotherapy were prognostic factors of disease progression/death. As expected, some of the neutropenic patients who had previously undergone multiple lines of treatment were at a higher risk of disease progression/death. Furthermore, neutropenia status was associated with a more than doubled risk of progression/death compared to patients without neutropenia (HR = 2.311; p = 0.025). Conclusions: Having identified certain factors that could be associated with the development of neutropenia and considering that neutropenia itself is associated with an increased risk of progression, we believe that the baseline characteristics should be taken into account to reduce cases of neutropenia and disease progression.

This study evaluated the economic burden of metastatic non-small cell lung cancer patients before and after the availability of an immuno-oncology (IO) regimen as a first-line (1L) treatment. Patients from 2014 to 2020 were categorized according to mutational status into mutation-positive and negative/unknown groups, which were further divided into pre-1L IO and post-1L IO sub-groups depending on the availability of pembrolizumab monotherapy in 1L. Healthcare costs and HCRU for a 1L treatment and overall follow-up were reported as the mean total and per-month cost per patient by groups. Of 644 patients, 125were mutation-positive and 519 negative/unknown (229 and 290 in pre- and post-1L IO, respectively). The mean total per-patient cost in 1L was lower in pre- (EUR 7804) and post-1L IO (EUR 19,301) than the mutation-positive group (EUR 45,247), persisting throughout overall disease follow-up. However, this difference was less when analyzing monthly costs. Therapy costs were the primary driver in 1L, while hospitalization costs rose during follow-up. In both mutation-positive and post-IO 1L groups, the 1L costs represented a significant portion (70.1% and 66.3%, respectively) of the total costs in the overall follow-up. Pembrolizumab introduction increased expenses but improved survival. Higher hospitalisation and emergency room occupation rates during follow-up reflected worsening clinical conditions of the negative/unknown group than the mutation-positive population.

A retrospective study was conducted among Italian cancer healthcare workers (HCWs) to describe how influenza vaccination attitudes have changed during the COVID-19 pandemic. The analysis was conducted on the last three influenza seasons (2018/19, 2019/20 and 2020/21). To account for different relationships and proximity with patients, the study population was grouped into three main professional categories: health personnel, administrative staff and technicians. Moreover, to explore the factors affecting the coverage of influenza vaccine, a multinomial regression analysis was performed.Over the years, the influenza vaccination uptake showed a gradual increase across the overall staff, the highest coverage (53.8%) was observed in the season 2020/21, in particular, for health personnel (57.7%). In general, males resulted in more adherent to vaccination campaigns; nevertheless, this gap decreased in the last season. A total of 28.6% workers were always vaccinated throughout the past three seasons, a remarkable 25.2% (mainly young and females) received for the first time the influenza vaccination in 2020/21.In this dramatic health crisis, the attitudes of HCWs toward flu vaccination have changed. The COVID-19 outbreak increased adherence to flu vaccination, reaching the highest coverage in the campaign 2020/21. However, further efforts should be made to achieve greater vaccination coverage.

Treatment of lung cancer depends on the stage of the tumor and the histological type. In recent years, the histological confirmation of lung non-small-cell lung cancer has become crucial since the availability of selective target therapeutic approaches. The aim of the study was to develop a validated procedure to estimate the incidence and prevalence of non-small-cell and small-cell lung cancer from healthcare administrative data. A latent class model for categorical variables was applied. The following observed variables were included in the analysis: ICD-9-CM codes in the Hospital Discharge Registry, ATC codes of medications dispensed present in the Drugs Prescriptions Registry, and the procedure codes in the Outpatient Registry. The proportion of non-small-cell lung cancer diagnoses was estimated to be 85% of the total number of lung cancer on the cohort of incident cases and 89% on the cohort of prevalent cases. External validation on a cohort of 107 patients with a lung cancer diagnosis and histological confirmation showed a sensitivity of 95.6% (95%CI: 89–98.8%) and specificity of 94.1% (95%CI: 71.3–99.9%). The procedure is an easy-to-use tool to design subpopulation-based studies on lung cancer and to better plan resource allocation, which is important since the introduction of new targeted therapies in non-small-cell lung carcinoma.