- Research Article
- 10.1016/j.ctrv.2026.103110
Phase III placebo-controlled oncology trials in the last decade: evolution, methodological foundations, and clinical impact.
- Mar 01, 2026
- Cancer treatment reviews
- Fausto Petrelli + 2 more +2
Publications from 2021 to 2026
Showing 10 of 145 papers
Phase III placebo-controlled oncology trials in the last decade: evolution, methodological foundations, and clinical impact.
Progression-free survival as a surrogate for overall survival in gastro-esophageal cancer trials with immunotherapy: A meta-analysis.
Optimizing diagnostic outcomes and sustainability in radiological practices: a multicentric study on guideline adherence and incidental findings in elective chest CT scans.
This multicentric retrospective study aimed to evaluate the diagnostic outcomes, adherence to guideline-based recommendations, and sustainability implications of 280 initial chest CT scans performed without contrast. The scans were conducted at the Radiology Unit of the Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan and the Radiology Department of Treviglio-Caravaggio Hospital-ASST Bergamo Ovest. The study focused on optimizing patient selection and radiological recommendations to align with evidence-based guidelines. This retrospective study included 280 patients (mean age 61.68years; 51.07% women, 48.93% men) who underwent their first chest CT scan without contrast. Diagnostic outcomes were analyzed across different clinical queries. Incidental findings and radiologists' recommendations were assessed for alignment with Fleischner Society and ACR guidelines. Deviations were categorized as unnecessary imaging suggestions or missed indications. Radiation exposure was quantified using the dose-length product (DLP). Diagnostic outcomes were positive in 54.64% of cases. Incidental findings occurred in 34.64% of cases, with guideline adherence at 81.43%. Deviations included unnecessary imaging in 14.29% and missed follow-up indications in 4.28% of cases. The median DLP was 237.5mGy·cm (IQR 171.8-320.1). This study highlights significant opportunities to refine patient selection and radiological recommendations through adherence to Fleischner Society and ACR guidelines. By integrating evidence-based practices into routine workflows, the findings advocate for reduced unnecessary imaging, enhanced diagnostic pathways, and sustainable healthcare practices in chest CT imaging.
Read moreThe role of oral ferric pyrophosphate protected by a phospholipid bilayer plus a sucrester matrix for treating cancer-related anemia
Where is clinical research in radiation oncology going? a snapshot from Lombardy, Italy-a study endorsed by AIRO Lombardia.
The research activity is fundamental to improve knowledge in Medicine. In the setting of clinical oncology, radiotherapy (RT) represents a cornerstone for patients treated with curative intent. The aim of this snapshot was to investigate the number and the characteristics of clinical trials currently ongoing in the Lombardy (Italy) RT divisions highlighting involved resources and eventual needs to improve the process of study activation. In April 2024, a survey composed of two parts, a snapshot of clinical and research activity and a database to report data on ongoing clinical trials, was proposed to the 30 RT centers in Lombardy. The snapshot consisted of 19 short answer questions. A total of 26 (87%) centers answered the survey. The total number of active studies was 161. The median age among principal investigators was 51 years. Most studies were multicentric (61%) national (76%). Among 72 studies with available phase, 43% resulted phase III studies. Fifty-three (33%) studies were sponsored. IRCCS (Istituti di Ricovero e Cura a carattere scientifico) RT have a median of 11 active studies vs versus 6 in non-IRCCS structures. More resources are available in IRCCS centers compared to non-IRCCS: data management service 50% vs 25%, dedicated scientific nurses 20% vs 0%, clinical statistics services 60% vs 25%. The main difficulties in conducting clinical trials were bureaucratic difficulties with ethics committees (5 centers), time constraints (5 centers), and a lack of resources and staff (15 centers). The most frequently (58% of the centers) proposed solution was an increase in resources and staff. While the RT centers in Lombardy demonstrate a commendable commitment to clinical research, disparities in resources and infrastructure remain significantly challenging.
Read moreSex differences in in-hospital management and outcomes of patients with acute pulmonary embolism
Abstract Background Acute pulmonary embolism (PE) is a life-threatening disease with specific risk factors among women. Systematic evaluation of contemporary quality of care and outcomes in women hospitalized with acute PE is needed. Methods The COPE Registry (COntemporary management of acute Pulmonary Embolism) is a nationwide registry that was run in Internal Medicine, Cardiology and Emergency Departments in Italy. Using data from the COPE Registry, we evaluated sex differences in acute management, medical therapies, in-hospital and 30-day mortality and major bleeding in 5,213 patients admitted for acute PE at 182 hospitals in Italy from 2018 to 2020. Results Women (n=2,728) were older than men (71.2 versus 66.6 years, P<0.001) and had different distribution of comorbidities, with dementia and severe renal failure being more prevalent (13.6 vs 6.4% and 6.1 vs 3.0%, respectively) and cancer, COPD and recent bed-rest less prevalent (15.2 vs 18.5% and 11.1 vs 14.5% and 23.5 vs 20.2%) in women than men. At presentation, PE was more severe in women than men in terms of hemodynamic instability (4.1 vs 2.7%), prevalence of right ventricle overload at echocardiography (64.5 vs 57%) and prevalence of sPESI=0 (29.4 vs 38.5%). Concerning the likelihood to receive evidence-based acute treatments for PE, women were more likely than men to receive reperfusion in the case of hemodynamic compromise at presentation after adjusting for age and dementia (63.1 vs 50.0%; OR 1.934, 95% CI 1.01-3.71), and to receive direct oral anticoagulants during hospitalization after adjusting for age, dementia and severe renal failure (50.9 vs 48.6%; OR 1.14, 95% CI 1.01-1.28); similar proportions of low-risk women and men were managed as outpatients or by short hospital stay (1.4% vs 1.4% and 8.6 vs 6.0%, respectively). In-hospital and 30-day mortality rates were not different in women and in men (3.7% versus 3.1% and 5.5 vs 4.8%), but PE-related mortality was higher in women than in men (2.1 vs 1.3%). The sex difference in PE-related mortality was no longer observed in after adjusting for age, hemodynamic instability and dementia (adjusted HR 1.20; 95% CI 0.77-1.88; P=0.415). Similar rates of early and delayed major bleedings occurred in women and in men, both at univariate analysis and after adjusting for age, creatinine clearance and use of thrombolysis. None of 22 pregnant women and 1 out of 204 women with estro-progestin associated PE died or experienced major bleeding. Conclusions Women hospitalized for acute PE in Italy received evidence-based acute treatments more commonly than men. The observed sex differences in PE-related mortality were mainly attributable to worse clinical profiles and older age. Women with sex-related risk factor for PE had favorable prognosis.
Read moreComparative Efficacy of 21 Treatment Strategies for Resectable Pancreatic Cancer: A Network Meta-Analysis.
The primary treatment for operable pancreatic cancer (PC) involves surgery followed by adjuvant therapy. Nevertheless, perioperative or neoadjuvant chemotherapy (CT) may be used to mitigate the likelihood of recurrence and mortality. This network meta-analysis (NMA) assesses the comparative efficacy of various treatment approaches for resectable PC. A thorough search was carried out on January 31, 2023, encompassing PubMed/MEDLINE, Cochrane Library, and Embase databases. We incorporated randomized clinical trials (RCTs) that compared surgical interventions with or without (neo)adjuvant or perioperative therapies for operable PC. We conducted a fixed-effects Bayesian NMA. We presented the effect sizes in terms of hazard ratios (HRs) for overall survival (OS) along with 95% credible intervals (95% CrIs). The treatment was deemed statistically superior when the 95% credible interval (CrI) did not encompass a null value (hazard ratio < 1). Treatment rankings were established based on the surface under the cumulative ranking curve (SUCRA). A total of 24 studies were incorporated, comparing 21 treatments with surgery in isolation. Eleven treatments showed superior efficacy compared to surgery alone, with HRs ranging from 0.38 for perioperative treatments to 0.73 for adjuvant 5-fluorouracil. After the exclusion of studies conducted in Asia, it was found that the perioperative regimen of gemcitabine combined with nab-paclitaxel was the most effective regimen (SUCRA, p = 0.99). The findings endorse the utilization of perioperative CT, especially multi-agent CT, as the favored intervention for operable PC in Western nations.
Read moreWhat patients with cancer think about the dehospitalization. A survey of Cipomo.
Ministerial Decrete 77 (DM 77) promotes dehospitalization for chronic patients and defines out-of-hospital health facilities at this purpose. It has never been investigated how much patients with cancer know and judge this decree law. The Collegio italiano dei primari oncologi medici ospedalieri (Cipomo) carried out a survey with a dedicated questionnaire on oncological patients attending public hospital to investigate the liking of DM 77. Anonymous responses were obtained from 1.443 patients. Median age 64ys, 42% males, 21% live alone, 70% have a companion. 19% thinks that oral chemotherapy could be managed outside the hospital, 26.68% carried out follow-up (FU),19.15% parenteral therapy, 32.16% basic examinations. Home is preferred by 21.8%, a health facility close to home by 36.3%, hospital by 37.54%. 59.67% would like FU in hospital by their personal oncologist, 5.47% by GP, 35.41% by both together and 9.45% by oncologist outside the hospital. Asked what they might feel about being followed out of the hospital, 29.94% say of not being treated at its best, 12.68% of not being able to be visited in hospital anymore, 5.27% of being abandoned, 30.7% of being freer and 10.88% of feeling less sick. Regarding the use of new technical tools to favor dehospitalisation, 44.15% answered yes, 15.88% no and 30.07% did not know. About the distance or traveling time from home to the therapy administration side, 20.26% answered this should be no more than 15 km or 30 mins, 9.91% no more than 30 km or 45 mins, 5.47% no more than 50 km or 60 mins but 39.5% say that the distance does not matter to them but only the continuity of care. The question related to the inconveniences with going to hospital for therapy: 40.81% waiting time, 20.47% lack of parking, 17.02% rotation of doctors,12.76% travel time and 5.62% bureaucracy. The patients' answers suggest that dehospitalization could improve their quality of life, but at the condition of being able to maintain a close relationship with the personal oncologist.
Read moreGastrointestinal Toxicity of Antibody Drug Conjugates (ADCs) in Metastatic Breast Cancer: A Pooled Analysis
BRAF mutations and survival with surgery for colorectal liver metastases: A systematic review and meta-analysis