Pub Date : 2025-12-01Epub Date: 2025-10-30DOI: 10.1177/03008916251386980
Anna Maria Merlotti, Stefania Martini, Anna Maria Vandone, Riccardo Bonomi, Salvatore Dario Solla, Francesco Olivero, Lavinia Spinelli, Paola Critelli, Luca Gianello, Riccardo Vigna Taglianti, Grazia Sciancalepore, Alessio Garetto, Gianmauro Numico, Richard Simcock
Background: De novo metastatic breast cancer (dnMBC) is diagnosed when breast cancer has spread at presentation and accounts for 5-10% of cases. The benefit of postoperative radiotherapy (PORT) after primary tumor surgery in this setting remains uncertain.
Methods: We conducted a review and meta-analysis of observational studies published between 2013 and 2024. Two databases (PubMed and Embase) were searched and the review followed PRISMA 2020 guidelines. The aim was to evaluate whether PORT improves overall survival (OS) in dnMBC patients undergoing surgery. The PICOTS framework was applied. Studies were eligible if they compared surgery with or without PORT. OS was analyzed at three and five years as a binary outcome. The study was not registered prospectively.
Results: Five studies were included qualitatively; three were eligible for quantitative synthesis (N=8,557). PORT was associated with improved OS at three years (OR=0.62; 95% CI: 0.56-0.68) and five years (OR=0.65; 95% CI: 0.60-0.71). Benefits were most evident in patients with bone-only metastases and luminal A tumors. No consistent survival advantage was seen in HER2+ or triple-negative disease.
Conclusions: PORT may offer a survival advantage for selected dnMBC patients undergoing surgery. Further prospective studies are needed to confirm these findings and define optimal candidates.
{"title":"Postoperative radiotherapy for stage IV breast cancer following primary tumor removal: Systematic review and meta-analysis.","authors":"Anna Maria Merlotti, Stefania Martini, Anna Maria Vandone, Riccardo Bonomi, Salvatore Dario Solla, Francesco Olivero, Lavinia Spinelli, Paola Critelli, Luca Gianello, Riccardo Vigna Taglianti, Grazia Sciancalepore, Alessio Garetto, Gianmauro Numico, Richard Simcock","doi":"10.1177/03008916251386980","DOIUrl":"10.1177/03008916251386980","url":null,"abstract":"<p><strong>Background: </strong>De novo metastatic breast cancer (dnMBC) is diagnosed when breast cancer has spread at presentation and accounts for 5-10% of cases. The benefit of postoperative radiotherapy (PORT) after primary tumor surgery in this setting remains uncertain.</p><p><strong>Methods: </strong>We conducted a review and meta-analysis of observational studies published between 2013 and 2024. Two databases (PubMed and Embase) were searched and the review followed PRISMA 2020 guidelines. The aim was to evaluate whether PORT improves overall survival (OS) in dnMBC patients undergoing surgery. The PICOTS framework was applied. Studies were eligible if they compared surgery with or without PORT. OS was analyzed at three and five years as a binary outcome. The study was not registered prospectively.</p><p><strong>Results: </strong>Five studies were included qualitatively; three were eligible for quantitative synthesis (N=8,557). PORT was associated with improved OS at three years (OR=0.62; 95% CI: 0.56-0.68) and five years (OR=0.65; 95% CI: 0.60-0.71). Benefits were most evident in patients with bone-only metastases and luminal A tumors. No consistent survival advantage was seen in HER2+ or triple-negative disease.</p><p><strong>Conclusions: </strong>PORT may offer a survival advantage for selected dnMBC patients undergoing surgery. Further prospective studies are needed to confirm these findings and define optimal candidates.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"463-471"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145401810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-09-29DOI: 10.1177/03008916251378266
Kosho Yamanouchi, Chika Sakimura, Ken Taniguchi, Yukio Kamohara
Objective: This study aimed to evaluate regional disparities in surgical approaches and patient-reported outcomes (PROs) among early breast cancer patients in urban and rural areas of Nagasaki Prefecture, Japan.
Methods: We retrospectively analyzed clinicopathological data from 1032 patients (urban: 818; rural: 214) who underwent breast cancer surgery between 2014 and 2021. PROs were assessed using the BREAST-Q survey conducted from October 2022 to June 2024 among patients; a total of 76 patients (urban n = 40; rural n = 36) completed the questionnaire.
Results: Total mastectomy was significantly more frequent in rural facilities (66.8%) than in urban ones (49.9%). Importantly, patients undergoing breast‑conserving surgery (BCS), regardless of geographic location, reported significantly better quality‑of‑life outcomes (higher satisfaction with body image, psychological well‑being, and sexual well‑being).
Conclusion: Geographic disparities in access to specialized surgeons and radiotherapy infrastructure may influence surgical strategies, which in turn impact PROs. These results underscore the need to address logistical barriers, surgeon availability, and rural healthcare infrastructure to ensure equitable access to BCS and improve PROs and overall quality of life.
{"title":"Comparison of breast cancer surgery cases in urban and rural areas: Clinical factors and patient-reported outcomes.","authors":"Kosho Yamanouchi, Chika Sakimura, Ken Taniguchi, Yukio Kamohara","doi":"10.1177/03008916251378266","DOIUrl":"10.1177/03008916251378266","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to evaluate regional disparities in surgical approaches and patient-reported outcomes (PROs) among early breast cancer patients in urban and rural areas of Nagasaki Prefecture, Japan.</p><p><strong>Methods: </strong>We retrospectively analyzed clinicopathological data from 1032 patients (urban: 818; rural: 214) who underwent breast cancer surgery between 2014 and 2021. PROs were assessed using the BREAST-Q survey conducted from October 2022 to June 2024 among patients; a total of 76 patients (urban n = 40; rural n = 36) completed the questionnaire.</p><p><strong>Results: </strong>Total mastectomy was significantly more frequent in rural facilities (66.8%) than in urban ones (49.9%). Importantly, patients undergoing breast‑conserving surgery (BCS), regardless of geographic location, reported significantly better quality‑of‑life outcomes (higher satisfaction with body image, psychological well‑being, and sexual well‑being).</p><p><strong>Conclusion: </strong>Geographic disparities in access to specialized surgeons and radiotherapy infrastructure may influence surgical strategies, which in turn impact PROs. These results underscore the need to address logistical barriers, surgeon availability, and rural healthcare infrastructure to ensure equitable access to BCS and improve PROs and overall quality of life.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"487-495"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145186795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Remarkable advancements in the therapeutic armamentarium for medullary thyroid cancer (MTC) have been observed in the last 10 years. The current understanding of driver mutations, such as RET and RAS, has enabled the development of new therapies for advanced and metastatic disease, demonstrating improved efficacy.
Patient findings: A patient with RET-positive hereditary MTC developed multiple skin cancers (basal cell and squamous cell carcinomas) along with progression of MTC after 12 years of treatment with vandetanib. Once surgery to manage skin cancers has been excluded, the patient received a combination of selpercatinib and cemiplimab, and has been on this treatment at the full dose for 15 months, with ongoing therapy.
Summary: The combination of selpercatinib and cemiplimab was possible, with no new safety signals observed.
{"title":"Selpercatinib plus cemiplimab in <i>RET</i> positive medullary thyroid cancer patient with skin cancers.","authors":"Laura Deborah Locati, Federica Puce, Vito Amoroso, Federico Sottotetti, Alfredo Berruti","doi":"10.1177/03008916251378278","DOIUrl":"10.1177/03008916251378278","url":null,"abstract":"<p><strong>Background: </strong>Remarkable advancements in the therapeutic armamentarium for medullary thyroid cancer (MTC) have been observed in the last 10 years. The current understanding of driver mutations, such as RET and RAS, has enabled the development of new therapies for advanced and metastatic disease, demonstrating improved efficacy.</p><p><strong>Patient findings: </strong>A patient with RET-positive hereditary MTC developed multiple skin cancers (basal cell and squamous cell carcinomas) along with progression of MTC after 12 years of treatment with vandetanib. Once surgery to manage skin cancers has been excluded, the patient received a combination of selpercatinib and cemiplimab, and has been on this treatment at the full dose for 15 months, with ongoing therapy.</p><p><strong>Summary: </strong>The combination of selpercatinib and cemiplimab was possible, with no new safety signals observed.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"NP12-NP15"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145483036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-21DOI: 10.1177/03008916251378261
Irene Possenti, Marco Scala, Anna Odone, Luc J M Smits, Silvano Gallus, Alessandra Lugo
Background: Despite past progress, smoking and secondhand smoke (SHS) remain major public health concerns in Italy. The absence of recent regulations and the spread of novel products highlight the need for continued monitoring.
Methods: We conducted a nationally representative survey in Italy in 2024 using face-to-face interviews on 3125 participants aged 15 years and older. Smoking prevalence, daily SHS exposure in indoor settings and their relationship with sociodemographic and behavioural factors were analysed using unconditional multiple logistic regression models.
Results: In 2024, 26.6% of Italian adults reported to be current conventional cigarette smokers (31.1% in men and 22.3% in women), 11.7% former smokers, and 61.7% never smokers. Compared to never, current smoking was more common among middle age groups (adjusted odds ratio; aOR=2.0; 95% confidence intervals; CI: 1.5-2.7 for individuals aged 25-64 compared with <25 years) and was related to higher levels of education (p for trend=0.008). Current smoking was also more frequent among users of electronic cigarettes (e-cigs; aOR=25.5; 95% CI: 10.8-60.2) and heated tobacco products (HTP; aOR=100.3; 95% CI: 35.4-284.2). Among nonsmokers, 16.3% reported daily indoor exposure to SHS, mainly at work (6.4%) and in other indoor places (7.1%). Daily SHS exposure at home and in private and public transport was 4.3%, 4.3% and 1.4%, respectively. Being exposed to SHS decreased significantly with age (p for trend<0.001).
Conclusion: This study highlights that smoking prevalence remains high and that SHS exposure continues to represent a significant public health concern in Italy. The results underline the need to update and enforce evidence-based tobacco control measures.
{"title":"Prevalence of cigarette smoking and secondhand smoke exposure in Italy in 2024.","authors":"Irene Possenti, Marco Scala, Anna Odone, Luc J M Smits, Silvano Gallus, Alessandra Lugo","doi":"10.1177/03008916251378261","DOIUrl":"10.1177/03008916251378261","url":null,"abstract":"<p><strong>Background: </strong>Despite past progress, smoking and secondhand smoke (SHS) remain major public health concerns in Italy. The absence of recent regulations and the spread of novel products highlight the need for continued monitoring.</p><p><strong>Methods: </strong>We conducted a nationally representative survey in Italy in 2024 using face-to-face interviews on 3125 participants aged 15 years and older. Smoking prevalence, daily SHS exposure in indoor settings and their relationship with sociodemographic and behavioural factors were analysed using unconditional multiple logistic regression models.</p><p><strong>Results: </strong>In 2024, 26.6% of Italian adults reported to be current conventional cigarette smokers (31.1% in men and 22.3% in women), 11.7% former smokers, and 61.7% never smokers. Compared to never, current smoking was more common among middle age groups (adjusted odds ratio; aOR=2.0; 95% confidence intervals; CI: 1.5-2.7 for individuals aged 25-64 compared with <25 years) and was related to higher levels of education (p for trend=0.008). Current smoking was also more frequent among users of electronic cigarettes (e-cigs; aOR=25.5; 95% CI: 10.8-60.2) and heated tobacco products (HTP; aOR=100.3; 95% CI: 35.4-284.2). Among nonsmokers, 16.3% reported daily indoor exposure to SHS, mainly at work (6.4%) and in other indoor places (7.1%). Daily SHS exposure at home and in private and public transport was 4.3%, 4.3% and 1.4%, respectively. Being exposed to SHS decreased significantly with age (p for trend<0.001).</p><p><strong>Conclusion: </strong>This study highlights that smoking prevalence remains high and that SHS exposure continues to represent a significant public health concern in Italy. The results underline the need to update and enforce evidence-based tobacco control measures.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"478-486"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145337741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-01-30DOI: 10.1177/03008916251316175
Luca Zambelli, Alberto Gigliotti, Clara Bianchessi, Simeone Liguori, Sergio Defendi
Background: Global migration has led to an increasing number of migrant patients receiving cancer diagnoses in foreign countries. These individuals often experience worse outcomes due to advanced disease at diagnosis and limited access to specialized care. When palliative care becomes the primary option, many express a wish to return to their home country for End-of-Life care. However, no guidelines or care pathways currently address this sensitive issue.
Case presentation: This case series describes three migrant patients who wished to return to their home countries for End-of-Life care. The first case highlights the critical role of early communication, administrative challenges, and disparities in palliative care availability. The second case demonstrates that even highly disabled patients can undertake a final journey if clinically stable, provided appropriate accommodations and support are in place. Both cases followed a similar framework: identifying a palliative care provider in the home country and having a Mini-Team member accompany the patient. In contrast, the third case underscores the difficulty of fulfilling this wish when clinical deterioration progresses rapidly, preventing repatriationConclusion:Fulfilling the desire of migrant oncology patients to return to their home countries for End-of-Life care presents various challenges. These obstacles may arise from differences in national healthcare systems, administrative issues, and the patient's clinical condition. It is crucial for the Mini-Team to identify this wish as early as possible to secure appropriate arrangements in the patient's home country. Additionally, having a member of the Mini-Team accompany the patient during the journey can provide significant support.
{"title":"The last journey, coming home before dying for migrant cancer patients: A case series.","authors":"Luca Zambelli, Alberto Gigliotti, Clara Bianchessi, Simeone Liguori, Sergio Defendi","doi":"10.1177/03008916251316175","DOIUrl":"10.1177/03008916251316175","url":null,"abstract":"<p><strong>Background: </strong>Global migration has led to an increasing number of migrant patients receiving cancer diagnoses in foreign countries. These individuals often experience worse outcomes due to advanced disease at diagnosis and limited access to specialized care. When palliative care becomes the primary option, many express a wish to return to their home country for End-of-Life care. However, no guidelines or care pathways currently address this sensitive issue.</p><p><strong>Case presentation: </strong>This case series describes three migrant patients who wished to return to their home countries for End-of-Life care. The first case highlights the critical role of early communication, administrative challenges, and disparities in palliative care availability. The second case demonstrates that even highly disabled patients can undertake a final journey if clinically stable, provided appropriate accommodations and support are in place. Both cases followed a similar framework: identifying a palliative care provider in the home country and having a Mini-Team member accompany the patient. In contrast, the third case underscores the difficulty of fulfilling this wish when clinical deterioration progresses rapidly, preventing repatriationConclusion:Fulfilling the desire of migrant oncology patients to return to their home countries for End-of-Life care presents various challenges. These obstacles may arise from differences in national healthcare systems, administrative issues, and the patient's clinical condition. It is crucial for the Mini-Team to identify this wish as early as possible to secure appropriate arrangements in the patient's home country. Additionally, having a member of the Mini-Team accompany the patient during the journey can provide significant support.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"NP37-NP40"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638448/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-22DOI: 10.1177/03008916251365032
Olga Nigro, Marta Podda, Elisabetta Schiavello, Veronica Biassoni, Roberto Luksch, Monica Terenziani, Andrea Ferrari, Filippo Spreafico, Michela Casanova, Cristina Meazza, Stefano Chiaravalli, Nadia Puma, Luca Bergamaschi, Giovanna Gattuso, Giovanna Sironi, Valeria Colombo, Igor Catalano, Federico Pellegatta, Francesco Barretta, Sabina Vennarini, Giuseppe Forzini, Maura Massimino
Introduction: The highest percentage of our patients referred to Pediatric Palliative Care (PPC) are those with brain tumors. Of these, we analyzed PPC activation modes and timing, occurrence of acute events during the period of PPC activation, and the time between acute event and death.MethodsDuring the period 1 January 2010 to 31 October 2023 approximately 1000 Cranial Nervous System (CNS) tumor patients were treated at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan. All records of patients with CNS tumors who were treated and who died during this period were retrieved and retrospectively analyzed.
Results: Data on 107 patients were retrieved. At the time of being taken over by PPC service, 32 patients were at diagnosis stage and 75 were beyond first-line of treatment. At diagnosis, 31 patients had already undergone surgery for placement of a ventriculoperitoneal shunt due to acute intracranial hypertension (IH). Twenty-nine out of 107 patients suffered an emergency while already managed by PPC service. In 18 out of 29 cases, emergency was an acute IH episode. Median time from diagnosis to PPC activation and from diagnosis to death (Overall Survival) were 12.1 months (6.2-27.3) and 16.7 months (10.8-31.1), respectively. Sixty-two patients died at home, 32 were admitted to and died in the referring hospice, 13 died in different hospitals.
Conclusions: Management of a "complex" pediatric patient with an unfavorable prognosis requires early activation of PPC, with a seamless continuation of the already existing partnerships between family, pediatric-oncology team, referring neurosurgeon and palliative care teams.
介绍:我们的儿童姑息治疗(PPC)的患者比例最高的是那些脑肿瘤患者。其中,我们分析了PPC的激活方式和时间,PPC激活期间急性事件的发生,以及急性事件与死亡之间的时间。方法2010年1月1日至2023年10月31日,在米兰国立肿瘤研究所(instituto Nazionale dei Tumori)接受颅神经系统(CNS)肿瘤治疗的患者约1000例。检索并回顾性分析在此期间接受治疗和死亡的所有中枢神经系统肿瘤患者的记录。结果:检索了107例患者的数据。接受PPC服务时,32例患者处于诊断阶段,75例患者已超出一线治疗。在诊断时,31例患者由于急性颅内高压(IH)已经接受了脑室-腹膜分流术的手术。107名患者中有29名在已经由PPC服务管理的情况下遭受了紧急情况。在29例病例中,有18例为急性IH发作。从诊断到PPC激活和从诊断到死亡(总生存期)的中位时间分别为12.1个月(6.2-27.3)和16.7个月(10.8-31.1)。62名患者在家中死亡,32名患者入院并在转介临终关怀中死亡,13名患者在不同的医院死亡。结论:对预后不良的“复杂”儿科患者的治疗需要早期激活PPC,并且家庭、儿科肿瘤团队、转诊神经外科医生和姑息治疗团队之间已经存在的伙伴关系的无缝延续。
{"title":"Pediatric palliative care in patients with brain tumors: Timing, activation, and management of acute events.","authors":"Olga Nigro, Marta Podda, Elisabetta Schiavello, Veronica Biassoni, Roberto Luksch, Monica Terenziani, Andrea Ferrari, Filippo Spreafico, Michela Casanova, Cristina Meazza, Stefano Chiaravalli, Nadia Puma, Luca Bergamaschi, Giovanna Gattuso, Giovanna Sironi, Valeria Colombo, Igor Catalano, Federico Pellegatta, Francesco Barretta, Sabina Vennarini, Giuseppe Forzini, Maura Massimino","doi":"10.1177/03008916251365032","DOIUrl":"10.1177/03008916251365032","url":null,"abstract":"<p><strong>Introduction: </strong>The highest percentage of our patients referred to Pediatric Palliative Care (PPC) are those with brain tumors. Of these, we analyzed PPC activation modes and timing, occurrence of acute events during the period of PPC activation, and the time between acute event and death.MethodsDuring the period 1 January 2010 to 31 October 2023 approximately 1000 Cranial Nervous System (CNS) tumor patients were treated at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan. All records of patients with CNS tumors who were treated and who died during this period were retrieved and retrospectively analyzed.</p><p><strong>Results: </strong>Data on 107 patients were retrieved. At the time of being taken over by PPC service, 32 patients were at diagnosis stage and 75 were beyond first-line of treatment. At diagnosis, 31 patients had already undergone surgery for placement of a ventriculoperitoneal shunt due to acute intracranial hypertension (IH). Twenty-nine out of 107 patients suffered an emergency while already managed by PPC service. In 18 out of 29 cases, emergency was an acute IH episode. Median time from diagnosis to PPC activation and from diagnosis to death (Overall Survival) were 12.1 months (6.2-27.3) and 16.7 months (10.8-31.1), respectively. Sixty-two patients died at home, 32 were admitted to and died in the referring hospice, 13 died in different hospitals.</p><p><strong>Conclusions: </strong>Management of a \"complex\" pediatric patient with an unfavorable prognosis requires early activation of PPC, with a seamless continuation of the already existing partnerships between family, pediatric-oncology team, referring neurosurgeon and palliative care teams.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"472-477"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145347629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-11DOI: 10.1177/03008916251392734
Celeste Cagnazzo, Giorgia Rocca, Franca Fagioli
The recent reform of Italian Ethics Committees (ECs), formalized between 2022 and 2023, aimed to streamline ethical oversight in clinical research by transitioning from a fragmented local system to a coordinated national framework. The new structure includes 40 Territorial Ethics Committees (CETs) and three National Committees (CENs), under the supervision of the National Coordination Centre (CCNCE). While the reform aligned Italy with European Regulation (EU) No 536/2014, significant implementation gaps remain. Many CETs face operational delays, non-compliance with legal composition requirements, inconsistent procedures, and limited resources. Technical-Scientific Secretariats (STS)-crucial to committee function-often lack adequate staffing and training, leading to geographic disparities in review efficiency. Financial sustainability is also a major concern, especially for committees handling unfunded non-commercial studies. Furthermore, the limited mandate of ECs excludes a large portion of ethically complex but non-regulated research. The CCNCE's coordinating role is constrained by scarce resources and insufficient authority. To ensure effective, equitable, and independent ethical review, the article calls for regulatory harmonization, organizational investment, financial support, and broader recognition of ECs' roles in all areas of health research.
意大利伦理委员会(ECs)最近的改革将于2022年至2023年之间正式实施,旨在通过从分散的地方系统过渡到协调的国家框架,简化临床研究的伦理监督。新的结构包括40个地区道德委员会(CETs)和3个国家委员会(cns),在国家协调中心(CCNCE)的监督下。虽然改革使意大利符合欧洲法规(EU) No 536/2014,但仍然存在重大的实施差距。许多cet面临着操作延迟、不符合法律组成要求、程序不一致和资源有限的问题。对委员会职能至关重要的技术-科学秘书处(STS)往往缺乏足够的人员配备和培训,导致审查效率的地域差异。财政可持续性也是一个主要问题,特别是对于处理没有资金支持的非商业研究的委员会。此外,ec有限的授权排除了很大一部分伦理复杂但不受监管的研究。CCNCE的协调作用受到资源稀缺和权力不足的制约。为了确保有效、公平和独立的伦理审查,本文呼吁监管协调、组织投资、财政支持以及更广泛地承认伦理委员会在卫生研究所有领域的作用。
{"title":"Two years after the reform of Italian Ethics Committees: Time for reflection.","authors":"Celeste Cagnazzo, Giorgia Rocca, Franca Fagioli","doi":"10.1177/03008916251392734","DOIUrl":"https://doi.org/10.1177/03008916251392734","url":null,"abstract":"<p><p>The recent reform of Italian Ethics Committees (ECs), formalized between 2022 and 2023, aimed to streamline ethical oversight in clinical research by transitioning from a fragmented local system to a coordinated national framework. The new structure includes 40 Territorial Ethics Committees (CETs) and three National Committees (CENs), under the supervision of the National Coordination Centre (CCNCE). While the reform aligned Italy with European Regulation (EU) No 536/2014, significant implementation gaps remain. Many CETs face operational delays, non-compliance with legal composition requirements, inconsistent procedures, and limited resources. Technical-Scientific Secretariats (STS)-crucial to committee function-often lack adequate staffing and training, leading to geographic disparities in review efficiency. Financial sustainability is also a major concern, especially for committees handling unfunded non-commercial studies. Furthermore, the limited mandate of ECs excludes a large portion of ethically complex but non-regulated research. The CCNCE's coordinating role is constrained by scarce resources and insufficient authority. To ensure effective, equitable, and independent ethical review, the article calls for regulatory harmonization, organizational investment, financial support, and broader recognition of ECs' roles in all areas of health research.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"3008916251392734"},"PeriodicalIF":3.1,"publicationDate":"2025-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145490520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-11DOI: 10.1177/03008916251389485
Simone Bruni, Francesco Raspagliesi, Enrico Vizza, Francesco Fanfani, Jvan Casarin, Fabio Ghezzi, Lorenzo Ceppi, Luca Sorrentino, Valentina Chiappa, Carlotta Caia, Andrea Giannini, Violante Di Donato, Stefano Restaino, Giuseppe Vizzielli, Giorgio Bogani
Objective: Endometrial cancer surgery has a low risk of specimen fragmentation, but removing large uteri can be challenging. This study aimed to assess whether the use of minilaparotomic incision for specimen retrieval compromises the benefits of minimally invasive surgery in endometrial cancer patients with a large uterus or utero-vaginal discrepancy.
Methods: This is a retrospective multi-institutional study, including endometrial cancer patients with FIGO 2009 clinical stage I-II, undergoing minimally invasive staging surgery (laparoscopic or robot-assisted) followed by minilaparotomic specimen retrieval. A propensity-matched algorithm was used to compare outcomes of minimally invasive staging with open surgery.
Results: The study included 45 propensity-matched pairs (90 patients): 45 underwent minimally invasive staging with minilaparotomic specimen retrieval and 45 underwent open staging. Patients undergoing minimally invasive surgery plus trans-abdominal specimen retrieval experienced longer median operative time (95 vs. 85 minutes; p=0.0017), lower blood loss (50 vs. 100 ml; p<0.001), and shorter length of hospital stay (3 vs. 5 days; p<0.001) in comparison to patients undergoing open surgery. No intraoperative complication occurred. No intraoperative transfusions were administered in both cohorts. No statistically significant differences in complications rates were registered between groups (p=0.266). No differences in term of disease-free (p=0.833, log-rank test) and overall (p=0.723, log-rank test) survival was noted between groups.
Conclusions: Transabdominal specimen retrieval does not reduce the benefits of minimally invasive staging in endometrial cancer with large uteri or utero-vaginal disproportion. Uterine size is not a limitation for minimally invasive surgery. Further studies are needed to confirm these results and define the optimal approach.
{"title":"Abdominal specimen retrieval in endometrial cancer patients with large uteri.","authors":"Simone Bruni, Francesco Raspagliesi, Enrico Vizza, Francesco Fanfani, Jvan Casarin, Fabio Ghezzi, Lorenzo Ceppi, Luca Sorrentino, Valentina Chiappa, Carlotta Caia, Andrea Giannini, Violante Di Donato, Stefano Restaino, Giuseppe Vizzielli, Giorgio Bogani","doi":"10.1177/03008916251389485","DOIUrl":"https://doi.org/10.1177/03008916251389485","url":null,"abstract":"<p><strong>Objective: </strong>Endometrial cancer surgery has a low risk of specimen fragmentation, but removing large uteri can be challenging. This study aimed to assess whether the use of minilaparotomic incision for specimen retrieval compromises the benefits of minimally invasive surgery in endometrial cancer patients with a large uterus or utero-vaginal discrepancy.</p><p><strong>Methods: </strong>This is a retrospective multi-institutional study, including endometrial cancer patients with FIGO 2009 clinical stage I-II, undergoing minimally invasive staging surgery (laparoscopic or robot-assisted) followed by minilaparotomic specimen retrieval. A propensity-matched algorithm was used to compare outcomes of minimally invasive staging with open surgery.</p><p><strong>Results: </strong>The study included 45 propensity-matched pairs (90 patients): 45 underwent minimally invasive staging with minilaparotomic specimen retrieval and 45 underwent open staging. Patients undergoing minimally invasive surgery plus trans-abdominal specimen retrieval experienced longer median operative time (95 vs. 85 minutes; p=0.0017), lower blood loss (50 vs. 100 ml; p<0.001), and shorter length of hospital stay (3 vs. 5 days; p<0.001) in comparison to patients undergoing open surgery. No intraoperative complication occurred. No intraoperative transfusions were administered in both cohorts. No statistically significant differences in complications rates were registered between groups (p=0.266). No differences in term of disease-free (p=0.833, log-rank test) and overall (p=0.723, log-rank test) survival was noted between groups.</p><p><strong>Conclusions: </strong>Transabdominal specimen retrieval does not reduce the benefits of minimally invasive staging in endometrial cancer with large uteri or utero-vaginal disproportion. Uterine size is not a limitation for minimally invasive surgery. Further studies are needed to confirm these results and define the optimal approach.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"3008916251389485"},"PeriodicalIF":3.1,"publicationDate":"2025-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145490554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-07-28DOI: 10.1177/03008916251351217
Shaoxin Li, Lina Yang, Zheng Huang
Objective: This study focused on comparing the efficacy of uniportal three-dimensional (3D) video-assisted thoracic surgery (VATS) lobectomy and traditional two-dimensional (2D) VATS lobectomy in patients with non-small cell lung cancer (NSCLC).
Methods: A retrospective analysis was performed on 84 NSCLC patients who underwent VATS lobectomy. Based on the type of thoracoscope used during surgery, patients were assigned to either the 3D group (n = 42), which received uniportal 3D VATS lobectomy, or the 2D group (n = 42), which underwent traditional 2D VATS lobectomy. Perioperative indicators, postoperative Visual Analog Scale (VAS) scores, pain-related factors [substance P (SP), norepinephrine (NE), and cortisol (COR)], immune function (CD3+, CD4+, and CD8+), lung function [forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and maximal voluntary ventilation (MVV)] were compared between the two groups.
Results: The 3D group exhibited lower intraoperative blood loss, postoperative 24-hour drainage volume, drainage tube indwelling time, surgery duration, and hospitalization time compared to the 2D group (P < 0.05). Postoperatively, the 3D group reported lower VAS scores, lower levels of SP, NE, and COR, higher serum levels of CD3+ and CD4+, and higher FVC, FEV1, and MVV values compared to the 2D group (all P < 0.05).
Conclusion: Uniportal 3D VATS lobectomy demonstrates clear advantages over traditional 2D VATS lobectomy for NSCLC patients by reducing perioperative pain, minimizing immune impairment, and preserving lung function.
{"title":"Effects of uniportal 3D video-assisted thoracic surgery lobectomy on postoperative pain and immune function in patients with NSCLC.","authors":"Shaoxin Li, Lina Yang, Zheng Huang","doi":"10.1177/03008916251351217","DOIUrl":"10.1177/03008916251351217","url":null,"abstract":"<p><strong>Objective: </strong>This study focused on comparing the efficacy of uniportal three-dimensional (3D) video-assisted thoracic surgery (VATS) lobectomy and traditional two-dimensional (2D) VATS lobectomy in patients with non-small cell lung cancer (NSCLC).</p><p><strong>Methods: </strong>A retrospective analysis was performed on 84 NSCLC patients who underwent VATS lobectomy. Based on the type of thoracoscope used during surgery, patients were assigned to either the 3D group (n = 42), which received uniportal 3D VATS lobectomy, or the 2D group (n = 42), which underwent traditional 2D VATS lobectomy. Perioperative indicators, postoperative Visual Analog Scale (VAS) scores, pain-related factors [substance P (SP), norepinephrine (NE), and cortisol (COR)], immune function (CD3<sup>+</sup>, CD4<sup>+</sup>, and CD8<sup>+</sup>), lung function [forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and maximal voluntary ventilation (MVV)] were compared between the two groups.</p><p><strong>Results: </strong>The 3D group exhibited lower intraoperative blood loss, postoperative 24-hour drainage volume, drainage tube indwelling time, surgery duration, and hospitalization time compared to the 2D group (<i>P</i> < 0.05). Postoperatively, the 3D group reported lower VAS scores, lower levels of SP, NE, and COR, higher serum levels of CD3<sup>+</sup> and CD4<sup>+</sup>, and higher FVC, FEV1, and MVV values compared to the 2D group (all <i>P</i> < 0.05).</p><p><strong>Conclusion: </strong>Uniportal 3D VATS lobectomy demonstrates clear advantages over traditional 2D VATS lobectomy for NSCLC patients by reducing perioperative pain, minimizing immune impairment, and preserving lung function.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"433-441"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Methods: We considered 67 patients with head-and-neck cancer receiving curative-intent radiotherapy. We developed logistic NTCP models for severe acute/late toxicities (grade ⩾3) using (i) the pATM-based RadioDtect test, (ii) clinical-dosimetric variables, and (iii) a combined model. Model performance was evaluated using AUC (Area Under the receiver operating characteristic Curve), calibration, and Net Reclassification Improvement (NRI), with internal validation via bootstrapping/permutation.
Results: Acute and late toxicity occurred in 70% and 15% of patients. The RadioDtect test alone yielded moderate performance for late toxicity (AUC=0.65) and low discriminatory power for acute toxicity (AUC=0.57). Clinical-dosimetric models for acute toxicity demonstrated substantial predictive value (AUC=0.77), primarily driven by doses to the pharyngeal constrictor muscles and parotid glands. Integrating RadioDtect modestly improved discrimination for acute toxicity (AUC=0.82) but added no clinical utility (NRI=0%). Conversely, for late toxicity, doses showed poor association and discrimination for the occurrence of severe side effects. The biological refined NTCP model showed improved discrimination (AUC=0.76) and meaningful clinical utility (NRI=46.3%).
Conclusions: The RadioDtect assay adds limited value for predicting acute toxicity in clinical settings entailing large volumes of organs at risk irradiated at high doses, but enhances NTCP models for late toxicity prediction.