Aureliano Stingi, Giuseppe Aprile, Sara Aspromonte, Alice Avancini, Francesco Bettariga, Luigia Carapezza, Sara Compagni, Raffaele Giusti, Sara Pilotto, Marta Schirripa, Fotios Loupakis
Modern oncology faces the need to integrate high-level evidence, non-pharmacological interventions into care pathways. Among these, structured physical exercise is shifting from a simple "virtuous recommendation" to a treatment that concretely influences clinical outcomes. The phase III CHALLENGE trial, conducted on 889 patients with stage II-III colon cancer, demonstrated a 6.4% absolute increase in 5-year disease-free survival (DFS) (HR 0.72) and a 37% reduction in overall mortality (HR 0.63). Observational evidence further confirms benefits in breast, prostate, and lung cancers. This review summarizes the literature, analyzes barriers and implementation strategies (tele-exercise, dedicated professionals, hub-and-spoke models), and assesses psychological and economic impacts.
{"title":"[CHALLENGE accepted! Exercise in oncology: from \"Supportive Care\" to \"Effective Treatment\"].","authors":"Aureliano Stingi, Giuseppe Aprile, Sara Aspromonte, Alice Avancini, Francesco Bettariga, Luigia Carapezza, Sara Compagni, Raffaele Giusti, Sara Pilotto, Marta Schirripa, Fotios Loupakis","doi":"10.1701/4631.46401","DOIUrl":"10.1701/4631.46401","url":null,"abstract":"<p><p>Modern oncology faces the need to integrate high-level evidence, non-pharmacological interventions into care pathways. Among these, structured physical exercise is shifting from a simple \"virtuous recommendation\" to a treatment that concretely influences clinical outcomes. The phase III CHALLENGE trial, conducted on 889 patients with stage II-III colon cancer, demonstrated a 6.4% absolute increase in 5-year disease-free survival (DFS) (HR 0.72) and a 37% reduction in overall mortality (HR 0.63). Observational evidence further confirms benefits in breast, prostate, and lung cancers. This review summarizes the literature, analyzes barriers and implementation strategies (tele-exercise, dedicated professionals, hub-and-spoke models), and assesses psychological and economic impacts.</p>","PeriodicalId":20887,"journal":{"name":"Recenti progressi in medicina","volume":"117 1","pages":"26-33"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Here we report the case of a 39 years old patient who experienced a hematological relapse of B-cell acute lymphoblastic leukemia 23 months after completion of maintenance therapy. Relapse occurred two days after brexu-cel approval for reimbursement within the Italian National Health System. This favourable timing enabled the prompt apheresis for brexu-cel manufacturing, bridge therapy with inotuzumab ozogamicin and subsequently brexu-cel infusion. The patient achieved a complete molecular remission and thereafter performed an allogeneic stem cell transplantation. Currently, at 19 and 15 months after brexu-cel infusion and transplant, respectively, the patient presents sustained MRD negative remission with no graft-versus-host-disease evidence and a good quality of life.
{"title":"[Brexu-cel cell therapy and subsequent allogeneic hematopoietic stem cell transplantation in the treatment of late-relapse B-cell acute lymphoblastic leukemia].","authors":"Lucia Brunello","doi":"10.1701/4631.46412","DOIUrl":"10.1701/4631.46412","url":null,"abstract":"<p><p>Here we report the case of a 39 years old patient who experienced a hematological relapse of B-cell acute lymphoblastic leukemia 23 months after completion of maintenance therapy. Relapse occurred two days after brexu-cel approval for reimbursement within the Italian National Health System. This favourable timing enabled the prompt apheresis for brexu-cel manufacturing, bridge therapy with inotuzumab ozogamicin and subsequently brexu-cel infusion. The patient achieved a complete molecular remission and thereafter performed an allogeneic stem cell transplantation. Currently, at 19 and 15 months after brexu-cel infusion and transplant, respectively, the patient presents sustained MRD negative remission with no graft-versus-host-disease evidence and a good quality of life.</p>","PeriodicalId":20887,"journal":{"name":"Recenti progressi in medicina","volume":"117 1","pages":"e5-e7"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The therapy of patients with acute lymphoblastic leukemia (ALL) in the latter has achieved significant progress by increasing the complete remission (CR) rate, re-binding allogeneic transplantation to patients with high-risk disease and/or not in MRD-negative CR. The flip side of these successes is the more difficult management for patients who are refractory to modern treatment regimens or who relapse. Historically, it was necessary to aim for a CR and consolidate the result with allogeneic transplantation, an option available only to young and fit patients. Introduction of CAR therapy T seems to undermine this dogma by allowing to offer a lasting therapeutic perspective even for elderly patients who do not obtain a clinical response with second line therapy.
{"title":"[CAR-T therapy in relapsed or refractory B-cell acute lymphoblastic leukemia: a new treatment paradigm].","authors":"Giovanni Grillo, Anna Mochi","doi":"10.1701/4631.46414","DOIUrl":"10.1701/4631.46414","url":null,"abstract":"<p><p>The therapy of patients with acute lymphoblastic leukemia (ALL) in the latter has achieved significant progress by increasing the complete remission (CR) rate, re-binding allogeneic transplantation to patients with high-risk disease and/or not in MRD-negative CR. The flip side of these successes is the more difficult management for patients who are refractory to modern treatment regimens or who relapse. Historically, it was necessary to aim for a CR and consolidate the result with allogeneic transplantation, an option available only to young and fit patients. Introduction of CAR therapy T seems to undermine this dogma by allowing to offer a lasting therapeutic perspective even for elderly patients who do not obtain a clinical response with second line therapy.</p>","PeriodicalId":20887,"journal":{"name":"Recenti progressi in medicina","volume":"117 1","pages":"e12-e16"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Malignant fungating wounds (MFW) pose a significant clinical challenge, affecting patients' quality of life through debilitating symptoms such as pain, exudate, and odor. This study aimed to translate, adapt, and validate the Malignant Wound Assessment Tool-Clinical version (MWAT-C) to assess malignant fungating wounds in Italy.
Methods: The study followed a multi-phase methodological design, including a backward and forward translation process and evaluation of the Italian version by 18 healthcare experts. Face and content validity were assessed using a Likert scale to rate item relevance and clarity.
Results: The overall S-CVI value was 0.96, with I-CVI values ranging from 0.78 to 1.00. Experts considered items related to pain, odor, and exudate particularly relevant. Some items, such as patient perception of the wound, received lower ratings, highlighting challenges in self-assessment.
Conclusion: Adopting this tool could improve the quality of care, reduce variability in clinical practices, and facilitate a multidimensional approach. However, further studies are needed to evaluate the scale's inter-rater reliability and internal consistency.
{"title":"[Malignant Wound Assessment Tool-Clinical version: Italian translation and content and face validation for the assessment of malignant cutaneous wounds].","authors":"Gabriele Cremona, Fiorella Bersanetti, Francesca Costa, Maurizio Beretta, Martina Maserati, Patrizia Dorsi, Marina Bolzoni, Monica Muroni, Cinzia Merlini, Lorella Cappucciati, Marco Alfredo Arcidiacono, Gianluca Conte, Arianna Magon, Rosario Caruso, Matteo Altavilla, Luigi Cavanna","doi":"10.1701/4631.46403","DOIUrl":"10.1701/4631.46403","url":null,"abstract":"<p><strong>Introduction: </strong>Malignant fungating wounds (MFW) pose a significant clinical challenge, affecting patients' quality of life through debilitating symptoms such as pain, exudate, and odor. This study aimed to translate, adapt, and validate the Malignant Wound Assessment Tool-Clinical version (MWAT-C) to assess malignant fungating wounds in Italy.</p><p><strong>Methods: </strong>The study followed a multi-phase methodological design, including a backward and forward translation process and evaluation of the Italian version by 18 healthcare experts. Face and content validity were assessed using a Likert scale to rate item relevance and clarity.</p><p><strong>Results: </strong>The overall S-CVI value was 0.96, with I-CVI values ranging from 0.78 to 1.00. Experts considered items related to pain, odor, and exudate particularly relevant. Some items, such as patient perception of the wound, received lower ratings, highlighting challenges in self-assessment.</p><p><strong>Conclusion: </strong>Adopting this tool could improve the quality of care, reduce variability in clinical practices, and facilitate a multidimensional approach. However, further studies are needed to evaluate the scale's inter-rater reliability and internal consistency.</p>","PeriodicalId":20887,"journal":{"name":"Recenti progressi in medicina","volume":"117 1","pages":"44-49"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In the context of clinical research, the Data Protection Impact Assessment (DPIA), as required by Article 35 of the GDPR 2016/679, is an essential tool to ensure the compliant and responsible processing of personal data, particularly health and genetic data. The adoption of the DPIA addresses the need to safeguard the fundamental rights and freedoms of data subjects in high-risk scenarios, such as multicenter studies and the use of innovative technologies. This article analyzes the ethical, regulatory, and organizational value of the DPIA in clinical trials, highlighting operational challenges such as lack of resources, insufficient training, interpretative ambiguities, and weak integration with ethics committees. A multidisciplinary approach is proposed that sees the DPIA not merely as a regulatory obligation but as a strategic lever to enhance transparency and quality in research. In conclusion, the importance of clarifying roles and responsibilities is emphasized, while promoting a culture of data protection from the earliest stages.
{"title":"Sotto la lente della valutazione d’impatto privacy: la ricerca clinica fra trasparenza e sfide regolatorie.","authors":"Alessandra Piccolo, Veronica Franchina, Celeste Cagnazzo","doi":"10.1701/4619.46279","DOIUrl":"10.1701/4619.46279","url":null,"abstract":"<p><p>In the context of clinical research, the Data Protection Impact Assessment (DPIA), as required by Article 35 of the GDPR 2016/679, is an essential tool to ensure the compliant and responsible processing of personal data, particularly health and genetic data. The adoption of the DPIA addresses the need to safeguard the fundamental rights and freedoms of data subjects in high-risk scenarios, such as multicenter studies and the use of innovative technologies. This article analyzes the ethical, regulatory, and organizational value of the DPIA in clinical trials, highlighting operational challenges such as lack of resources, insufficient training, interpretative ambiguities, and weak integration with ethics committees. A multidisciplinary approach is proposed that sees the DPIA not merely as a regulatory obligation but as a strategic lever to enhance transparency and quality in research. In conclusion, the importance of clarifying roles and responsibilities is emphasized, while promoting a culture of data protection from the earliest stages.</p>","PeriodicalId":20887,"journal":{"name":"Recenti progressi in medicina","volume":"116 12","pages":"711-717"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145757405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: The evolving epidemiological landscape of transthyretin amyloid cardiomyopathy (ATTR-CM), particularly in its wild-type form, highlights a progressive increase in diagnoses. This trend calls for a critical reflection on the economic sustainability of tafamidis treatment, given the expanding eligible patient population and the lack of price renegotiation.
Methods: A retrospective study was conducted on patients treated at an Asl (2023-2025). Persistence and adherence to the treatment were evaluated. A linear regression model estimated future incidence and economic impact.
Results: Among 17 patients, persistence was 58.82%, adherence (>80%) 100%. Incidence rose from 15.2 to 35.73 cases/million (2018-2025). The 5-year cost per patient exceeded € 815,000. Based on the ATTR-ACT trial NNT (7.46), 2.3 deaths may be prevented, though this benefit may be overestimated.
Discussion: The rising incidence was not followed by a price revision. Use in older, frail patients and the absence of dynamic pricing agreements raise questions about cost-effectiveness and equitable access.
{"title":"[Tafamidis between real-world evidence and registration trials: towards a price renegotiation with a view to sustainability and appropriateness].","authors":"Tiziano Lupi, Fiorenzo Santoleri, Maurizio Belfiglio","doi":"10.1701/4619.46281","DOIUrl":"10.1701/4619.46281","url":null,"abstract":"<p><strong>Introduction: </strong>The evolving epidemiological landscape of transthyretin amyloid cardiomyopathy (ATTR-CM), particularly in its wild-type form, highlights a progressive increase in diagnoses. This trend calls for a critical reflection on the economic sustainability of tafamidis treatment, given the expanding eligible patient population and the lack of price renegotiation.</p><p><strong>Methods: </strong>A retrospective study was conducted on patients treated at an Asl (2023-2025). Persistence and adherence to the treatment were evaluated. A linear regression model estimated future incidence and economic impact.</p><p><strong>Results: </strong>Among 17 patients, persistence was 58.82%, adherence (>80%) 100%. Incidence rose from 15.2 to 35.73 cases/million (2018-2025). The 5-year cost per patient exceeded € 815,000. Based on the ATTR-ACT trial NNT (7.46), 2.3 deaths may be prevented, though this benefit may be overestimated.</p><p><strong>Discussion: </strong>The rising incidence was not followed by a price revision. Use in older, frail patients and the absence of dynamic pricing agreements raise questions about cost-effectiveness and equitable access.</p>","PeriodicalId":20887,"journal":{"name":"Recenti progressi in medicina","volume":"116 12","pages":"723-729"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145757327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sandro Libianchi, Assunta Giordano, Giuseppe Scuderi, Emanuela Falconi, Ornella Vagnozzi, Anna Luisa Giustiniani, Sandra Milani, Francesca Benedetta Felici, Davide Marino
Health status and nutrition are fundamental determinants of overall well-being among incarcerated populations, who constitute a particularly vulnerable group. The prison environment functions as a microcosm where the rights to health and adequate food must be safeguarded without compromise, given that detainees rely entirely on institutional provisions for their care and nourishment. The cultural specificity of immigrant inmates introduces particular needs, including adherence to dietary requirements during Ramadan for individuals of Islamic faith. This raises significant health and nutritional considerations. Prolonged fasting can pose serious health risks, especially for individuals with underlying conditions such as diabetes mellitus, requiring the use of long-acting pharmacological formulations to ensure therapeutic continuity. Furthermore, the adequacy of food - considering its type, timing of administration, and ritual aspects - represents a central component of the rights to health and cultural diversity, as food carries symbolic meanings beyond mere sustenance. The State, responsible for safeguarding the rights and well-being of detainees, must ensure that nutritional provisions are both nutritionally appropriate and culturally respectful. Food is not only a primary necessity but also an element of identity and psychological well-being: inadequate or culturally insensitive meals can negatively affect psycho-physical health, potentially contributing to self-harm and, in severe cases, suicide, which is unfortunately on the rise within Italian prisons. Implementing a more attentive and inclusive food system can therefore improve detainees' health outcomes and promote greater emotional and social stability within correctional facilities.
{"title":"[Right to food and health in prisons: managing Ramadan for incarcerated individuals of Islamic faith].","authors":"Sandro Libianchi, Assunta Giordano, Giuseppe Scuderi, Emanuela Falconi, Ornella Vagnozzi, Anna Luisa Giustiniani, Sandra Milani, Francesca Benedetta Felici, Davide Marino","doi":"10.1701/4619.46278","DOIUrl":"10.1701/4619.46278","url":null,"abstract":"<p><p>Health status and nutrition are fundamental determinants of overall well-being among incarcerated populations, who constitute a particularly vulnerable group. The prison environment functions as a microcosm where the rights to health and adequate food must be safeguarded without compromise, given that detainees rely entirely on institutional provisions for their care and nourishment. The cultural specificity of immigrant inmates introduces particular needs, including adherence to dietary requirements during Ramadan for individuals of Islamic faith. This raises significant health and nutritional considerations. Prolonged fasting can pose serious health risks, especially for individuals with underlying conditions such as diabetes mellitus, requiring the use of long-acting pharmacological formulations to ensure therapeutic continuity. Furthermore, the adequacy of food - considering its type, timing of administration, and ritual aspects - represents a central component of the rights to health and cultural diversity, as food carries symbolic meanings beyond mere sustenance. The State, responsible for safeguarding the rights and well-being of detainees, must ensure that nutritional provisions are both nutritionally appropriate and culturally respectful. Food is not only a primary necessity but also an element of identity and psychological well-being: inadequate or culturally insensitive meals can negatively affect psycho-physical health, potentially contributing to self-harm and, in severe cases, suicide, which is unfortunately on the rise within Italian prisons. Implementing a more attentive and inclusive food system can therefore improve detainees' health outcomes and promote greater emotional and social stability within correctional facilities.</p>","PeriodicalId":20887,"journal":{"name":"Recenti progressi in medicina","volume":"116 12","pages":"707-710"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145757317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}