Cancer Medicine最新文献

{"title":"Low Testosterone Level and Mortality Risk in Patients With Prostate Cancer: A Post-Randomization Analysis","authors":"Sayeh Fattahi,&nbsp;Ming-Hui Chen,&nbsp;Jing Wu,&nbsp;Alicia C. Smart,&nbsp;Anthony V. D'Amico","doi":"10.1002/cam4.71124","DOIUrl":"https://doi.org/10.1002/cam4.71124","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>A low serum testosterone can prolong the time needed for PSA to exceed normal and prompt a work-up to rule out prostate cancer (PC), delaying diagnosis. We evaluated PC aggressiveness at diagnosis and PC-specific and all-cause mortality (PCSM, ACM)-risk within comorbidity subgroups in patients with low versus normal testosterone.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Between 2005 and 2015, 350 PSA-screened patients with tumor (T) category1c-4N0M0 unfavorable-risk PC were enrolled in a randomized trial and comprised the study cohort. Fine and Gray and Cox multivariable regression analyses were used to evaluate PCSM and ACM risk, respectively, adjusting for age, known PC prognostic factors, randomized treatment arm, and the time-dependent use of salvage androgen deprivation therapy. An interaction term between the Adult Comorbidity Evaluation-27 defined comorbidity and low versus normal testosterone was included in the models to enable an assessment of PCSM and ACM risk within comorbidity subgroups in patients with low versus normal testosterone levels at randomization.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>After a median follow up of 10.20 years, 89 of 350 patients died (25.43%) with 42 of 89 deaths (47.19%) from PC. In patients with no or minimal but not moderate to severe comorbidity, a significant association was observed between low compared to normal testosterone level at randomization and increased PCSM (AHR: 2.70 [95% CI: 1.27, 5.76], <i>p</i> = 0.01) and ACM risk (AHR: 1.90 [95% CI: 1.11, 3.26], <i>p</i> = 0.02).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Unlike PSA, multiparametric MRI (mpMRI) images are not influenced by the serum testosterone level; therefore, evaluating whether PCSM can be reduced by incorporating mpMRI into PC-screening in otherwise healthy men or transgender women with a low serum testosterone level should be considered.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>The statisical code used to derive the results from the interaction model for this post randomization analysis can be found in the Supporting Information.</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71124","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144751518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer","authors":"Nicole M. G. Fleege,&nbsp;Elise A. Miller,&nbsp;Kelley M. Kidwell,&nbsp;Zeb R. Zacharias,&nbsp;Jon Houtman,&nbsp;Kelly Scheu,&nbsp;Kathleen Kemmer,&nbsp;Kevin F. Boehnke,&nbsp;N. Lynn Henry","doi":"10.1002/cam4.71117","DOIUrl":"https://doi.org/10.1002/cam4.71117","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Aromatase inhibitor (AI) therapy reduces breast cancer recurrence risk. However, some patients stop treatment early because of AI-associated musculoskeletal symptoms (AIMSS). AIMSS is due in part to systemic inflammation. Cannabidiol (CBD) has anti-nociceptive and anti-inflammatory properties, making it a potential treatment option for AIMSS.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Women with stage 0–3 hormone receptor-positive breast cancer experiencing AIMSS enrolled in this phase 2 clinical trial. Patients received CBD (Epidiolex), titrated over 4 weeks to 100 mg BID, for a total of 15 weeks. Patient-reported outcomes were collected serially. The primary endpoint was the number of patients with at least a 2-point reduction in worst pain from baseline to 15 weeks. Statistical analysis was completed using paired <i>t</i>-tests and linear mixed models.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 39 eligible patients, 28 completed protocol-directed study treatment. Eleven discontinued treatment due to toxicity (<i>n</i> = 5) or per patient preference (<i>n</i> = 6). Seventeen of 39 patients met the primary endpoint (43.6%, 95% CI [28%, 60%]). Worst pain improved 0.13 per week of treatment (<i>p</i> &lt; 0.001) for all patients; average improvement in worst pain was 1.95 points at the end of 15 weeks. Of the 28 patients who completed the study, average reduction in worst pain was 2.36 points (95% CI [−3.22, −1.49]) between baseline and Week 15.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Treatment with CBD was safe, tolerable, and associated with improvement in joint pain for a subset of patients. Additional studies are needed to further understand the impact of CBD on AIMSS and which patients are most likely to benefit from CBD treatment.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>www.clinicaltrials.gov: NCT04754399</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71117","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144758472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early Cancer Survivorship Distress Trajectories Associated With Socioeconomic Status and Age: Findings From a Multicenter Prospective Study","authors":"Anja Mehnert-Theuerkauf,&nbsp;Ute Goerling,&nbsp;Tanja Zimmermann,&nbsp;Jochen Ernst,&nbsp;Myriel Hermann,&nbsp;Beate Hornemann,&nbsp;Ulrich Keilholz,&nbsp;Florian Lordick,&nbsp;Olaf von dem Knesebeck,&nbsp;David Kissane,&nbsp;Anne-Kathrin Köditz,&nbsp;Franziska Springer","doi":"10.1002/cam4.71076","DOIUrl":"https://doi.org/10.1002/cam4.71076","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Socioeconomic status' (SES) impact on distress during cancer survivorship has been insufficiently studied, although the consequences of low SES can be cumulative and adversely impact a person's ability to access resources required for improved health and quality of life.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Patients and Methods</h3>\u0000 \u0000 <p>We conducted a prospective study involving newly diagnosed patients within 2 months of diagnosis (t1), and at 6-, 12-, and 18-month follow-up (t2–t4) using the Distress Thermometer (DT). Generalized Linear Mixed Models (GLMM) were used to test for changes in distress over time, with fixed effects of time, SES, and age.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Out of 1702 eligible patients, 965 completed the baseline DT (53% men, 60.5 years); 779, 681, and 626 participated at follow-ups. Out of 554 completers, 9% were chronically distressed, while 40.8% were never distressed. Distress decreased in 21.3%, increased in 11.0%, and 17.8% fluctuated over time. Low-SES patients consistently had the highest rates of distress. Distress scores and the frequency of distress (DT ≥ 5) decreased over time in all SES and age groups: For DT mean scores, GLMM revealed a significant effect of time (<i>χ</i>²(3) = 72.0, <i>p</i> &lt; 0.001), but not of SES (<i>χ</i>²(2) = 5.9, <i>p</i> = 0.052). For frequency of distress, there was a main effect of time (<i>χ</i>²(3) = 41.4, <i>p</i> &lt; 0.001) and SES (<i>χ</i>²(2) = 15.5, <i>p</i> &lt; 0.001). Younger patients (&lt; 65 years) consistently experienced more distress than older patients (≥ 65 years). For DT mean scores, GLMM showed an effect of time (<i>χ</i>²(3) = 72.1, <i>p</i> &lt; 0.001) and age (<i>χ</i>²(1) = 66.2, <i>p</i> &lt; 0.001). Similarly, for frequency of distress we found an effect of time (<i>χ</i>²(3) = 41.7, <i>p</i> &lt; 0.001) and age (<i>χ</i>²(1) = 52.8, <i>p</i> &lt; 0.001).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Effective psychosocial interventions require a customized approach to decrease distress in vulnerable groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>This study was registered in the International Clinical Trials Registry (NCT04620564, https://clinicaltrials.gov/)</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71076","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144751517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-Reported Symptoms and Mental Health Event Risks in Adolescents and Young Adults With Cancer","authors":"Sumit Gupta,&nbsp;Qing Li,&nbsp;Paul Nathan,&nbsp;Paul Kurdyak,&nbsp;Nancy Baxter,&nbsp;Rinku Sutradhar,&nbsp;Natalie Coburn","doi":"10.1002/cam4.71096","DOIUrl":"https://doi.org/10.1002/cam4.71096","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Adolescents and young adults (AYA) with cancer are at risk of adverse mental health outcomes during and after treatment. Tools identifying AYA at the highest risk would guide screening and interventions. We determined whether self-reported symptoms following cancer diagnosis were associated with early and late severe mental health events (SMHEs).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Ontario AYA diagnosed with cancer aged 15–29 between 2010 and 2018 were identified and linked to healthcare databases, including one capturing self-reported Edmonton Symptom Assessment System (ESAS) scores at cancer-related visits. Scores for depression, anxiety, and poor well-being were categorized as not measured, mild, moderate, or severe. SMHEs were defined as mental health-related Emergency Department visits or hospitalizations. We determined the association of ESAS scores with subsequent early SMHEs (&lt; 5 years). Among 5-year survivors, we determined the association between the maximum ESAS score within 1 year of cancer diagnosis and late SMHEs (occurring &gt; 5 years from cancer diagnosis).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among 5435 AYA, symptom severity was associated with subsequent SMHE risk. AYA who reported severe versus mild anxiety were at &gt; 3-fold higher risk of subsequent early SMHEs [adjusted hazard ratio (aHR) 3.6, 95th confidence interval (CI) 1.9–6.7; <i>p</i> &lt; 0.001]. Among 3518 (64.7%) 5-year survivors, symptom severity predicted late SMHE. At 5 years postcancer diagnosis, those who reported severe versus mild depression within 1 year following cancer diagnosis were at 3-fold elevated risk (aHR 3.0, 95 CI 1.8–4.9; <i>p</i> &lt; 0.0001).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Systematic symptom screening early postcancer diagnosis identifies AYA at high risk of both early and late SMHEs who may benefit from targeted screening and interventions.</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71096","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144751609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Voices of Survivorship: The Unmet Needs of Italian Cancer Survivors. A Qualitative Study","authors":"Angela Contri,&nbsp;Stefania Costi,&nbsp;Monica Guberti,&nbsp;Silvia Soncini,&nbsp;Stefano Botti,&nbsp;Andrea Frasoldati,&nbsp;Martina Torreggiani,&nbsp;Luca Ghirotto","doi":"10.1002/cam4.71121","DOIUrl":"https://doi.org/10.1002/cam4.71121","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The increasing number of cancer survivors (CSs) globally highlights the critical need for healthcare systems to address their unmet needs. These needs span physical, psychosocial, spiritual, informational, and practical dimensions and, if unaddressed, can impact quality of life and healthcare satisfaction.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>This study aimed to identify and understand the unmet needs of CSs in Italy to guide the development of patient-centered survivorship care services.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A cross-sectional qualitative study was conducted between April 2023 and January 2024 at the Comprehensive Cancer Centre of Reggio Emilia, Italy. Data were collected through focus groups and individual interviews with 35 CSs and seven caregivers selected via convenience sampling. Eligibility criteria included non-cutaneous CSs with a 5-year survival rate of ≥ 65% who had completed active treatment and were in follow-up care. Data were analyzed using the Framework Method.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Four key themes emerged: (1) Dignity and Respect: Emphasis on the importance of treating CSs with dignity and respect within healthcare settings; (2) Desire for Normality: Highlighting CSs' strong desire to regain a sense of normalcy post-treatment; (3) Pursuit of Control Over One's Life: CSs' need to maintain control, particularly regarding information needs and treatment management; (4) Existential Vulnerability: The vulnerability and fragility felt by CSs, underscoring their need for emotional support and reassurance.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Unmet needs remain a significant challenge for CSs, necessitating the implementation of tailored, patient-centered care interventions. Addressing these needs can enhance quality of life, satisfaction, and outcomes for CSs worldwide.</p>\u0000 \u0000 <p><b>Trial Registration:</b> ClinicalTrials.gov Identifier: NCT06236373</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71121","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144751444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcome and Challenges in the Treatment of Pediatric Hodgkin Lymphoma With Euronet-PHL-C1 Protocol: Experience From a Resource-Limited Country","authors":"Elie Bechara,&nbsp;Toufic Eid,&nbsp;Arwa El-Dhuwaib,&nbsp;Hani Tamim,&nbsp;Dolly Noun,&nbsp;Raphah Borghol,&nbsp;Zaher Chakhachiro,&nbsp;Miguel R. Abboud,&nbsp;Samar Muwakkit","doi":"10.1002/cam4.71095","DOIUrl":"https://doi.org/10.1002/cam4.71095","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The Euronet-PHL-C1 protocol has yielded excellent results for pediatric Hodgkin Lymphoma (HL), by omitting radiotherapy (RT) in early responders, thereby decreasing long-term toxicities. However, its application in resource-limited countries remains challenging. This study aims to evaluate patient outcomes using this protocol and the feasibility of omitting RT for early responders.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We conducted a retrospective analysis of 87 previously untreated pediatric HL patients at our Center from 2012 to 2022, following the Euronet-PHL-C1 protocol. RT was omitted for patients with an early rapid response at interim evaluation. Collected data were analyzed to determine survival outcomes and predictors of relapse.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The mean age of the patients was 13 years, with 51.7% female. B-symptoms were present in 59.8% of the patients, while 37.9% had bulky disease, 57.1% had elevated erythrocyte sedimentation rate, and 42.5% had stage IV disease. RT was omitted for early rapid responders in 22.9% of the patients. The therapy was generally well tolerated, with only 36 episodes of febrile neutropenia and no treatment-related mortality. The 5-year progression-free survival and overall survival of the entire cohort were 89.3% and 97.6%, respectively. Nine patients relapsed, and two patients died. No independent predictors of event-free survival were identified.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The implementation of Euronet-HL protocol in our center provided excellent outcomes and a safety profile despite a few challenges. While RT can be removed in low-stage, rapid-responder patients, caution persists in resource-limited settings for those with advanced stage or bulky disease, highlighting the need for prospective trials to guide safe RT omission.</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71095","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144740280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient, Physician, and Assessor Blinding in Phase III Randomized Trials in Oncology: A Meta-Epidemiological Analysis","authors":"Gabrielle Brown,&nbsp;Pavlos Msaouel,&nbsp;Avital M. Miller,&nbsp;Ramez Kouzy,&nbsp;Timothy A. Lin,&nbsp;Joseph Abi Jaoude,&nbsp;Ethan B. Ludmir,&nbsp;Alexander D. Sherry","doi":"10.1002/cam4.71097","DOIUrl":"https://doi.org/10.1002/cam4.71097","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Blinding mitigates bias in randomized trials and may be especially crucial for surrogate endpoints, such as progression-free survival (PFS). Here, we characterize utilization of and factors associated with blinding in Phase III oncology trials with PFS primary endpoints.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Two-arm, superiority-design trials investigating systemic therapy were identified in May 2024 from ClinicalTrials.gov with no date limitation. Trials were required to have a PFS primary endpoint. The study outcomes were the presence of double-blind designs and blinded independent central review (BICR) for the primary endpoint. Ninety-five percent credible intervals for binary outcomes were estimated from beta distributions, and multivariable logistic regressions explored associations with trial-level features.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>After screening, 237 trials were included, enrolling 127,518 patients. A double-blind design was used in 105 trials (44%, 95% CrI 38%–51%). BICR was used in 111 trials (47%, 95% CrI 41%–53%), including 39 double-blind trials (16%, 95% CrI 12%–22%). Trials with BICR had higher odds of meeting the primary endpoint (OR 1.84; 95% CI 1.06–3.18; <i>p</i> = 0.03). The PFS assessor identity (central vs. local) or blinding status was not reported in 50 trials (26%, 95% CrI 16%–27%). Trials that met prespecified significance criteria for PFS were more likely to report whether PFS assessors were blinded/unblinded and central/local (OR, 3.05; 95% Cl: 1.60–5.81; <i>p</i> = 0.0007).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Despite the importance of double blinding in combination with BICR for reducing bias, only a few trials blinded physicians, patients, and primary endpoint assessors. This meta-epidemiological study illuminates the prevalence of potential assessment biases affecting PFS in Phase III oncology and secondarily emphasizes the need for improved methodology reporting.</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71097","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144751430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Economic Benefits of Sponsored Clinical Trials in Cancer for the Colombian Healthcare System: A Real-World Evidence Approach","authors":"Leonardo Rojas,&nbsp;Natalia Sánchez,&nbsp;Jorge Ceballos,&nbsp;Antonio Robles,&nbsp;Carlos A. Badillo,&nbsp;Virginia Abello,&nbsp;Carlos Bonilla,&nbsp;William A. Mantilla,&nbsp;Jairo Zuluaga,&nbsp;Gilberto Lopes,&nbsp;Oscar Arrieta,&nbsp;Andrés F. Cardona","doi":"10.1002/cam4.71099","DOIUrl":"https://doi.org/10.1002/cam4.71099","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Purpose</h3>\u0000 \u0000 <p>Clinical trials (CTs) are essential for the research and development of new cancer treatment technologies. Evaluating their economic impact and the potential cost savings for healthcare systems in low- and middle-income countries is crucial for informing healthcare policy and decision-making. This study estimates the economic benefits to the Colombian healthcare system from the inclusion of hematology and oncology patients in sponsored CTs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This study utilized real-world data from the Luis Carlos Sarmiento Angulo Cancer Treatment and Research Centre (CTIC), a comprehensive cancer center in Bogotá, Colombia. Tumor types were selected based on their prevalence and economic burden. A Budget Impact Analysis was conducted following the methodology of the local Health Technology Assessment Agency, using data from five prioritized tumor types. Clinical data and associated costs were extracted from the institutional data lake, and cost-generating events for each disease were validated by CTIC clinical experts. The estimated eligible population for phase 3 CTs was derived from literature reviews and expert opinions from CTIC clinicians. Prevalent and incident population data were obtained from the Colombian High-Cost Account.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 7703 potential patients were eligible for inclusion in the CTs, with an associated healthcare cost of USD 244,151,552 by 2023 (1 USD = 4325 COP). If at least 20% of these patients participated in CTs by 2023, the projected annual cost savings would be USD 48,830,310. Among the evaluated cancers, advanced prostate cancer incurred the highest costs due to its high prevalence and potential for inclusion in CTs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Over 5 years, potential cost savings could range from USD 244 million (assuming a 20% enrolment rate) to 1.22 billion (with 100% enrolment), alleviating financial pressures on the Colombian healthcare system. These savings would contribute to the system's long-term financial sustainability while ensuring timely access to innovative cancer treatments.</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71099","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144740279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of COVID-19 on Hematologic Cancer Patients: Insights From the Late Pandemic Phase","authors":"Daniele Caracciolo,&nbsp;Giuseppe D'Aquino,&nbsp;Caterina Froio,&nbsp;Caterina Romeo,&nbsp;Vincenzo Bosco,&nbsp;Giulia Pensabene,&nbsp;Ludovica Tedesco,&nbsp;Pierosandro Tagliaferri,&nbsp;Pierfrancesco Tassone","doi":"10.1002/cam4.71112","DOIUrl":"https://doi.org/10.1002/cam4.71112","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The COVID-19 pandemic significantly increased mortality risks for individuals with hematological malignancies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Patients and Methods</h3>\u0000 \u0000 <p>We conducted a single-center observational study, focusing on the late pandemic phase of the infection (2022–2023), to identify risk factors associated with COVID-19 outcomes in vaccinated patients with hematological malignancies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Eighty-five COVID-19 cases were recorded among patients with hematological malignancies, primarily Multiple Myeloma (MM) (38.8%), chronic lymphocytic leukemia (CLL) (10.6%) and Non-Hodgkin Lymphoma (NHL) (35.3%). Despite a high COVID-19 vaccination rate (97.6%), severe/critical illness occurred in 23.5% of patients. The overall COVID-19-related mortality rate was 22.4%, with a 30-day mortality rate of 11.8%. Although mortality rates significantly decreased over the observation time (27.7% vs. 16.7%), this trend was not confirmed in critical infection carriers.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Our data confirm that, despite a reduction in critical infections and overall mortality rates over time, patients with hematological malignancies remain at high risk during the endemic phase of SARS-CoV-2 infection.</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71112","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144740376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ASAP1 Promotes Epithelial to Mesenchymal Transition by Activating the TGFβ Pathway in Papillary Thyroid Cancer","authors":"Shiji Song,&nbsp;Zixing Leng,&nbsp;Xinxin Zhao,&nbsp;Ziping Liu,&nbsp;Yongshuai Li,&nbsp;Wenjing Zhang,&nbsp;Junming Yue,&nbsp;Yuxia Fan","doi":"10.1002/cam4.71075","DOIUrl":"https://doi.org/10.1002/cam4.71075","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Papillary thyroid cancer (PTC) is the most common type of thyroid malignancy. While the prognosis of PTC is generally favorable, some cases exhibit aggressive behavior, leading to metastasis and recurrence. ASAP1 (ArfGAP with SH3, ankyrin repeats, and PH domain 1), an ADP-ribosylation factor GTPase-activating protein, has been implicated in tumor metastasis. However, its role in PTC remains unclear.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>ASAP1 expression in PTC was evaluated using TCGA and GEO databases. Studies in PTC cell lines (MDA-T32 and MDA-T85) included lentiviral-mediated knockdown and overexpression of ASAP1 to assess effects on epithelial–mesenchymal transition (EMT) marker expression, cell proliferation, and invasive capacity. TGFβ pathway activity was examined by p-SMAD2 Western blotting and luciferase reporter assays. ASAP1-SMAD2/3 interactions were analyzed using co-immunoprecipitation (CO-IP) and immunofluorescence.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>ASAP1 was aberrantly upregulated in PTC. Lentiviral knockdown of ASAP1 in PTC cells suppressed the EMT process. Reduced ASAP1 expression also inhibited cell survival, proliferation, migration, invasion, and the expression of p-SMAD2 in the TGFβ pathway in PTC cells. Conversely, ASAP1 overexpression reversed these effects. Mechanistically, ASAP1 interacts with the SMAD2/3 complex, forming a positive feedback loop with TGFβ signaling that promotes EMT and cell invasiveness in PTC cells, which suggests its potential role in PTC metastasis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>These findings suggest that targeting ASAP1 may offer a novel therapeutic strategy to limit PTC metastasis by suppressing EMT and attenuating the TGFβ pathway.</p>\u0000 </section>\u0000 </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 15","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71075","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144740214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}