Clinical oncology最新文献

{"title":"Comparative Outcomes and Toxicity in Patients With Esophageal Cancer After Trimodality Therapy With Step-and-Shoot Intensity-Modulated Radiation Therapy Versus Volumetric Modulated Arc Therapy: The MD Anderson Experience.","authors":"C O Abana, P P Carriere, P J Damen, P S N van Rossum, A K Yoder, P L Bravo, X Wei, J M Pollard-Larkin, P L Nitsch, M B Murphy, W L Hofstetter, Z Liao, S H Lin","doi":"10.1016/j.clon.2024.103668","DOIUrl":"https://doi.org/10.1016/j.clon.2024.103668","url":null,"abstract":"<p><strong>Aims: </strong>To evaluate outcomes and toxicity after intensity-modulated radiation therapy given as step-and-shoot (SS) or volumetric modulated arc therapy (VMAT) for patients with locally advanced esophageal cancer treated with trimodality therapy (i.e. neoadjuvant concurrent chemoradiation therapy followed by surgery).</p><p><strong>Materials and methods: </strong>Patients consecutively treated with trimodality therapy including IMRT in 2001-2022 (n = 449) were retrospectively reviewed, and 106 pairs of propensity-matched SS and VMAT patients were identified. Survival, recurrence, surgery-related prognostic factors, and chemoradiation-related toxicities were evaluated between groups.</p><p><strong>Results: </strong>Baseline characteristics were balanced between both groups except for body mass index, history of other cancer, clinical disease stage, and use of induction chemotherapy. Median follow-up time was 40 months. Relative to SS, VMAT led to higher 3-year overall survival (OS; P = 0.028, hazard ratio [HR] 0.645, 95% confidence interval [CI] 0.436-0.954) but not progression-free, locoregional recurrence-free, or distant metastasis-free survival. No predictor of excellent OS by SS versus VMAT was identified in multivariable analyses. However, VMAT was associated with reduced odds of postoperative cardiac complications (P < 0.001, odds ratio [OR] 0.296, 95% CI 0.148-0.591), pulmonary complications (P = 0.048, OR 0.539, 95% CI 0.292-0.994), pathologic partial response or worse (≥10% viable cells; P = 0.003, OR 0.418, 95% CI 0.235-0.743), and positive/close margins (P = 0.023, OR 0.346, 95% CI 0.138-0.867) relative to SS. VMAT was also associated with reduced rates of chemoradiation therapy-related weight loss (33.0% versus 79.2%, P < 0.001), fatigue (40.6% versus 68.9%, P < 0.001), nausea (31.1% versus 58.5%, P < 0.001) and cardiac toxicity (0% versus 6.6%, P = 0.007) than SS.</p><p><strong>Conclusion: </strong>Based on this single institution, retrospective study with a 40-month median follow-up, VMAT utilization in trimodality treatment for locally advanced esophageal cancer appears to be associated with improved OS and rates of concurrent chemoradiation therapy-related toxicity and reduced initial 12-month postoperative complications relative to SS IMRT. Multi-institutional prospective trials addressing the limitations of this study and with longer follow-ups are warranted to validate these findings.</p>","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"38 ","pages":"103668"},"PeriodicalIF":3.2,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reirradiation in Paediatric Tumours of the Central Nervous System: Outcome and Side Effects After Implementing National Guidelines","authors":"A. Asklid ,&nbsp;M.P. Nilsson ,&nbsp;J. Engellau ,&nbsp;I. Kristensen ,&nbsp;M. Blomstrand ,&nbsp;C. Fröjd ,&nbsp;M. Agrup ,&nbsp;A. Flejmer ,&nbsp;U. Martinsson ,&nbsp;A.-M. Svärd ,&nbsp;E. Almhagen ,&nbsp;A. Embring","doi":"10.1016/j.clon.2024.103667","DOIUrl":"10.1016/j.clon.2024.103667","url":null,"abstract":"<div><h3>Aims</h3><div>Reirradiation is becoming more frequently used in paediatric tumours of the central nervous system (CNS). To fill the void of clinical guidelines, the Swedish Working Group of Paediatric Radiotherapy compiled consensus guidelines on reirradiation in 2019. The aim of this study was to evaluate the outcome of children reirradiated for CNS tumours since implementing the guidelines.</div></div><div><h3>Material and methods</h3><div>All children in Sweden who were reirradiated for CNS tumours between 2019 and 2023 were retrospectively analysed. Data were collected on patient and treatment characteristics, outcome, and severe side effects. Radiation treatment plans were reviewed, and cumulative doses to organs at risk at reirradiation were extracted following rigid registration.</div></div><div><h3>Results</h3><div>Thirty-one patients (male 55%, female 45%) were included, and the median age at start of reirradiation was 10.2 years. The median time between primary irradiation and reirradiation was 19 months (range 2–141). The most common treatment intent at reirradiation was palliative (68%), followed by curative (32%). With a median follow-up of 8.5 months (range 0–49), the median overall survival from the end of reirradiation was 11.4 months. In the 8 patients where the treatment goal at reirradiation was symptom relief, 6 patients (75%) had relief of symptoms. The median cumulative near maximum doses (D2%) to the brain, brainstem, and chiasm/optic nerves were 71 Gy_EQD2 (range 44–102), 72 Gy_EQD2 (range 0–94), and 40 Gy_EQD2 (range 0–76), respectively. Following reirradiation, only 2 patients had grade ≥3 side effects. One with transient neurological deficit and one with rapid onset of blindness that persisted.</div></div><div><h3>Conclusion</h3><div>The implementation of national guidelines has harmonised the way paediatric patients are reirradiated for CNS tumours in Sweden. A structured follow-up shows that severe side effects are rare despite high cumulative doses to organs at risk, and that reirradiation can offer relief of symptoms and/or local control for selected patients.</div></div>","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"37 ","pages":"Article 103667"},"PeriodicalIF":3.2,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Switching to a Fixed-dose Combined Pertuzumab and Trastuzumab With Recombinant Human Hyaluronidase Subcutaneous Injection to Treat Human Epidermal Growth Factor Receptor 2-positive Breast Cancer in Real-world UK Clinical Practice","authors":"S. Harding,&nbsp;A. Borley","doi":"10.1016/j.clon.2024.103671","DOIUrl":"10.1016/j.clon.2024.103671","url":null,"abstract":"<div><div>Current standard of care for human epidermal growth factor receptor 2 (HER2)–positive breast cancer is first-line treatment with chemotherapy in combination with the HER2-targeting monoclonal antibodies, trastuzumab and pertuzumab. While this treatment approach is associated with improved clinical outcomes, there is a treatment burden associated with the invasive and time-consuming nature of separate intravenous (IV) administration of pertuzumab and trastuzumab. In 2020, a novel subcutaneous (SC) formulation of pertuzumab plus trastuzumab with recombinant human hyaluronidase, available as a fixed-dose combination vial that can be administered in 5–8 minutes, was approved for use by the US Food and Drug Administration and the European Medicines Agency.</div></div><div><h3>Aim</h3><div>A UK cancer centre set out to switch all patients currently receiving IV infusion of pertuzumab and trastuzumab over to the combined SC injection in a safe and timely manner and to initiate all future patients on the combined SC injection.</div></div><div><h3>Materials and methods</h3><div>Organisational governance approval was obtained before a novel project model approach was used to implement the treatment switch which incorporated aspects such as education and multidisciplinary team collaboration.</div></div><div><h3>Results</h3><div>Of the 97 eligible patients, 99% were switched to the combined SC injection safely and effectively over a 4-week period. Between 1st April 2021 and 30th September 2022, 3062 hours of pharmacy aseptic preparation time and 6764 hours of day unit chair time were saved. The number of aseptic unit operation days above the maximum capacity was reduced post-switch.</div></div><div><h3>Conclusion</h3><div>This initiative demonstrated the ability to rapidly and effectively transition &gt;95% of eligible breast cancer patients from separate IV trastuzumab and pertuzumab to a fixed combined SC formulation. Patient benefits included shorter administration appointments and a less invasive form of treatment, whereas healthcare system benefits included substantial savings in aseptic preparation time and chair time, and a meaningful increase in clinic capacity. The reported treatment-switch process provides a model that can be adopted by other centres wishing to implement similar treatment switches.</div></div>","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"37 ","pages":"Article 103671"},"PeriodicalIF":3.2,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correspondence to the Editor: Assessing a Suitable Radiotherapy Utilisation Benchmark for Older Patients With Head and Neck Cancer","authors":"R. Dineshkumar","doi":"10.1016/j.clon.2024.103666","DOIUrl":"10.1016/j.clon.2024.103666","url":null,"abstract":"","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"37 ","pages":"Article 103666"},"PeriodicalIF":3.2,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Evolving Role of Genomics in Colorectal Cancer","authors":"A.M. Berner ,&nbsp;N. Murugaesu","doi":"10.1016/j.clon.2024.10.033","DOIUrl":"10.1016/j.clon.2024.10.033","url":null,"abstract":"<div><div>Approximately 75% of colorectal cancers (CRCs) harbour an identifiable driver mutation, 5% of which are heritable. These drivers have recognised implications for prognosis and therapy selection. In addition, potential germline mutations require investigations to inform testing of relatives, as well as surveillance for other malignancies. With increasing numbers of targeted drugs being approved, judicious testing is required to ensure sufficient tumour sample is available for testing and at the right point in the cancer pathway. Liquid biopsy with circulating tumour DNA (ctDNA) in the blood presents an exciting adjunct to tumour tissue testing for molecular drivers, as well as escalation and de-escalation of therapy. Here, we review the most frequent molecular alterations in CRC, how genomic testing should be integrated into the treatment pathway for CRC, and sources of further education.</div></div>","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"37 ","pages":"Article 103661"},"PeriodicalIF":3.2,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Impact of Somatic Genomic Testing on Breast Cancer Care","authors":"T. Khalid ,&nbsp;R.I. Cutress ,&nbsp;M. Remer ,&nbsp;E.R. Copson","doi":"10.1016/j.clon.2024.10.037","DOIUrl":"10.1016/j.clon.2024.10.037","url":null,"abstract":"<div><div>Developments in our understanding of the molecular biology of breast cancer have had a direct impact on the investigations needed to provide optimal breast cancer care. Somatic genomic tests are now used routinely to inform decisions regarding adjuvant chemotherapy use in selected early breast cancer patients, and to identify patients with advanced disease who can potentially benefit from novel targeted agents.</div><div>In this overview, we describe the somatic genomic tests currently available within the National Health Service (NHS) for early and advanced breast cancer patients. We review the underlying biology and the evidence base for clinical utility of these tests in routine clinical practice. In addition, we identify the somatic genomic biomarkers currently in use in breast cancer clinical trials that are most likely to influence future breast cancer management. We also consider the challenges associated with tissue-based genomic testing in advanced breast cancer and the role of circulating tumour deoxyribonucleic acid (ctDNA) testing.</div></div>","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"37 ","pages":"Article 103665"},"PeriodicalIF":3.2,"publicationDate":"2024-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Experiences of Using Wearable Health Monitors During Cancer Treatment: A Qualitative Study","authors":"S. Collinson ,&nbsp;S. Ingram-Walpole ,&nbsp;C. Jackson ,&nbsp;A. Soliman ,&nbsp;A.K.C. Chan ,&nbsp;E. Tholouli ,&nbsp;H. Balata ,&nbsp;M. Merchant ,&nbsp;K.J. Kirkby ,&nbsp;S. Sweeney ,&nbsp;F. Blackhall ,&nbsp;T. Bashall ,&nbsp;E. Searle ,&nbsp;S. Pan ,&nbsp;M. Braun ,&nbsp;G.B. Kitchen ,&nbsp;J.A. Moore ,&nbsp;Z. Merchant ,&nbsp;A.J. Wilson","doi":"10.1016/j.clon.2024.10.036","DOIUrl":"10.1016/j.clon.2024.10.036","url":null,"abstract":"<div><h3>Introduction</h3><div>Wearable health monitors (WHM) offer minimally invasive, ambulatory monitoring of physiological parameters and activity. WHMs are being used increasingly in healthcare but adoption for patients undergoing cancer treatment is limited in part due to a lack of understanding of patient intentions as they receive treatment. The aim of this study explores the patient experience of using WHMs during their cancer pathway, including barriers and enablers of WHM use.</div></div><div><h3>Methods</h3><div>A phenomenological qualitative approach was used with single semi-structured interviews conducted in focus groups with individuals enrolled in the EMBRaCE-GM study, where WHMs were worn for up to six months prior to, during and after treatment of either colorectal, lung, or head and neck cancer, or leukaemia/lymphoma.</div></div><div><h3>Results</h3><div>We identified three major themes: perceived patient benefits, barriers to the adoption of WHMs and the importance of treatment partnerships between patients and healthcare professionals. WHMs promoted positive behaviour change, prioritisation of own health, and represented a form of ‘digital advocacy’. Potential barriers were aesthetic, experiential and technological. WHM introduction was time-sensitive, with patients finding their use acceptable at different stages in their cancer pathway. Patients desired reciprocal interaction with WHMs and were less concerned with data accuracy.</div></div><div><h3>Discussion</h3><div>This study identifies factors influencing patient decisions to use WHMs as part of cancer treatment. Novel findings include the optimal time to start wearing WHMs and the validity of measurements perceived as less of a concern for patients (in contrast to clinicians) who use wearable data with their own experiences as part of a sense-making exercise. Future work should focus on balancing patient and clinician expectations to provide guidance on the feasibility of WHM in routine clinical practice.</div></div>","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"37 ","pages":"Article 103664"},"PeriodicalIF":3.2,"publicationDate":"2024-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142646637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immune-related and Common Adverse Events With Programmed Cell Death 1/Programmed Cell Death Ligand 1 inhibitors combined with other Anticancer Therapy for Solid Tumors: A Systematic Review and Meta-analysis","authors":"T. Inoue ,&nbsp;M. Narukawa","doi":"10.1016/j.clon.2024.10.034","DOIUrl":"10.1016/j.clon.2024.10.034","url":null,"abstract":"<div><h3>Aims</h3><div>The combination of programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors and anticancer therapies has been in the spotlight in recent years. However, the risks associated with these combination therapies are not fully elucidated. The primary objective of this study was to evaluate the relative risk of organ-specific immune-related adverse events (irAEs) and common adverse events (AEs) in patients treated with PD-1/PD-L1 inhibitor–based combination therapies compared to those treated with PD-1/PD-L1 inhibitor monotherapy for solid tumors.</div></div><div><h3>Materials and methods</h3><div>An electronic database search was performed using ClinicalTrials.gov, Medline, and American Society of Clinical Oncology (ASCO)/European Society for Medical Oncology (ESMO) annual meeting libraries. We included randomized controlled trials designed to assess the safety of combination therapies using PD-1/PD-L1 inhibitors and other anticancer drugs. All the selected clinical studies included solid tumors and provided information on the incidence of nonserious and serious AEs. The quality of evidence was assessed using the Cochrane risk-of-bias tool. A meta-analysis was performed using random-effect models to pool the results.</div></div><div><h3>Results</h3><div>The primary analysis included 16 relevant clinical studies comprising 4232 patients, of whom 2071 and 2161 patients received PD-1/PD-L1 inhibitor–-based combination therapy and PD-1/PD-L1 inhibitor monotherapy, respectively. Serious organ-specific irAEs were infrequent, even when PD-1/PD-L1 inhibitors were combined with other anticancer drugs. The incidence of serious colitis was significantly higher in the combination therapy group than in the monotherapy group. Among the common AEs associated with PD-1/PD-L1 inhibitors, the incidence of serious pyrexia/fever, nonserious pyrexia/fever, fatigue, nausea, decreased appetite, vomiting, diarrhea, dyspnea, and rash significantly increased in the combination therapy group. In the subgroup analysis based on the modes of action of concomitant anticancer drugs, the combination of PD-1/PD-L1 inhibitors and DNA synthesis inhibitors significantly increased the risk of serious colitis compared to PD-1/PD-L1 inhibitor monotherapy.</div></div><div><h3>Conclusion</h3><div>Organ-specific irAEs occur infrequently when combinations of PD-1/PD-L1 inhibitors and other anticancer drugs are used. However, the risk of serious colitis and certain AEs is higher than that associated with PD-1/PD-L1 inhibitor monotherapy. Vigilant monitoring of AEs and implementation of appropriate clinical management strategies guided by the mode of action of the combination drugs are essential.</div></div>","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"37 ","pages":"Article 103662"},"PeriodicalIF":3.2,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Outcomes and Relevance of Composite V12 Gy in Patients With Four or More Brain Metastases Treated With Single Fraction Stereotactic Radiosurgery","authors":"S. Parikh ,&nbsp;U. Alluri ,&nbsp;G. Heyes ,&nbsp;F. Evison ,&nbsp;S. Meade ,&nbsp;H. Benghiat ,&nbsp;A. Hartley ,&nbsp;M. Hickman ,&nbsp;V. Sawlani ,&nbsp;S. Chavda ,&nbsp;V. Wykes ,&nbsp;P. Sanghera","doi":"10.1016/j.clon.2024.10.035","DOIUrl":"10.1016/j.clon.2024.10.035","url":null,"abstract":"<div><h3><em>Aims</em></h3><div>Tissue V12Gy (total brain volume receiving 12Gy including target) can predict for late toxicity in single target benign disease treated with stereotactic radiosurgery (SRS). The value of this metric remains uncertain for multiple brain metastases. This retrospective cohort study reports the outcomes and evaluates the predictors of toxicity in patients with four or more brain metastases treated with single-fraction SRS.</div></div><div><h3><em>Materials and methods</em></h3><div>Two hundred twenty-six patients with 2160 metastases treated from 2014-21 were retrospectively studied. Symptomatic late toxicity (new/progressive neurological symptoms ≥3 months post SRS) with magnetic resonance imaging (MRI) changes suggestive of treatment effect were analysed. Kaplan–Meier and competing risk analysis was used to assess survival and toxicity respectively.</div></div><div><h3><em>Results</em></h3><div>median number of metastases/patient was 6 (range: 4-41) and median composite tissue V12Gy (inclusive of planning target volume (PTV)) was 11.3 cc (IQR: 6.1 cc–17.1 cc). Sixteen out of the 226 patients developed symptomatic late radiation adverse event (R-AE), and the cumulative incidence was 4.9% at 1 year and 6.9% at 2 years. The total target volume was significantly predictive of the risk of late R-AE. Volume of the largest lesion, V12Gy and V15Gy did not predict for late R-AE, but plotted graphs showed suggestions of linear relationships between dosimetric parameters and late R-AE.</div></div><div><h3><em>Conclusion</em></h3><div>Within the limitations of this study, the cumulative incidence of symptomatic toxicity remains acceptable despite routinely accepting a composite tissue V12Gy in excess of 10 cc to treat multiple brain metastases.</div></div><div><h3><em>Advances in knowledge</em></h3><div>V12Gy has limitations as a plan quality metric in multiple brain metastases treated with SRS. There is insufficient evidence to have a defined target limit as &lt;10 cc.</div></div>","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"37 ","pages":"Article 103663"},"PeriodicalIF":3.2,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"OSAIRIS: Lessons Learned From the Hospital-Based Implementation and Evaluation of an Open-Source Deep-Learning Model for Radiotherapy Image Segmentation","authors":"A.D. Constantinou ,&nbsp;A. Hoole ,&nbsp;D.C. Wong ,&nbsp;G.S. Sagoo ,&nbsp;J. Alvarez-Valle ,&nbsp;K. Takeda ,&nbsp;T. Griffiths ,&nbsp;A. Edwards ,&nbsp;A. Robinson ,&nbsp;L. Stubbington ,&nbsp;N. Bolger ,&nbsp;Y. Rimmer ,&nbsp;T. Elumalai ,&nbsp;K.T. Jayaprakash ,&nbsp;R. Benson ,&nbsp;I. Gleeson ,&nbsp;R. Sen ,&nbsp;L. Stockton ,&nbsp;T. Wang ,&nbsp;S. Brown ,&nbsp;R. Jena","doi":"10.1016/j.clon.2024.10.032","DOIUrl":"10.1016/j.clon.2024.10.032","url":null,"abstract":"<div><div>Several studies report the benefits and accuracy of using autosegmentation for organ at risk (OAR) outlining in radiotherapy treatment planning. Typically, evaluations focus on accuracy metrics, and other parameters such as perceived utility and safety are routinely ignored. Here, we report our finding from the implementation and clinical evaluation of OSAIRIS, an open-source AI model for radiotherapy image segmentation that was carried out as part of its development into a medical device. The device contours OARs in the head and neck and male pelvis (referred to as the prostate model), and is designed to be used as a time-saving workflow device, alongside a clinician. Unlike standard evaluation processes, which heavily rely on accuracy metrics alone, our evaluation sought to demonstrate the tangible benefits, quantify utility and assess risk within a specific clinical workflow. We evaluated the time-saving benefit this device affords to clinicians, and how this time-saving might be linked to accuracy metrics, as well as the clinicians' assessment of the usability of the OSAIRIS contours in comparison to their colleagues' contours and those from other commercial AI contouring devices. Our safety evaluation focused on whether clinicians can notice and correct any errors should they be included in the output of the device.</div><div>We found that OSAIRIS affords a significant time-saving of 36% (5.4 ± 2.1 minutes) when used for prostate contouring and 67% (30.3 ± 8.7 minutes) for head and neck contouring. Combining editing time data with accuracy metrics, we found the Hausdorff distance best correlated with editing-time, outperforming dice, the industry-standard, with a Spearman correlation coefficient of 0.70, and a Kendall coefficient of 0.52. Our safety and risk-mitigation exercise showed that anchoring bias is present when clinicians edit AI-generated contours, with the effect seemingly more pronounced for some structures over others. Most errors, however, were corrected by clinicians, with 72% of the head and neck errors 81% of the prostate errors removed in the editing step. Notably, our blinded clinician contour rating exercise showed that gold standard clinician contours are not rated more highly than the AI-generated contours.</div><div>We conclude that evaluations of AI in a clinical setting must consider the clinical workflow in which the device will be used, and not rely on accuracy metrics alone, in order to reliably assess the benefits, utility and safety of the device. The effects of human-AI inter-operation must be evaluated to accurately assess the practical usability and potential uptake of the technology, as demonstrated in our blinded clinical utility review. The clinical risks posed by the use of the device must be studied and mitigated as far as possible, and our ‘Mystery Shopping’ experiment provides a template for future such assessments.</div></div>","PeriodicalId":10403,"journal":{"name":"Clinical oncology","volume":"37 ","pages":"Article 103660"},"PeriodicalIF":3.2,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}