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CompreHensive Digital ArchiVe of Cancer Imaging - Radiation Oncology (CHAVI-RO) is a multi-tier WEB-based medical image databank. It supports archiving de-identified radiological and clinical datasets in a relational database. A semantic relational database model is designed to accommodate imaging and treatment data of cancer patients. It aims to provide key datasets to investigate and model the use of radiological imaging data in response to radiation. This domain of research area addresses the modeling and analysis of complete treatment data of oncology patient. A DICOM viewer is integrated for reviewing the uploaded de-identified DICOM dataset. In a prototype system we carried out a pilot study with cancer data of four diseased sites, namely breast, head and neck, brain, and lung cancers. The representative dataset is used to estimate the data size of the patient. A role-based access control module is integrated with the image databank to restrict the user access limit. We also perform different types of load tests to analyze and quantify the performance of the CHAVI databank.
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Neoplasias , Sistemas de Informação em Radiologia , Radiologia , Bases de Dados Factuais , Humanos , Projetos Piloto , SoftwareRESUMO
Management of breast cancer is multidisciplinary requiring critical analysis of emerging evidence especially with its appropriateness to local practice. A high level expert committee meeting was held to arrive at a consensus on controversial practical breast cancer management policies for Indian patients. Indian experts (n=39) from government and private centres who were part of the breast cancer multidisciplinary group, participated in the consensus meeting. A set of controversial yet practical questions were circulated among the experts at least two weeks in advance of the consensus meeting. International experts from the UK (n=6) also participated in the scientific discussions to add further light on the topics. The experts voted on the practical acceptable management policy for India. Consensus was defined as overwhelming (90-100% concurrence in voting), moderate (70-89% concurrence), low (50-70% concurrence) and non-consensus (<50% concurrence). Fifty eight questions based on pragmatic management strategies were framed and circulated to 39 participants. An overwhelming consensus was received in 51 of the 58 questions. The group considered the available evidence with a view for its practical applicability in Indian patients. This consensus document may aid in shaping breast cancer care for the breast oncology practitioners as well as the policymakers in the country.
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Neoplasias da Mama , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/terapia , Consenso , Feminino , Humanos , Índia/epidemiologiaRESUMO
Breast cancer is the most common cancer among women in India, and adjuvant radiotherapy is an integral part of curative treatment in most patients. The recent decades have witnessed several advances in radiation therapy delivery. Several advances in radiation oncology have been identified which include technological advances, change in fractionation used, use of cardiac-sparing radiotherapy as well as efforts to personalize radiotherapy using accelerated partial breast irradiation or avoidance of radiotherapy in certain subpopulations. Indian data are available in most areas which have been summarized. However, increasing emphasis on research in these areas is needed so that effectiveness and safety in our setting can be established. Advances in breast cancer radiotherapy have resulted in improved outcomes. Data published from India suggest that these improved outcomes can be replicated in patients when appropriate treatment protocols are followed.
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Neoplasias da Mama , Radioterapia de Intensidade Modulada , Neoplasias da Mama/radioterapia , Suspensão da Respiração , Feminino , Humanos , Dosagem Radioterapêutica , Radioterapia Adjuvante/efeitos adversos , Radioterapia Adjuvante/métodos , Radioterapia de Intensidade Modulada/efeitos adversos , Radioterapia de Intensidade Modulada/métodosRESUMO
There are various efforts in de-identifying patient's radiation oncology data for their uses in the advancement of research in medicine. Though the task of de-identification needs to be defined in the context of research goals and objectives, existing systems lack the flexibility of modeling data and normalization of names of attributes for accomplishing them. In this work, we describe a de-identification process of radiation and clinical oncology data, which is guided by a data model and a schema of dynamically capturing domain ontology and normalization of terminologies, defined in tune with the research goals in this area. The radiological images are obtained in DICOM format. It consists of diagnostic, radiation therapy (RT) treatment planning, RT verification, and RT response images. During the DICOM de-identification, a few crucial pieces of information are taken about the dataset. The proposed model is generic in organizing information modeling in sync with the de-identification of a patient's clinical information. The treatment and clinical data are provided in the comma-separated values (CSV) format, which follows a predefined data structure. The de-identified data is harmonized throughout the entire process. We have presented four specific case studies on four different types of cancers, namely glioblastoma multiforme, head-neck, breast, and lung. We also present experimental validation on a few patients' data in these four areas. A few aspects are taken care of during de-identification, such as preservation of longitudinal date changes (LDC), incremental de-identification, referential data integrity between the clinical and image data, de-identified data harmonization, and transformation of the data to an underlined database schema.
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Objetivos , Radiologia , Bases de Dados Factuais , Humanos , Modelos TeóricosRESUMO
We propose a de-identification system which runs in a standalone mode. The system takes care of the de-identification of radiation oncology patient's clinical and annotated imaging data including RTSTRUCT, RTPLAN, and RTDOSE. The clinical data consists of diagnosis, stages, outcome, and treatment information of the patient. The imaging data could be the diagnostic, therapy planning, and verification images. Archival of the longitudinal radiation oncology verification images like cone beam CT scans along with the initial imaging and clinical data are preserved in the process. During the de-identification, the system keeps the reference of original data identity in encrypted form. These could be useful for the re-identification if necessary.
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Anonimização de Dados/normas , Registros Eletrônicos de Saúde/organização & administração , Radioterapia (Especialidade)/organização & administração , Tomografia Computadorizada de Feixe Cônico/métodos , Registros Eletrônicos de Saúde/normas , Humanos , Processamento de Imagem Assistida por Computador/métodos , Radioterapia (Especialidade)/normasRESUMO
AIM: To report the prevalence and outcomes of pressure ulcers (PU) seen in a cohort of cancer patients requiring home-based palliative care. MATERIALS AND METHODS: All patients referred for home care were eligible for this prospective observational study, provided they were living within a distance of 35 km from the institute and gave informed consent. During each visit, caregivers were trained and educated for providing nursing care for the patient. Dressing material for PU care was provided to all patients free of cost and care methods were demonstrated. Factors influencing the occurrence and healing of PUs were analyzed using logistic regression. Duration for healing of PU was calculated using the Kaplan Meier method. P < 0.05 are taken as significant. RESULTS: Twenty-one of 108 (19.4%) enrolled patients had PU at the start of homecare services. None of the patients developed new PU during the course of home care. Complete healing of PU was seen in 9 (42.9%) patients. The median duration for healing of PU was found to be 56 days. Median expenditure incurred in patients with PU was Rs. 2323.40 with a median daily expenditure of Rs. 77.56. CONCLUSIONS: The present model of homecare service delivery was found to be effective in the prevention and management of PUs. The high prevalence of PU in this cohort indicates a need for greater awareness for this complication. CLINICAL TRIAL REGISTRY NUMBER: CTRI/2014/03/004477.
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BACKGROUND: This study assessed a palliative radiotherapy regimen using daily radiation over 4 days for three courses in inoperable head and neck cancers, emphasizing oral primary cancers. METHODS: Retrospective data of 116 patients treated with a daily dose of 3.6-3.7 Gy in four fractions over 4 days to a total of three courses, with a 2-week gap after every course, were analyzed for survival outcomes. A subgroup analysis was done for oral cancer. RESULTS: Ninety-nine (85%) completed three courses. Overall subjective response rate was 77%. Median overall survival and progression-free survival were 12 months (95% confidence interval [CI]: 8-20) and 8 months (95% CI: 6-10), with numerically higher overall survival in oral cancer. The treatment was well tolerated, with no on-treatment hospitalization or grade 3-4 toxicities. CONCLUSION: The modified QUAD SHOT regimen is practical for palliation in head and neck cancers.
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Neoplasias Bucais , Cuidados Paliativos , Humanos , Masculino , Estudos Retrospectivos , Feminino , Cuidados Paliativos/métodos , Pessoa de Meia-Idade , Idoso , Neoplasias Bucais/radioterapia , Neoplasias Bucais/mortalidade , Neoplasias Bucais/terapia , Neoplasias Bucais/patologia , Idoso de 80 Anos ou mais , Adulto , Fracionamento da Dose de Radiação , Resultado do Tratamento , Carcinoma de Células Escamosas/mortalidade , Carcinoma de Células Escamosas/radioterapia , Carcinoma de Células Escamosas/terapia , Carcinoma de Células Escamosas/patologiaRESUMO
OBJECTIVES: Ensuring high-quality radiotherapy requires peer-reviewing target volumes. The Royal College of Radiologists recommends peer review specifically for individual target volumes in cases of gynaecological cancers. This study presents the outcomes of implementing an on-demand peer review system for gynaecological cancers within our institute. METHODS: The peer review process was planned for gynaecological cancer cases intended for curative radiotherapy. After junior clinical oncologists (COs) completed the segmentation, two senior COs specializing in gynaecological cancers conducted the peer review. All peer review outcomes were recorded prospectively. The audit process compliance, the proportion of patients requiring major and minor modifications in target volumes, the direction of changes, and the factors influencing these changes were reported. RESULTS: A total of 230 patients were eligible, and out of these, 204 (88.3%) patients underwent at least one peer review. Among the patients, 108 required major modifications in their target volumes. P-charts revealed a stabilization in the need for major modifications at the end of three months, indicating that 38.2% and 28% of patients still required major modifications for the nodal and primary CTV, respectively. Multivariable analysis demonstrated that major modifications were associated with the use of extended field radiotherapy and radical radiation in non-cervical primary cases. CONCLUSIONS: An on-demand peer review system was feasible and resulted in clinically meaningful, major modifications in the target volumes for 53% of patients. ADVANCES IN KNOWLEDGE: Gynaecological cancers require ongoing peer review to ensure quality of care in radiotherapy. A flexible on-demand system not only ensures that patient treatment start is not delayed but also has an important educational role for junior trainees.
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Neoplasias dos Genitais Femininos , Radioterapia (Especialidade) , Feminino , Humanos , Revisão por Pares/métodos , Neoplasias dos Genitais Femininos/radioterapia , Planejamento da Radioterapia Assistida por Computador/métodos , RadiologistasRESUMO
INTRODUCTION: Locally advanced carcinoma cervix (LACC) is a heterogeneous disease with variable combinations of primary tumour extensions with or without nodal involvement. Metabolic information from 18 fluro-deoxyglucose positron emission tomography combined with contrast-enhanced computerized tomography (FDG PET-CT) may potentially augment treatment decision-making for LACC. This study ascertained FDG-PET CT influence on chemoradiation therapy (CTRT) decisions in LACC. We report oncologic and patient-reported outcome measures (PROMs). METHODS: FDG PET-CT scans were reviewed independently by two nuclear medicine specialists and two radiation oncologists. Pelvic CTRT plan digressions were documented and therapy was adapted accordingly. Pelvis radiation (50 Gy/25#/5 weeks) using tomotherapy with weekly cisplatin was used in node-negative disease. Dose-escalated simultaneous integrated boost (SIB) 60 Gy/25#/5 weeks was delivered to involved pelvic nodes. All received brachytherapy. Post-treatment PET-CT scans were at 6 months. Functional assessment of cancer therapy scores were calculated at baseline, treatment completion, 3 months, 1 year and 3 years. RESULTS: Between November 2015 and January 2018, 85 patients were screened, and 77 consented. Extrapelvic disease was seen in 12 (16%) patients (9 para-aortic nodes, 2 distant metastases and 1 synchronous carcinoma breast); 60 patients were included in the final analysis. Decision changes were seen in 10/77 (13%) screened, 8/60 (13%) included and 32 (53.3%) received SIB. Post-treatment, 27 (45%) had grade 2 GI/GU/GYN toxicity, one (2%) had grade 3 GI and five (8.3%) had grade 3 neutropenia. At median overall survival of 54.2 months (95% CI 52.8-58.3), 5-year local failure, pelvic nodal and para-aortic nodal-free survival were 86.8% (95% CI 78.0-96.6), 85.2% (95% CI 76.1-95.3) and 85.2% (95% CI 76.2-95.4). Functional assessment of cancer therapy trial outcome index (FACT TOI) improved by 10.43 at 3 months with no further decline. Grade 3 toxicity was noted for abdominal pain in one (1.7%), cystitis in four (6.7%) and lymphoedema in one (1.7%) at 5 years. CONCLUSION: PET-CT resulted in major decision changes in 13%. PET-adapted CTRT was associated with acceptable toxicity, encouraging long-term survival and improvement in PROMS.
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Purpose: /Objective(S)A low-cost, prior knowledge-based individualized dose-constraint generator for organs-at-risk has been developed for prostate cancer radiation therapy (RT) planning. In this study, we aimed to evaluate the feasibility and improvements in organs-at-risk (OAR) doses in prostate cancer RT planning using this tool served on a web application. Materials And Methods: A set of previously treated prostate cancer cases planned and treated with generic constraints were replanned using individualized dose constraints derived from a library of cases with similar volumes of target, OAR, and overlap regions and served on the web-based application. The goal was to assess the reduction in mean dose, specified dose volumes (V59Gy, V56Gy, V53Gy, V47Gy, and V40Gy), and generalized equivalent uniform dose (gEUD) to the rectum and bladder. Planners and assessors were blinded to the initial achieved doses and penalties. Sample size estimation was based on improvement in V53Gy for the rectum and bladder with a paired evaluation. Results: Twenty-four patients were replanned. All the plans had a PTV D95 of at least 97% of the prescribed dose. The individualized OAR constraints could be met for 87.5% of patients for all dose levels. The mean dose, V59Gy, V53Gy, and V47Gy for the bladder was reduced by 7.5 Gy, 1.12%, 5.51%, and 10.53% respectively. Similarly for the rectum, the mean dose, V59Gy, V53Gy, V47Gy and was reduced by 5.5 Gy, 4.34%, 6.97%, and 11.61% respectively. All dose reductions were statistically significant. The gEUD of the bladder was reduced by 2.47 Gy (p < 0.001) and the rectum by 3.21 Gy (p < 0.001). Conclusion: Treatment planning based on individualized dose constraints served on a web application is feasible and leads to improvement at clinically important dose volumes in prostate cancer RT planning. This application can be served publicly for improvements in RT plan quality.
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BACKGROUND: Limited data exists regarding the impact of intensification of adjuvant therapy in resected Oral Cavity Squamous Cell Carcinomas (OCSCC) with adverse prognostic features on histopathology. PATIENTS AND METHODS: This was a three-arm phase III, randomised trial including patients with resected advanced OCSCC. Randomisation was done in a 1:1:1 ratio: Arm-A- standard adjuvant radiation therapy (RT) 60Gy/30 fractions over 6 weeks versus Arm-B-concurrent chemoradiation versus Arm-C-accelerated radiation therapy (6 d a week). The trial was powered to detect an absolute difference of 10% in 5-year Locoregional Control (LRC). RESULTS: The trial was conducted between June 2005 and March 2013. Majority of the patients were males, had T3-T4 disease, had N2-N3 nodal status and had Extra-Capsular Extension (ECE) in nodes. The median follow-up was 95.9 months. There was no difference between the three arms (A versus B versus C) for 10-year locoregional control (LRC): 60.2% versus 61.4% versus 65.7%, p = 0.57; disease free survival (DFS): 37.4% versus 43.9% versus 39.6%, p = 0.40; or Overall Survival (OS): 39.7% versus 46.6% versus 40.4%, p = 0.40. There was no benefit of intensification with either modality in patients with any single adverse pathological factor. A benefit of intensification could be seen in patients with a combination of high-risk features: T3-T4 primary tumours with N2-N3 nodes along with ECE for DFS (Arm B versus Arm A HR) = 0.53, Arm C versus Arm A HR = 0.63) and OS (Arm B versus Arm A HR = 0.58, Arm C versus Arm A HR = 0.60). CONCLUSIONS: All optimally resected OCSCC with adverse features did not benefit from intensification of adjuvant therapy. Only a cohort of patients with a combination of high-risk features are likely candidates for intensification. CLINICAL TRIAL REGISTRATION: NCT00193843.
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Carcinoma de Células Escamosas , Neoplasias de Cabeça e Pescoço , Neoplasias Bucais , Masculino , Humanos , Feminino , Carcinoma de Células Escamosas/cirurgia , Terapia Combinada , Carcinoma de Células Escamosas de Cabeça e Pescoço/terapia , Neoplasias Bucais/cirurgia , Neoplasias Bucais/patologia , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: HYPORT adjuvant trial is a randomised phase III open-label noninferiority trial comparing standard moderately hypofractionated 3 week adjuvant radiation therapy in breast cancer with a novel 1-week schedule. The trial was initiated in March 2019 and is open to recruitment with a total sample size of 2100. We report the results of dosimetric quality assurance, acute toxicity and pre planned first interim safety analysis in the first 271 patients. METHODS: Stage I-III breast cancer planned for adjuvant radiation therapy to the breast/chest-wall (along with regional nodes as indicated) were randomised to receive 40 Gy/15 fractions/3 weeks or 26 Gy/5 fractions/1 week. For simultaneous integrated boost, the patients in the control arm received 8 Gy/15 fractions/3 weeks, while those in the experimental arm received 6 Gy/5 fractions/1 week (to the tumour bed). For sequential boost, the prescribed dose was 12 Gy/4 fractions/4 days in both arms. Compliance to pre specified dosimetric parameters and acute toxicities were evaluated. RESULT: Data of the first 271 patients was analysed of whom 104 patients received tumour bed boost using SIB. All mandatory dosimetric criteria were met apart from one patient with a higher contralateral breast dose due to optimal internal mammary nodal coverage. Overall three patients (1.1%) experienced grade 3 radiation dermatitis (none received SIB), no other Grade 3 or higher toxicities reported. CONCLUSION: This acute toxicity interim analysis demonstrates that hypofractionated adjuvant radiotherapy with SIB for patients with breast cancer is feasible, and associated with minimal severe acute toxicities.
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Neoplasias da Mama , Hipofracionamento da Dose de Radiação , Mama/patologia , Neoplasias da Mama/patologia , Neoplasias da Mama/radioterapia , Feminino , Humanos , Radiometria , Radioterapia Adjuvante/métodosRESUMO
PURPOSE: There are limited reports of quality metrics in glioblastoma. We audited our adherence to quality indicators as proposed in the PRIME Quality Improvement study. METHODS: This is a retrospective audit of patients treated between 2017 and 2020. After postsurgical integrated diagnosis, patients received radiotherapy (RT) with concurrent and adjuvant temozolomide (TMZ). Multiparametric magnetic resonance imaging at predefined times guided management. Numbers with proportions for indices were calculated. Survival was estimated using the Kaplan-Meier method. RESULTS: One hundred six patients were consecutively treated. The median age was 55 years (interquartile range of 47-61 years) with a male preponderance (68%). Ninety-six (90.6%) patients underwent subtotal resection, and 10 (9.4%) biopsy alone. Isocitrate dehydrogenase was wild-type in 96 (91%), and O6-methylguanine-DNA methyltransferase was unmethylated in 70 (66.0%) patients. Telomerase reverse transcriptase promoter was mutated in 64 (60.4%), and TP53 was mutated in 22 (20.8%). Concurrent radiation and TMZ were planned for 104 (98.1%), and radiation alone for 2 (1.9%). The median time to concurrent RT-TMZ was 36 days (interquartile range 30-44 days). All patients planned for RT-TMZ completed treatment, but only 81 (76%) completed adjuvant TMZ. Sixty-three (59%) completed six cycles, 18 (17%) received less than six cycles, and 25 (24%) did not receive adjuvant TMZ. At a median follow-up of 24 months (range 21-31 months), the median (95% CI) progression-free survival and overall survival were 11 (95% CI, 9.4 to 13.0) and 20.0 (95% CI, 15 to 26) months, respectively. CONCLUSION: Our patients met quality indices in most domains; outcomes are comparable with global results. Metrics will be periodically evaluated to include new standards and assess continuous service appropriateness.
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Neoplasias Encefálicas , Glioblastoma , Antineoplásicos Alquilantes/uso terapêutico , Neoplasias Encefálicas/diagnóstico , Neoplasias Encefálicas/genética , Neoplasias Encefálicas/terapia , Dacarbazina/uso terapêutico , Glioblastoma/tratamento farmacológico , Glioblastoma/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Indicadores de Qualidade em Assistência à Saúde , Estudos Retrospectivos , Temozolomida/uso terapêutico , Atenção Terciária à SaúdeRESUMO
BACKGROUND: Definite concurrent chemoradiation is the standard of care for locally advanced unresectable oesophageal cancers. However, heterogeneity exists in the practice of concurrent chemoradiation approaches. Here we describe the efficacy and toxicities of the standard arm of SCOPE1 protocol implemented at our institute. METHODS: Treatment records of 36 patients with unresectable oesophageal cancers treated with concurrent chemoradiation between January 2015 and June 2019 were audited. Treatment was based on the standard arm of SCOPE1 protocol (neoadjuvant and concurrent platinum and capecitabine with external beam radiation to a dose of 50 Gy/25 fractions/5 weeks). The electronic hospital information system and oncology information system were queried to obtain information on patient characteristics and treatment delivery patterns. RESULTS: Out of 36 patients, 35 had squamous cell carcinomas. 25% of the patients (9/36) were 70 years or older. 66.7% of patients (24/36) had T4 disease, and 16 (44.4%) had N2-N3 nodal disease at presentation. A total of 30 patients (83.3%) could not undergo surgery because of the location and locoregional extent of the disease. The median follow-up of the entire cohort and the surviving patients was 10 months (range 3-51 months) and 13 months (range 4-51 months), respectively. The median overall survival (OS) of the entire cohort was 28 months. The 2-year local progression-free survival and OS were 71.2% (95% CI: 48.5%-85.3%) and 57.4% (95%CI: 29.6%-77.6%), respectively. Commonly observed acute Grade 3 toxicities were dysphagia (22.2%) and thrombocytopenia (19.4%). CONCLUSION: The outcomes of the SCOPE1 protocol have been validated for the first time in a different geographical, racial and ethnic population. Implementation of the standard arm of SCOPE1 protocol is feasible in our setting with acceptable adverse effects and good treatment compliance. Results are comparable to the results of the published trial.
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INTRODUCTION: The current study was aimed at quantifying the disparity in geographic access to cancer clinical trials in India. METHODS: We collated data of cancer clinical trials from the Clinical Trial Registry of India and data on state-wise cancer incidence from the Global Burden of Disease Study. The total sample size for each clinical trial was divided by the trial duration to get the sample size per year. This was then divided by the number of states in which accrual was planned to get the sample size per year per state (SSY).For interventional trials investigating a therapy, the SSY was divided by the number of incident cancers in the state to get the SSY per 1,000 incident cancer cases. The SSY data was then mapped to visualise the geographical disparity. RESULTS: We identified 181 ongoing studies, of which 132 were interventional studies. There was a substantial inter-state disparity-with a median SSY of 1.55 per 1,000 incident cancer cases (range 0.00-296.81 per 1,000 incident cases) for therapeutic interventional studies. Disparities were starker when cancer site-wise SSY was considered. Even in the state with the highest SSY, only 29.7% of the newly diagnosed cancer cases have an available slot in a therapeutic cancer clinical trial. Disparities in access were also apparent between academic (range: 0.21-226.60) and industry-sponsored trials (range: 0.17-70.21). CONCLUSION: There are significant geographic disparities in access to cancer clinical trials in India. Future investigations should evaluate the reasons and mitigation approaches for such disparities.
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PURPOSE: Malignant melanoma (MM) is rare in India. Indian data on demography and treatment outcome on advanced MM is very limited in the literature. MATERIALS & METHODS: This is a retrospective study of advanced MM treated between January 2013 and December 2020. We evaluated the clinicopathologic features, mutational profiles, survival outcome and prognostic factors in advanced MM patients. RESULTS: Out of a total 460 patients, 185 (42%) had metastatic disease at presentation and were enrolled in this study with a median age of 63 years (range: 28-93) and male:female ratio of 94:91. The mucosal primary was predominant (n = 110, 59%) than cutaneous primary (38%) and anorectum was the most common site (n = 84, 45%). Tumour mutational analysis was performed in 65 (35%) patients. BRAF mutations were detected in 12 patients and KIT mutations in 7 patients. Thirteen patients didn't have any mutations and 22 patients had mutations other than KIT & BRAF. Only 59 (32%) patients took any systemic treatment - immune checkpoint inhibitors (ICIs) in 17, temozolomide in 18 and paclitaxel/carboplatin in 18, tyrosine kinase inhibitors in 6 patients. After a median follow-up of 26 months (95% confidence interval (CI): 11.6-not reached), median progression-free survival (PFS) was 7.1 months (95% CI: 4.4-9.1) and median overall survival was 14.8 months (95% CI: 7.7-18.2 months). The use of ICI emerged as an only significant good prognostic factor (p ≤ 0.001) for PFS, on multivariate analysis. CONCLUSION: Mucosal origin was more common than cutaneous primary with anorectum being the most common site. BRAF mutation was less as compared to published literature. Very few patients received systemic therapy and the use of ICI showed superior PFS.
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BACKGROUND: The Chemoradiotherapy for Oesophageal Cancer Followed by Surgery Study (CROSS) trial established a new benchmark in the management of oesophageal cancer with neoadjuvant chemoradiation followed by surgery with a marked benefit for squamous cell carcinomas (SCCs). We evaluate if the CROSS protocol can be safely implemented with a broader eligibility criteria in a real-world setting. METHODS: A retrospective analysis of 80 patients of SCC oesophagus was performed, who were treated with neoadjuvant chemoradiation with radiation therapy (RT) to 41.4 Gy/23 Fr/4.5 weeks and weekly paclitaxel and carboplatin, followed by surgery at our institute between 2012 and 2019. Eligibility for the use of this regimen was expanded beyond the limits of size and stage allowed in the CROSS trial. RESULTS: The median age of this cohort was 57 years (range: 39-78 years). Most of the patients (77/80; 96.3%) had T3 disease and 25% patients (20/80) had N2/N3 disease. Thirty-three patients (41.3%) had the disease beyond CROSS eligibility criteria. All patients completed planned course of RT and five cycles of weekly chemotherapy were received by 61 patients (76.2%). Overall pathological complete response (pCR) could be achieved in 33 patients (41.3%). Among 33 CROSS ineligible patients, 14 (42.4%) had pCR. Acute grade 3 dysphagia and grade ≥ 3 neutropenia were seen in seven cases (8.3%) and nine cases (10.7%), respectively. At a median follow-up of 16 months, 1-year and 2-year overall survival (OS) were 84.4% (95% confidence interval (CI): 73.5%-91.1%) and 76.3% (95% CI: 63.2%-85.2%), respectively, for the entire cohort. For CROSS ineligible patients, 1-year and 2-year OS were 82% (95% CI: 61.8%-92.2%) and 72.7% (95% CI: 50.4%-86.2%), respectively. On univariate analysis, patients who had pathologically N0 disease had significantly better 2-year OS (85.7% versus 48.4%; p = 0.03) as compared to pathologically N+ patients. On univariate and multivariate analysis, there was no significant difference in OS and progression free survival between CROSS eligible and CROSS ineligible patients. CONCLUSION: CROSS protocol can be safely implemented for carefully selected patients of SCC oesophagus outside clinical trial settings with expanded eligibility criteria.
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PURPOSE: A COVID-19 lockdown in India posed significant challenges to the continuation of radiotherapy (RT) and systemic therapy services. Although several COVID-19 service guidelines have been promulgated, implementation data are yet unavailable. We performed a comprehensive audit of the implementation of services in a clinical oncology department. METHODS: A departmental protocol of priority-based treatment guidance was developed, and a departmental staff rotation policy was implemented. Data were collected for the period of lockdown on outpatient visits, starting, and delivery of RT and systemic therapy. Adherence to protocol was audited, and factors affecting change from pre-COVID standards analyzed by multivariate logistic regression. RESULTS: Outpatient consults dropped by 58%. Planned RT starts were implemented in 90%, 100%, 92%, 90%, and 75% of priority level 1-5 patients. Although 17% had a deferred start, the median time to start of adjuvant RT and overall treatment times were maintained. Concurrent chemotherapy was administered in 89% of those eligible. Systemic therapy was administered to 84.5% of planned patients. However, 33% and 57% of curative and palliative patients had modifications in cycle duration or deferrals. The patient's inability to come was the most common reason for RT or ST deviation. Factors independently associated with a change from pre-COVID practice was priority-level allocation for RT and age and palliative intent for systemic therapy. CONCLUSION: Despite significant access limitations, a planned priority-based system of delivery of treatment could be implemented.