FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3132134476> ?p ?o ?g. }

• W3132134476 endingPage "303" @default.
• W3132134476 startingPage "292" @default.
• W3132134476 abstract "BackgroundPatients with advanced oesophageal cancer have a median survival of 3–6 months, and most require intervention for dysphagia. Self-expanding metal stent (SEMS) insertion is the most typical form of palliation in these patients, but dysphagia deterioration and re-intervention are common. This study examined the efficacy of adjuvant external beam radiotherapy (EBRT) compared with usual care alone in preventing dysphagia deterioration and reducing service use after SEMS insertion.MethodsThis was a multicentre, open-label, phase 3 randomised controlled trial based at cancer centres and acute care hospitals in England, Scotland, and Wales. Patients (aged ≥16 years) with incurable oesophageal carcinoma receiving stent insertion for primary management of dysphagia were randomly assigned (1:1) to receive usual care alone or EBRT (20 Gy in five fractions or 30 Gy in ten fractions) plus usual care after stent insertion. Usual care was implemented according to need as identified by the local multidisciplinary team (MDT). Randomisation was via the method of minimisation stratified by treating centre, stage at diagnosis (I–III vs IV), histology (squamous or non-squamous), and MDT intent to give chemotherapy (yes vs no). The primary outcome was difference in proportions of participants with dysphagia deterioration (>11 point decrease on patient-reported European Organisation for Research and Treatment of Cancer quality of life questionnaire-oesophagogastric module [QLQ-OG25], or a dysphagia-related event consistent with such a deterioration) or death by 12 weeks in a modified intention-to-treat (ITT) population, which excluded patients who did not have a stent inserted and those without a baseline QLQ-OG25 assessment. Secondary outcomes included survival, quality of life (QoL), morbidities (including time to first bleeding event or hospital admission for bleeding event and first dysphagia-related stent complications or re-intervention), and cost-effectiveness. Safety analysis was undertaken in the modified ITT population. The study is registered with the International Standard Randomised Controlled Trial registry, ISRCTN12376468, and ClinicalTrials.gov, NCT01915693, and is completed.Findings220 patients were randomly assigned between Dec 16, 2013, and Aug 24, 2018, from 23 UK centres. The modified ITT population (n=199) comprised 102 patients in the usual care group and 97 patients in the EBRT group. Radiotherapy did not reduce dysphagia deterioration, which was reported in 36 (49%) of 74 patients receiving usual care versus 34 (45%) of 75 receiving EBRT (adjusted odds ratio 0·82 [95% CI 0·40–1·68], p=0·59) in those with complete data for the primary endpoint. No significant difference was observed in overall survival: median overall survival was 19·7 weeks (95% CI 14·4–27·7) with usual care and 18·9 weeks (14·7–25·6) with EBRT (adjusted hazard ratio 1·06 [95% CI 0·78–1·45], p=0·70; n=199). Median time to first bleeding event or hospital admission for a bleeding event was 49·0 weeks (95% CI 33·3–not reached) with usual care versus 65·9 weeks (52·7–not reached) with EBRT (adjusted subhazard ratio 0·52 [95% CI 0·28–0·97], p=0·038; n=199). No time versus treatment interaction was observed for prespecified QoL outcomes. We found no evidence of differences between trial group in time to first stent complication or re-intervention event. The most common (grade 3–4) adverse event was fatigue, reported in 19 (19%) of 102 patients receiving usual care alone and 22 (23%) of 97 receiving EBRT. On cost-utility analysis, EBRT was more expensive and less efficacious than usual care.InterpretationPatients with advanced oesophageal cancer having SEMS insertion for the primary management of their dysphagia did not gain additional benefit from concurrent palliative radiotherapy and it should not be routinely offered. For a minority of patients clinically considered to be at high risk of tumour bleeding, concurrent palliative radiotherapy might reduce bleeding risk and the need for associated interventions.FundingNational Institute for Health Research Health Technology Assessment Programme. Patients with advanced oesophageal cancer have a median survival of 3–6 months, and most require intervention for dysphagia. Self-expanding metal stent (SEMS) insertion is the most typical form of palliation in these patients, but dysphagia deterioration and re-intervention are common. This study examined the efficacy of adjuvant external beam radiotherapy (EBRT) compared with usual care alone in preventing dysphagia deterioration and reducing service use after SEMS insertion. This was a multicentre, open-label, phase 3 randomised controlled trial based at cancer centres and acute care hospitals in England, Scotland, and Wales. Patients (aged ≥16 years) with incurable oesophageal carcinoma receiving stent insertion for primary management of dysphagia were randomly assigned (1:1) to receive usual care alone or EBRT (20 Gy in five fractions or 30 Gy in ten fractions) plus usual care after stent insertion. Usual care was implemented according to need as identified by the local multidisciplinary team (MDT). Randomisation was via the method of minimisation stratified by treating centre, stage at diagnosis (I–III vs IV), histology (squamous or non-squamous), and MDT intent to give chemotherapy (yes vs no). The primary outcome was difference in proportions of participants with dysphagia deterioration (>11 point decrease on patient-reported European Organisation for Research and Treatment of Cancer quality of life questionnaire-oesophagogastric module [QLQ-OG25], or a dysphagia-related event consistent with such a deterioration) or death by 12 weeks in a modified intention-to-treat (ITT) population, which excluded patients who did not have a stent inserted and those without a baseline QLQ-OG25 assessment. Secondary outcomes included survival, quality of life (QoL), morbidities (including time to first bleeding event or hospital admission for bleeding event and first dysphagia-related stent complications or re-intervention), and cost-effectiveness. Safety analysis was undertaken in the modified ITT population. The study is registered with the International Standard Randomised Controlled Trial registry, ISRCTN12376468, and ClinicalTrials.gov, NCT01915693, and is completed. 220 patients were randomly assigned between Dec 16, 2013, and Aug 24, 2018, from 23 UK centres. The modified ITT population (n=199) comprised 102 patients in the usual care group and 97 patients in the EBRT group. Radiotherapy did not reduce dysphagia deterioration, which was reported in 36 (49%) of 74 patients receiving usual care versus 34 (45%) of 75 receiving EBRT (adjusted odds ratio 0·82 [95% CI 0·40–1·68], p=0·59) in those with complete data for the primary endpoint. No significant difference was observed in overall survival: median overall survival was 19·7 weeks (95% CI 14·4–27·7) with usual care and 18·9 weeks (14·7–25·6) with EBRT (adjusted hazard ratio 1·06 [95% CI 0·78–1·45], p=0·70; n=199). Median time to first bleeding event or hospital admission for a bleeding event was 49·0 weeks (95% CI 33·3–not reached) with usual care versus 65·9 weeks (52·7–not reached) with EBRT (adjusted subhazard ratio 0·52 [95% CI 0·28–0·97], p=0·038; n=199). No time versus treatment interaction was observed for prespecified QoL outcomes. We found no evidence of differences between trial group in time to first stent complication or re-intervention event. The most common (grade 3–4) adverse event was fatigue, reported in 19 (19%) of 102 patients receiving usual care alone and 22 (23%) of 97 receiving EBRT. On cost-utility analysis, EBRT was more expensive and less efficacious than usual care. Patients with advanced oesophageal cancer having SEMS insertion for the primary management of their dysphagia did not gain additional benefit from concurrent palliative radiotherapy and it should not be routinely offered. For a minority of patients clinically considered to be at high risk of tumour bleeding, concurrent palliative radiotherapy might reduce bleeding risk and the need for associated interventions." @default.
• W3132134476 created "2021-03-01" @default.
• W3132134476 creator A5006274396 @default.
• W3132134476 creator A5016857639 @default.
• W3132134476 creator A5019985889 @default.
• W3132134476 creator A5022218716 @default.
• W3132134476 creator A5026115891 @default.
• W3132134476 creator A5027946039 @default.
• W3132134476 creator A5028118350 @default.
• W3132134476 creator A5028145382 @default.
• W3132134476 creator A5062112734 @default.
• W3132134476 creator A5062851652 @default.
• W3132134476 creator A5065507595 @default.
• W3132134476 creator A5069947870 @default.
• W3132134476 creator A5070432856 @default.
• W3132134476 creator A5077508057 @default.
• W3132134476 creator A5084659683 @default.
• W3132134476 creator A5086940546 @default.
• W3132134476 creator A5087951378 @default.
• W3132134476 date "2021-04-01" @default.
• W3132134476 modified "2023-10-10" @default.
• W3132134476 title "Palliative radiotherapy after oesophageal cancer stenting (ROCS): a multicentre, open-label, phase 3 randomised controlled trial" @default.
• W3132134476 cites W1947426236 @default.
• W3132134476 cites W1979290264 @default.
• W3132134476 cites W1996739625 @default.
• W3132134476 cites W2007899593 @default.
• W3132134476 cites W2020275075 @default.
• W3132134476 cites W2032665998 @default.
• W3132134476 cites W2057994672 @default.
• W3132134476 cites W2094094601 @default.
• W3132134476 cites W2103607521 @default.
• W3132134476 cites W2107107117 @default.
• W3132134476 cites W2109715215 @default.
• W3132134476 cites W2112800524 @default.
• W3132134476 cites W2118249259 @default.
• W3132134476 cites W2129055079 @default.
• W3132134476 cites W2144026725 @default.
• W3132134476 cites W2150168239 @default.
• W3132134476 cites W2164003190 @default.
• W3132134476 cites W2283294549 @default.
• W3132134476 cites W2399355639 @default.
• W3132134476 cites W2473786944 @default.
• W3132134476 cites W2550957715 @default.
• W3132134476 cites W2791089605 @default.
• W3132134476 cites W293908896 @default.
• W3132134476 cites W3141716500 @default.
• W3132134476 doi "https://doi.org/10.1016/s2468-1253(21)00004-2" @default.
• W3132134476 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/7955283" @default.
• W3132134476 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/33610215" @default.
• W3132134476 hasPublicationYear "2021" @default.
• W3132134476 type Work @default.
• W3132134476 sameAs 3132134476 @default.
• W3132134476 citedByCount "22" @default.
• W3132134476 countsByYear W31321344762021 @default.
• W3132134476 countsByYear W31321344762022 @default.
• W3132134476 countsByYear W31321344762023 @default.
• W3132134476 crossrefType "journal-article" @default.
• W3132134476 hasAuthorship W3132134476A5006274396 @default.
• W3132134476 hasAuthorship W3132134476A5016857639 @default.
• W3132134476 hasAuthorship W3132134476A5019985889 @default.
• W3132134476 hasAuthorship W3132134476A5022218716 @default.
• W3132134476 hasAuthorship W3132134476A5026115891 @default.
• W3132134476 hasAuthorship W3132134476A5027946039 @default.
• W3132134476 hasAuthorship W3132134476A5028118350 @default.
• W3132134476 hasAuthorship W3132134476A5028145382 @default.
• W3132134476 hasAuthorship W3132134476A5062112734 @default.
• W3132134476 hasAuthorship W3132134476A5062851652 @default.
• W3132134476 hasAuthorship W3132134476A5065507595 @default.
• W3132134476 hasAuthorship W3132134476A5069947870 @default.
• W3132134476 hasAuthorship W3132134476A5070432856 @default.
• W3132134476 hasAuthorship W3132134476A5077508057 @default.
• W3132134476 hasAuthorship W3132134476A5084659683 @default.
• W3132134476 hasAuthorship W3132134476A5086940546 @default.
• W3132134476 hasAuthorship W3132134476A5087951378 @default.
• W3132134476 hasBestOaLocation W31321344761 @default.
• W3132134476 hasConcept C121608353 @default.
• W3132134476 hasConcept C126322002 @default.
• W3132134476 hasConcept C143998085 @default.
• W3132134476 hasConcept C159110408 @default.
• W3132134476 hasConcept C168563851 @default.
• W3132134476 hasConcept C17744445 @default.
• W3132134476 hasConcept C199539241 @default.
• W3132134476 hasConcept C2779473830 @default.
• W3132134476 hasConcept C2994186709 @default.
• W3132134476 hasConcept C3017768548 @default.
• W3132134476 hasConcept C3019800554 @default.
• W3132134476 hasConcept C509974204 @default.
• W3132134476 hasConcept C71924100 @default.
• W3132134476 hasConceptScore W3132134476C121608353 @default.
• W3132134476 hasConceptScore W3132134476C126322002 @default.
• W3132134476 hasConceptScore W3132134476C143998085 @default.
• W3132134476 hasConceptScore W3132134476C159110408 @default.
• W3132134476 hasConceptScore W3132134476C168563851 @default.
• W3132134476 hasConceptScore W3132134476C17744445 @default.
• W3132134476 hasConceptScore W3132134476C199539241 @default.
• W3132134476 hasConceptScore W3132134476C2779473830 @default.
• W3132134476 hasConceptScore W3132134476C2994186709 @default.
• W3132134476 hasConceptScore W3132134476C3017768548 @default.

• next