Use of thoracic radiotherapy for extensive stage small-cell lung cancer : a phase 3 randomised controlled trial
Autor: | Sherif Y. El Sharouni, Ben J. Slotman, Matthew Hatton, Harm van Tinteren, Astrid Keijser, J. Knegjens, Suresh Senan, Corinne Faivre-Finn, J. Praag |
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Přispěvatelé: | Radiation Oncology, CCA - Innovative therapy, Radiotherapy |
Jazyk: | angličtina |
Rok vydání: | 2015 |
Předmět: |
Adult
Male medicine.medical_specialty Lung Neoplasms Population Clinical Trial Phase III Research Support Disease-Free Survival DISEASE law.invention Phase III Randomized controlled trial Belgium SDG 3 - Good Health and Well-being law RADIATION-THERAPY Clinical endpoint Journal Article Medicine Humans Extensive stage education Lung cancer Non-U.S. Gov't Aged Netherlands Aged 80 and over Medicine(all) education.field_of_study business.industry Norway Research Support Non-U.S. Gov't Hazard ratio General Medicine Middle Aged medicine.disease Small Cell Lung Carcinoma Clinical Trial United Kingdom Surgery Clinical trial Multicenter Study Treatment Outcome Randomized Controlled Trial Female Prophylactic cranial irradiation business |
Zdroj: | Lancet, 384(9962), 36-42. Elsevier Limited Lancet (UK), 385(9962), 36-42. Elsevier Ltd. The Lancet, 384(9962), 36. Elsevier Limited Slotman, B J, van Tinteren, H, Praag, J O, Knegjens, J L, El Sharouni, S Y, Hatton, M, de Keijser, A, Faivre-Finn, C & Senan, S 2015, ' Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial ', Lancet, vol. 384, no. 9962, pp. 36-42 . https://doi.org/10.1016/S0140-6736(14)61085-0 |
ISSN: | 0140-6736 |
Popis: | Summary Background Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. We assessed thoracic radiotherapy for treatment of this patient group. Methods We did this phase 3 randomised controlled trial at 42 hospitals: 16 in Netherlands, 22 in the UK, three in Norway, and one in Belgium. We enrolled patients with WHO performance score 0–2 and confirmed ES-SCLC who responded to chemotherapy. They were randomly assigned (1:1) to receive either thoracic radiotherapy (30 Gy in ten fractions) or no thoracic radiotherapy. All underwent prophylactic cranial irradiation. The primary endpoint was overall survival at 1 year in the intention-to-treat population. Secondary endpoints included progression-free survival. This study is registered with the Nederlands Trial Register, number NTR1527. Findings We randomly assigned 498 patients between Feb 18, 2009, and Dec 21, 2012. Three withdrew informed consent, leaving 247 patients in the thoracic radiotherapy group and 248 in the control group. Mean interval between diagnosis and randomisation was 17 weeks. Median follow-up was 24 months. Overall survival at 1 year was not significantly different between groups: 33% (95% CI 27–39) for the thoracic radiotherapy group versus 28% (95% CI 22–34) for the control group (hazard ratio [HR] 0·84, 95% CI 0·69–1·01; p=0·066). However, in a secondary analysis, 2-year overall survival was 13% (95% CI 9–19) versus 3% (95% CI 2–8; p=0·004). Progression was less likely in the thoracic radiotherapy group than in the control group (HR 0·73, 95% CI 0·61–0·87; p=0·001). At 6 months, progression-free survival was 24% (95% CI 19–30) versus 7% (95% CI 4–11; p=0·001). We recorded no severe toxic effects. The most common grade 3 or higher toxic effects were fatigue (11 vs 9) and dyspnoea (three vs four). Interpretation Thoracic radiotherapy in addition to prophylactic cranial irradiation should be considered for all patients with ES-SCLC who respond to chemotherapy. Funding Dutch Cancer Society (CKTO), Dutch Lung Cancer Research Group, Cancer Research UK, Manchester Academic Health Science Centre Trials Coordination Unit, and the UK National Cancer Research Network. |
Databáze: | OpenAIRE |
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