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Association of Chemoradiotherapy With Outcomes Among Patients With Stage I to II vs Stage III Small Cell Lung Cancer: Secondary Analysis of a Randomized Clinical Trial

IMPORTANCE: There is limited evidence to guide stage I to II small cell lung cancer (SCLC) treatment. OBJECTIVE: To examine the characteristics and outcomes among patients with stage I to II SCLC treated with modern chemoradiotherapy. DESIGN, SETTING, AND PARTICIPANTS: In this post hoc secondary ana...

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Autores principales: Salem, Ahmed, Mistry, Hitesh, Hatton, Matthew, Locke, Imogen, Monnet, Isabelle, Blackhall, Fiona, Faivre-Finn, Corinne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439849/
https://www.ncbi.nlm.nih.gov/pubmed/30520977
http://dx.doi.org/10.1001/jamaoncol.2018.5335
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author Salem, Ahmed
Mistry, Hitesh
Hatton, Matthew
Locke, Imogen
Monnet, Isabelle
Blackhall, Fiona
Faivre-Finn, Corinne
author_facet Salem, Ahmed
Mistry, Hitesh
Hatton, Matthew
Locke, Imogen
Monnet, Isabelle
Blackhall, Fiona
Faivre-Finn, Corinne
author_sort Salem, Ahmed
collection PubMed
description IMPORTANCE: There is limited evidence to guide stage I to II small cell lung cancer (SCLC) treatment. OBJECTIVE: To examine the characteristics and outcomes among patients with stage I to II SCLC treated with modern chemoradiotherapy. DESIGN, SETTING, AND PARTICIPANTS: In this post hoc secondary analysis of the Concurrent Once-Daily vs Twice-Daily Radiotherapy Trial (CONVERT), a multicenter phase 3 trial conducted in patients with limited-stage SCLC from April 7, 2008, to November 29, 2013, patients with TNM stage I to II SCLC were compared with those with stage III disease. Data analysis was performed from November 1, 2017, to February 28, 2018. INTERVENTIONS: In CONVERT, patients were randomized to receive twice-daily (45 Gy in 30 fractions) or once-daily (66 Gy in 33 fractions) chemoradiotherapy. Prophylactic cranial irradiation (PCI) was offered, if indicated. MAIN OUTCOMES AND MEASURES: The primary trial end point was overall survival (OS). TNM staging information was collected prospectively; this was an unplanned analysis because stratification was not performed according to TNM stage. RESULTS: A total of 509 (277 [54.4%] men; mean [SD] age, 61.5 [8.3] years) of 543 patients (93.7%) with TNM staging information were eligible for this subgroup analysis, and 86 of the 509 (16.9%) had TNM stage I to II disease. The median gross tumor volume was smaller in patients with stage I to II disease (38.4 cm(3); range, 2.2-593.0 cm(3)) compared with patients with stage III disease (93 cm(3); range, 0.5-513.4 cm(3)) (P < .001). No other significant differences were found in baseline and treatment characteristics and chemoradiotherapy adherence between the 2 groups or the number of patients with stage I to II disease (78 [90.7%]) and stage III disease (346 [81.8%]) who received PCI (P = .10). Patients with stage I to II disease achieved longer OS (median, 50 months [95% CI, 38 to not reached months] vs 25 months [95% CI, 21-29 months]; hazard ratio, 0.60 [95% CI, 0.44-0.83]; P = .001) compared with patients with stage III disease. In patients with stage I to II disease, no significant survival difference was found between the trial arms (median, 39 months in the once-daily arm vs 72 months in the twice-daily arm; P = .38). Apart from lower incidence of acute esophagitis in patients with stage I to II disease compared with patients with stage III disease (grade ≥3, 9 [11.3%] vs 82 [21.1%]; P < .001), the incidences of acute and late toxic effects were not significantly different. CONCLUSIONS AND RELEVANCE: Patients with stage I to II SCLC in CONVERT achieved long-term survival with acceptable toxic effects after chemoradiotherapy and PCI. This study suggests that patients with stage I to II small cell lung cancer treated with modern chemoradiotherapy have better outcomes compared with patients with stage III disease, providing information that practitioners can potentially give their patients to aid clinical decisions. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00433563
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spelling pubmed-64398492019-04-24 Association of Chemoradiotherapy With Outcomes Among Patients With Stage I to II vs Stage III Small Cell Lung Cancer: Secondary Analysis of a Randomized Clinical Trial Salem, Ahmed Mistry, Hitesh Hatton, Matthew Locke, Imogen Monnet, Isabelle Blackhall, Fiona Faivre-Finn, Corinne JAMA Oncol Original Investigation IMPORTANCE: There is limited evidence to guide stage I to II small cell lung cancer (SCLC) treatment. OBJECTIVE: To examine the characteristics and outcomes among patients with stage I to II SCLC treated with modern chemoradiotherapy. DESIGN, SETTING, AND PARTICIPANTS: In this post hoc secondary analysis of the Concurrent Once-Daily vs Twice-Daily Radiotherapy Trial (CONVERT), a multicenter phase 3 trial conducted in patients with limited-stage SCLC from April 7, 2008, to November 29, 2013, patients with TNM stage I to II SCLC were compared with those with stage III disease. Data analysis was performed from November 1, 2017, to February 28, 2018. INTERVENTIONS: In CONVERT, patients were randomized to receive twice-daily (45 Gy in 30 fractions) or once-daily (66 Gy in 33 fractions) chemoradiotherapy. Prophylactic cranial irradiation (PCI) was offered, if indicated. MAIN OUTCOMES AND MEASURES: The primary trial end point was overall survival (OS). TNM staging information was collected prospectively; this was an unplanned analysis because stratification was not performed according to TNM stage. RESULTS: A total of 509 (277 [54.4%] men; mean [SD] age, 61.5 [8.3] years) of 543 patients (93.7%) with TNM staging information were eligible for this subgroup analysis, and 86 of the 509 (16.9%) had TNM stage I to II disease. The median gross tumor volume was smaller in patients with stage I to II disease (38.4 cm(3); range, 2.2-593.0 cm(3)) compared with patients with stage III disease (93 cm(3); range, 0.5-513.4 cm(3)) (P < .001). No other significant differences were found in baseline and treatment characteristics and chemoradiotherapy adherence between the 2 groups or the number of patients with stage I to II disease (78 [90.7%]) and stage III disease (346 [81.8%]) who received PCI (P = .10). Patients with stage I to II disease achieved longer OS (median, 50 months [95% CI, 38 to not reached months] vs 25 months [95% CI, 21-29 months]; hazard ratio, 0.60 [95% CI, 0.44-0.83]; P = .001) compared with patients with stage III disease. In patients with stage I to II disease, no significant survival difference was found between the trial arms (median, 39 months in the once-daily arm vs 72 months in the twice-daily arm; P = .38). Apart from lower incidence of acute esophagitis in patients with stage I to II disease compared with patients with stage III disease (grade ≥3, 9 [11.3%] vs 82 [21.1%]; P < .001), the incidences of acute and late toxic effects were not significantly different. CONCLUSIONS AND RELEVANCE: Patients with stage I to II SCLC in CONVERT achieved long-term survival with acceptable toxic effects after chemoradiotherapy and PCI. This study suggests that patients with stage I to II small cell lung cancer treated with modern chemoradiotherapy have better outcomes compared with patients with stage III disease, providing information that practitioners can potentially give their patients to aid clinical decisions. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00433563 American Medical Association 2018-12-06 2019-03 /pmc/articles/PMC6439849/ /pubmed/30520977 http://dx.doi.org/10.1001/jamaoncol.2018.5335 Text en Copyright 2018 Salem A et al. JAMA Oncology. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Salem, Ahmed
Mistry, Hitesh
Hatton, Matthew
Locke, Imogen
Monnet, Isabelle
Blackhall, Fiona
Faivre-Finn, Corinne
Association of Chemoradiotherapy With Outcomes Among Patients With Stage I to II vs Stage III Small Cell Lung Cancer: Secondary Analysis of a Randomized Clinical Trial
title Association of Chemoradiotherapy With Outcomes Among Patients With Stage I to II vs Stage III Small Cell Lung Cancer: Secondary Analysis of a Randomized Clinical Trial
title_full Association of Chemoradiotherapy With Outcomes Among Patients With Stage I to II vs Stage III Small Cell Lung Cancer: Secondary Analysis of a Randomized Clinical Trial
title_fullStr Association of Chemoradiotherapy With Outcomes Among Patients With Stage I to II vs Stage III Small Cell Lung Cancer: Secondary Analysis of a Randomized Clinical Trial
title_full_unstemmed Association of Chemoradiotherapy With Outcomes Among Patients With Stage I to II vs Stage III Small Cell Lung Cancer: Secondary Analysis of a Randomized Clinical Trial
title_short Association of Chemoradiotherapy With Outcomes Among Patients With Stage I to II vs Stage III Small Cell Lung Cancer: Secondary Analysis of a Randomized Clinical Trial
title_sort association of chemoradiotherapy with outcomes among patients with stage i to ii vs stage iii small cell lung cancer: secondary analysis of a randomized clinical trial
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439849/
https://www.ncbi.nlm.nih.gov/pubmed/30520977
http://dx.doi.org/10.1001/jamaoncol.2018.5335
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