Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. (Registro nro. 17034)
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Campo de control de longitud fija | nab a22 7a 4500 |
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Campo de control | PC17034 |
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Campo de control | 20221026094206.0 |
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Campo de control de longitud fija | 221026b xxu||||| |||| 00| 0 eng d |
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Centro transcriptor | H12O |
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Código de lengua del texto/banda sonora o título independiente | eng |
100 ## - PUNTO DE ACCESO PRINCIPAL - NOMBRE DE PERSONA | |
9 (RLIN) | 2378 |
Nombre de persona | Ponce Aix, Santiago |
Término indicativo de función | Oncología Médica |
245 00 - MENCIÓN DE TÍTULO | |
Título | Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. |
Tipo de material | [artículo] |
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
Nombre del editor distribuidor etc. | The Lancet. Oncology, |
Fecha de publicación distribución etc. | 2015 |
300 ## - DESCRIPCIÓN FÍSICA | |
Extensión | 16(8):990-8. |
500 ## - NOTA GENERAL | |
Nota general | Formato Vancouver: Soria JC, Wu YL, Nakagawa K, Kim SW, Yang JJ, Ahn MJ et al. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol. 2015 Aug;16(8):990-8. |
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Nota de "Con" | PMID: 26159065 |
504 ## - NOTA DE BIBLIOGRAFÍA; ETC. | |
Nota de bibliografía etc. | Contiene 28 referencias |
520 ## - NOTA DE SUMARIO; ETC. | |
Sumario etc. | Background: Optimum management strategies for patients with advanced non-small-cell lung cancer (NSCLC) with acquired resistance to EGFR tyrosine-kinase inhibitors are undefined. We aimed to assess the efficacy and safety of continuing gefitinib combined with chemotherapy versus chemotherapy alone in patients with EGFR-mutation-positive advanced NSCLC with acquired resistance to first-line gefitinib. Methods: The randomised, phase 3, multicentre IMPRESS study was done in 71 centres in 11 countries in Europe and the Asia-Pacific region. Eligible patients were aged at least 18 years with histologically confirmed, chemotherapy-naive, stage IIIB-IV EGFR-mutation-positive advanced NSCLC with previous disease control with first-line gefitinib and recent disease progression (Response Evaluation Criteria in Solid Tumors version 1.1). Participants were randomly assigned (1:1) by central block randomisation to oral gefitinib 250 mg or placebo once daily in tablet form; randomisation did not include stratification factors. All patients also received the platinum-based doublet chemotherapy cisplatin 75 mg/m(2) plus pemetrexed 500 mg/m(2) on the first day of each cycle. After completion of a maximum of six chemotherapy cycles, patients continued their randomly assigned treatment until disease progression or another discontinuation criterion was met. All study investigators and participants were masked to treatment allocation. The primary endpoint was progression-free survival in the intention-to-treat population. Safety was assessed in patients who received at least one dose of study treatment. The study has completed enrolment, but patients are still in follow-up for overall survival. This trial is registered with ClinicalTrials.gov, number NCT01544179. Findings: Between March 29, 2012, and Dec 20, 2013, 265 patients were randomly assigned: 133 to the gefitinib group and 132 to the placebo group. At the time of data cutoff (May 5, 2014), 98 (74%) patients had disease progression in the gefitinib group compared with 107 (81%) in the placebo group (hazard ratio 0·86, 95% CI 0·65-1·13; p=0·27; median progression-free survival 5·4 months in both groups [95% CI 4·5-5·7 in the gefitinib group and 4·6-5·5 in the placebo group]). The most common adverse events of any grade were nausea (85 [64%] of 132 patients in the gefitinib group and 81 [61%] of 132 patients in the placebo group) and decreased appetite (65 [49%] and 45 [34%]). The most common adverse events of grade 3 or worse were anaemia (11 [8%] of 132 patients in the gefitinib group and five [4%] of 132 patients in the placebo group) and neutropenia (nine [7%] and seven [5%]). 37 (28%) of 132 patients in the gefitinib group and 28 (21%) of 132 patients in the placebo group reported serious adverse events. Interpretation: Continuation of gefitinib after radiological disease progression on first-line gefitinib did not prolong progression-free survival in patients who received platinum-based doublet chemotherapy as subsequent line of treatment. Platinum-based doublet chemotherapy remains the standard of care in this setting. |
710 ## - PUNTO DE ACCESO ADICIONAL - NOMBRE DE ENTIDAD | |
9 (RLIN) | 303 |
Nombre de entidad o nombre de jurisdicción como elemento inicial | Servicio de Oncología Médica |
856 ## - LOCALIZACIÓN Y ACCESO ELECTRÓNICOS | |
Identificador Uniforme del Recurso (URI) | http://pc-h12o-es.m-hdoct.a17.csinet.es/pdf/pc/1/pc17034.pdf |
Acceso | Solicitar documento |
Nota pública | |
942 ## - ENTRADA PARA ELEMENTOS AGREGADOS (KOHA) | |
Fuente de clasificación o esquema de ordenación en estanterías | |
Koha [por defecto] tipo de item | Artículo |
Suprimido en OPAC | Público |
Suprimido | Estado de pérdida | Fuente de clasificación o esquema de ordenación en estanterías | Estropeado | No para préstamo | Localización permanente | Localización actual | Fecha de adquisición | Signatura completa | Fecha última consulta | Fecha del precio de reemplazo | Tipo de item de Koha |
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Hospital Universitario 12 de Octubre | Hospital Universitario 12 de Octubre | 2022-10-26 | PC17034 | 2022-10-26 | 2022-10-26 | Artículo |