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REFINE-Lung implements a novel multi-arm randomised trial design to address possible immunotherapy overtreatment.
Ghorani, Ehsan; Quartagno, Matteo; Blackhall, Fiona; Gilbert, Duncan C; O'Brien, Mary; Ottensmeier, Christian; Pizzo, Elena; Spicer, James; Williams, Alex; Badman, Philip; Parmar, Mahesh K B; Seckl, Michael J.
Afiliación
  • Ghorani E; Department of Medical Oncology, Charing Cross Gestational Trophoblastic Disease Centre, Charing Cross Hospital Campus of Imperial College London, London, UK.
  • Quartagno M; Institute for Clinical Trials and Methodology, University College London, London, UK.
  • Blackhall F; Christie National Health Service Foundation Trust, Manchester, UK.
  • Gilbert DC; Institute for Clinical Trials and Methodology, University College London, London, UK.
  • O'Brien M; Royal Marsden Hospital, Imperial College London, London, UK.
  • Ottensmeier C; Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK; Clatterbridge Cancer Center NHS Foundation Trust, Liverpool, UK.
  • Pizzo E; Department of Applied Health Research, University College London, London, UK.
  • Spicer J; King's College London, Guy's Hospital, London, UK.
  • Williams A; Imperial College Trials Unit-Cancer, Department of Surgery and Cancer, Imperial College London, London, UK.
  • Badman P; Imperial College Trials Unit-Cancer, Department of Surgery and Cancer, Imperial College London, London, UK.
  • Parmar MKB; Institute for Clinical Trials and Methodology, University College London, London, UK. Electronic address: m.parmar@ucl.ac.uk.
  • Seckl MJ; Department of Medical Oncology, Charing Cross Gestational Trophoblastic Disease Centre, Charing Cross Hospital Campus of Imperial College London, London, UK. Electronic address: m.seckl@imperial.ac.uk.
Lancet Oncol ; 24(5): e219-e227, 2023 05.
Article en En | MEDLINE | ID: mdl-37142383
Increasing evidence suggests that some immunotherapy dosing regimens for patients with advanced cancer could result in overtreatment. Given the high costs of these agents, and important implications for quality of life and toxicity, new approaches are needed to identify and reduce unnecessary treatment. Conventional two-arm non-inferiority designs are inefficient in this context because they require large numbers of patients to explore a single alternative to the standard of care. Here, we discuss the potential problem of overtreatment with anti-PD-1 directed agents in general and introduce REFINE-Lung (NCT05085028), a UK multicentre phase 3 study of reduced frequency pembrolizumab in advanced non-small-cell lung cancer. REFINE-Lung uses a novel multi-arm multi-stage response over continuous interventions (MAMS-ROCI) design to determine the optimal dose frequency of pembrolizumab. Along with a similarly designed basket study of patients with renal cancer and melanoma, REFINE-Lung and the MAMS-ROCI design could contribute to practice-changing advances in patient care and form a template for future immunotherapy optimisation studies across cancer types and indications. This new trial design is applicable to many new or existing agents for which optimisation of dose, frequency, or duration of therapy is desirable.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Humans Idioma: En Revista: Lancet Oncol Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Humans Idioma: En Revista: Lancet Oncol Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido