Consensus on the use of immune-related response criteria to evaluate the efficacy of immunotherapy in non-small cell lung cancer
Many methods used to assess the effectiveness of immune checkpoint (programmed death-ligand 1 or cytotoxic T-lymphocyte-associated protein 4) inhibitors for non-small cell lung cancer (NSCLC) are insufficient, as the therapeutic benefit of these agents is often underestimated. Consequently, immune-related evaluation criteria have been developed to better reflect their efficacy. The aim of this consensus was to obtain the opinion of lung cancer experts on the adequacy of immune-response criteria for evaluating the efficacy of these treatments.
Through two rounds of a modified Delphi consensus, 18 Spanish lung cancer experts participated in a 15-item questionnaire regarding the use of immunotherapies for NSCLC and the assessment criteria used to evaluate their effectiveness.
Consensus was achieved on 80% of the items in the questionnaire. The panelists agreed that although the Response Evaluation Criteria in Solid Tumors (RECIST) are standard for the evaluation of solid tumors, immune-related response criteria would be useful for measuring the efficacy of immunotherapy. In addition, they considered that an overall survival (OS) rate at 2–5 years is the most useful end point for assessing the benefit of immunotherapy, as clinical benefit may extend beyond the RECIST criteria-defined progression of disease.
Although immune-related response criteria have been developed to better evaluate the efficacy of immunotherapy, their use has not been validated and is restricted to investigational applications. However, they may prove to be a useful tool for measuring the efficacy of immunotherapy agents in NSCLC, especially the OS rate at 2–5 years.
KeywordsImmunotherapy Immune checkpoint Overall survival Response criteria
Cytotoxic T-lymphocyte-associated protein
Non-small cell lung cancer
Programmed cell death protein 1
Programmed death-ligand 1
Response Evaluation Criteria in Solid Tumors
The authors would like to thank all panelists that participated in this project: Joaquim Bosch (Instituto Catalán de Oncología – Hospital Dr.Trueta, Girona), Manuel Cobo (Hospital Universitario Carlos Haya, Málaga), Juan Coves (Hospital Son Llatzer, Palma de Mallorca), Ramón de las Peñas (Hospital Provincial de Castellón, Castellón), Manuel Dómine (Fundación Jiménez Díaz, Madrid), Enriqueta Felip (Hospital Universitario Vall D’Hebron, Barcelona), Rosario García Campelo (Hospital Teresa Herrera, A Coruña), Javier Garde (Hospital Arnau de Vilanova de Valencia, Valencia), José Luis González-Larriba (Hospital Clínico San Carlos, Madrid), Mónica Guillot (Hospital Universitario Son Espases, Palma de Mallorca), María Guirado (Hospital General Universitario de Elche, Alicante), Amelia Insa (Hospital Clínico Universitario de Valencia, Valencia), Dolores Isla (Hospital Clínico Universitario Lozano Blesa, Zaragoza), Guillermo López-Vivanco (Hospital de Cruces Baracaldo, Vizcaya), Bartomeu Massutí (Hospital General Universitario de Alicante, Alicante), Ana Laura Ortega (Hospital Ciudad de Jaen, Jaén), Luis Paz-Ares (Hospital Universitario 12 de Octubre, Madrid), Delvys Rodríguez (Hospital Universitario Insular de Gran Canaria, Gran Canaria). Also, the authors thank Dr. Fernando Sánchez Barbero who provided assistance in the preparation of this manuscript on behalf of Springer Healthcare, and Sarah Greig, PhD, of Springer Healthcare Communications, for editing the manuscript before submission. This medical writing assistance was funded by Bristol-Myers Squibb.
Bristol-Myers Squibb promoted and financed this study without participating in its design, analysis of data, or preparation of the manuscript.
Compliance with ethical standards
Conflict of interest
M Provencio has served as consultant or advisor for Bristol-Myers Squibb, Celgene, Merck Sharp and Dohme, Pierre Fabre, and Roche. E. Carcereny has served as consultant or advisor for Bristol-Myers Squibb, Merck, Pfizer, and Roche; and has received travel and expenses funding from Bristol-Myers Squibb, and Pfizer. Á. Artal has participated on the speaker´s bureau and advisory boards for Bristol-Myers Squibb, Merck Sharp and Dohme, and Roche-Genentech; and has received travel and expenses funding form Bristol-Myers Squibb and Roche.
This article does not contain any studies with human participants performed by any of the authors.
This article does not contain any studies with human participants performed by any of the authors, so informed consent was not required.
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