Surrogate endpoints in immunotherapy trials for solid tumors
| Autor: | Valentina Rampulla, Antonio Costanzo, Gianluca Tomasello, Michele Ghidini, Antonio Varricchio, Fausto Petrelli |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Oncology medicine.medical_specialty Time Factors Endpoint Determination medicine.medical_treatment Programmed Cell Death 1 Receptor B7-H1 Antigen 03 medical and health sciences Antineoplastic Agents Immunological Clinical Trials Phase II as Topic 0302 clinical medicine Neoplasms Internal medicine medicine Overall survival Humans Objective response Response Evaluation Criteria in Solid Tumors Antitumor activity business.industry Surrogate endpoint Cancer General Medicine Immunotherapy medicine.disease Disease control Progression-Free Survival Editorial Commentary 030104 developmental biology Clinical Trials Phase III as Topic Research Design 030220 oncology & carcinogenesis business Signal Transduction |
| Zdroj: | Annals of translational medicine. 7(7) |
| ISSN: | 2305-5839 |
| Popis: | We aimed to assess whether the Response Evaluation Criteria in Solid Tumors (RECIST) criteria-based objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS) could be valid surrogate end-points for overall survival (OS) in anti-programmed death-1 (PD-1)/programmed death ligand 1 (PD-L1) trials.We systematically reviewed phase 2 and phase 3 trials of anti-PD-1/PD-L1 drug trials of advanced or recurrent solid tumours that reported OS and at least one of the RECIST criteria-based end-points. We used Spearman rank correlation to evaluate the strength of the association between these end-points and OS and a linear regression model, weighted by the sample size, to assess the association between the treatment effect on these end-points and OS. We also performed sensitivity analyses and a leave-one-out cross-validation approach to evaluate the robustness of our findings.Forty-three qualifying trails comprising 15,088 patients were eligible. PFS showed good correlation with OS (squared Spearman rank correlation coefficient [rNo RECIST criteria-based end-points could be a valid surrogate for OS. At present, we proposed to set OS as the primary end-point in anti-PD-1/PD-L1 drug trials of advanced or recurrent solid tumours. |
| Databáze: | OpenAIRE |
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