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Phase I prognostic online (PIPO): A web tool to improve patient selection for oncology early phase clinical trials
- Source :
- Scientia
- Publication Year :
- 2021
- Publisher :
- Elsevier, 2021.
-
Abstract
- Immunotherapy; Phase 1 trials; Prognostic model Inmunoterapia; Ensayos de fase 1; Modelo pronóstico Immunoteràpia; Assajos de fase 1; Model pronòstic Purpose Patient selection in phase 1 clinical trials (Ph1t) continues to be a challenge. The aim of this study was to develop a user-friendly prognostic calculator for predicting overall survival (OS) outcomes in patients to be included in Ph1t with immune checkpoint inhibitors (ICIs) or targeted agents (TAs) based on clinical parameters assessed at baseline. Methods Using a training cohort with consecutive patients from the VHIO phase 1 unit, we constructed a prognostic model to predict median OS (mOS) as a primary endpoint and 3-month (3m) OS rate as a secondary endpoint. The model was validated in an internal cohort after temporal data splitting and represented as a web application. Results We recruited 799 patients (training and validation sets, 558 and 241, respectively). Median follow-up was 21.2 months (m), mOS was 10.2 m (95% CI, 9.3–12.7) for ICIs cohort and 7.7 m (95% CI, 6.6–8.6) for TAs cohort. In the multivariable analysis, six prognostic variables were independently associated with OS – ECOG, number of metastatic sites, presence of liver metastases, derived neutrophils/(leukocytes minus neutrophils) ratio [dNLR], albumin and lactate dehydrogenase (LDH) levels. The phase 1 prognostic online (PIPO) calculator showed adequate discrimination and calibration performance for OS, with C-statistics of 0.71 (95% CI 0.64–0.78) in the validation set. The overall accuracy of the model for 3m OS prediction was 87.2% (95% CI 85%–90%). Conclusions PIPO is a user-friendly objective and interactive tool to calculate specific survival probabilities for each patient before enrolment in a Ph1t. The tool is available at https://pipo.vhio.net/. The research leading to these results has received funding from “la Caixa” Foundation (LCF/PR/CE07/50610001). Cellex Foundation for providing research facilities and equipment. This work was supported by the Accelerator Award (UpSMART) from Fundacion Científica – Asociacion Espanola Contra el Cancer (FC -AECC)/ Associazione Italiana per la Ricerca sul Cancro (AIRC) /Cancer Research United Kingdom (CRUK).
- Subjects :
- Male
Oncology
Information Science::Informatics::Medical Informatics::Medical Informatics Applications [INFORMATION SCIENCE]
Cancer Research
medicine.medical_specialty
Prognostic variable
Oncologia
Phases of clinical research
Ciencias de la información::informática::informática médica::aplicaciones de la informática médica [CIENCIA DE LA INFORMACIÓN]
Medicina - Informàtica
Medical Oncology
Web tool
neoplasias [ENFERMEDADES]
Patient Portals
Internal medicine
medicine
Humans
Selection (genetic algorithm)
técnicas de investigación::métodos::diseño de la investigación::selección de los pacientes [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS]
Aged
Clinical Trials as Topic
business.industry
Patient Selection
Middle Aged
Prognosis
Clinical trial
Neoplasms [DISEASES]
Cohort
Prognostic model
Investigative Techniques::Methods::Research Design::Patient Selection [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT]
Female
Early phase
business
Internet-Based Intervention
Assaigs clínics
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Scientia
- Accession number :
- edsair.doi.dedup.....c6c8e375a408516cff89589a7095f1b9