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Record W3189971813 · doi:10.1016/j.ejca.2021.05.040

Phase I prognostic online (PIPO): A web tool to improve patient selection for oncology early phase clinical trials

2021· article· en· W3189971813 on OpenAlexfundno aff
Ignacio Matos, Guillermo Villacampa, Cinta Hierro, Juan Martín-Liberal, Roger Berché, Anna Pedrola, Irene Braña, Analía Azaro, María Vieito, Omar Saavedra, Itziar Gardeazábal, Alberto Hernando‐Calvo, Guzmán Alonso, Vladimir Galvao, María Ochoa de Olza, Javier Ros, Cristina Viaplana, Eva Muñoz‐Couselo, Elena Élez, Jordi Rodón, Cristina Saura, Teresa Macarulla, Ana Oaknin, Joan Carles, Enriqueta Felip, Josep Tabernero, Rodrigo Dienstmann, Elena Garralda

Bibliographic record

VenueEuropean Journal of Cancer · 2021
Typearticle
Languageen
FieldMedicine
TopicCancer Immunotherapy and Biomarkers
Canadian institutionsnot available
FundersFoundation MedicinePharmacyclicsChugai PharmaceuticalGenentechSociedad Española de Oncología MédicaPharmaMarEuropean Society for Medical OncologyAstellas PharmaEisaiCancer Research UKSeagenCilagPuma BiotechnologyArog PharmaceuticalsEisai CanadaBeiGeneClovis OncologyTeva Pharmaceutical IndustriesLes Laboratories Pierre FabreRegeneron PharmaceuticalsIpsenArray BioPharmaMersana TherapeuticsExelixisKaryopharm TherapeuticsSymphogenPfizerIncyteGrifolsF. Hoffmann-La RocheAmgenDeciphera PharmaceuticalsTakeda OncologyHalozymeSanofiGlaxoSmithKlineCelgeneDaiichi Sankyo EuropeServierBayerAstraZenecaEli Lilly and CompanySamsungBristol-Myers Squibb
KeywordsMedicineCohortClinical endpointOncologyInternal medicineConfidence intervalClinical trialSurrogate endpoint

Abstract

fetched live from OpenAlex

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/.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.004
metaresearch head score (Gemma)0.003
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.845
Threshold uncertainty score0.471

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0040.003
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.106
GPT teacher head0.476
Teacher spread0.370 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNot applicable
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations5
Published2021
Admission routes1
Has abstractyes

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