Litcius/Paper detail

Early predictions of response and survival from a tumor dynamics model in patients with recurrent, metastatic head and neck squamous cell carcinoma treated with immunotherapy

Ignacio Ferreira González, Vadryn Pierre, Vincent F. S. Dubois, Nassim Morsli, Stuart Spencer, Paul Baverel, Helen Moore

2021CPT Pharmacometrics & Systems Pharmacology14 citationsDOIOpen Access PDF

Abstract

We developed and evaluated a method for making early predictions of best overall response (BOR) and overall survival at 6 months (OS6) in patients with cancer treated with immunotherapy. This method combines machine learning with modeling of longitudinal tumor size data. We applied our method to data from durvalumab-exposed patients with recurrent/metastatic head and neck cancer. A fivefold cross-validation was used for model selection. Independent trial data, with various degrees of data truncation, were used for model validation. Mean classification error rates (90% confidence intervals [CIs]) from cross-validation were 5.99% (90% CI 2.98%-7.50%) for BOR and 19.8% (90% CI 15.8%-39.3%) for OS6. During model validation, the area under the receiver operating characteristic curves was preserved for BOR (0.97, 0.97, and 0.94) and OS6 (0.85, 0.84, and 0.82) at 24, 18, and 12 weeks, respectively. These results suggest our method predicts trial outcomes accurately from early data and could be used to aid drug development.

Topics & Concepts

MedicineConfidence intervalHead and neck cancerReceiver operating characteristicImmunotherapyOncologyInternal medicineHead and neckHead and neck squamous-cell carcinomaBasal cellPatient dataCancerSurgeryDatabaseComputer scienceStatistical Methods in Clinical TrialsLung Cancer Treatments and MutationsCancer Genomics and Diagnostics