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Simulations Using a Drug–Disease Modeling Framework and Phase II Data Predict Phase III Survival Outcome in First‐Line Non–Small‐Cell Lung Cancer
Author(s) -
Claret L,
Lu JF,
Bruno R,
Hsu CP,
Hei YJ,
Sun YN
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.78
Subject(s) - bevacizumab , paclitaxel , carboplatin , lung cancer , medicine , hazard ratio , oncology , confidence interval , drug , clinical pharmacology , disease , pharmacology , cancer , chemotherapy , cisplatin
Simulations were performed for carboplatin/paclitaxel (C/P) plus motesanib or bevacizumab vs. C/P as first‐line treatment for advanced non–small‐cell lung cancer (NSCLC) using a published drug–disease model. With 700 patients in each arm, simulated hazard ratios for motesanib (0.87; 95% confidence interval [CI], 0.71–1.1) and bevacizumab (0.89; 95% CI, 0.73–1.1) agreed with results from the respective phase III studies but did not discriminate between failed and successful studies. The current model may require further enhancement to improve its utility for predicting phase III outcomes. Clinical Pharmacology & Therapeutics (2012); 92 5, 631–634. doi: 10.1038/clpt.2012.78