Selected Oncology References
Journal Articles
Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer, RJ. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/ pharmacodynamic meta-analysis. Cancer Chemother Pharmacol published online 5 December, 2009. DOI 10.1007/s00280-009-1170-y.
Claret L, Girard P, Hoff PM, Van Cutsem E, Zuideveld KP, Jorga K, Fagerberg J, Bruno R. Model-Based Prediction of Phase III Overall Survival in Colorectal Cancer on the Basis of Phase II Tumor Dynamics. Journal of Clinical Oncology published online ahead of print Jul 27 2009; 10.1200/JCO.2008.21.0807.
Bruno R, Claret L. On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies:
Toward a New Paradigm to Design and Evaluate Phase II Studies.
Clin Pharmacol Ther 86: 136-138; doi:10.1038/clpt.2009.97.
Lu JF, Bruno R, Eppler S, Novotny W, Lum B, Gaudreault J. Clinical pharmacokinetics of bevacizumab in patients with solid tumors. Cancer Chemotherapy and Pharamcology. 2008 Jan 19 [Epub ahead of print].
Lu JF, Eppler SM, Wolf J, Hamilton M, Rakhit A, Bruno R, Lum BL. Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Clin Pharmacol Ther. 2006 Aug;80(2):136-45.
Bruno R, Hille D, Riva A, et al. Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer. Journal of Clinical Oncology, Volume 16, 1998: 187-196. Selected as one “of the best papers regarding the clinical pharmacology of anticancer agents published in JCO during the past 10 years” and reprinted in Classic Papers and Current Comments - Highlights of Cancer Pharmacology Research, Ratain M.J. editor, 4 (1), 195-204, 1999.
Bruno R, Vivier N, Vergniol JC, et al. A population pharmacokinetic model for docetaxel (Taxotere): model building and validation. J Pharmacokinet Biopharm, Apr;24(2), 1996: 153-72.
Veyrat-Follet C, Bruno R, Olivares R, Rhodes GR, Chaiken P. Clinical trial simulation of docetaxel in patients with cancer as a tool for dosage optimization. Clin Pharmacol Ther, Dec;68(6), 2000: 677-87.
Presentations & Posters
Reck M, Kaiser R, Eschbach C, Stefanic M, Love J, Staab A, Freiwald M, Bruno R, Stopfer P, Gatzemeier U, Von Pawel J. A Phase II Double-Blind Study to Investigate Efficacy and Safety of the Triple Angiokinase Inhibitor BIBF 1120 in Patients Suffering from Relapsed Advanced Non-Small Cell Lung Cancer. [poster presentation]. Presented at: International Thoracic Oncology Congress Dresen (ITOCD); October 1-5, 2008; Dresden, Germany.
Bruno R, Claret L. On the Use and Value of Drug-Independent Survival Models to Support Clinical Drug Development in Oncology: Application of FDA's NSCLC Model. Quantitative Clinical Pharmacology: Critical Path Opportunities. FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; March 18-19, 2008; Rockville, MD.
Latz J, Claret L, Symanowski J, Falcoz C, Bruno R, Smith I, Calvert H. Evaluation of pemetrexed (PEM) dosing paradigms using exposure-response relationships (ERRs). [poster abstract 2530]. Presented at: 43rd ASCO Annual Meeting; June 1-5, 2007; Chicago, Illinois.
Claret L, Girard P, O'Shaughnessy J, Hoff P, Van Cutsem E, Blum J, Zuideveld KP, Jorga K, Fagerberg J, Bruno R. Model-based predictions of expected anti-tumor response and survival in phase III studies based on phase II data of an investigational agent. Proceedings of the American Society of Clinical Oncology, 24, 307s (abstract 6025); June 2006.
Claret L, Girard P, Zuideveld KP, Jorga K, Fagerberg J, Bruno R. A Longitudinal Model for Tumor Size Measurements in Clinical Oncology Studies. [poster presentation]. Annual Meeting of the Population Approach Group in Europe (PAGE); June 2006; Bruges, Belgium.
Houk B, Garrett M, Bello C, Poland B, Wagg J, Gao Y. Population Pharmacokinetics (PK) of Sunitinib Malate (SU11248) and Its Primary Metabolite (SU12662) in Oncology Patients and Healthy Volunteers [poster]. Presented at: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; November 14-18, 2005; Philadelphia, PA. Poster Abstract (B171) available at: http://www.aacr.org.
Houk B, Bello C, Garrett M, Poland B, Wagg J, Wada R, Motzer R, Rosen L, Demetri G. Population Pharmacokinetic (PK)-pharmacodynamic (PD) Meta-analysis of Sunitinib Malate (SU11248) Efficacy and Tolerability Endpoints in Gastrointestinal Stromal Tumor (GIST), Metastatic Renal Cell Carcinoma (MRCC), and Solid Tumor Patients [poster]. Presented at: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; November 14-18, 2005; Philadelphia, PA. Poster Abstract (B174) available at: http://www.aacr.org.