Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer.

作者: Shakun M. Malik , Richard Pazdur , Jeffrey S. Abrams , Mark A. Socinski , William T. Sause

DOI: 10.1097/JTO.0000000000000314

关键词: Alternative medicineCancerSteering committeePathologyMedical physicsLung cancerFood and drug administrationClinical trialMedicine

摘要: On February 2, 2012, the National Cancer Institute (NCI) sponsored a 2-day workshop with NCI Thoracic Malignancies Steering Committee and Food Drug Administration to bring together leading academicians, clinicians, industry government representatives identify challenges potential solutions in clinical development of novel targeted therapies for lung cancer. Measures success are rapidly evolving from scientific regulatory perspective objectives this were achieve initial consensus on high priority biomarker-driven trial designed assess activity agents molecularly defined cancer subsets facilitate generation data approval these new therapies. Additionally, meeting focused identification barriers conduct such strategies overcome those barriers. The “Lung Master Protocols” recently launched by direct outcome workshop.

参考文章(32)
Stephen L. George, Xiaofei Wang, Targeted Clinical Trials Designs for Clinical Trials. pp. 157- 177 ,(2012) , 10.1007/978-1-4614-0140-7_7
Bruce E. Johnson, Pasi A. Jänne, Epidermal Growth Factor Receptor Mutations in Patients with Non–Small Cell Lung Cancer Cancer Research. ,vol. 65, pp. 7525- 7529 ,(2005) , 10.1158/0008-5472.CAN-05-1257
Boris Freidlin, Edward L. Korn, Biomarker enrichment strategies: matching trial design to biomarker credentials Nature Reviews Clinical Oncology. ,vol. 11, pp. 81- 90 ,(2014) , 10.1038/NRCLINONC.2013.218
Edward S Kim, Roy S Herbst, Ignacio I Wistuba, J Jack Lee, George R Blumenschein Jr, Anne Tsao, David J Stewart, Marshall E Hicks, Jeremy Erasmus Jr, Sanjay Gupta, Christine M Alden, Suyu Liu, Ximing Tang, Fadlo R Khuri, Hai T Tran, Bruce E Johnson, John V Heymach, Li Mao, Frank Fossella, Merrill S Kies, Vassiliki Papadimitrakopoulou, Suzanne E Davis, Scott M Lippman, Waun K Hong, None, The BATTLE Trial: Personalizing Therapy for Lung Cancer Cancer Discovery. ,vol. 1, pp. 44- 53 ,(2011) , 10.1158/2159-8274.CD-10-0010
William Pao, Katherine E Hutchinson, Chipping away at the lung cancer genome Nature Medicine. ,vol. 18, pp. 349- 351 ,(2012) , 10.1038/NM.2697
AD Barker, CC Sigman, GJ Kelloff, NM Hylton, DA Berry, LJ Esserman, I‐SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy Clinical Pharmacology & Therapeutics. ,vol. 86, pp. 97- 100 ,(2009) , 10.1038/CLPT.2009.68
Gabriella Farina, Flavia Longo, Olga Martelli, Ida Pavese, Andrea Mancuso, Luca Moscetti, Roberto Labianca, Alessandro Bertolini, Enrico Cortesi, Antonio Farris, Daniele Fagnani, Maria Cristina Locatelli, Giuseppe Valmadre, Antonio Ardizzoia, Maurizio Tomirotti, Eliana Rulli, Marina Chiara Garassino, Alberto Scanni, Rationale for treatment and study design of tailor: a randomized phase III trial of second-line erlotinib versus docetaxel in the treatment of patients affected by advanced non-small-cell lung cancer with the absence of epidermal growth factor receptor mutations. Clinical Lung Cancer. ,vol. 12, pp. 138- 141 ,(2011) , 10.1016/J.CLLC.2011.03.008
Edward L. Korn, Boris Freidlin, Jeffrey S. Abrams, Overall Survival As the Outcome for Randomized Clinical Trials With Effective Subsequent Therapies Journal of Clinical Oncology. ,vol. 29, pp. 2439- 2442 ,(2011) , 10.1200/JCO.2011.34.6056
Ying Yuan, Guosheng Yin, On the Usefulness of Outcome-Adaptive Randomization Journal of Clinical Oncology. ,vol. 29, ,(2011) , 10.1200/JCO.2010.34.5330
Elizabeth Mansfield, Timothy J. O'Leary, Steven I. Gutman, Food and Drug Administration Regulation of in Vitro Diagnostic Devices The Journal of Molecular Diagnostics. ,vol. 7, pp. 2- 7 ,(2005) , 10.1016/S1525-1578(10)60002-5