Integrating biomarkers in colorectal cancer trials in the West and China

作者: Sabine Tejpar , Lin Shen , Xicheng Wang , Richard L. Schilsky

DOI: 10.1038/NRCLINONC.2015.88

关键词: MedicinePrecision medicineBiomarker (medicine)Clinical trialBiomarker discoveryData scienceEfficacyPharmacologyMEDLINEColorectal cancerPersonalized medicine

摘要: The discovery of biomarkers that provide information on drug efficacy is recognized as essential for successful and cost-effective treatment cancer. However, biomarker difficult, requires multiple independent studies to identify a target serves suitable predictor ensure appropriate validation. Clinical trials are performed, sometimes sequentially, in Europe, the USA or Asia, often similar their design, part owing regulatory, marketing, safety considerations. We believe some these offer additional unique opportunities There hurdles overcome, such homogenous tissue acquisition analysis, defining aligning hypotheses across trials, need adapt sample sizes trial designs. Nevertheless, we collaborative engagement academic, regulatory pharmaceutical community can go long way addressing issues producing more-rapid results field personalized medicine. In this Perspectives, describe our views current fragmented approach validation relevant run within own regions-that is, China, USA-and hope article base further reflection.

参考文章(37)
Sebastian Stintzing, Stefan Stremitzer, Ana Sebio, Heinz-Josef Lenz, Predictive and Prognostic Markers in the Treatment of Metastatic Colorectal Cancer (mCRC) Hematology/Oncology Clinics of North America. ,vol. 29, pp. 43- 60 ,(2015) , 10.1016/J.HOC.2014.09.009
C.H. Köhne, R. Labianca, T. Price, W. Scheithauer, A. Sobrero, J. Tabernero, D. Aderka, S. Barroso, G. Bodoky, J.Y. Douillard, H. El Ghazaly, J. Gallardo, A. Garin, R. Glynne-Jones, K. Jordan, A. Meshcheryakov, D. Papamichail, P. Pfeiffer, I. Souglakos, S. Turhal, A. Cervantes, H.J. Schmoll, E. Van Cutsem, A. Stein, V. Valentini, B. Glimelius, K. Haustermans, B. Nordlinger, C.J. van de Velde, J. Balmana, J. Regula, I.D. Nagtegaal, R.G. Beets-Tan, D. Arnold, F. Ciardiello, P. Hoff, D. Kerr, ESMO Consensus Guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making Annals of Oncology. ,vol. 23, pp. 2479- 2516 ,(2012) , 10.1093/ANNONC/MDS236
Volker Heinemann, Ludwig Fischer von Weikersthal, Thomas Decker, Alexander Kiani, Ursula Vehling-Kaiser, Salah-Eddin Al-Batran, Tobias Heintges, Christian Lerchenmüller, Christoph Kahl, Gernot Seipelt, Frank Kullmann, Martina Stauch, Werner Scheithauer, Jörg Hielscher, Michael Scholz, Sebastian Müller, Hartmut Link, Norbert Niederle, Andreas Rost, Heinz-Gert Höffkes, Markus Moehler, Reinhard U Lindig, Dominik P Modest, Lisa Rossius, Thomas Kirchner, Andreas Jung, Sebastian Stintzing, FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial Lancet Oncology. ,vol. 15, pp. 1065- 1075 ,(2014) , 10.1016/S1470-2045(14)70330-4
Rodrigo Dienstmann, Ramon Salazar, Josep Tabernero, None, The evolution of our molecular understanding of colorectal cancer: what we are doing now, what the future holds, and how tumor profiling is just the beginning. American Society of Clinical Oncology Educational book. American Society of Clinical Oncology. Annual Meeting. ,vol. 34, pp. 91- 99 ,(2014) , 10.14694/EDBOOK_AM.2014.34.91
Antonio Fabio Di Narzo, Pu Yan, John Graeme Hodgson, Scott Weinrich, Fred Bosman, Arnaud Roth, Mauro Delorenzi, Eva Budinska, Vlad Popovici, Sabine Tejpar, Giovanni D'Ario, Nicolas Lapique, Katarzyna Otylia Sikora, Gene expression patterns unveil a new level of molecular heterogeneity in colorectal cancer The Journal of Pathology. ,vol. 231, pp. 63- 76 ,(2013) , 10.1002/PATH.4212
Lin Shen, Jin Li, Jianming Xu, Hongming Pan, Guanghai Dai, Shukui Qin, Liwei Wang, Jinwan Wang, Zhenzhou Yang, Yongqian Shu, Ruihua Xu, Lei Chen, Yunpeng Liu, Shiying Yu, Lilian Bu, Yongzhe Piao, Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study) Gastric Cancer. ,vol. 18, pp. 168- 176 ,(2015) , 10.1007/S10120-014-0351-5
Jean-Yves Douillard, Kelly S Oliner, Salvatore Siena, Josep Tabernero, Ronald Burkes, Mario Barugel, Yves Humblet, Gyorgy Bodoky, David Cunningham, Jacek Jassem, Fernando Rivera, Ilona Kocákova, Paul Ruff, Maria Błasińska-Morawiec, Martin Šmakal, Jean Luc Canon, Mark Rother, Richard Williams, Alan Rong, Jeffrey Wiezorek, Roger Sidhu, Scott D Patterson, None, Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer The New England Journal of Medicine. ,vol. 369, pp. 1023- 1034 ,(2013) , 10.1056/NEJMOA1305275
Lisa M. McShane, Douglas G. Altman, Willi Sauerbrei, Sheila E. Taube, Massimo Gion, Gary M. Clark, Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) Journal of the National Cancer Institute. ,vol. 97, pp. 1180- 1184 ,(2005) , 10.1093/JNCI/DJI237
Jean-Yves Douillard, Salvatore Siena, James Cassidy, Josep Tabernero, Ronald Burkes, Mario Barugel, Yves Humblet, György Bodoky, David Cunningham, Jacek Jassem, Fernando Rivera, Ilona Kocákova, Paul Ruff, Maria Błasińska-Morawiec, Martin Šmakal, Jean-Luc Canon, Mark Rother, Kelly S Oliner, Michael Wolf, Jennifer Gansert, None, Randomized, Phase III Trial of Panitumumab With Infusional Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX4) Versus FOLFOX4 Alone As First-Line Treatment in Patients With Previously Untreated Metastatic Colorectal Cancer: The PRIME Study Journal of Clinical Oncology. ,vol. 28, pp. 4697- 4705 ,(2010) , 10.1200/JCO.2009.27.4860
Yung-Jue Bang, Eric Van Cutsem, Andrea Feyereislova, Hyun C Chung, Lin Shen, Akira Sawaki, Florian Lordick, Atsushi Ohtsu, Yasushi Omuro, Taroh Satoh, Giuseppe Aprile, Evgeny Kulikov, Julie Hill, Michaela Lehle, Josef Rüschoff, Yoon-Koo Kang, None, Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial The Lancet. ,vol. 376, pp. 687- 697 ,(2010) , 10.1016/S0140-6736(10)61121-X