IASLC Sept 2013 | Page 62

Chapter 9
Guidelines and Standardization Studies
By Yasushi Yatabe, Sylvie Lantuéjoul, Erik Thunnissen, Keith Kerr, and Ming Sound Tsao

With the development of ALK targeted therapy for NSCLC, several oncology and pathology organizations around the world have established recommendations for ALK testing, either as stand-alone documents or as part of broader guidelines on molecular testing. In addition, several regional or international multicenter studies have been conducted to standardize ALK testing protocols across laboratories.

Guidelines
Guidelines for molecular testing on lung cancer specimens may include clinical and methodologic recommendations. In 2011, the European Society for Medical Oncology (ESMO) noted that routine ALK testing could not be recommended at that time, but acknowledged that emerging data may lead to a clinical indication for such testing (Felip 2011). Since then, several expert groups have published consensus opinion and recommendations for molecular testing in lung cancer, including testing for ALK gene rearrangement (Table 1). The most comprehensive guideline is the result of a collaborative effort by experts representing CAP, IASLC, and AMP. This effort was based on a systematic review of studies published before February 2012. (See Appendix 2 for a summary of the recommendations in this guideline.) The guideline recomm V?G2F?B??F?V?G2v?F?Gf?6VB?44?2&RFW7FVBf?"?vV?R&V'&?vV?V?B?bF?RGV??"?2?bFV??6&6????7V'G?R?"?2?FV??6&6????6????V?B?FW7F??rf?"?vV?R&V'&'&?vV?V?B6??V?B?6?&RW&f?&?VB?bF?R7V6??V??26????B?FV??6&6????6????V?B6???B&RW?6?VFVB????FV??#2??6???"F?FW7F??rf?"F?RTte"?WFF?????B?2?V6W76'?f?"F????v?7BF?&R??f??fVB??F?R6V?V7F????bF?77VR6??W2F?FWFW&??RF?RFWV7??b7V6??V?2?F?R7W'&V?BFW7F??r?WF??F???w??b6???6R?2F?R?d?4?'&V??'B76??g?6?2?4?'&V?'Bd?4?&?&R??B?&&?GB???V7V?"??v??6??27W'&V?F?F?R???U2dD?&?fVBFW7BF?FWFW&??RV?v?&??G?f?"G&VF?V?Bv?F?????&?F?"???vWfW"?F?RwV?FV??R7FFW2F?B???26?&RW6VBf?"?67&VV???r?bf?FFVB??276??2W6VB?7F?F&F??F???7GVF?W0???F?RV??FVB7FFW2?F?R?&V?f?"7&???F???"??FW2F?R&WV?&V?V?Bf?"?FW7F??rv?F?U2dD&?fVB76??7W'&V?F??F?R?d?4?'&V??'B76??&&?GB???V7V?"??2F?R???7V6?&?fVB?d?4?76?????F?W"'G2?bF?Rv?&?B?&VwV?F?'?vV?6?W2F???B??FFRF?RW6R?b7V6?f?2?WF??B'WBF?W?F?&WV?&RF?RW6R?bf?FFVB76????F?W6R6?V?G&?W2??F?W"?WF??G2?"76?2??&RW6VB?bF?W??fR&VV?7F?F&F??VBF?FWFV7B?vV?R&V'&?vV?V?B?F?RW?W'@??