REVIEW OF NCCN GUIDELINES FOR NSCLC DX & TX

Review of NCCN guidelines for treatment of non-small cell lung cancer (NSCLC), with a focus on next generation sequencing.

1. NCCN REVIEW DO STRATEGY NSCLC

2. NCCN….. WHO are they? NCCN Guidelines….. What are they? Why are they followed? The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. By defining and advancing high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers around the world. AND THEY ARE FREE FOR EVERYONE. All you need is a valid email to create an account

3. NCCN GUIDELINES BY CANCER TYPE NAVIGATION https://www.nccn.org/guidelines/category_1

4. PATIENT & PROVIDER JOURNEY BEGINS CLINICAL PRESENTATION: EARLY STAGE

5. CLINICAL PRESENTATION: METASTATIC

6. PROGRESSION EXAMPLES OF FREQUENCY OF RECOMMENDED NGS

7. WHEN DO I USE IT? What does NCCN say about CONCURRENT? Broad molecular profiling should be considered at progression for genomic resistance mechanisms. …. historically, providers would just put a pt on the next line of therapy. This was SOC. It is new to them to biopsy again and again. If plasma testing is negative, tissue- rebiopsy is strongly recommended. “Practitioners may want to consider scheduling the biopsy concurrently with plasma testing referral.”

8. MORE PROGRESSION SAME VERBAGE IS ON ALL RECOMMENDATIONS AT PROGRESSION

9. We have all heard this once or twice: What about patient anxiety about delaying treatment start?

10. Identification of effective targeted therapy…..patient lives longer Avoidance of tx with no clinical benefit….. Less financial toxicity for the patient Cost savings to the health plan. “Not all types of alterations are detected by individual NGS assays” Even in cases where rapid testing was warranted, still follow with broad based.

11. Major elements of molecular testing CRITICAL for utilization of results Understanding what constitutes informative vs null results Opportunity for path to educate on best specimen: free standing IR? Pulmonology/thoracic? Ask Provider how often they have to send their patient for biopsy?

12. PRINCIPLES OF PATHOLOGICAL REVIEW: IHC CONSIDERATIONS

13. PATHOLOGICAL EVALUATION Is it cytology intended for initial dx? Cytology: make dx and preserve tissue. Is it a resection? Is it for molecular eval of established NSCLC dx? Preservation of material is CRITICAL. Minimize the number of IHC done IHC ONLY IN SUSPECTED SMALL CELL to preserve tissue

14. Just so you know what you are up against Mario’s Rebuttal here

15. O Limitations of ctDNA testing (everyone except us) that can impact interpretation include: Low tumor fraction/ ctDNA ; some assays include a measure of ctDNA fraction, which identifies situations in which low ctDNA fraction suggests compromised sensitivity………….. If the test does not have tumor fraction, how do you know if its valid> For stages I—III, tissue-based testing is preferred.. Studies have demonstrated ctDNA and tissue testing to have very high specificity. Both ctDNA and tissue testing have appreciable false- negative rates, supporting the complementarity of these approaches data support complementary testing to reduce turnaround time and increase yield Of targetable alteration detection .