NCCN Non Small Cell Lung Cancer V Meeting July 18, 2014

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1 External request: Consider a position statement of the Fleischner Society, an international, multidisciplinary medical society for thoracic radiology, which makes its own recommendations for the follow up of pulmonary nodules found incidentally for incorporation into the guidelines. For patients with stage IIIA disease, include a statement mentioning FDG PET/CT can be used in lieu of contrast enhanced CT alone in those patients with allergies to iodinated intravenous contrast or poor renal function precluding the safe administration of iodinated intravenous contrast. External request: Recommend adding results from molecular testing for tumor aggressiveness using independently validated RNA expression based prognostic signatures to the list of high risk factors cited for consideration when determining treatment options for patients with stage IB lung adenocarcinoma. submission, the panel consensus was to make no changes to the current recommendations. submission, the panel consensus was to make no changes to the current recommendations.

2 NSCL 2 Internal request: Add recommendation for neoadjuvant therapy as an alternate for patients that would receive adjuvant therapy. The panel consensus was to add the following footnote: After surgical evaluation, patients likely to receive adjuvant chemotherapy may be treated with induction chemotherapy as an alternative NSCL 13 for oligometastases, oligorecurrence and oligoprogression to create additional NSCLC stage IV M1a and M1b treatment sub categories for oligometastases, and corresponding new oligometastases, oligorecurrence, and oligoprogression. submission, the panel consensus was to add a footnote: Aggressive local therapy may be appropriate for selected patients with limited site oligometastatic disease. See submission for references NSCL 14 External request: Suggest adding a statement that If FDG PET/CT is to be used as a problem solving tool in the post radiation therapy patient, histopathologic confirmation of recurrent disease is needed given areas treated previously with radiation therapy can remain FDG avid for up to 2 years after treatment. NSCL 17 for erlotinib + bevacizumab versus erlotinib alone as first line treatment for patients with advanced EGFR mutation positive non squamous NSCLC. The panel consensus was to add the following footnote: FDG PET/CT is currently not warranted in the routine surveillance and follow up of patients with NSCLC. However, many benign conditions (such as atelectasis, consolidation, and radiation fibrosis) are difficult to differentiate from neoplasm on standard CT imaging, and FDG PET/CT can be used to differentiate true malignancy in these settings. However, if FDG PET/CT is to be used as a problem solving tool in patients after radiation therapy, histopathologic confirmation of recurrent disease is needed because areas previously treated with radiation therapy can remain FDG avid for up to 2 years. of erlotinib + bevacizumab as a first line treatment option for advanced EGFR mutation positive non squamous non smallcell lung cancer. See submission for references See submission for references

3 NSCL 17/NSCL 18 Internal request: consider changing second line/third line therapy to subsequent therapy, since the line of therapy may vary based on previous treatment with targeted agents. NSCLC 18 for ceritinib as a treatment option for patients with ALK+ metastatic NSCLC without prior treatment with an ALK inhibitor. The panel consensus was to change second line and third line therapy to subsequent therapy. For progressive disease with multiple symptomatic systemic lesions, recommendation is for treatment with first line Adenocarcinoma or Squamous cell carcinoma therapy options. If there is second disease progression after subsequent therapy with erlotinib, afatinib, crizotinib, or ceritinib, the recommendation is for treatment with first line Adenocarcinoma or Squamous cell carcinoma therapy options. of ceritinib for the treatment of patients with ALK+ metastatic NSCLC without prior treatment with an ALK inhibitor NSCL 18 Internal request: Vote on the category designation for crizotinib. panel consensus supported crizotinib for ALK rearrangement discovered prior to first line chemotherapy as a category 1 recommendation. Shaw AT, Yeap BY, Solomon BJ, et al. Effect of crizotinib on overall survival in patients with advanced non small cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis. Lancet Oncol 2011;12: NSCL 19 for maintenance bevacizumab + pemetrexed for patients with advanced nonsquamous NSCLC. submission, the panel consensus was to make no change to the current recommendation for maintenance bevacizumab + pemetrexed for patients with advanced nonsquamous NSCLC.

4 Internal request: Revote on the recommendation for cetuximab/vinorelbine/cisplatin as a treatment option in first line therapy for advanced NSCLC and maintenance therapy with cetuximab. External request: Consider the inclusion of a serum proteomic test that is both prognostic and predictive, as a recommendation to help guide decisions regarding 2nd line treatment for advanced NSCLC. The panel consensus supported the removal of cetuximab/vinorelbine/cisplatin as a treatment option in firstline therapy and maintenance therapy for advanced NSCLC. panel consensus was to add the following footnote: Recommend proteomic testing for patients with NSCLC and wild type EGFR or with unknown EGFR status. A patient with a poor classification should not be offered erlotinib in the second line setting. Gregorc V, Novello S, Lazzari C, et al. Predictive value of a proteomic signature in patients with non small cell lung cancer treated with second line erlotinib or chemotherapy (PROSE): a biomarker stratified, randomised phase 3 trial. Lancet Oncol 2014; 15: Internal request: Discuss whether ramucirumab + docetaxel should be added as an option for in secondline therapy. panel consensus was to add ramucirumab + docetaxel as a treatment option after progression on first line therapy as a category 2B recommendation. Garon EB, CiuleanuTE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second line treatment of stage IV non small cell lung cancer after disease progression on platinum based therapy (REVEL): a multicentre, double blind, randomised phase 3 trial. Lancet 2014;384: NSCL D for erlotinib as a treatment option in the adjuvant setting for patients with EGFR+ NSCLC. of erlotinib for the treatment of patients with EGFR+ NSCLC.

5 NSCL H for the agents listed in the table Emerging Targeted Agents for Patients With Genetic Alterations The panel voted on each agent noted in the table. The results are noted below. targeted at HER2 mutations (trastuzumab, afatinib) changed from a category 2A to a category 2B. See submission for references targeted at BRAF mutations (vemurafenib, dabrafenib) remained a category 2A targeted at MET amplification (crizotinib) remained a category 2A targeted at ROS1 rearrangements (crizotinib) remained a category 2A targeted at RET rearrangements (cabozantinib) changed from a category 2A to a category 2B