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NCCN Guidelines for Central Nervous System Cancers V.1.2019 –Follow-Up Email Vote on 01/26/19

Guideline Page Panel Discussion/References Institution Vote and Request YES NO ABSTAIN ABSENT

ASTR-1 Based on the data in the noted references, the panel consensus was to include 19 0 2 8 Internal request: Consider (as an example of an mTOR inhibitor) to be included as an adjuvant everolimus (as an example treatment option for patients with subependymal giant cell astrocytoma (SEGA). of an mTOR inhibitor) to be This is a category 2A recommendation. included as an adjuvant  Franz DN, Belousova E, Sparagana S, et al. Everolimus for treatment option for subependymal giant cell astrocytoma in patients with tuberous sclerosis patients with subependymal complex: 2-year open-label extension of the randomised EXIST-1 study. giant cell astrocytoma Lancet Oncol 2014;15:1513-1520. (SEGA).  Franz DN, Belousova E, Sparagana S, et al. Efficacy and safety of everolimus for subependymal giant cell astrocytomas associated with tuberous sclerosis complex (EXIST-1): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet 2013;381:125-132.

LEPT-2 The panel consensus was to include the changes to the treatment algorithms for 18 2 2 7 Internal request: Please leptomeningeal metastases. review the edits made to the treatment algorithms on this page for clarity.

BRAIN-D (4 of 13) Based on the data in the noted reference, the panel consensus was to include 15 3 4 7 Internal request: + temozolomide as a treatment option for progression of recurrent Should consideration of disease in patients with adult intracranial and/or spinal ependymoma. This is a lapatinib + temozolomide category 2B recommendation. be included as a treatment  Gilbert M, Yuan Y, Wani K, et al. AT-23 a phase II study of lapatinib and option for progression of dose-dense temozolomide (TMZ) for adults with recurrent ependymoma: recurrent disease in a CERN clinical trial. Neuro-Oncology 2014;16:v13-v13. patients with adult intracranial and/or spinal ependymoma?

NCCN Guidelines for Central Nervous System Cancers V.1.2019 –Follow-Up Email Vote on 01/26/19

BRAIN-D (7 of 13) Based on the data in the noted reference, the panel consensus was to include 19 2 1 7 Should be nivolumab as a treatment option for select patients (eg, patients with small included as a treatment asymptomatic brain metastases) with limited brain metastases from melanoma option for select patients with newly diagnosed disease or stable systemic disease or reasonable systemic (eg, patients with small treatment options. This is a category 2A recommendation. asymptomatic brain  Long GV, Atkinson V, Lo S, et al. Combination nivolumab and metastases) with limited or nivolumab alone in melanoma brain metastases: a brain metastases from multicentre randomised phase 2 study. Lancet Oncol 2018;19:672-681. melanoma with newly diagnosed disease or stable systemic disease or reasonable systemic treatment options?

BRAIN-D (7 of 13) Based on the data in the noted references, the panel consensus was to include Should nivolumab, the following for select patients (eg, patients with small asymptomatic brain (ALK metastases) with limited brain metastases from non-small cell with rearrangement-positive newly diagnosed disease or stable systemic disease or reasonable systemic disease only), and treatment options: (ALK rearrangement- positive disease only) be Nivolumab (category 2B) 17 5 0 7 included as treatment  Gauvain C, Vauleon E, Chouaid C, et al. Intracerebral efficacy and options for select patients tolerance of nivolumab in non-small-cell lung cancer patients with brain (eg, patients with small metastases. Lung Cancer 2018;116:62-66. asymptomatic brain  Goldman JW, Crino L, Vokes EE, et al. P2.36: Nivolumab (nivo) in metastases) with limited patients (pts) with advanced (adv) NSCLC and central nervous system brain metastases from non- (CNS) metastases (mets). J Thorac Oncol 2016;11:S238-S239. small cell lung cancer with  Rizvi NA, Mazieres J, Planchard D, et al. Activity and safety of newly diagnosed disease or nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with stable systemic disease or advanced, refractory squamous non-small-cell lung cancer (CheckMate reasonable systemic 063): a phase 2, single-arm trial. Lancet Oncol 2015;16:257-265. treatment options? Brigatinib (ALK rearrangement-positive) (category 2A) 18 2 2 7  Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus in ALK- positive non-small-cell lung cancer. N Engl J Med 2018;379:2027-2039.

Ceritinib (ALK rearrangement-positive) (category 2B) 16 4 2 7  Kim DW, Mehra R, Tan DSW, et al. Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase 1 trial. Lancet Oncol 2016;17:452-463.

NCCN Guidelines for Central Nervous System Cancers V.1.2019 –Follow-Up Email Vote on 01/26/19

BRAIN-D (7 of 13) Based on the data in the noted references, the panel consensus was to include Should cisplatin/etoposide, the following for patients with recurrent brain metastases from breast cancer (if capecitabine/, extensive brain metastases, stable systemic disease or reasonable systemic capecitabine/lapatinib, and treatment options exist: paclitaxel/neratinib be included as treatment Capecitabine + lapatinib (HER2-positive) (category 2A) 19 1 2 7 options for patients with  Bachelot T, Romieu G, Campone M, et al. Lapatinib plus capecitabine in recurrent brain metastases patients with previously untreated brain metastases from HER2-positive from breast cancer (if metastatic breast cancer (LANDSCAPE): a single-group phase 2 study. extensive brain Lancet Oncol 2013;14:64-71. metastases, stable  Petrelli F, Ghidini M, Lonati V, et al. The efficacy of lapatinib and systemic disease or capecitabine in HER-2 positive breast cancer with brain metastases: A reasonable systemic systematic review and pooled analysis. Eur J Cancer 2017;84:141-148. treatment options exist, HER2-positive disease only Capecitabine + neratinib (HER2-positive) (category 2B) 15 3 4 7 except for  Freedman RA, Gelman RS, Melisko ME, et al. TBCRC 022: phase II trial cisplatin/etoposide)? of neratinib + capecitabine for patients (Pts) with human epidermal receptor 2 (HER2+) breast cancer brain metastases (BCBM). J Clin Oncol 2017;35:1005-1005.

Paclitaxel + neratinib (HER2-positive) (category 2B) 14 5 3 7  Awada A, Colomer R, Inoue K, et al. Neratinib plus paclitaxel vs plus paclitaxel in previously untreated metastatic ERBB2- positive breast cancer: the NEfERT-T randomized clinical trial. JAMA Oncol 2016;2:1557-1564.

Cisplatin + etoposide (category 2B) 13 4 5 7  Franciosi V, Cocconi G, Michiara M, et al. Front-line with cisplatin and etoposide for patients with brain metastases from breast carcinoma, nonsmall cell lung carcinoma, or malignant melanoma: a prospective study. Cancer 1999;85:1599-1605.  Vinolas N, Graus F, Mellado B, et al. Phase II trial of cisplatinum and etoposide in brain metastases of solid tumors. J Neurooncol 1997;35:145-148.

NCCN Guidelines for Central Nervous System Cancers V.1.2019 –Follow-Up Email Vote on 01/26/19

BRAIN-D (7 of 13) The panel consensus was to include nivolumab as a treatment option for patients 20 1 1 7 Should nivolumab be with recurrent brain metastases from melanoma (if extensive brain metastases, included as a treatment stable systemic disease or reasonable systemic treatment options exist). This is option for patients with a category 2A recommendation. recurrent brain metastases from melanoma (if extensive brain metastases, stable systemic disease or reasonable systemic treatment options exist)?

BRAIN-D (7 of 13) Should be The panel consensus was to include pembrolizumab as a treatment option for 20 1 1 7 included as a treatment patients with recurrent brain metastases from PD-L1 positive non-small cell lung option for patients with cancer (if extensive brain metastases, stable systemic disease or reasonable recurrent brain metastases systemic treatment options exist). This is a category 2A recommendation. from PD-L1 positive non-  Goldberg SB, Gettinger SN, Mahajan A, et al. Pembrolizumab for small cell lung cancer (if patients with melanoma or non-small-cell lung cancer and untreated extensive brain brain metastases: early analysis of a non-randomized, open-label, phase metastases, stable 2 trial. Lancet Oncol 2016;17:976-983. systemic disease or reasonable systemic treatment options exist)?