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NCCN Guidelines for Soft Tissue Sarcoma V 1.2021 – Annual on 08/25/20

Guideline Page Institution Vote Panel Discussion/References

and Request YES NO ABSTAIN ABSENT SARC-F (1 of 9) The panel consensus was to include a category 2A 20 0 0 7 Internal request: preferred recommendation for trabectedin in other Preferred regimens, subsequent lines of therapy we subtypes. specifically say 2A for for other subtypes, what about trabectedin as a category 2A for other subtypes. SARC-F (1 of 9) The panel consensus was to include trabectedin (for 20 0 0 7 Internal request: myxoid liposarcoma) under useful in certain Consider adding trabectedin (for myxoid liposarcoma) circumstances for neoadjuvant/adjuvant therapy for under useful in certain circumstances. soft tissue sarcoma subtypes with non-specific histologies. This is a category 2A, useful in certain circumstances recommendation. SARC-F (1 of 9) The panel consensus was to move the regimen MAID 20 0 0 7 Internal request: (mesna, , , ) for Consider moving the regimen MAID (mesna, first-line therapy advanced/metastatic. This is a doxorubicin, ifosfamide, dacarbazine) from preferred, category 2A, useful in certain circumstances first-line therapy advanced/metastatic to useful in recommendation certain circumstances. SARC-F (1 of 9) The panel consensus was to move pembrolizumab 20 0 0 7 Internal request: from other recommended regimens for UPS to useful Suggest moving pembrolizumab from other in certain circumstances for subsequent lines of recommended regimens for UPS to useful in certain therapy for advanced/metastatic STS with non- circumstances for subsequent lines of therapy for specific histologies. This is a category 2A, useful in advanced/metastatic STS with non-specific histologies. certain circumstances recommendation. SARC-F (1 of 9) Based on a review of the data and discussion, the 0 20 0 7 External request: panel consensus was not to include pembrolizumab Foundation Medicine (6/23/20). Add pembrolizumab as as a treatment option under useful in certain a treatment option useful in certain circumstances for circumstances for patients with unresectable or patients with unresectable or metastatic tumors with metastatic tumors with tissue tumor mutational tissue tumor mutational burden-high (TMB-H) ≥10 burden-high (TMB-H) ≥10 mutations/megabase, as mutations/megabase, as determined by an FDA- determined by an FDA-approved test, who have approved test, who have progressed following prior progressed following prior treatment and who have treatment and who have no satisfactory alternative no satisfactory alternative treatment options. (SARC- treatment options. (SARC-F 1 of 9) and add a footnote F 1 of 9) and add a footnote referencing the referencing the validation standards published in validation standards published in Merino DM, et al. J Merino DM, et al. J Immunother Cancer Immunother Cancer 2020;8:e000147. 2020;8:e000147.

NCCN Guidelines for Soft Tissue Sarcoma V 1.2021 – Annual on 08/25/20

Guideline Page Panel Discussion/References Institution Vote and Request YES NO ABSTAIN ABSENT SARC-F (1 of 9) Based on a review of the data and discussion, the 0 20 0 7 External request: panel consensus was not to include pembrolizumab Foundation Medicine (6/23/20). Add pembrolizumab as as a treatment option under useful in certain a treatment option useful in certain circumstances for circumstances for patients with microsatellite patients with microsatellite instability-high (MSI-H) instability-high (MSI-H) cancer for the treatment of cancer for the treatment of adult and pediatric patients adult and pediatric patients with unresectable or with unresectable or metastatic, microsatellite metastatic, microsatellite instability-high (MSI-H) or instability-high (MSI-H) or mismatch repair deficient mismatch repair deficient tumors that have tumors that have progressed following prior treatment progressed following prior treatment and who have and who have no satisfactory alternative treatment no satisfactory alternative treatment options. options. SARC-F (2 of 9) Based on a review of the data and discussion, the 20 0 0 7 Internal request: panel consensus was to include extraskeletal Include extraskeletal osteosarcoma with ifosfamide or osteosarcoma as a subtype. platinum-based therapy (/doxorubicin). ifosfamide or platinum-based therapy (cisplatin/doxorubicin) are included as an option for extraskeletal osteosarcoma. This is a category 2A preferred recommendation. SARC-F (2 of 9) Based on a review of the data and discussion, the 20 0 0 7 Internal request: panel consensus was to include pazopanib as a Consider including pazopanib as a treatment option for treatment option for desmoid tumors. This is a desmoid tumors. category 2A preferred regimen for Time to response more critical recommendation. • Toulmonde M, et al. Pazopanib or - combination in adult patients with progressive desmoid tumors (DESMOPAZ): a non-comparative, randomize, open-label, multicentre, phase 2 study. Lancet Oncol. 2019;20:1263-1272. SARC-F (2 of 9) The panel consensus was to move the requested 20 0 0 7 Internal request: regimens from preferred to useful in certain Consider moving the following regimens for desmoid circumstances as follows: tumors: • Sulindac or other nonsteroidal anti- • Tamoxifen ± Sulindac inflammatory drugs (NSAIDs), including • Toremifene (for pain) This is a category 2A recommendation

NCCN Guidelines for Soft Tissue Sarcoma V 1.2021 – Annual on 08/25/20

Guideline Page Panel Discussion/References Institution Vote and Request YES NO ABSTAIN ABSENT SARC-F (3 of 9) The panel consensus was to include alternating 20 0 0 7 Internal request: ifosfamide and with , doxorubicin Consider adding ifosfamide and etoposide to and . vincristine, doxorubicin and cyclophosphamide for Non- Pleomorphic Rhabdomyosarcoma. SARC-F (3 of 9) The panel consensus was to remove the following 20 0 0 7 Internal request: regimens: Under Non-Pleomorphic Rhabdomyosarcoma consider Vincristine and removing the following regimens: Doxorubicin Vincristine and dactinomycin High-dose methotrexate Doxorubicin Trabectedin High-dose methotrexate Trabectedin SARC-F (4 of 9) Based on a review of the data and discussion, the 20 0 0 7 External request: panel consensus was to include brigatinib for Please consider the following update: Under Inflammatory Myofibroblastic tumor (IMT) with ALK Inflammatory Myofibroblastic tumor (IMT) with ALK Translocation. This is a category 2A preferred Translocation, Preferred regimens, ALK inhibitors: add recommendation. Brigatinib. SARC-F (5 of 9) Based on a review of the data and discussion, the 0 20 0 7 Internal request: panel consensus was not to include . Add abemaciclib to the useful under certain circumstances for Well-Differentiated/Dedifferentiated Liposarcoma. SARC-F (5 of 9) Based on a review of the data and discussion, the 0 20 0 7 External request: panel consensus was not to include pembrolizumab, Submission from Merck & Co., Inc. (4/29/20). We either 200 mg every 3 weeks or 400 mg every 6 request the inclusion of the updated dosing weeks administered as a 30-minute intravenous (IV) recommendations for pembrolizumab, either 200 mg infusion until disease progression, unacceptable every 3 weeks or 400 mg every 6 weeks administered toxicity, or up to 24 months for the treatment of adult as a 30-minute intravenous (IV) infusion until disease patients with microsatellite instability-high (MSI-H) progression, unacceptable toxicity, or up to 24 months soft tissue sarcoma. for the treatment of adult patients with microsatellite instability-high (MSI-H) soft tissue sarcoma. SARC-F (5 of 9) Based on a review of the data and discussion, the 0 20 0 7 External request: panel consensus was not to include pembrolizumab Submission from Merck & Co., Inc. (3/20/20). We in the treatment of advanced MSI-H soft tissue request that the recommendation for pembrolizumab in sarcoma be added as a category 2A based on the the treatment of advanced MSI-H soft tissue sarcoma efficacy data from the publication by Marabelle et al. NCCN Guidelines for Soft Tissue Sarcoma V 1.2021 – Annual on 08/25/20

be added as a category 2A based on the efficacy data from the publication by Marabelle et al.

NCCN Guidelines for Soft Tissue Sarcoma V 1.2021 – Annual on 08/25/20

Guideline Page Panel Discussion/References Institution Vote and Request YES NO ABSTAIN ABSENT SARC-F (5 of 9) Based on a review of the data and discussion, the 0 20 0 7 External request: panel consensus was not to include the updated Submission from Merck & Co., Inc. (3/11/20). We publication by Marabelle et al, be used as a reference request that the updated publication by Marabelle et al, in the NCCN Guidelines for MSI-H sarcoma and be used as a reference in the NCCN Guidelines for recommendation for pembrolizumab be a category MSI-H sarcoma and recommendation for 2A. pembrolizumab be a category 2A.