NCCN Guidelines for Prostate V Meeting on 06/28/18

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1 Guideline Page and Request PROS-2 through PROS-11 and PROS-D (pages 3 and 4). External request from GenomeDx Biosciences Request the NCCN Prostate Cancer Guidelines Panel to review the data in support for inclusion of additional data for the tumor tissue-based molecular assay (Decipher) in the NCCN Clinical Practice Guidelines for localized prostate cancer. PROS-2: suggest addition of the use of gene expression testing for unfavorable intermediate or high risk prostate cancer. PROS-4 through PROS-8: When adverse pathological features are present after prostatectomy, suggest the inclusion of bullet points to calculate nomogram predictors of clinical or biochemical progression (i.e. CAPRA-S which has been validated in this setting) and additionally a bullet point for the Decipher as an independent prognostic marker that can augment the accuracy of these nomograms. PROS-12: suggest adding reference. PROS-D 3 OF 5: suggest the addition to footnote b stating that Decipher assay can be considered to provide an additional independent measure of metastasis risk. PROS-D 4 OF 5: For patients considering postprostatectomy radiation therapy, we suggest adding the statement, Men with adverse risk features after RP may consider the use of Decipher. Retrospective studies have shown that Decipher performed on RP specimens provides likelihood of prostate cancer-specific mortality, metastasis and biochemical failure. PROS-3 Consider changing footnote to Consider the use of tumor-based molecular assays (Decipher, Oncotype Panel Discussion/References consensus did not support the addition of these specific recommendations into the Guidelines. consensus did not support the addition of these specific recommendations into the Guidelines Institution Vote YES NO ABSTAIN ABSENT

2 DX, Prolaris, and ProMark) in men with low or favorable intermediate risk disease with life expectancy of 10 y PROS-3 Request modifying footnote by inserting the following sentence Consider germline testing when personal history of high-grade prostate cancer (Gleason score 7) at any age with 1 close blood relative with ovarian carcinoma of any age or breast cancer 50 y or two relatives with breast, pancreatic, or prostate cancer (Gleason score 7 or metastasis) at any age. PROS-4 PROS-8 Internal request from NCCN Institutional Review. Post radical prostatectomy with adverse features and no lymph node metastases the current recommendation is EBRT or observation. Suggest changing to: EBRT ± ADT (6 mo) or observation. ADT should be considered with the RT even if lymph node negative. PROS-8 External request from Kansas City Urology Care, PA Request to review the data for inclusion of abiraterone acetate in the management of prostate cancer patients on ADT with high-risk prostate cancer. PROS-8 Internal request from NCCN Institutional Review. Request removing docetaxel based on insufficient data in this setting. did not use the language proposed in the submission. However, the panel supported the following language: Family history for known germline variants and genetic testing for germline variants should include MLH1, MSH2, MSH6, and PMS2 (for Lynch syndrome) and homologous recombination genes BRCA1, BRCA2, ATM, PALB2, and CHEK2. Consider cancer predisposition NGS panel testing, which includes BRCA2, BRCA1, ATM, CHEK2, PALB2, MLH1, MSH2, MSH6, and PMS2. Additional genes may be appropriate depending on clinical context. For example, HOXB13 is a prostate cancer risk gene that does not have clear therapeutic implications in advanced disease, but testing may be valuable for family counseling. Based on discussion, the panel consensus supported the addition of this specific recommendation into the guidelines. Based on insufficient data and discussion, the panel consensus supported removing the following footnote from the guidelines: Six cycles of docetaxel every 3 weeks with concurrent steroid may be administered after completion of radiation in selected patients who are fit for chemotherapy.

3 PROS-10 Request the Prolaris Post-RP test for biochemical recurrence be included under Monitoring following Initial definitive therapy. PROS-14 External request from Janssen Biotech, Consider adding a footnote to systemic therapy for M0 Castration-Resistant Prostate Cancer (CRPC) algorithm. Currently, there are no specific recommendations in the apalutamide prescribing information regarding treatment discontinuation based on disease progression. In SPARTAN, the phase 3, randomized, double-blind, placebocontrolled, multicenter study evaluation the efficacy and safety of apalutamide compared to placebo in patients with highrisk NM-CRPC receiving continuous ADT, treatment with apalutamide was continued until radiographic disease progression confirmed by blinded central imaging review, locoregional-only progression, initiation of new treatment, unacceptable toxicity, or withdrawal. PSA results were blinded and were not used for treatment discontinuation. PROS-17 and -18 External request from Epic Sciences, Request the panel consider strengthening the footnote language around utilization of nuclearlocalized AR-V7 testing given the literature and consider algorithm placement and table insertion of AR-V7 testing. PROS-B (page 3) External request from Blue Earth Diagnostics, Request NCCN clarify statement on PROS-B and the implication that F-18 fluciclovine has generally poor diagnostic performance at PSA values < 2.0 ng/ml, as this statement is inconsistent with the Based on the data in the noted references and discussion, the panel supported changing the footnote as follows: Consider AR-V7 testing to help guide selection of therapy (See Discussion). See Submission for Reference Based on the data in the noted references and discussion, the panel supported removing the following statement: Performance is generally poor at low PSA where pre-test probability of disease is low (PSA <2.0 ng/ml) and where salvage treatment is most likely to be beneficial.

4 FDA-approved label, the reported clinical findings and increasing clinical experience. PROS-D (page 1) External request from Prostate Health Education Network (PHEN) Suggest strengthening the current guideline statement by changing Perirectal spacer materials may be employed to is recommended to be employed PROS-F page 3 of 4 External request from Janssen Biotech, Suggest revising for apalutamide: No significant difference was seen in overall survival to Overall survival data were not mature at the time of final analysis for metastasis-free survival (24% of the required number of events). PROS-G (page 3) External request from PHEN Both denosumab and zolendronic acid are designated as category 1 in the guidelines for treatment of bone metastases. However the guidelines states: when compared to zolendronic acid, denosumab was shown to be superior in prevention of skeletal-related events. Consider listing denosumab as preferred. consensus was edit the current language to read: No significant difference was seen in overall survival at the first interim analysis. consensus supported the addition of this specific

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