The panel discussed 4 requests regarding the NCCN Guidelines for Gastric Cancer:
1. They removed docetaxel, carboplatin, and fluorouracil as a first-line therapy option based on a review of data.
2. They did not support adding nivolumab + ipilimumab as a second-line option for patients with high tumor mutational burden gastric cancer.
3. They added dabrafenib and trametinib as a second-line option for BRAF V600E mutated gastric cancer.
4. They deferred a submission requesting changes to genetic risk evaluation criteria until a future interim update is published.
The panel discussed 4 requests regarding the NCCN Guidelines for Gastric Cancer:
1. They removed docetaxel, carboplatin, and fluorouracil as a first-line therapy option based on a review of data.
2. They did not support adding nivolumab + ipilimumab as a second-line option for patients with high tumor mutational burden gastric cancer.
3. They added dabrafenib and trametinib as a second-line option for BRAF V600E mutated gastric cancer.
4. They deferred a submission requesting changes to genetic risk evaluation criteria until a future interim update is published.
The panel discussed 4 requests regarding the NCCN Guidelines for Gastric Cancer:
1. They removed docetaxel, carboplatin, and fluorouracil as a first-line therapy option based on a review of data.
2. They did not support adding nivolumab + ipilimumab as a second-line option for patients with high tumor mutational burden gastric cancer.
3. They added dabrafenib and trametinib as a second-line option for BRAF V600E mutated gastric cancer.
4. They deferred a submission requesting changes to genetic risk evaluation criteria until a future interim update is published.
and Request YES NO ABSTAIN ABSENT GAST-F (4 of 17) Based on a review of the data and discussion, the 0 24 1 8 Internal request panel consensus supported removing docetaxel, Reassess the data for docetaxel, carboplatin, and carboplatin, and fluorouracil as a first-line therapy fluorouracil as a first-line therapy option. option for patients with gastric cancer. GAST-F (5 of 17) Based on a review of the data and discussion, the 0 24 1 8 External request panel consensus did not support the inclusion of Submission from Bristol Meyers Squibb (04/11/22) nivolumab in combination with ipilimumab as a requesting the panel’s consideration of the enclosed data second-line or subsequent therapy option for and to include nivolumab in combination with ipilimumab as patients with tissue TMB-H (tTMB-H) gastric a treatment option for patients with tissue TMB-H (tTMB-H) cancer. gastric cancer who are refractory to standard therapies or have no standard treatment options available. GAST-F (5 of 17) Based on the review of the panel consensus was 24 0 1 8 Internal request to include dabrafenib and trametinib as a second- Consider adding Dabrafenib and trametinib as a second-line line or subsequent therapy option for BRAF or subsequent therapy option for the treatment of BRAF V600E mutated gastric cancer. This is a category V600E mutated gastric cancer. 2A, [useful in certain circumstances] recommendation.
Salama AKS, Li S, Macrae ER, et al. Dabrafenib
and Trametinib in Patients With Tumors With BRAF(V600E) Mutations: Results of the NCI- MATCH Trial Subprotocol H. J Clin Oncol 2020;38:3895-3904. GAST-D (1 of 7) The Panel consensus was to defer the submission 24 0 1 8 External request until the publication of a future interim update. Submission from Ambry Genetics, GeneDx (Sema4), illumina, Myriad Genetic Laboratories, Inc., Quest Diagnostics Laboratories requesting the following:
1. Recommend verbiage change regarding evaluation
of individuals presenting for risk assessment: a. Please substitute the first bullet point under “Criteria for Further Risk Evaluation for High-Risk Syndromes” as follows: Genetic risk assessment, counseling and germline genetic testing is clinically indicated for an individual with one or more of the following: 2. Recommend additional criteria for further risk evaluation for high-risk syndromes: NCCN Guidelines for Gastric Cancer V.1.2023 Annual on 08/30/22
a. Please add the following bullets to the list:
i. The presence of one or more pathogenic variants in known hereditary cancer genes detected through tumor testing. ii. If the tumor is determined to be MSI-High by PCR, NGS or other DNA analysis, or IHC analysis. 3. Request for clarification of existing criteria: a. Please reword and divide the last bullet under the “Or a family history of” section as follows to improve clarity: i. Gastric and breast cancer in a first or second degree relative, with one diagnosis before age 50, or ii. Gastric cancer at any age in a first or second degree relative, and a family history of juvenile polyps or gastrointestinal polyposis. b. On pages GAST-D 1 and GAST-D 2, some of the family history criteria are based on first- or second-degree relatives, and others based on “close relatives”, defined on page GAST-D 2 as first-, second- or third-degree relatives. Insert the following in footnote at the bottom of GAST-D1 to define a “close relative” A close relative is defined as a first-, second-, or third-degree relative. First-degree relatives include parents, siblings, and offspring. Second degree relatives include grandparents, aunts, and uncles. Third-degree relatives include cousins and great grandparents.