Table 6.
Recommendations | Level |
---|---|
CQ1: Targets of NTRK fusion testing | |
CQ1-1. Is NTRK fusion testing recommended for patients with metastatic/recurrent solid cancers? | |
1. NTRK fusion testing is not recommended for patients with solid cancers that have genetic alterations mutually exclusive with NTRK fusions | NR |
2. NTRK fusion testing is strongly recommended for known cancer types in which NTRK fusions are detected at a high frequency | SR |
3. NTRK fusion testing is recommended for all patients with metastatic/recurrent solid cancers other than those described above in order to determine the applicability of TRK inhibitors | R |
CQ1-2. Is NTRK fusion testing recommended for patients with early solid cancers? | |
1. NTRK fusion testing is recommended for patients with known cancer types in which NTRK fusions are detected at a high frequency even when their solid cancers can be radically treated | R |
2. NTRK fusion testing is considered for all patients with early solid cancers other than those described above to determine the applicability of TRK inhibitors | ECO |
CQ1-3. When should NTRK fusion testing be performed? | |
It is strongly recommended that NTRK fusion testing should be performed before the start of the standard treatment or during the standard treatment | SR |
CQ2: Testing methods for detecting NTRK fusions | |
CQ2-1: Are NGS tests recommended for determining the applicability of TRK inhibitors? | |
For determining the applicability of TRK inhibitors, NGS tests for which analytical validity has been established are strongly recommended | SR |
CQ2-2: Are FISH and PCR recommended for the detection of NTRK fusions? | |
1. FISH is not recommended as a screening test for NTRK fusions | NR |
2. At this point, it is not possible to determine whether PCR is recommended as a screening test for NTRK fusions | None |
3. Testing for NTRK fusions (particularly ETV6-NTRK3 fusion genes) using FISH or PCR may be performed for known cancer types in which NTRK fusions are detected at a high frequency | ECO |
CQ2-3: Is IHC recommended for the detection of NTRK fusions? | |
1. IHC is recommended as a screening test for NTRK fusions | R |
2. IHC is not recommended for determining the applicability of TRK inhibitors | NR |
CQ3: Treatment for NTRK fusions | |
CQ3-1: Are TRK inhibitors recommended for unresectable/metastatic/recurrent solid cancers possessing NTRK fusions? | |
The use of TRK inhibitors is strongly recommended | SR |
CQ3-2: When should TRK inhibitors be used? | |
The use of TRK inhibitors from the initial treatment is recommended | R |
NR Not recommended, SR Strong recommendation, R Recommendation, ECO Expert consensus opinion, NGS next-generation sequencing, FISH: fluorescence in situ hybridization, PCR polymerase chain reaction, IHC: immunohistochemistry