Difference between revisions of "Malignant solid neoplasm, NTRK-mutated"
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===References=== | ===References=== | ||
| − | # '''Phase 1:''' Drilon A, Siena S, Ou SI, Patel M, Ahn MJ, Lee J, Bauer TM, Farago AF, Wheler JJ, Liu SV, Doebele R, Giannetta L, Cerea G, Marrapese G, Schirru M, Amatu A, Bencardino K, Palmeri L, Sartore-Bianchi A, Vanzulli A, Cresta S, Damian S, Duca M, Ardini E, Li G, Christiansen J, Kowalski K, Johnson AD, Patel R, Luo D, Chow-Maneval E, Hornby Z, Multani PS, Shaw AT, De Braud FG. Safety and antitumor activity of the multitargeted pan-TRK, ROS1, and ALK inhibitor entrectinib: combined results from two phase I trials (ALKA-372-001 and STARTRK-1). Cancer Discov. 2017 Apr;7(4):400-409. Epub 2017 Feb 9. [http://cancerdiscovery.aacrjournals.org/content/7/4/400.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5380583/ link to PMC article] [https:// | + | # '''Phase 1:''' Drilon A, Siena S, Ou SI, Patel M, Ahn MJ, Lee J, Bauer TM, Farago AF, Wheler JJ, Liu SV, Doebele R, Giannetta L, Cerea G, Marrapese G, Schirru M, Amatu A, Bencardino K, Palmeri L, Sartore-Bianchi A, Vanzulli A, Cresta S, Damian S, Duca M, Ardini E, Li G, Christiansen J, Kowalski K, Johnson AD, Patel R, Luo D, Chow-Maneval E, Hornby Z, Multani PS, Shaw AT, De Braud FG. Safety and antitumor activity of the multitargeted pan-TRK, ROS1, and ALK inhibitor entrectinib: combined results from two phase I trials (ALKA-372-001 and STARTRK-1). Cancer Discov. 2017 Apr;7(4):400-409. Epub 2017 Feb 9. [http://cancerdiscovery.aacrjournals.org/content/7/4/400.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5380583/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28183697 PubMed] |
==Larotrectinib monotherapy {{#subobject:e0d17a|Regimen=1}}== | ==Larotrectinib monotherapy {{#subobject:e0d17a|Regimen=1}}== | ||
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# '''Abstract:''' Hyman DM, Laetsch TW, Kummar S, DuBois SG, Farago AF, Pappo AS, Demetri GD, El-Deiry WS, Lassen UN, Dowlati A, Brose MS. The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers. [https://ascopubs.org/doi/full/10.1200/JCO.2017.35.18_suppl.LBA2501 link to abstract] --> | # '''Abstract:''' Hyman DM, Laetsch TW, Kummar S, DuBois SG, Farago AF, Pappo AS, Demetri GD, El-Deiry WS, Lassen UN, Dowlati A, Brose MS. The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers. [https://ascopubs.org/doi/full/10.1200/JCO.2017.35.18_suppl.LBA2501 link to abstract] --> | ||
| − | # '''SCOUT; NAVIGATE:''' Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of larotrectinib in TRK fusion-positive cancers in adults and children. N Engl J Med. 2018 Feb 22;378(8):731-739. [https://www.nejm.org/doi/full/10.1056/NEJMoa1714448 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5857389/ link to PMC article] [https:// | + | # '''SCOUT; NAVIGATE:''' Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of larotrectinib in TRK fusion-positive cancers in adults and children. N Engl J Med. 2018 Feb 22;378(8):731-739. [https://www.nejm.org/doi/full/10.1056/NEJMoa1714448 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5857389/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29466156 PubMed] |
[[Category:NTRK regimens]] | [[Category:NTRK regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Site-agnostic regimens]] | [[Category:Site-agnostic regimens]] | ||
Revision as of 01:38, 25 February 2020
2 regimens on this page
3 variants on this page
|
All lines of therapy
Entrectinib monotherapy
| back to top |
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence |
|---|---|---|
| Drilon et al. 2017 (ALKA-372-001) | 2012-2016 | Phase I |
| Drilon et al. 2017 (STARTRK-1) | 2012-2016 | Phase I (RT) |
Note: this is the MTD used in the phase 2 portion; it is also the FDA-recommended dose for adults.
Chemotherapy
- Entrectinib (Rozlytrek) 600 mg PO once per day
Continued indefinitely
References
- Phase 1: Drilon A, Siena S, Ou SI, Patel M, Ahn MJ, Lee J, Bauer TM, Farago AF, Wheler JJ, Liu SV, Doebele R, Giannetta L, Cerea G, Marrapese G, Schirru M, Amatu A, Bencardino K, Palmeri L, Sartore-Bianchi A, Vanzulli A, Cresta S, Damian S, Duca M, Ardini E, Li G, Christiansen J, Kowalski K, Johnson AD, Patel R, Luo D, Chow-Maneval E, Hornby Z, Multani PS, Shaw AT, De Braud FG. Safety and antitumor activity of the multitargeted pan-TRK, ROS1, and ALK inhibitor entrectinib: combined results from two phase I trials (ALKA-372-001 and STARTRK-1). Cancer Discov. 2017 Apr;7(4):400-409. Epub 2017 Feb 9. link to original article link to PMC article PubMed
Larotrectinib monotherapy
| back to top |
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence |
|---|---|---|
| Drilon et al. 2018 (LOXO-TRK-14001) | 2015-2017 | Phase 1 (RT) |
| Drilon et al. 2018 (SCOUT) | 2015-2017 | Phase I/II (RT) |
| Drilon et al. 2018 (NAVIGATE) | 2015-2017 | Phase II (RT) |
Note: these three trials are all reported in a single publication; the doses here are the FDA-recommended doses.
Chemotherapy
- Larotrectinib (Vitrakvi) as follows:
- Adults: 100 mg PO twice per day
- Pediatrics: 100 mg/m2 (maximum dose of 100 mg) PO twice per day
Continued indefinitely
References
- SCOUT; NAVIGATE: Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of larotrectinib in TRK fusion-positive cancers in adults and children. N Engl J Med. 2018 Feb 22;378(8):731-739. link to original article contains protocol link to PMC article PubMed