Difference between revisions of "Tenosynovial giant cell tumor"
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6860022/ Tap et al. 2019 (ENLIVEN)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6860022/ Tap et al. 2019 (ENLIVEN)] | ||
| − | |2015-2016 | + | |2015-05 to 2016-09 |
| style="background-color:#1a9851" |Phase 3 (E-RT-esc) | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) | ||
| − | |[[# | + | |[[Tenosynovial_giant_cell_tumor_-_null_regimens#Placebo|Placebo]]<sup>1</sup> |
| style="background-color:#1a9850" |Superior ORR (primary endpoint) | | style="background-color:#1a9850" |Superior ORR (primary endpoint) | ||
|- | |- | ||
Revision as of 20:39, 14 October 2023
| Section editor | |
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Elizabeth J. Davis, MD Vanderbilt University Nashville, TN, USA |
Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!
Note: these are regimens tested in subtype-specific populations, please see the main soft tissue sarcoma page for other regimens.
1 regimens on this page
1 variants on this page
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Guidelines
NCCN
- NCCN does not have guidelines at this granular level; please see NCCN Guidelines - Soft Tissue Sarcoma.
All lines of therapy
Pexidartinib monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Tap et al. 2019 (ENLIVEN) | 2015-05 to 2016-09 | Phase 3 (E-RT-esc) | Placebo1 | Superior ORR (primary endpoint) |
1Patents assigned to placebo were offered open-label pexidartinib after week 24.
Targeted therapy
- Pexidartinib (Turalio) as follows:
- Cycle 1: 400 mg PO every morning and 600 mg PO every evening
- Cycle 2 onwards: 400 mg PO twice per day
14-day cycles
References
- ENLIVEN: Tap WD, Gelderblom H, Palmerini E, Desai J, Bauer S, Blay JY, Alcindor T, Ganjoo K, Martín-Broto J, Ryan CW, Thomas DM, Peterfy C, Healey JH, van de Sande M, Gelhorn HL, Shuster DE, Wang Q, Yver A, Hsu HH, Lin PS, Tong-Starksen S, Stacchiotti S, Wagner AJ; ENLIVEN investigators. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial. Lancet. 2019 Aug 10;394(10197):478-487. Epub 2019 Jun 19. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02371369