Latest revision as of 11:27, 13 May 2024

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Section editor
	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

Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

NCCN

NCCN does not currently 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

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-{{#lst:Section editor transclusions|sarcoma}}
+{{#lst:Editorial board transclusions|sarcoma}}
+''Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit [[Tenosynovial giant cell tumor - null regimens|this page]]. If you still can't find it, please let us know so we can add it!''<br>
 Note: these are regimens tested in subtype-specific populations, please see the '''[[Soft_tissue_sarcoma|main soft tissue sarcoma page]]''' for other regimens.
 {| class="wikitable" style="float:right; margin-right: 5px;"
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 |}
 {{TOC limit|limit=3}}
+=Guidelines=
+'''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
+==NCCN==
+*''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1464 NCCN Guidelines - Soft Tissue Sarcoma].''
 =All lines of therapy=
 ==Pexidartinib monotherapy {{#subobject:a9367b|Regimen=1}}==
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 |-
 |[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)
-|[[#Placebo_888|Placebo]]<sup>1</sup>
+|[[Tenosynovial_giant_cell_tumor_-_null_regimens#Placebo|Placebo]]<sup>1</sup>
-| style="background-color:#1a9850" |Superior ORR
+| style="background-color:#1a9850" |Superior ORR (primary endpoint)
 |-
 |}
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 </div></div>
 ===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. [https://doi.org/10.1016/s0140-6736(19)30764-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6860022/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31229240/ PubMed] [https://clinicaltrials.gov/study/NCT02371369 Clinical Trials Registry]
+# '''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. [https://doi.org/10.1016/s0140-6736(19)30764-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6860022/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31229240/ PubMed] [https://clinicaltrials.gov/study/NCT02371369 NCT02371369]
 [[Category:Tenosynovial giant cell tumor regimens]]
 [[Category:Disease-specific pages]]
 [[Category:Soft tissue sarcomas]]

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