nyuuzyou/wikis huggingface dataset:
Tegafur, gimeracil, oteracil (S-1)

Note: this drug is approved in Japan and Europe but not the US.
=Mechanism of action=
From the NCI Drug Dictionary: An orally bioavailable fluoropyrimidine antagonist composed of tegafur combined with two modulators of 5-flurouracil (5-FU) activity, 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate, in a molar ratio of 1:0.4:1. Tegafur is a prodrug of 5-fluorouracil, an antimetabolite that inhibits thymidylate synthase, DNA synthesis and cell division, and competes with uridine triphosphate, thus inhibiting RNA and protein synthesis. CDHP is a reversible inhibitor of dihydropyrimidine dehydrogenase (DPD), the liver enzyme responsible for rapid catabolism of 5-FU into inactive metabolites. Potassium oxonate preferentially localizes in the gut and inhibits the enzyme orotate phosphoribosyl-transferase (OPRT), thereby decreasing activation of 5-FU in the gut and activated 5-FU-related gastrointestinal toxicity.
==Diseases for which it is established==
*Breast cancer
*Cholangiocarcinoma
*Colorectal cancer
**Colon cancer
**Rectal cancer
*Gallbladder cancer
*Gastric cancer
*Head and neck cancer
*Non-small cell lung cancer
**Non-small cell lung cancer, squamous
*Pancreatic cancer
==Diseases for which it is used==
*Esophageal cancer
==History of changes in EMA indication==
*2011-03-14: Initial marketing authorization as Teysuno.
==History of changes in PMDA indication==
*2005-11-14: New indication for the treatment of inoperable or recurrent breast cancer.
*2006-08-10: New indication for pancreatic cancer.
*2007-08-23: New indication for the treatment of biliary cancer in addition to gastric cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, and pancreatic cancer.
*2007-08-23: New indication for the treatment of inoperable or relapsed breast cancer.
*2022-11-24: New indication and a new dosage for the postoperative adjuvant treatment of hormone receptor(HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer with a high risk of recurrence.
==Also known as==
*Code name: S-1
*Brand name: Teysuno, TS-One, TS-1
Category:Drugs
Category:Combination drugs
Category:Oral medications
Category:Fluoropyrimidines
Category:Breast cancer medications
Category:Cholangiocarcinoma medications
Category:Colon cancer medications
Category:Colorectal cancer medications
Category:Esophageal cancer medications
Category:Gallbladder cancer medications
Category:Gastric cancer medications
Category:Non-small cell lung cancer medications
Category:Non-small cell lung cancer, squamous medications
Category:Pancreatic cancer medications
Category:Rectal cancer medications
Category:EMA approved in 2011
Category:PMDA approved drugs
Tegafur and uracil (UFT)

Note: this drug combination is not FDA approved but is used widely in other countries.
==General information==
Class/mechanism: Contains a fixed molar ratio (4:1) of uracil to tegafur. Tegafur is metabolized in vivo to Fluorouracil (5-FU), which is a pyrimidine analog antimetabolite that is metabolized to 5-fluoro-2'-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP). FdUMP inhibits DNA synthesis by binding to thymidylate synthase and inhibiting production of thymidylate; FUTP interferes with RNA processing when it is mistakenly incorporated in place of uridine triphosphate (UTP). Uracil helps to maintain intracellular levels of Fluorouracil (5-FU) by inhibiting its degradation.Uracil-tegafur (UFT) package insert; adapted from source: South African Electronic Package InsertsUracil-tegafur (UFT) informationUFT manufacturer's site
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information. 
==Patient safety==
EMA has recommended that patients should be tested for the lack of the enzyme dihydropyrimidine dehydrogenase (DPD) before starting cancer treatment with fluorouracil given by injection or infusion (drip) or with the related medicines, capecitabine and tegafur.
==Diseases for which it is used==
*Colorectal cancer
**Colon cancer
**Rectal cancer
*Esophageal cancer
*Gastric cancer
*Head and neck cancer
*Non-small cell lung cancer
**Non-small cell lung cancer, nonsquamous
==Patient drug information==
*Uracil-tegafur (UFT) patient information siteUracil-tegafur (UFT) patient information site
*Macmillan Uracil-tegafur (UFT) patient informationMacmillan Uracil-tegafur (UFT) patient information
==Also known as==
*Generic name: tegafur-uracil
*Brand names: Ftorafur, Luporal, Tefudex, Ufur, Uftoral, Uracel
==References==
Category:Drugs
Category:Combination drugs
Category:Oral medications
Category:Fluoropyrimidines
Category:Colorectal cancer medications
Category:Colon cancer medications
Category:Esophageal cancer medications
Category:Gastric cancer medications
Category:Head and neck cancer medications
Category:Non-small cell lung cancer medications
Category:Non-small cell lung cancer, nonsquamous medications
Category:Rectal cancer medications
Category:PMDA approved drugs
Telotristat (Xermelo)

==General information==
Class/mechanism: Tryptophan hydroxylase inhibitor. Tryptophan hydroxylase controls the rate limiting step of the biosynthesis of serotonin, which plays a role in regulating the secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-produced in patients with carcinoid syndrome. Telotristat reduces the frequency of carcinoid syndrome diarrhea by decreasing the production of serotonin.Telotristat (Xermelo) package insert Telotristat (Xermelo) package insert (locally hosted backup)Xermelo manufacturer's website
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.
==Patient drug information==
*Brief patient counseling information can be found in the Telotristat (Xermelo) package insert
==History of changes in FDA indication==
*2017-02-28: Initial FDA approval to be used in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled.
==History of changes in EMA ndication==
*2017-09-17: Initial authorization
==Also known as==
*Generic name: telotristat ethyl as telotristat etiprate
*Brand name: Xermelo
==References==
Category:Drugs
Category:Oral medications
Category:Tryptophan hydroxylase inhibitors
Category:EMA approved in 2017
Category:FDA approved in 2017
Temsirolimus (Torisel)

==General information==
Class/mechanism: mTOR (mammalian target of rapamycin) inhibitor. mTOR inhibition by temsirolimus interferes with the ability of mTOR to phosphorylate downstream targets in the PI3 kinase/AKT pathway, such as p70S6k and the S6 ribosomal protein. Temsirolimus has also been observed to reduce levels of VEGF (vascular endothelial growth factor) and hypoxia-inducible factors HIF-1 and HIF-2 alpha.Temsirolimus (Torisel) package insert Temsirolimus (Torisel) package insert (locally hosted backup)Torisel manufacturer's website
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information. 
==Diseases for which it is established==
*Mantle cell lymphoma (EMA)
*Renal cell carcinoma (EMA, FDA, PMDA)
==Diseases for which it is used==
*CNS lymphoma
*Diffuse large B-cell lymphoma
*Endometrial cancer
*Hepatoblastoma
*Indolent lymphoma
==Patient drug information==
*Temsirolimus (Torisel) package insert
*Temsirolimus (Torisel) patient drug information (Chemocare)Temsirolimus (Torisel) patient drug information (Chemocare)
*Temsirolimus (Torisel) patient drug information (UpToDate)Temsirolimus (Torisel) patient drug information (UpToDate)
==History of changes in FDA indication==
*2007-05-30: Initial FDA approval for the treatment of advanced renal cell carcinoma. (Based on ARCC)
==History of changes in EMA indication==
*2007-11-19: Initial authorization as Torisel. Torisel is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. (Based on ARCC)
*2009-10-14: Extension of Indication to add treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL).
==History of changes in Health Canada indication==
*2007-12-21: Initial notice of compliance
==History of changes in PMDA indication==
*2010-07-23: Initial approval for the treatment of unresectable or metastatic renal cell carcinoma.
==Also known as==
*Code name: CCI-779
*Brand name: Sirotem, Torisel
==References==
Category:Drugs
Category:Intravenous medications
Category:mTOR inhibitors
Category:CNS lymphoma medications
Category:Diffuse large B-cell lymphoma medications
Category:Hepatoblastoma medications
Category:Indolent lymphoma medications
Category:Mantle cell lymphoma medications
Category:Renal_cell_carcinoma medications
Category:Endometrial cancer medications
Category:EMA approved in 2007
Category:FDA approved in 2007
Category:Health Canada approved in 2007
Category:PMDA approved in 2010
Teniposide (Vumon)

==General information==
Class/mechanism: Topoisomerase II inhibitor. Teniposide inhibits type II topoisomerase, which results in single and double-stranded DNA breaks and DNA-protein crosslinks. It is cell-cycle specific, acting in late S or early G2, preventing cells from entering mitosis. It is dissolved in Cremophor EL (polyoxyethylated castor oil), which may cause hypersensitivity infusion reactions.Teniposide (Vumon) package insertTeniposide (Vumon) package insert (locally hosted backup)
Route: IV
Extravasation: irritant
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information. 
==Diseases for which it is used==
*B-cell acute lymphoblastic leukemia
*Burkitt lymphoma
*CNS lymphoma
*HIV-associated lymphoma
*Low-grade glioma
*Small cell lung cancer
==Diseases for which it was used==
*Diffuse large B-cell lymphoma
*Follicular lymphoma
==Patient drug information==
*Teniposide (Vumon) patient drug information (Chemocare)Teniposide (Vumon) patient drug information (Chemocare)
*Teniposide (Vumon) patient drug information (UpToDate)Teniposide (Vumon) patient drug information (UpToDate)
==History of changes in FDA indication==
* 1992-07-14: Initial approval for induction therapy in patients with refractory childhood acute lymphoblastic leukemia
==History of changes in EMA indication==
*1976-04-05: EURD
==Also known as==
*Code name: VM-26
*Brand name: Vumon
==References==
Category:Drugs
Category:Intravenous medications
Category:Irritant
Category:Topoisomerase II inhibitors
Category:B-cell acute lymphoblastic leukemia medications
Category:Burkitt lymphoma medications
Category:CNS lymphoma medications
Category:HIV-associated lymphoma medications
Category:Low-grade glioma medications
Category:Small cell lung cancer medications
Category:Diffuse large B-cell lymphoma medications (historic)
Category:Follicular lymphoma medications (historic)
Category:FDA approved in 1992
Category:EMA approved in 1976
Tenosynovial giant cell tumor

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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.
Last updated on 2024-07-23:1 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 	Higher 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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT02371369
==Vimseltinib monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator	Comparative Efficacy
Gelderblom et al. 2024 (MOTION)	2022-01-21 to 2023-02-21	Phase 3 (E-RT-esc)	Placebo 	Higher ORR (primary endpoint)
====Targeted therapy====
*Vimseltinib (Romvimza) 30 mg PO once per day on days 1 & 5
7-day cycle for 24 cycles
===References===
#MOTION: Gelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, López Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martín-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herráez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. Epub 2024 Jun 3. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT05059262
Category:Tenosynovial giant cell tumor regimens
Category:Disease-specific pages
Category:Soft tissue sarcomas
Tenosynovial giant cell tumor - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main TGCT page for regimens that include active anticancer treatment.
=All lines of therapy=
==Placebo==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Tap et al. 2019 (ENLIVEN) 	2015-05 to 2016-09 	Phase 3 (C)	Pexidartinib	Lower ORR (primary endpoint)
Gelderblom et al. 2024 (MOTION)	2022-01-21 to 2023-02-21	Phase 3 (C)	Vimseltinib 	Lower ORR (primary endpoint)
No active antineoplastic treatment.
===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 EuroPMC NCT02371369
#MOTION: Gelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, López Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martín-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herráez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. Epub 2024 Jun 3. link to original article EuroPMC NCT05059262
Category:Tenosynovial giant cell tumor regimens
Category:Disease-specific pages
Category:Soft tissue sarcomas
Category:Null regimens
Tepotinib (Tepmetko)

==General information==
Class/mechanism: C-Met inhibitor. Inappropriate or constitutive activation of the receptor tyrosine kinase c-Met and its signalling pathway is implicated in many cancers, playing a role in abnormal proliferation, survival, invasion, metastasis, and angiogenesis.Tepotinib (Tepmetko) package insert Tepotinib (Tepmetko) package insert (locally hosted backup)Tepmetko manufacturer's website
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.
==Diseases for which it is established==
*Non-small cell lung cancer, MET-mutated (EMA, FDA, HC, PMDA)
==Patient drug information==
*Tepotinib (Tepmetko) package insert
*Tepotinib (Tepmetko) patient drug information (UpToDate)Tepotinib (Tepmetko) patient drug information (UpToDate)
==History of changes in FDA indication==
*2021-02-03: Granted accelerated approval for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. (Based on VISIONNSCLC)
**2024-02-15: Granted full approval for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. (Based on VISIONNSCLC)
==History of changes in EMA indication==
*2022-02-16: Initial authorization as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
==History of changes in Health Canada indication==
*2021-05-27: Initial notice of compliance with conditions for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations.
==History of changes in PMDA indication==
*2020-03-25: Newly indicated for the treatment of unresectable advanced or recurrent MET exon 14 (METex14) skipping mutation-positive non-small cell lung cancer.
==Also known as==
*Code names: EMD-1214063, MSC-2156119, MSC-2156119J
*Brand name: Tepmetko
==References==
Category:Drugs
Category:Oral medications
Category:Mutation-specific medications
Category:MET inhibitors
Category:Non-small cell lung cancer medications
Category:FDA approved in 2021
Category:EMA approved in 2022
Category:Health Canada approved in 2021
Category:PMDA approved in 2020
Tesetaxel (DJ-927)

==Mechanism of action==
From NCI Drug Dictionary: A semi-synthetic, orally bioavailable taxane derivative with potential antineoplastic and antiangiogenic properties. Tesetaxel binds to and stabilizes tubulin, promoting microtubule assembly and thereby preventing microtubule depolymerization. This may lead to cell cycle arrest and an inhibition of cell proliferation. This agent may also inhibit pro-angiogenic factors such as vascular endothelial growth factor (VEGF). As it represents poor substrate for P-glycoprotein-related drug resistance mechanisms, this agent may be useful for treating multi-drug resistant tumors. 
==Also known as==
*Code name: DJ-927
Category:Drugs
Category:Oral medications
Category:Taxanes
Category:Investigational drugs
Testicular cancer - null regimens

The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main testicular cancer page for regimens that include active anticancer treatment.
=Adjuvant therapy for resectable disease=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Williams et al. 1987	1979-1984 	Phase 3 (C)	1a. BVP1b. VAB-6	Shorter RFS
====Preceding treatment====
*Orchiectomy & RPLND
===References===
# Williams SD, Stablein DM, Einhorn LH, Muggia FM, Weiss RB, Donohue JP, Paulson DF, Brunner KW, Jacobs EM, Spaulding JT, DeWys WD, Crawford ED. Immediate adjuvant chemotherapy versus observation with treatment at relapse in pathological stage II testicular cancer. N Engl J Med. 1987 Dec 3;317(23):1433-8. link to original article EuroPMC
Category:Testicular cancer regimens
Category:Disease-specific pages
Category:Genitourinary cancers
Category:Null regimens