nyuuzyou/wikis huggingface dataset:
Selinexor (Xpovio)

==Mechanism of action==
From NCI Drug Dictionary: An orally available, small molecule inhibitor of CRM1 (chromosome region maintenance 1 protein, exportin 1 or XPO1), with potential antineoplastic activity. Selinexor modifies the essential CRM1-cargo binding residue cysteine-528, thereby irreversibly inactivating CRM1-mediated nuclear export of cargo proteins such as tumor suppressor proteins (TSPs), including p53, p21, BRCA1/2, pRB, FOXO, and other growth regulatory proteins. As a result, this agent, via the approach of selective inhibition of nuclear export (SINE), restores endogenous tumor suppressing processes to selectively eliminate tumor cells while sparing normal cells.
==Diseases for which it is established==
*Multiple myeloma
==Diseases for which it is used==
*Diffuse large B-cell lymphoma
*Liposarcoma
*Transformed lymphoma
==History of changes in FDA indication==
===Diffuse large B-cell lymphoma===
*2020-06-22: Granted accelerated approval for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. (New disease entity; based on SADAL)
===Multiple myeloma===
*2019-07-03: Granted accelerated approval in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. (Based on STORM)
**2020-12-18: Full approval in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. (Based on BOSTON)
==History of changes in EMA indication==
*2021-03-26: Initial authorization as Nexpovio
==Also known as==
*Code name: KPT-330
*Brand name: Nexpovio, Xpovio
Category:Drugs
Category:Oral medications
Category:XPO1 inhibitors
Category:Diffuse large B-cell lymphoma medications
Category:Liposarcoma medications
Category:Multiple myeloma medications
Category:Transformed lymphoma medications
Category:FDA approved in 2019
Category:EMA approved in 2021
Selumetinib (Koselugo)

==Mechanism of action==
Inhibits the enzyme MAPK kinase (MEK), specifically the MEK1 and MEK2 subtypes of the enzyme.
==Diseases for which it is used==
*Low-grade serous ovarian cancer
*Differentiated thyroid cancer
*Uveal melanoma
==History of changes in FDA indication==
Note: this is not an antineoplastic indication. This drug does have some preliminary data in cancer settings.
*2020-04-10: Approved for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
==History of changes in EMA indication==
*2020-04-10: Initial marketing authorisation.
==History of changes in PMDA indication==
*2022-09-26: Drugs with a new active ingredient indicated for the treatment of plexiform neurofibroma in patients with neurofibromatosis type 1.
==Also known as==
*Code name: AZD-6244
*Brand name: Koselugo
Category:Drugs
Category:Oral medications
Category:MAP2K1 inhibitors
Category:MAP2K2 inhibitors
Category:Low-grade serous ovarian cancer medications
Category:Thyroid cancer, differentiated medications
Category:Uveal melanoma medications
Category:FDA approved in 2020
Category:EMA approved in 2020
Category:PMDA approved in 2022
Semuloparin (AVE-5026)

==General information==
Class/mechanism: Hemisynthetic ultra low molecular weight heparin (ULMWH), binds to antithrombin III, accelerating its activity and inhibiting factor Xa, factor IIa, and thrombin. Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. link to original article EuroPMC
Route: SC
Extravasation: n/a
==Patient drug information==
No information available.
==Also known as==
*Code name: AVE-5026
==References==
Category:Drugs
Category:Hematology medications
Category:Subcutaneous medications
Category:Anticoagulants
Category:Heparins
Category:Ultralow molecular weight heparins
Category:Investigational drugs
Semustine (MeCCNU)

==General information==
Class/mechanism: Nitrosourea, alkylates DNA and RNA and may inhibit certain key enzymatic reactions by carbamoylation of amino acids in proteins. Very similar to lomustine, with a methyl group added.
Route: PO
Extravasation: n/a
==Diseases for which it was used==
*Colorectal cancer
*Colon cancer
==Also known as==
*Generic names: MeCCNU, methyl-CCNU, methyl-lomustine
*Brand names: Semustina
==References==
Category:Drugs
Category:Oral medications
Category:Nitrosoureas
Category:Colon cancer medications (historic)
Category:Colorectal cancer medications (historic)
Category:Discontinued drugs
Serplulimab (Hansizhuang)

==General information==
Class/mechanism: PD-1 receptor antibody.
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.
==Toxicity management==
*Immunotherapy toxicity management
==Diseases for which it is used==
*Esophageal squamous cell carcinoma
*MSI-H or dMMR solid tumors (tissue-agnostic)
*Non-small cell lung cancer, nonsquamous
*Non-small cell lung cancer, squamous
*Small cell lung cancer
==History of changes in NMPA indication==
*2022-03-25: Initial approval for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) solid tumors that have failed to respond to previous standard treatments. (Based on HLX10-010-MSI201)
*2022-11-01: Approved in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). (Based on ASTRUM-004)
*2023-01-18: Approved for ES-SCLC in combination with carboplatin & etoposide. (Based on ASTRUM-005)
*2023-09-22: Approved with fluorouracil and platinum for the first-line treatment of patients with PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC). (Based on ASTRUM-007)
*2024-12-03: Approved in combination with pemetrexed and carboplatin for the first-line treatment of patients with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK).
==Also known as==
*Code name: HLX-10
*Brand name: Hansizhuang
Category:Drugs
Category:Intravenous medications
Category:Protein expression-specific medications
Category:Anti-PD-1 antibodies
Category:Esophageal squamous cell carcinoma medications
Category:Malignant solid neoplasm, MSI-H or dMMR medications
Category:Non-small cell lung cancer, nonsquamous medications
Category:Non-small cell lung cancer, squamous medications
Category:Small cell lung cancer medications
Category:NMPA approved in 2022
Siltuximab (Sylvant)

==General information==
Class/mechanism: Human-mouse chimeric monoclonal antibody which binds interleukin-6 (IL-6). Siltuximab prevents IL-6 from binding to soluble and membrane-bound IL-6 receptors. Blocking IL-6 activity interferes with its processes such immunoglobulin secretion. Systemic manifestations in patients with multicentric Castleman’s disease (MCD) has been associated with overproduction of IL-6.Siltuximab (Sylvant) package insert Siltuximab (Sylvant) package insert (locally hosted backup)Sylvant 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 used==
*Castleman disease
==Patient drug information==
*Siltuximab (Sylvant) package insert PDF pages 16-17
==History of changes in FDA indication==
*2014-04-23: FDA approved for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. (Based on CR016705)
==Also known as==
*Code name: CNTO-328
*Brand name: Sylvant
==References==
Category:Drugs
Category:Intravenous medications
Category:Anti-IL-6 antibodies
Category:Castleman disease medications
Category:FDA approved in 2014
Sintilimab (Tyvyt)

==Mechanism of action==
From NCI Drug Dictionary: A recombinant human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1; PDCD1; PD1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, sintilimab binds to PD-1 and inhibits the binding of PD-1 to the PD-1 ligands programmed cell death-1 ligand 1 (PD-L1), and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.
==Diseases for which it is used==
*Classical Hodgkin lymphoma
*Esophageal squamous cell carcinoma
*Hepatocellular carcinoma
*Nasopharyngeal carcinoma
*Non-small cell lung cancer
**Non-small cell lung cancer, nonsquamous
**Non-small cell lung cancer, squamous
==History of changes in NMPA indication==
*2018-12-24: Initial approval
==Also known as==
*Code name: IBI-308
*Brand names: Daboshu, Tyvyt
Category:Drugs
Category:Intravenous medications
Category:Anti-PD-1 antibodies
Category:Classical Hodgkin lymphoma medications
Category:Esophageal squamous cell carcinoma medications
Category:Hepatocellular carcinoma medications
Category:Nasopharyngeal carcinoma medications
Category:Non-small cell lung cancer medications
Category:Non-small cell lung cancer, nonsquamous medications
Category:Non-small cell lung cancer, squamous medications
Category:NMPA approved in 2018
Category:PMDA approved drugs
Sipuleucel-T (Provenge)

==General information==
Class/mechanism: Autologous cellular immunotherapy, with each dose containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. Autologous peripheral blood mononuclear cells, which include antigen presenting cells (APCs), are obtained via leukapheresis. They are then activated in vitro with prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), and reinfused into the patient. The reinfused cells are then hypothesized to mediate immune reactions against prostate cancer cells.Sipuleucel-T (Provenge) package insert Sipuleucel-T (Provenge) package insert (locally hosted backup)Provenge 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 used==
*Prostate cancer
==Patient drug information==
*Sipuleucel-T (Provenge) package insert
*Sipuleucel-T (Provenge) patient drug information (Chemocare)Sipuleucel-T (Provenge) patient drug information (Chemocare)
*Sipuleucel-T (Provenge) patient drug information (UpToDate)Sipuleucel-T (Provenge) patient drug information (UpToDate)
==History of changes in FDA indication==
*2010-04-29: Initial FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. (Based on D9901 and IMPACTprostate)
==History of changes in EMA indication==
*2013-09-06: Initial authorization for treating men with asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in whom chemotherapy is not yet clinically indicated.
*2015-05-06: Authorization withdrawn at the request of the manufacturer, for commercial reasons
==Also known as==
*Code name: APC-8015
*Brand name: Provenge
==References==
Category:Dendritic cell vaccines
Category:Intravenous medications
Category:Prostate cancer medications
Category:FDA approved in 2010
Category:EMA approved in 2013
Category:EMA withdrawn in 2015
Sirolimus (Rapamune)

==Mechanism of action==
From the NCI Drug Dictionary: A natural macrocyclic lactone produced by the bacterium Streptomyces hygroscopicus, with immunosuppressant properties. In cells, sirolimus binds to the immunophilin FK Binding Protein-12 (FKBP-12) to generate an immunosuppressive complex that binds to and inhibits the activation of the mammalian target of rapamycin (mTOR), a key regulatory kinase. This results in inhibition of T lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (IL-2, IL-4, and IL-15) stimulation and inhibition of antibody production.
==Diseases for which it is used==
*Aplastic anemia
*Autoimmune cytopenia
*Castleman disease
*Erdheim-Chester disease
==Diseases for which it was used==
*Classical Hodgkin lymphoma
==Also known as==
*Code names: AY-22989, SILA-9268A, SLM, WY-090217
*Generic names: RAPA, rapamycin
*Brand name: Rapamune
Category:Drugs
Category:Oral medications
Category:mTOR inhibitors
Category:Aplastic anemia medications
Category:Autoimmune cytopenia medications
Category:Castleman disease medications
Category:Erdheim-Chester disease medications
Category:Classical Hodgkin lymphoma medications (historic)
Category:FDA approved in 1999
Sirolimus protein-bound particles (Fyarro)

==Mechanism of action==
From the NCI Drug Dictionary: The macrolide antibiotic rapamycin bound to nanoparticle albumin with immunosuppressant (see sirolimus) and potential antiangiogenic and antineoplastic activities. Rapamycin binds to the immunophilin FK Binding Protein-12 (FKBP-12) to generate a complex that binds to and inhibits the activation of the mammalian Target Of Rapamycin (mTOR), a key regulatory kinase. In turn, inhibition of mTOR may result in the inhibition of the phosphatidylinositol 3 (PI-3) kinase/Akt pathway and vascular endothelial cell growth factor (VEGF) secretion, which may result in decreased tumor cell proliferation and tumor angiogenesis. The binding of water-insoluble rapamycin to nanoparticle albumin permits the albumin-mediated endocytosis of rapamycin by tumor cells and endothelial cells.
==Diseases for which it is used==
*PEComa
==History of changes in FDA indication==
*2021-11-22: Approved for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). (Based on AMPECT)
==Also known as==
*Code name: ABI-009
*Generic names: nab-rapamycin, nab-sirolimus
*Brand name: Fyarro
Category:Drugs
Category:Intravenous medications
Category:Nanoparticle albumin bound chemotherapy
Category:MTOR inhibitors
Category:PEComa medications
Category:FDA approved in 2021
Small bowel adenocarcinoma

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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.
==French Intergroup==
*2017: Locher et al. Small bowel adenocarcinoma: French intergroup clinical practice guidelines for diagnosis, treatments and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO) EuroPMC
==NCCN==
*NCCN Guidelines - Small Bowel Adenocarcinoma
=Subsequent lines of therapy=
==Pembrolizumab monotherapy==
===Regimen===
FDA-recommended dose
Study 	Dates of enrollment	Evidence
Marabelle et al. 2019 (KEYNOTE-158)	2016-2018 	Phase 2 (RT)
Note: 7.4% of patients enrolled in KEYNOTE-158 cohort K had small intestine cancer.
====Biomarker eligibility criteria====
*MSI-H or dMMR
====Immunotherapy====
*Pembrolizumab (Keytruda) 200 mg IV over 30 minutes once on day 1
21-day cycle for up to 35 cycles (2 years)
===References===
# KEYNOTE-158: Marabelle A, Le DT, Ascierto PA, Di Giacomo AM, De Jesus-Acosta A, Delord JP, Geva R, Gottfried M, Penel N, Hansen AR, Piha-Paul SA, Doi T, Gao B, Chung HC, Lopez-Martin J, Bang YJ, Frommer RS, Shah M, Ghori R, Joe AK, Pruitt SK, Diaz LA Jr. Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2020 Jan 1;38(1):1-10. Epub 2019 Nov 4. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02628067
##Update: Maio M, Ascierto PA, Manzyuk L, Motola-Kuba D, Penel N, Cassier PA, Bariani GM, De Jesus Acosta A, Doi T, Longo F, Miller WH, Oh DY, Gottfried M, Xu L, Jin F, Norwood K, Marabelle A. Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study. Ann Oncol. 2022 Sep;33(9):929-938. Epub 2022 Jun 6. link to original article EuroPMC
Category:Small bowel carcinoma regimens
Category:Disease-specific pages
Category:Gastrointestinal cancers
Smoldering multiple myeloma - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main SMM page for current regimens.
Last updated on 2024-12-02:1 regimens on this page
2 variants on this page
 
=All lines of therapy=
==Melphalan & Prednisone (MP)==
MP: Melphalan & Prednisone
===Regimen variant #1, 6 cycles===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Riccardi et al. 2000 (MM87/MM90)	1987-1993 	Phase 3 (E-esc)	Observation	Did not meet endpoint of OS
Note: Patients on the observation arm of this study received this regimen at progression to symptomatic MM
====Chemotherapy====
*Melphalan (Alkeran) 0.21 mg/kg PO once per day on days 1 to 4
====Glucocorticoid therapy====
*Prednisone (Sterapred) 0.5 mg/kg PO once per day on days 1 to 10
42-day cycle for 6 cycles
===Regimen variant #2, Indefinite therapy===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Hjorth et al. 1993	1983-1988 	Phase 3 (E-esc)	Observation	Did not meet endpoint of OS
====Chemotherapy====
*Melphalan (Alkeran) 0.25 mg/kg PO once per day on days 1 to 4
====Glucocorticoid therapy====
*Prednisone (Sterapred) 2 mg/kg PO once per day on days 1 to 4
42-day cycles
===References===
# Hjorth M, Hellquist L, Holmberg E, Magnusson B, Rödjer S, Westin J; Myeloma Group of Western Sweden. Initial versus deferred melphalan-prednisone therapy for asymptomatic multiple myeloma stage I--a randomized study. Eur J Haematol. 1993 Feb;50(2):95-102. link to original article dosing details in abstract have been reviewed by our editors EuroPMC
# MM87/MM90: Riccardi A, Mora O, Tinelli C, Valentini D, Brugnatelli S, Spanedda R, De Paoli A, Barbarano L, Di Stasi M, Giordano M, Delfini C, Nicoletti G, Bergonzi C, Rinaldi E, Piccinini L, Ascari E; Cooperative Group of Study and Treatment of Multiple Myeloma. Long-term survival of stage I multiple myeloma given chemotherapy just after diagnosis or at progression of the disease: a multicentre randomized study. Br J Cancer. 2000 Apr;82(7):1254-60. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC
Category:Smoldering multiple myeloma regimens
Category:Disease-specific pages
Category:Plasma cell dyscrasias
Category:Historical regimens
Socazolimab (ZKAB-001)

==Mechanism of action==
From the NCI Drug Dictionary: A human monoclonal antibody directed against the immunosuppressive ligand programmed cell death-1 ligand 1 (PD-L1; cluster of differentiation 274; CD274), with potential immune checkpoint inhibitory and antineoplastic activities. Upon intravenous administration, anti-PD-L1 monoclonal antibody ZKAB001 specifically targets and binds to PD-L1, blocking its binding to and activation of its receptor programmed cell death 1 (PD-1; cluster of differentiation 279; CD279). This reverses T-cell inactivation caused by PD-1/PD-L1 signaling and enhances the cytotoxic T-lymphocyte (CTL)-mediated anti-tumor immune response against PD-L1-expressing tumor cells.
==Preliminary data==
Note: This is not meant to be an exhaustive list of preliminary results. References included in this section include non-randomized studies published in high-profile journals (e.g., NEJM) and experimental arms of phase 3 RCTs. Inclusion here is not an indication of impending regulatory approval, although many of these drugs do end up receiving approval by a regulatory authority.
===Small cell lung cancer===
#ZKAB001-LEES-2020-07: Chen Z, Chen J, Huang D, Zhang W, Wu L, Yi T, Wang Q, Han L, Tan L, Li Y, Zhang Z, Li N, Li J, Zhang T, Hu Y, Sun H, Wu Y, He Z, Yang R, Cheng P, Li X, Shi J, Yu G, Ma D, Li BX, Dai X, Wong M, Li Y, Yu X, Lu S; Socazolimab Study Group. A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer. Signal Transduct Target Ther. 2025 Jan 13;10(1):28. link to original article link to PMC article EuroPMC NCT04878016
==Also known as==
*Code names: STI-A1014, ZKAB-001
Category:Drugs
Category:Intravenous medications
Category:Anti-PD-L1 antibodies
Category:Small cell lung cancer medications (investigational)
Category:Investigational drugs
Sonidegib (Odomzo)

==General information==
Class/mechanism: Hedgehog pathway inhibitor. Sonidegib binds to and inhibits the transmembrane protein Smoothened (SMO), which is part of the Hedgehog signal transduction pathway that is clinically relevant in diseases such as basal cell cancer.Sonidegib (Odomzo) package insert Sonidegib (Odomzo) package insert (locally hosted backup)
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==
*Cutaneous basal cell carcinoma
==Patient drug information==
*Sonidegib (Odomzo) package insert
==History of changes in FDA indication==
*2015-07-24: Initial approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy. (Based on BOLT)
*2015-07-24: Initial approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who are not candidates for surgery or radiation therapy. (Based on BOLT)
==History of changes in EMA indication==
*2015-08-14: Initial authorization 
*Uncertain date: Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
==Also known as==
*Code name: LDE-225
*Generic name: erismodegib 
*Brand name: Odomzo
==References==
Category:Drugs
Category:Oral medications
Category:Hedgehog pathway inhibitors
Category:SMO inhibitors
Category:Cutaneous basal cell carcinoma medications
Category:EMA approved in 2015
Category:FDA approved in 2015