Leiomyosarcoma

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Note: these are regimens tested in subtype-specific populations, please see the main soft tissue sarcoma page for other regimens.
For placebo or observational studies in this condition, please visit this page.
Last updated on 2024-07-23:9 regimens on this page
15 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.
=Advanced or metastatic disease, first-line=
==Docetaxel & Gemcitabine==
===Regimen variant #1, 60/675===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Hensley et al. 2015 (GOG-250)	2009-2013 	Phase 3 (C)	DG & Bevacizumab	Did not meet primary endpoint of PFSMedian PFS: 6.2 vs 4.2 mo(HR 0.89)
Note: This regimen was intended for patients who received prior radiation.
====Chemotherapy====
*Docetaxel (Taxotere) 60 mg/m2 IV over 60 minutes once on day 8, given second
*Gemcitabine (Gemzar) 675 mg/m2 IV over 70 to 90 minutes once per day on days 1 & 8, given first
21-day cycles 
===Regimen variant #2, 75/675===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Hensley et al. 2002 	Not reported 	Phase 2 	 	
Seddon et al. 2017 (GeDDiS)	2010-2014 	Phase 3 (E-switch-ic)	Doxorubicin	Did not meet primary endpoint of alive and progression free at 24 weeks
Note: In Hensley et al. 2002, this regimen was intended for patients who received prior radiation.
====Chemotherapy====
*Docetaxel (Taxotere) 75 mg/m2 IV over 60 minutes once on day 8, given second
*Gemcitabine (Gemzar) 675 mg/m2 IV over 90 minutes once per day on days 1 & 8, given first
====Supportive therapy====
*Dexamethasone (Decadron) 8 mg PO twice per day on days 7 to 9 (the day before, the day of, and day after docetaxel)
*Patients could receive diuretics at physician discretion for peripheral edema related to docetaxel
*One of the following growth factors (varies depending on reference):
**G-CSF (type not specified) 150 mcg/m2 (dose rounded to 300 or 480 mcg) SC once per day on days 9 to 15 as primary neutropenia prophylaxis; could be stopped before day 15 if ANC greater than 1200/μL on two separate measurements
**Pegfilgrastim (Neulasta) 6 mg SC once on either day 9 or 10
21-day cycle for varying durations: 6 cycles (GeDDiS); 6 to 8 cycles (Hensley et al. 2002)
===Regimen variant #3, 75/900===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Hensley et al. 2015 (GOG-250)	2009-2013 	Phase 3 (C)	DG & Bevacizumab	Did not meet primary endpoint of PFSMedian PFS: 6.2 vs 4.2 mo(HR 0.89)
Note: This regimen was intended for patients with no prior radiation.
====Chemotherapy====
*Docetaxel (Taxotere) 75 mg/m2 IV over 60 minutes once on day 8, given second
*Gemcitabine (Gemzar) 900 mg/m2 IV over 90 minutes once per day on days 1 & 8, given first
21-day cycles 
===Regimen variant #4, 100/900===
Study 	Dates of enrollment	Evidence
Hensley et al. 2002 	Not reported 	Phase 2
Hensley et al. 2008 (GOG 87L)	2003-2006 	Phase 2
Note: This regimen was intended for patients with no prior radiation.
====Chemotherapy====
*Docetaxel (Taxotere) 100 mg/m2 IV over 60 minutes once on day 8, given second
*Gemcitabine (Gemzar) 900 mg/m2 IV over 90 minutes once per day on days 1 & 8, given first
====Supportive therapy====
*Dexamethasone (Decadron) 8 mg PO twice per day on days 7 to 9 (the day before, the day of, and day after docetaxel)
*Patients could receive diuretics at physician discretion for peripheral edema related to docetaxel
*One of the following growth factors (varies depending on reference):
**G-CSF (type not specified) 150 mcg/m2 (dose rounded to 300 or 480 mcg) SC once per day on days 9 to 15 as primary neutropenia prophylaxis; could be stopped before day 15 if ANC greater than 1200/μL on two separate measurements
**Pegfilgrastim (Neulasta) 6 mg SC once on either day 9 or 10
21-day cycle for varying durations: 6 to 8 cycles (Hensley et al. 2002); indefinitely (GOG 87L)
===References===
# Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
# GOG 87L: Hensley ML, Blessing JA, Mannel R, Rose PG. Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol. 2008 Jun;109(3):329-34. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC
# GOG-250: Hensley ML, Miller A, O'Malley DM, Mannel RS, Behbakht K, Bakkum-Gamez JN, Michael H. Randomized phase III trial of gemcitabine plus docetaxel plus bevacizumab or placebo as first-line treatment for metastatic uterine leiomyosarcoma: an NRG Oncology/Gynecologic Oncology Group study. J Clin Oncol. 2015 Apr 1;33(10):1180-5. Epub 2015 Feb 23. link to original article link to PMC article EuroPMC NCT01012297
# GeDDiS: Seddon B, Strauss SJ, Whelan J, Leahy M, Woll PJ, Cowie F, Rothermundt C, Wood Z, Benson C, Ali N, Marples M, Veal GJ, Jamieson D, Küver K, Tirabosco R, Forsyth S, Nash S, Dehbi HM, Beare S. Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomised controlled phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1397-1410. Epub 2017 Sep 4. link to original article link to PMC article EuroPMC ISRCTN07742377
==Doxorubicin monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Seddon et al. 2017 (GeDDiS) 	2010-2014 	Phase 3 (C)	DG 	Did not meet primary endpoint of alive and progression free at 24 weeks
Pautier et al. 2022 (LMS-04)	2017-2019 	Phase 3 (C)	Doxorubicin & Trabectedin	Shorter PFS1Median PFS: 6.2 vs 12.2 mo(HR 2.44, 95% CI 1.72-3.45)
1Reported efficacy for LMS-04 is based on the 2024 update.
====Chemotherapy====
*Doxorubicin (Adriamycin) 75 mg/m2 IV over 10 to 15 minutes once on day 1
21-day cycle for 6 cycles
===References===
# GeDDiS: Seddon B, Strauss SJ, Whelan J, Leahy M, Woll PJ, Cowie F, Rothermundt C, Wood Z, Benson C, Ali N, Marples M, Veal GJ, Jamieson D, Küver K, Tirabosco R, Forsyth S, Nash S, Dehbi HM, Beare S. Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomised controlled phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1397-1410. Epub 2017 Sep 4. link to original article link to PMC article EuroPMC ISRCTN07742377
#LMS-04: Pautier P, Italiano A, Piperno-Neumann S, Chevreau C, Penel N, Firmin N, Boudou-Rouquette P, Bertucci F, Balleyguier C, Lebrun-Ly V, Ray-Coquard I, Kalbacher E, Bardet A, Bompas E, Collard O, Isambert N, Guillemet C, Rios M, Archambaud B, Duffaud F; French Sarcoma Group. Doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin alone as first-line therapy for metastatic or unresectable leiomyosarcoma (LMS-04): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2022 Aug;23(8):1044-1054. Epub 2022 Jul 11. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02997358
##Update: Pautier P, Italiano A, Piperno-Neumann S, Chevreau C, Penel N, Firmin N, Boudou-Rouquette P, Bertucci F, Lebrun-Ly V, Ray-Coquard I, Kalbacher E, Bompas E, Collard O, Isambert N, Guillemet C, Rios M, Le Cesne A, Balleyguier C, Archambaud B, Duffaud F; French Sarcoma Group. Doxorubicin-Trabectedin with Trabectedin Maintenance in Leiomyosarcoma. N Engl J Med. 2024 Sep 5;391(9):789-799. link to original article EuroPMC
==Doxorubicin & Trabectedin==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Pautier et al. 2022 (LMS-04)	2017-2019 	Phase 3 (E-esc)	Doxorubicin	Longer PFS1 (primary endpoint)Median PFS: 12 vs 6 mo(aHR 0.37, 95% CI 0.26-0.53)Longer OS1 (secondary endpoint)Median OS: 33 vs 24 mo(aHR 0.65, 95% CI 0.44-0.95)
1Reported efficacy is based on the 2024 update.
====Chemotherapy====
*Doxorubicin (Adriamycin) as follows:
**Cycles 1 to 6: 60 mg/m2 IV over 10 to 15 minutes once on day 1, given first
*Trabectedin (Yondelis) 1.1 mg/m2 IV over 3 hours once on day 1, given second
21-day cycle for up to 23 cycles
===References===
#LMS-04: Pautier P, Italiano A, Piperno-Neumann S, Chevreau C, Penel N, Firmin N, Boudou-Rouquette P, Bertucci F, Balleyguier C, Lebrun-Ly V, Ray-Coquard I, Kalbacher E, Bardet A, Bompas E, Collard O, Isambert N, Guillemet C, Rios M, Archambaud B, Duffaud F; French Sarcoma Group. Doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin alone as first-line therapy for metastatic or unresectable leiomyosarcoma (LMS-04): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2022 Aug;23(8):1044-1054. Epub 2022 Jul 11. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02997358
##Update: Pautier P, Italiano A, Piperno-Neumann S, Chevreau C, Penel N, Firmin N, Boudou-Rouquette P, Bertucci F, Lebrun-Ly V, Ray-Coquard I, Kalbacher E, Bompas E, Collard O, Isambert N, Guillemet C, Rios M, Le Cesne A, Balleyguier C, Archambaud B, Duffaud F; French Sarcoma Group. Doxorubicin-Trabectedin with Trabectedin Maintenance in Leiomyosarcoma. N Engl J Med. 2024 Sep 5;391(9):789-799. link to original article EuroPMC
=Advanced or metastatic disease, subsequent lines of therapy=
==Dacarbazine monotherapy==
===Regimen variant #1, 850 mg/m2===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Schöffski et al. 2016 (E7389-G000-309)	2011-2013 	Phase 3 (C)	Eribulin 	Did not meet primary endpoint of OS1
1Reported efficacy is based on the 2019 subgroup analysis.
====Chemotherapy====
*Dacarbazine (DTIC) 850 mg/m2 IV over 20 to 120 minutes once on day 1
21-day cycles
===Regimen variant #2, 1000 mg/m2===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Demetri et al. 2015 (ET743-SAR-3007) 	2011-2013 	Phase 3 (C)	Trabectedin	Did not meet primary endpoint of OS
Schöffski et al. 2016 (E7389-G000-309)	2011-2013 	Phase 3 (C)	Eribulin 	Did not meet primary endpoint of OS1
1Reported efficacy for E7389-G000-309 is based on the 2019 subgroup analysis.
Note: this is listed as a "starting dose" in Demetri et al. 2015, but no adjustment instructions were provided in the manuscript.
====Chemotherapy====
*Dacarbazine (DTIC) 1000 mg/m2 IV over 20 to 120 minutes once on day 1
21-day cycles
===Regimen variant #3, 1200 mg/m2===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Schöffski et al. 2016 (E7389-G000-309)	2011-2013 	Phase 3 (C)	Eribulin 	Did not meet primary endpoint of OS1
1Reported efficacy is based on the 2019 subgroup analysis.
====Chemotherapy====
*Dacarbazine (DTIC) 1200 mg/m2 IV over 20 minutes once on day 1
====Supportive therapy====
*Buesa et al. 1991: Calcium gluconate (10% solution) 5 mL IV every 10 minutes x 3 doses (total of 15 mL) after the start of dacarbazine; 2 additional doses of calcium gluconate (10% solution) 5 mL IV every 10 minutes were given to patients whose systolic blood pressure decreased below 80 mmHg or heart rate more than 160 bpm.
21-day cycles
===References===
# ET743-SAR-3007: Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. Epub 2015 Sep 14. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT01343277
## Subgroup analysis: Hensley ML, Patel SR, von Mehren M, Ganjoo K, Jones RL, Staddon A, Rushing D, Milhem M, Monk B, Wang G, McCarthy S, Knoblauch RE, Parekh TV, Maki RG, Demetri GD. Efficacy and safety of trabectedin or dacarbazine in patients with advanced uterine leiomyosarcoma after failure of anthracycline-based chemotherapy: Subgroup analysis of a phase 3, randomized clinical trial. Gynecol Oncol. 2017 Sep;146(3):531-537. Epub 2017 Jun 24. link to original article link to PMC article EuroPMC
## Update: Patel S, von Mehren M, Reed DR, Kaiser P, Charlson J, Ryan CW, Rushing D, Livingston M, Singh A, Seth R, Forscher C, D'Amato G, Chawla SP, McCarthy S, Wang G, Parekh T, Knoblauch R, Hensley ML, Maki RG, Demetri GD. Overall survival and histology-specific subgroup analyses from a phase 3, randomized controlled study of trabectedin or dacarbazine in patients with advanced liposarcoma or leiomyosarcoma. Cancer. 2019 Aug 1;125(15):2610-2620. Epub 2019 Jun 7. link to original article link to PMC article EuroPMC
# E7389-G000-309: Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. Epub 2016 Feb 10. link to original article EuroPMC NCT01327885
## Subgroup analysis: Blay JY, Schöffski P, Bauer S, Krarup-Hansen A, Benson C, D'Adamo DR, Jia Y, Maki RG. Eribulin versus dacarbazine in patients with leiomyosarcoma: subgroup analysis from a phase 3, open-label, randomised study. Br J Cancer. 2019 May;120(11):1026-1032. Epub 2019 May 8. link to original article link to PMC article EuroPMC
==Dacarbazine & Gemcitabine==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
García-Del-Muro et al. 2011	2005-2008 	Randomized Phase 2, fewer than 20 pts in this subgroup (E-esc)	Dacarbazine	Longer OS (secondary endpoint)Median OS: 16.8 vs 8.2 mo(HR 0.56, 95% CI 0.36-0.90)
====Chemotherapy====
*Dacarbazine (DTIC) 500 mg/m2 IV over 20 minutes once on day 1, given second
*Gemcitabine (Gemzar) 1800 mg/m2 IV at fixed dosed rate over 3 hours once on day 1, given first
14-day cycle for at least 12 cycles
===References===
# García-Del-Muro X, López-Pousa A, Maurel J, Martín J, Martínez-Trufero J, Casado A, Gómez-España A, Fra J, Cruz J, Poveda A, Meana A, Pericay C, Cubedo R, Rubió J, De Juan A, Laínez N, Carrasco JA, de Andrés R, Buesa JM; Spanish Group for Research on Sarcomas. Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: a Spanish Group for Research on Sarcomas study. J Clin Oncol. 2011 Jun 20;29(18):2528-33. Epub 2011 May 23. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC EudraCT 2005-001709-24
==Docetaxel & Gemcitabine==
===Regimen variant #1, 75/675===
Study 	Dates of enrollment	Evidence
Hensley et al. 2002	Not reported 	Phase 2
Note: This regimen was intended for patients who received prior radiation.
====Chemotherapy====
*Docetaxel (Taxotere) 75 mg/m2 IV over 60 minutes once on day 8, given second
*Gemcitabine (Gemzar) 675 mg/m2 IV over 90 minutes once per day on days 1 & 8, given first
====Supportive therapy====
*Dexamethasone (Decadron) 8 mg PO twice per day on days 7 to 9 (the day before, the day of, and day after docetaxel)
*Patients could receive diuretics at physician discretion for peripheral edema related to docetaxel
*One of the following growth factors (varies depending on reference):
**G-CSF (type not specified) 150 mcg/m2 (dose rounded to 300 or 480 mcg) SC once per day on days 9 to 15 as primary neutropenia prophylaxis; could be stopped before day 15 if ANC greater than 1200/μL on two separate measurements
**Pegfilgrastim (Neulasta) 6 mg SC once on either day 9 or 10
21-day cycle for 6 to 8 cycles
===Regimen variant #2, 100/900===
Study 	Dates of enrollment	Evidence
Hensley et al. 2002	Not reported 	Phase 2
Note: This regimen was intended for patients with no prior radiation.
====Chemotherapy====
*Docetaxel (Taxotere) 100 mg/m2 IV over 60 minutes once on day 8, given second
*Gemcitabine (Gemzar) 900 mg/m2 IV over 90 minutes once per day on days 1 & 8, given first
====Supportive therapy====
*Dexamethasone (Decadron) 8 mg PO twice per day on days 7 to 9 (the day before, the day of, and day after docetaxel)
*Patients could receive diuretics at physician discretion for peripheral edema related to docetaxel
*One of the following growth factors (varies depending on reference):
**G-CSF (type not specified) 150 mcg/m2 (dose rounded to 300 or 480 mcg) SC once per day on days 9 to 15 as primary neutropenia prophylaxis; could be stopped before day 15 if ANC greater than 1200/μL on two separate measurements
**Pegfilgrastim (Neulasta) 6 mg SC once on either day 9 or 10
21-day cycle for 6 to 8 cycles
===References===
# Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
==Eribulin monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Schöffski et al. 2016 (E7389-G000-309)	2011-2013 	Phase 3 (E-switch-ic)	Dacarbazine	Did not meet primary endpoint of OS1
1Reported efficacy is based on the 2019 subgroup analysis.
====Chemotherapy====
*Eribulin (Halaven) 1.4 mg/m2 IV once per day on days 1 & 8
21-day cycles
===References===
# E7389-G000-309: Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. Epub 2016 Feb 10. link to original article dosing details in abstract have been reviewed by our editors EuroPMC NCT01327885
## Subgroup analysis: Blay JY, Schöffski P, Bauer S, Krarup-Hansen A, Benson C, D'Adamo DR, Jia Y, Maki RG. Eribulin versus dacarbazine in patients with leiomyosarcoma: subgroup analysis from a phase 3, open-label, randomised study. Br J Cancer. 2019 May;120(11):1026-1032. Epub 2019 May 8. link to original article link to PMC article EuroPMC
==Regorafenib monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator	Comparative Efficacy
Mir et al. 2016 (REGOSARC)	2013-08-05 to 2014-11-26	Randomized Phase 2 (E-esc)	Placebo 	Longer PFS1 (primary endpoint)Median PFS: 3.7 vs 1.8 mo(HR 0.46, 95% CI 0.46-0.80)
1Reported efficacy is for the leiomyosarcoma cohort.
====Targeted therapy====
*Regorafenib (Stivarga) 160 mg PO once per day on days 1 to 21
28-day cycles
===References===
# REGOSARC: Mir O, Brodowicz T, Italiano A, Wallet J, Blay JY, Bertucci F, Chevreau C, Piperno-Neumann S, Bompas E, Salas S, Perrin C, Delcambre C, Liegl-Atzwanger B, Toulmonde M, Dumont S, Ray-Coquard I, Clisant S, Taieb S, Guillemet C, Rios M, Collard O, Bozec L, Cupissol D, Saada-Bouzid E, Lemaignan C, Eisterer W, Isambert N, Chaigneau L, Cesne AL, Penel N. Safety and efficacy of regorafenib in patients with advanced soft tissue sarcoma (REGOSARC): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Dec;17(12):1732-1742. Epub 2016 Oct 14. link to original article dosing details in abstract have been reviewed by our editors EuroPMC NCT01900743
==Trabectedin monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Demetri et al. 2009 	2003 to not reported	Randomized Phase 2 (E-switch-ic)	Trabectedin; alternate schedule	Seems to have longer TTP (primary endpoint)
Demetri et al. 2015 (ET743-SAR-3007)	2011-2013 	Phase 3 (E-RT-switch-ic) 	Dacarbazine 	Did not meet primary endpoint of OS
Note: in Demetri et al. 2015, this is listed as a "starting dose," but no adjustment instructions were provided in the manuscript.
====Chemotherapy====
*Trabectedin (Yondelis) 1.5 mg/m2 IV continuous infusion over 24 hours, started on day 1
====Supportive therapy====
*Dexamethasone (Decadron) 20 mg IV once on day 1, prior to trabectedin
21-day cycles
===References===
# Demetri GD, Chawla SP, von Mehren M, Ritch P, Baker LH, Blay JY, Hande KR, Keohan ML, Samuels BL, Schuetze S, Lebedinsky C, Elsayed YA, Izquierdo MA, Gómez J, Park YC, Le Cesne A. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol. 2009 Sep 1;27(25):4188-96. Epub 2009 Aug 3. link to original article dosing details in abstract have been reviewed by our editors EuroPMC
# ET743-SAR-3007: Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. Epub 2015 Sep 14. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT01343277
## Subgroup analysis: Hensley ML, Patel SR, von Mehren M, Ganjoo K, Jones RL, Staddon A, Rushing D, Milhem M, Monk B, Wang G, McCarthy S, Knoblauch RE, Parekh TV, Maki RG, Demetri GD. Efficacy and safety of trabectedin or dacarbazine in patients with advanced uterine leiomyosarcoma after failure of anthracycline-based chemotherapy: Subgroup analysis of a phase 3, randomized clinical trial. Gynecol Oncol. 2017 Sep;146(3):531-537. Epub 2017 Jun 24. link to original article link to PMC article EuroPMC
## Update: Patel S, von Mehren M, Reed DR, Kaiser P, Charlson J, Ryan CW, Rushing D, Livingston M, Singh A, Seth R, Forscher C, D'Amato G, Chawla SP, McCarthy S, Wang G, Parekh T, Knoblauch R, Hensley ML, Maki RG, Demetri GD. Overall survival and histology-specific subgroup analyses from a phase 3, randomized controlled study of trabectedin or dacarbazine in patients with advanced liposarcoma or leiomyosarcoma. Cancer. 2019 Aug 1;125(15):2610-2620. Epub 2019 Jun 7. link to original article link to PMC article EuroPMC
Category:Leiomyosarcoma regimens
Category:Disease-specific pages
Category:Soft tissue sarcomas