Difference between revisions of "Leiomyosarcoma"
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===Regimen variant #1, 850 mg/m<sup>2</sup> {{#subobject:f09c3f|Variant=1}}=== | ===Regimen variant #1, 850 mg/m<sup>2</sup> {{#subobject:f09c3f|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
− | !style="width: | + | !style="width: 20%"|Study |
− | !style="width: | + | !style="width: 20%"|Years of enrollment |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01283-0/fulltext Schöffski et al. 2016 (E7389-G000-309)] | |[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01283-0/fulltext Schöffski et al. 2016 (E7389-G000-309)] | ||
+ | |2011-2013 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (C) | ||
|[[#Eribulin_monotherapy|Eribulin]] | |[[#Eribulin_monotherapy|Eribulin]] | ||
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===Regimen variant #2, 1000 mg/m<sup>2</sup> {{#subobject:4b5552|Variant=1}}=== | ===Regimen variant #2, 1000 mg/m<sup>2</sup> {{#subobject:4b5552|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
− | !style="width: | + | !style="width: 20%"|Study |
− | !style="width: | + | !style="width: 20%"|Years of enrollment |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ Demetri et al. 2015 (ET743-SAR-3007)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ Demetri et al. 2015 (ET743-SAR-3007)] | ||
+ | |2011-2013 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (C) | ||
|[[#Trabectedin_monotherapy|Trabectedin]] | |[[#Trabectedin_monotherapy|Trabectedin]] | ||
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|- | |- | ||
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01283-0/fulltext Schöffski et al. 2016 (E7389-G000-309)] | |[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01283-0/fulltext Schöffski et al. 2016 (E7389-G000-309)] | ||
+ | |2011-2013 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (C) | ||
|[[#Eribulin_monotherapy|Eribulin]] | |[[#Eribulin_monotherapy|Eribulin]] | ||
Line 65: | Line 70: | ||
===Regimen variant #3, 1200 mg/m<sup>2</sup> {{#subobject:2c183b|Variant=1}}=== | ===Regimen variant #3, 1200 mg/m<sup>2</sup> {{#subobject:2c183b|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
− | !style="width: | + | !style="width: 20%"|Study |
− | !style="width: | + | !style="width: 20%"|Years of enrollment |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01283-0/fulltext Schöffski et al. 2016 (E7389-G000-309)] | |[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01283-0/fulltext Schöffski et al. 2016 (E7389-G000-309)] | ||
+ | |2011-2013 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (C) | ||
|[[#Eribulin_monotherapy|Eribulin]] | |[[#Eribulin_monotherapy|Eribulin]] | ||
Line 86: | Line 93: | ||
===References=== | ===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. [http://jco.ascopubs.org/content/34/8/786.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26371143 PubMed] | + | # '''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. [http://jco.ascopubs.org/content/34/8/786.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26371143 PubMed] 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. [https://pubmed.ncbi.nlm.nih.gov/28651804 PubMed] | ## '''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. [https://pubmed.ncbi.nlm.nih.gov/28651804 PubMed] | ||
## '''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. [https://onlinelibrary.wiley.com/doi/10.1002/cncr.32117 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31173362 PubMed] | ## '''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. [https://onlinelibrary.wiley.com/doi/10.1002/cncr.32117 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31173362 PubMed] | ||
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===Regimen {{#subobject:9aaddf|Variant=1}}=== | ===Regimen {{#subobject:9aaddf|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
− | !style="width: | + | !style="width: 20%"|Study |
− | !style="width: | + | !style="width: 20%"|Years of enrollment |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://doi.org/10.1200/JCO.2010.33.6107 García-Del-Muro et al. 2011] | |[https://doi.org/10.1200/JCO.2010.33.6107 García-Del-Muro et al. 2011] | ||
+ | |2005-2008 | ||
| style="background-color:#ffffbe" |Randomized Phase II, <20 pts in this subgroup (E-esc) | | style="background-color:#ffffbe" |Randomized Phase II, <20 pts in this subgroup (E-esc) | ||
|[[#Dacarbazine_monotherapy|Dacarbazine]] | |[[#Dacarbazine_monotherapy|Dacarbazine]] | ||
Line 126: | Line 135: | ||
===Regimen variant #1, 60/675 {{#subobject:270ac9|Variant=1}}=== | ===Regimen variant #1, 60/675 {{#subobject:270ac9|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
− | !style="width: | + | !style="width: 20%"|Study |
− | !style="width: | + | !style="width: 20%"|Years of enrollment |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4372854/ Hensley et al. 2015 (GOG-250)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4372854/ Hensley et al. 2015 (GOG-250)] | ||
+ | |2009-2013 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (C) | ||
|Docetaxel, Gemcitabine, Bevacizumab | |Docetaxel, Gemcitabine, Bevacizumab | ||
Line 146: | Line 157: | ||
===Regimen variant #2, 75/675 {{#subobject:2898f9|Variant=1}}=== | ===Regimen variant #2, 75/675 {{#subobject:2898f9|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
− | !style="width: | + | !style="width: 20%"|Study |
− | !style="width: | + | !style="width: 20%"|Years of enrollment |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/20/12/2824.long Hensley et al. 2002] | |[http://jco.ascopubs.org/content/20/12/2824.long Hensley et al. 2002] | ||
+ | |NR | ||
| style="background-color:#91cf61" |Phase II | | style="background-color:#91cf61" |Phase II | ||
| style="background-color:#d3d3d3" | | | style="background-color:#d3d3d3" | | ||
Line 157: | Line 170: | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5622179/ Seddon et al. 2017 (GeDDiS)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5622179/ Seddon et al. 2017 (GeDDiS)] | ||
+ | |2010-2014 | ||
| style="background-color:#1a9851" |Phase III (E-switch-ic) | | style="background-color:#1a9851" |Phase III (E-switch-ic) | ||
|[[#Doxorubicin_monotherapy|Doxorubicin]] | |[[#Doxorubicin_monotherapy|Doxorubicin]] | ||
Line 178: | Line 192: | ||
===Regimen variant #3, 75/900 {{#subobject:2a13c9|Variant=1}}=== | ===Regimen variant #3, 75/900 {{#subobject:2a13c9|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
− | !style="width: | + | !style="width: 20%"|Study |
− | !style="width: | + | !style="width: 20%"|Years of enrollment |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4372854/ Hensley et al. 2015 (GOG-250)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4372854/ Hensley et al. 2015 (GOG-250)] | ||
+ | |2009-2013 | ||
| style="background-color:#1a9851" |Phase III (C) | | style="background-color:#1a9851" |Phase III (C) | ||
|Docetaxel, Gemcitabine, Bevacizumab | |Docetaxel, Gemcitabine, Bevacizumab | ||
Line 225: | Line 241: | ||
# 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. [http://jco.ascopubs.org/content/20/12/2824.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/12065559 PubMed] | # 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. [http://jco.ascopubs.org/content/20/12/2824.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/12065559 PubMed] | ||
# '''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. [http://www.gynecologiconcology-online.net/article/S0090-8258(08)00204-7/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2504727/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18534250 PubMed] | # '''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. [http://www.gynecologiconcology-online.net/article/S0090-8258(08)00204-7/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2504727/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18534250 PubMed] | ||
− | # '''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. [https://doi.org/10.1200/JCO.2014.58.3781 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4372854/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25713428 PubMed] | + | # '''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. [https://doi.org/10.1200/JCO.2014.58.3781 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4372854/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25713428 PubMed] 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. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30622-8/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5622179/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28882536 PubMed] | + | # '''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. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30622-8/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5622179/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28882536 PubMed] ISRCTN07742377 |
==Eribulin monotherapy {{#subobject:427859|Regimen=1}}== | ==Eribulin monotherapy {{#subobject:427859|Regimen=1}}== | ||
Line 235: | Line 251: | ||
===Regimen {{#subobject:2bcda0|Variant=1}}=== | ===Regimen {{#subobject:2bcda0|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
− | !style="width: | + | !style="width: 20%"|Study |
− | !style="width: | + | !style="width: 20%"|Years of enrollment |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01283-0/fulltext Schöffski et al. 2016 (E7389-G000-309)] | |[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01283-0/fulltext Schöffski et al. 2016 (E7389-G000-309)] | ||
+ | |2011-2013 | ||
| style="background-color:#1a9851" |Phase III (E-switch-ic) | | style="background-color:#1a9851" |Phase III (E-switch-ic) | ||
|[[#Dacarbazine_monotherapy|Dacarbazine]] | |[[#Dacarbazine_monotherapy|Dacarbazine]] | ||
Line 264: | Line 282: | ||
===Regimen {{#subobject:b5ff4e|Variant=1}}=== | ===Regimen {{#subobject:b5ff4e|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
− | !style="width: | + | !style="width: 20%"|Study |
− | !style="width: | + | !style="width: 20%"|Years of enrollment |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30507-1/fulltext Mir et al. 2016 (REGOSARC)] | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30507-1/fulltext Mir et al. 2016 (REGOSARC)] | ||
+ | |2013-2014 | ||
| style="background-color:#1a9851" |Randomized Phase II (E-esc) | | style="background-color:#1a9851" |Randomized Phase II (E-esc) | ||
|[[#Placebo|Placebo]] | |[[#Placebo|Placebo]] | ||
Line 304: | Line 324: | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ Demetri et al. 2015 (ET743-SAR-3007)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ Demetri et al. 2015 (ET743-SAR-3007)] | ||
− | |2011- | + | |2011-2013 |
| style="background-color:#1a9851" |Phase III (E-RT-switch-ic) | | style="background-color:#1a9851" |Phase III (E-RT-switch-ic) | ||
|[[#Dacarbazine_monotherapy|Dacarbazine]] | |[[#Dacarbazine_monotherapy|Dacarbazine]] | ||
Line 321: | Line 341: | ||
===References=== | ===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. [https://doi.org/10.1200/JCO.2008.21.0088 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/19652065 PubMed] | # 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. [https://doi.org/10.1200/JCO.2008.21.0088 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/19652065 PubMed] | ||
− | # '''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. [http://jco.ascopubs.org/content/34/8/786.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26371143 PubMed] | + | # '''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. [http://jco.ascopubs.org/content/34/8/786.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26371143 PubMed] 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. [https://pubmed.ncbi.nlm.nih.gov/28651804 PubMed] | ## '''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. [https://pubmed.ncbi.nlm.nih.gov/28651804 PubMed] | ||
## '''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. [https://onlinelibrary.wiley.com/doi/10.1002/cncr.32117 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31173362 PubMed] | ## '''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. [https://onlinelibrary.wiley.com/doi/10.1002/cncr.32117 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31173362 PubMed] |
Revision as of 13:41, 10 October 2020
Section editor | |
---|---|
Elizabeth J. Davis, MD Vanderbilt University Nashville, TN ejdavis25 |
Note: these are regimens tested in subtype-specific populations, please see the main soft tissue sarcoma page for other regimens.
9 regimens on this page
15 variants on this page
|
Advanced or metastatic disease, all lines of therapy
Dacarbazine monotherapy
back to top |
Regimen variant #1, 850 mg/m2
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Schöffski et al. 2016 (E7389-G000-309) | 2011-2013 | Phase III (C) | Eribulin | Did not meet primary endpoint of OS (*) |
Note: reported 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 | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Demetri et al. 2015 (ET743-SAR-3007) | 2011-2013 | Phase III (C) | Trabectedin | Did not meet primary endpoint of OS |
Schöffski et al. 2016 (E7389-G000-309) | 2011-2013 | Phase III (C) | Eribulin | Did not meet primary endpoint of OS (*) |
Note: this is listed as a "starting dose" in Demetri et al. 2015, but no adjustment instructions were provided in the manuscript. Reported efficacy for E7389-G000-309 is based on the 2019 subgroup analysis.
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 | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Schöffski et al. 2016 (E7389-G000-309) | 2011-2013 | Phase III (C) | Eribulin | Did not meet primary endpoint of OS (*) |
Note: reported efficacy is based on the 2019 subgroup analysis.
Chemotherapy
- Dacarbazine (DTIC) 1200 mg/m2 IV over 20 minutes once on day 1
Supportive medications
- 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 contains verified protocol link to PMC article PubMed 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. PubMed
- 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 PubMed
- 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 PubMed 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 PubMed
Dacarbazine & Gemcitabine
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
García-Del-Muro et al. 2011 | 2005-2008 | Randomized Phase II, <20 pts in this subgroup (E-esc) | Dacarbazine | Seems to have superior OS |
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 contains verified protocol PubMed
Docetaxel & Gemcitabine
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Regimen variant #1, 60/675
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Hensley et al. 2015 (GOG-250) | 2009-2013 | Phase III (C) | Docetaxel, Gemcitabine, Bevacizumab | Did not meet primary endpoint of PFS |
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 | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Hensley et al. 2002 | NR | Phase II | ||
Seddon et al. 2017 (GeDDiS) | 2010-2014 | Phase III (E-switch-ic) | Doxorubicin | Might have inferior PFS |
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 medications
- Dexamethasone (Decadron) 8 mg PO twice per day on days 7 to 9 (the day before, the day of, and day after Docetaxel (Taxotere))
- 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/uL 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 #3, 75/900
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Hensley et al. 2015 (GOG-250) | 2009-2013 | Phase III (C) | Docetaxel, Gemcitabine, Bevacizumab | Did not meet primary endpoint of PFS |
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 | Evidence |
---|---|
Hensley et al. 2002 | Phase II |
Hensley et al. 2008 (GOG 87L) | Phase II |
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 medications
- Dexamethasone (Decadron) 8 mg PO twice per day on days 7 to 9 (the day before, the day of, and day after Docetaxel (Taxotere))
- 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/uL on two separate measurements
- Pegfilgrastim (Neulasta) 6 mg SC once on either day 9 or 10
21-day cycle for 6 to 8 cycles; Hensley et al. 2008 did not specify a maximum number of 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 contains verified protocol PubMed
- 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 contains verified protocol link to PMC article PubMed
- 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 PubMed 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 PubMed ISRCTN07742377
Eribulin monotherapy
back to top |
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Schöffski et al. 2016 (E7389-G000-309) | 2011-2013 | Phase III (E-switch-ic) | Dacarbazine | Did not meet primary endpoint of OS (*) |
Note: reported 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 PubMed 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 PubMed
Regorafenib monotherapy
back to top |
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Mir et al. 2016 (REGOSARC) | 2013-2014 | Randomized Phase II (E-esc) | Placebo | Superior PFS |
Note: reported efficacy is for the leiomyosarcoma, synovial sarcoma, and other sarcoma cohorts; there was no significant difference in outcome for the liposarcoma 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 contains protocol PubMed
Trabectedin monotherapy
back to top |
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Demetri et al. 2009 | 2003-NR | Randomized Phase II (E-switch-ic) | Trabectedin; alternate schedule | Seems to have superior TTP |
Demetri et al. 2015 (ET743-SAR-3007) | 2011-2013 | Phase III (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 medications
- Dexamethasone (Decadron) 20 mg IV once on day 1, prior to Trabectedin (Yondelis)
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 contains protocol PubMed
- 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 contains verified protocol link to PMC article PubMed 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. PubMed
- 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 PubMed