Difference between revisions of "Liposarcoma"
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Warner-admin (talk | contribs) m (Text replacement - "====Supportive medications" to "====Supportive therapy") |
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=All lines of therapy= | =All lines of therapy= | ||
==Dacarbazine monotherapy {{#subobject:62426f|Regimen=1}}== | ==Dacarbazine monotherapy {{#subobject:62426f|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===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;" | ||
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|} | |} | ||
''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Dacarbazine (DTIC)]] 850 mg/m<sup>2</sup> IV over 20 to 120 minutes once on day 1 | *[[Dacarbazine (DTIC)]] 850 mg/m<sup>2</sup> IV over 20 to 120 minutes once on day 1 | ||
| − | |||
'''21-day cycles''' | '''21-day cycles''' | ||
| − | + | </div></div><br> | |
| + | <div class="toccolours" style="background-color:#eeeeee"> | ||
===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;" | ||
| Line 58: | Line 59: | ||
''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.''<br> | ''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.''<br> | ||
''Note: this is listed as a "starting dose" in Demetri et al. 2015, but no adjustment instructions were provided in the manuscript.'' | ''Note: this is listed as a "starting dose" in Demetri et al. 2015, but no adjustment instructions were provided in the manuscript.'' | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Dacarbazine (DTIC)]] 1000 mg/m<sup>2</sup> IV over 20 to 120 minutes once on day 1 | *[[Dacarbazine (DTIC)]] 1000 mg/m<sup>2</sup> IV over 20 to 120 minutes once on day 1 | ||
| − | |||
'''21-day cycles''' | '''21-day cycles''' | ||
| − | + | </div></div><br> | |
| + | <div class="toccolours" style="background-color:#eeeeee"> | ||
===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;" | ||
| Line 79: | Line 81: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Dacarbazine (DTIC)]] 1200 mg/m<sup>2</sup> IV over 20 minutes once on day 1 | *[[Dacarbazine (DTIC)]] 1200 mg/m<sup>2</sup> IV over 20 minutes once on day 1 | ||
| − | |||
====Supportive therapy==== | ====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. | *'''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''' | '''21-day cycles''' | ||
| − | + | </div></div> | |
===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. [https://doi.org/10.1200/jco.2015.62.4734 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26371143 PubMed] NCT01343277 | # '''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. [https://doi.org/10.1200/jco.2015.62.4734 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26371143 PubMed] NCT01343277 | ||
| Line 93: | Line 94: | ||
# '''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. [https://doi.org/10.1016/S0140-6736(15)01283-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26874885 PubMed] NCT01327885 | # '''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. [https://doi.org/10.1016/S0140-6736(15)01283-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26874885 PubMed] NCT01327885 | ||
## '''Subgroup analysis:''' Demetri GD, Schöffski P, Grignani G, Blay JY, Maki RG, Van Tine BA, Alcindor T, Jones RL, D'Adamo DR, Guo M, Chawla S. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. 2017 Oct 20;35(30):3433-3439. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.6605 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854066 PubMed] | ## '''Subgroup analysis:''' Demetri GD, Schöffski P, Grignani G, Blay JY, Maki RG, Van Tine BA, Alcindor T, Jones RL, D'Adamo DR, Guo M, Chawla S. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. 2017 Oct 20;35(30):3433-3439. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.6605 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854066 PubMed] | ||
| − | |||
==Eribulin monotherapy {{#subobject:427859|Regimen=1}}== | ==Eribulin monotherapy {{#subobject:427859|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:2bcda0|Variant=1}}=== | ===Regimen {{#subobject:2bcda0|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
| Line 109: | Line 109: | ||
|- | |- | ||
|[https://doi.org/10.1016/S0140-6736(15)01283-0 Schöffski et al. 2016 (E7389-G000-309)] | |[https://doi.org/10.1016/S0140-6736(15)01283-0 Schöffski et al. 2016 (E7389-G000-309)] | ||
| + | {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26" | ||
| + | |'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-202-1 <span style="color:white;">ESMO-MCBS (3)</span>]''' | ||
| + | |- | ||
| + | |} | ||
|2011-2013 | |2011-2013 | ||
| style="background-color:#1a9851" |Phase 3 (E-RT-switch-ic) | | style="background-color:#1a9851" |Phase 3 (E-RT-switch-ic) | ||
| Line 116: | Line 120: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Eribulin (Halaven)]] 1.4 mg/m<sup>2</sup> IV once per day on days 1 & 8 | *[[Eribulin (Halaven)]] 1.4 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
| − | |||
'''21-day cycles''' | '''21-day cycles''' | ||
| − | + | </div></div> | |
===References=== | ===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. [https://doi.org/10.1016/S0140-6736(15)01283-0 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26874885 PubMed] NCT01327885 | # '''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. [https://doi.org/10.1016/S0140-6736(15)01283-0 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26874885 PubMed] NCT01327885 | ||
## '''Subgroup analysis:''' Demetri GD, Schöffski P, Grignani G, Blay JY, Maki RG, Van Tine BA, Alcindor T, Jones RL, D'Adamo DR, Guo M, Chawla S. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. 2017 Oct 20;35(30):3433-3439. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.6605 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854066 PubMed] | ## '''Subgroup analysis:''' Demetri GD, Schöffski P, Grignani G, Blay JY, Maki RG, Van Tine BA, Alcindor T, Jones RL, D'Adamo DR, Guo M, Chawla S. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. 2017 Oct 20;35(30):3433-3439. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.6605 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854066 PubMed] | ||
| − | |||
==Trabectedin monotherapy {{#subobject:cfc3ed|Regimen=1}}== | ==Trabectedin monotherapy {{#subobject:cfc3ed|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:05c55d|Variant=1}}=== | ===Regimen {{#subobject:05c55d|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| Line 149: | Line 152: | ||
|} | |} | ||
''Note: in Demetri et al. 2015, this is listed as a "starting dose," but no adjustment instructions were provided in the manuscript.'' | ''Note: in Demetri et al. 2015, this is listed as a "starting dose," but no adjustment instructions were provided in the manuscript.'' | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Trabectedin (Yondelis)]] 1.5 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1 | *[[Trabectedin (Yondelis)]] 1.5 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1 | ||
| − | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
*[[Dexamethasone (Decadron)]] 20 mg IV once on day 1, prior to [[Trabectedin (Yondelis)]] | *[[Dexamethasone (Decadron)]] 20 mg IV once on day 1, prior to [[Trabectedin (Yondelis)]] | ||
| − | |||
'''21-day cycles''' | '''21-day cycles''' | ||
| − | + | </div></div> | |
===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 dosing details in abstract''' [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 dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/19652065 PubMed] | ||
| Line 162: | Line 164: | ||
## '''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://doi.org/10.1016/j.ygyno.2017.06.018 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5783302/ link to PMC article] [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://doi.org/10.1016/j.ygyno.2017.06.018 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5783302/ link to PMC article] [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://doi.org/10.1002/cncr.32117 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771856/ link to PMC 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://doi.org/10.1002/cncr.32117 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771856/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31173362 PubMed] | ||
| − | |||
[[Category:Liposarcoma regimens]] | [[Category:Liposarcoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Soft tissue sarcomas]] | [[Category:Soft tissue sarcomas]] | ||
Revision as of 03:06, 20 February 2023
Section editor transclusions Note: these are regimens tested in subtype-specific populations, please see the main soft tissue sarcoma page for other regimens.
3 regimens on this page
5 variants on this page
|
All lines of therapy
Dacarbazine monotherapy
Regimen variant #1, 850 mg/m2
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Schöffski et al. 2016 (E7389-G000-309) | 2011-2013 | Phase 3 (C) | Eribulin | Inferior OS1 |
1Reported efficacy is based on the 2017 subgroup analysis.
Regimen variant #2, 1000 mg/m2
| Study | Years 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 | Inferior OS1 |
1Reported efficacy is based on the 2017 subgroup analysis.
Note: this is listed as a "starting dose" in Demetri et al. 2015, but no adjustment instructions were provided in the manuscript.
Regimen variant #3, 1200 mg/m2
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Schöffski et al. 2016 (E7389-G000-309) | 2011-2013 | Phase 3 (C) | Eribulin | Inferior OS1 |
1Reported efficacy is based on the 2017 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 contains dosing details in manuscript 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. link to original article link to PMC article 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 link to PMC 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: Demetri GD, Schöffski P, Grignani G, Blay JY, Maki RG, Van Tine BA, Alcindor T, Jones RL, D'Adamo DR, Guo M, Chawla S. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. 2017 Oct 20;35(30):3433-3439. Epub 2017 Aug 30. link to original article contains dosing details in manuscript PubMed
Eribulin monotherapy
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy | |
|---|---|---|---|---|---|
Schöffski et al. 2016 (E7389-G000-309)
|
2011-2013 | Phase 3 (E-RT-switch-ic) | Dacarbazine | Superior OS1 Median OS: 15.6 vs 8.4 mo (HR 0.51, 95% CI 0.35-0.75) |
1Reported efficacy is based on the 2017 subgroup analysis.
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 contains dosing details in abstract PubMed NCT01327885
- Subgroup analysis: Demetri GD, Schöffski P, Grignani G, Blay JY, Maki RG, Van Tine BA, Alcindor T, Jones RL, D'Adamo DR, Guo M, Chawla S. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. 2017 Oct 20;35(30):3433-3439. Epub 2017 Aug 30. link to original article contains dosing details in manuscript PubMed
Trabectedin monotherapy
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Demetri et al. 2009 | 2003-NR | Randomized Phase 2 (E-switch-ic) | Trabectedin; alternate schedule | Seems to have superior TTP |
| 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 (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 dosing details in abstract 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 dosing details in manuscript 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. link to original article link to PMC article 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 link to PMC article PubMed