Difference between revisions of "Soft tissue sarcoma - null regimens"
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− | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | <span id="BackToTop"></span> |
+ | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | ||
+ | [[#top|Back to Top]] | ||
+ | </div> | ||
+ | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Soft tissue sarcoma|main STS page]] for regimens that include active anticancer treatment. | ||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
=Neoadjuvant therapy= | =Neoadjuvant therapy= | ||
− | =No neoadjuvant therapy= | + | ==No neoadjuvant therapy== |
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | | | + | |[https://www.clinicaltrials.gov/study/NCT04031677 Awaiting publication (STRASS2)] |
− | |2020- | + | |2020-2027 |
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | | | + | |1a. [[#Doxorubicin_.26_Ifosfamide_.28AI.29_888|AI]]<br>1b. [[#Epirubicin_.26_Ifosfamide_888|EI]] |
− | | style="background-color:#d3d3d3" | | + | | style="background-color:#d3d3d3" |TBD if different primary endpoint of DFS |
|- | |- | ||
|} | |} | ||
''No systemic anticancer treatment before surgery.'' | ''No systemic anticancer treatment before surgery.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
*[[Surgery#Surgical_resection|Surgery]] | *[[Surgery#Surgical_resection|Surgery]] | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | #'''STRASS2:''' NCT04031677 | + | #'''STRASS2:''' [https://clinicaltrials.gov/study/NCT04031677 NCT04031677] |
=Adjuvant therapy= | =Adjuvant therapy= | ||
==Observation== | ==Observation== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 51: | Line 51: | ||
| style="background-color:#d73027" |Inferior RFS | | style="background-color:#d73027" |Inferior RFS | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S1470-2045(12)70346-7 Woll et al. 2012 (EORTC 62931)] |
|1995-2003 | |1995-2003 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |AI | + | |[[#Doxorubicin_.26_Ifosfamide_.28AI.29_888|AI]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
Line 60: | Line 60: | ||
|2002-2007 | |2002-2007 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |EI | + | |[[#Epirubicin_.26_Ifosfamide_888|EI]] |
| style="background-color:#eeee01" |Non-inferior OS | | style="background-color:#eeee01" |Non-inferior OS | ||
|- | |- | ||
|} | |} | ||
''No further treatment.'' | ''No further treatment.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | *Gronchi et al. 2012: [[#Epirubicin_.26_Ifosfamide| | + | *Gronchi et al. 2012: Neoadjuvant [[#Epirubicin_.26_Ifosfamide|EI]] x 3, then [[Surgery#Surgical_resection|surgery]] |
*EORTC 62931: [[Surgery#Surgical_resection|Surgery]] +/- RT | *EORTC 62931: [[Surgery#Surgical_resection|Surgery]] +/- RT | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # '''EORTC 62771:''' Bramwell V, Rouesse J, Steward W, Santoro A, Schraffordt-Koops H, Buesa J, Ruka W, Priario J, Wagener T, Burgers M, Van Unnik J, Contesso G, Thomas D, Van Glabbeke M, Markham D, Pinedo H. Adjuvant CYVADIC chemotherapy for adult soft tissue sarcoma--reduced local recurrence but no improvement in survival: a study of the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1994 Jun;12(6):1137-49. [https://doi.org/10.1200/JCO.1994.12.6.1137 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8201375 PubMed] | + | # '''EORTC 62771:''' Bramwell V, Rouesse J, Steward W, Santoro A, Schraffordt-Koops H, Buesa J, Ruka W, Priario J, Wagener T, Burgers M, Van Unnik J, Contesso G, Thomas D, Van Glabbeke M, Markham D, Pinedo H. Adjuvant CYVADIC chemotherapy for adult soft tissue sarcoma--reduced local recurrence but no improvement in survival: a study of the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1994 Jun;12(6):1137-49. [https://doi.org/10.1200/JCO.1994.12.6.1137 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8201375/ PubMed] |
− | ## '''Pooled update:''' Le Cesne A, Ouali M, Leahy MG, Santoro A, Hoekstra HJ, Hohenberger P, Van Coevorden F, Rutkowski P, Van Hoesel R, Verweij J, Bonvalot S, Steward WP, Gronchi A, Hogendoorn PC, Litiere S, Marreaud S, Blay JY, Van Der Graaf WT. Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials. Ann Oncol. 2014 Dec;25(12):2425-32. Epub 2014 Oct 6. [https://doi.org/10.1093/annonc/mdu460 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25294887 PubMed] | + | ## '''Pooled update:''' Le Cesne A, Ouali M, Leahy MG, Santoro A, Hoekstra HJ, Hohenberger P, Van Coevorden F, Rutkowski P, Van Hoesel R, Verweij J, Bonvalot S, Steward WP, Gronchi A, Hogendoorn PC, Litiere S, Marreaud S, Blay JY, Van Der Graaf WT. Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials. Ann Oncol. 2014 Dec;25(12):2425-32. Epub 2014 Oct 6. [https://doi.org/10.1093/annonc/mdu460 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25294887/ PubMed] |
− | # Gronchi A, Frustaci S, Mercuri M, Martin J, Lopez-Pousa A, Verderio P, Mariani L, Valagussa P, Miceli R, Stacchiotti S, Dei Tos AP, De Paoli A, Longhi A, Poveda A, Quagliuolo V, Comandone A, Casali PG, Picci P; Italian Sarcoma Group; Spanish Sarcoma Group. Short, full-dose adjuvant chemotherapy in high-risk adult soft tissue sarcomas: a randomized clinical trial from the Italian Sarcoma Group and the Spanish Sarcoma Group. J Clin Oncol. 2012 Mar 10;30(8):850-6. Epub 2012 Feb 6. [https://doi.org/10.1200/JCO.2011.37.7218 link to original article] | + | # Gronchi A, Frustaci S, Mercuri M, Martin J, Lopez-Pousa A, Verderio P, Mariani L, Valagussa P, Miceli R, Stacchiotti S, Dei Tos AP, De Paoli A, Longhi A, Poveda A, Quagliuolo V, Comandone A, Casali PG, Picci P; Italian Sarcoma Group; Spanish Sarcoma Group. Short, full-dose adjuvant chemotherapy in high-risk adult soft tissue sarcomas: a randomized clinical trial from the Italian Sarcoma Group and the Spanish Sarcoma Group. J Clin Oncol. 2012 Mar 10;30(8):850-6. Epub 2012 Feb 6. [https://doi.org/10.1200/JCO.2011.37.7218 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22312103/ PubMed] EudraCT 2004-003979-36 |
− | # '''EORTC 62931:''' Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, Hoekstra HJ, Leahy M, Van Coevorden F, Verweij J, Hogendoorn PC, Ouali M, Marreaud S, Bramwell VH, Hohenberger P; [[Study_Groups#EORTC|EORTC]] Soft Tissue and Bone Sarcoma Group; NCIC Clinical Trials Group Sarcoma Disease Site Committee. Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol. 2012 Oct;13(10):1045-54. Epub 2012 Sep 4. [https:// | + | # '''EORTC 62931:''' Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, Hoekstra HJ, Leahy M, Van Coevorden F, Verweij J, Hogendoorn PC, Ouali M, Marreaud S, Bramwell VH, Hohenberger P; [[Study_Groups#EORTC|EORTC]] Soft Tissue and Bone Sarcoma Group; NCIC Clinical Trials Group Sarcoma Disease Site Committee. Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol. 2012 Oct;13(10):1045-54. Epub 2012 Sep 4. [https://doi.org/10.1016/S1470-2045(12)70346-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22954508/ PubMed] [https://clinicaltrials.gov/study/NCT00002641 NCT00002641] |
− | ## '''Pooled update:''' Le Cesne A, Ouali M, Leahy MG, Santoro A, Hoekstra HJ, Hohenberger P, Van Coevorden F, Rutkowski P, Van Hoesel R, Verweij J, Bonvalot S, Steward WP, Gronchi A, Hogendoorn PC, Litiere S, Marreaud S, Blay JY, Van Der Graaf WT. Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials. Ann Oncol. 2014 Dec;25(12):2425-32. Epub 2014 Oct 6. [https://doi.org/10.1093/annonc/mdu460 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25294887 PubMed] | + | ## '''Pooled update:''' Le Cesne A, Ouali M, Leahy MG, Santoro A, Hoekstra HJ, Hohenberger P, Van Coevorden F, Rutkowski P, Van Hoesel R, Verweij J, Bonvalot S, Steward WP, Gronchi A, Hogendoorn PC, Litiere S, Marreaud S, Blay JY, Van Der Graaf WT. Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials. Ann Oncol. 2014 Dec;25(12):2425-32. Epub 2014 Oct 6. [https://doi.org/10.1093/annonc/mdu460 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25294887/ PubMed] |
=Locally advanced or metastatic disease= | =Locally advanced or metastatic disease= | ||
==Best supportive care== | ==Best supportive care== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 91: | Line 89: | ||
|- | |- | ||
|[https://doi.org/10.1016/j.annonc.2021.04.014 Le Cesne et al. 2021 (T-SAR)] | |[https://doi.org/10.1016/j.annonc.2021.04.014 Le Cesne et al. 2021 (T-SAR)] | ||
− | |2015 | + | |2015-01-26 to 2015-11-05 |
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
|[[Soft_tissue_sarcoma#Trabectedin_monotherapy|Trabectedin]] | |[[Soft_tissue_sarcoma#Trabectedin_monotherapy|Trabectedin]] | ||
Line 97: | Line 95: | ||
|- | |- | ||
|} | |} | ||
+ | ''No antineoplastic treatment.'' | ||
+ | </div> | ||
===References=== | ===References=== | ||
− | # '''T-SAR:''' Le Cesne A, Blay JY, Cupissol D, Italiano A, Delcambre C, Penel N, Isambert N, Chevreau C, Bompas E, Bertucci F, Chaigneau L, Piperno-Neumann S, Salas S, Rios M, Guillemet C, Bay JO, Ray-Coquard I, Haddag L, Bonastre J, Kapso R, Fraslin A, Bouvet N, Mir O, Foulon S. A randomized phase III trial comparing trabectedin to best supportive care in patients with pre-treated soft tissue sarcoma: T-SAR, a French Sarcoma Group trial. Ann Oncol. 2021 Aug;32(8):1034-1044. Epub 2021 Apr 29. [https://doi.org/10.1016/j.annonc.2021.04.014 link to original article] | + | # '''T-SAR:''' Le Cesne A, Blay JY, Cupissol D, Italiano A, Delcambre C, Penel N, Isambert N, Chevreau C, Bompas E, Bertucci F, Chaigneau L, Piperno-Neumann S, Salas S, Rios M, Guillemet C, Bay JO, Ray-Coquard I, Haddag L, Bonastre J, Kapso R, Fraslin A, Bouvet N, Mir O, Foulon S. A randomized phase III trial comparing trabectedin to best supportive care in patients with pre-treated soft tissue sarcoma: T-SAR, a French Sarcoma Group trial. Ann Oncol. 2021 Aug;32(8):1034-1044. Epub 2021 Apr 29. [https://doi.org/10.1016/j.annonc.2021.04.014 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33932507/ PubMed] [https://clinicaltrials.gov/study/NCT02672527 NCT02672527] |
==Placebo== | ==Placebo== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 117: | Line 113: | ||
|2007-2010 | |2007-2010 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |Ridaforolimus | + | |[[#Ridaforolimus_monotherapy_777|Ridaforolimus]] |
| style="background-color:#d73027" |Inferior PFS | | style="background-color:#d73027" |Inferior PFS | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S0140-6736(12)60651-5 van der Graaf et al. 2012 (PALETTE)] |
|2008-2010 | |2008-2010 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
Line 126: | Line 122: | ||
| style="background-color:#d73027" |Inferior PFS | | style="background-color:#d73027" |Inferior PFS | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S1470-2045(15)70098-7 Kawai et al. 2015] |
|2012-2014 | |2012-2014 | ||
− | | style="background-color:#1a9851" |Randomized Phase | + | | style="background-color:#1a9851" |Randomized Phase 2 (C) |
|[[Soft_tissue_sarcoma#Trabectedin_monotherapy|Trabectedin]] | |[[Soft_tissue_sarcoma#Trabectedin_monotherapy|Trabectedin]] | ||
| style="background-color:#d73027" |Inferior PFS | | style="background-color:#d73027" |Inferior PFS | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S1470-2045(16)30507-1 Mir et al. 2016 (REGOSARC)] |
− | |2013-2014 | + | |2013-08-05 to 2014-11-26 |
− | | style="background-color:#1a9851" |Randomized Phase | + | | style="background-color:#1a9851" |Randomized Phase 2 (C) |
|[[Soft_tissue_sarcoma#Regorafenib_monotherapy|Regorafenib]] | |[[Soft_tissue_sarcoma#Regorafenib_monotherapy|Regorafenib]] | ||
| style="background-color:#d73027" |Inferior PFS<sup>1</sup> | | style="background-color:#d73027" |Inferior PFS<sup>1</sup> | ||
Line 140: | Line 136: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy in REGOSARC is for the leiomyosarcoma, synovial sarcoma, and other sarcoma cohorts; there was no significant difference in outcome for the liposarcoma cohort.''<br> | ''<sup>1</sup>Reported efficacy in REGOSARC is for the leiomyosarcoma, synovial sarcoma, and other sarcoma cohorts; there was no significant difference in outcome for the liposarcoma cohort.''<br> | ||
− | ''No active antineoplastic treatment | + | ''No active antineoplastic treatment.'' |
+ | </div> | ||
===References=== | ===References=== | ||
− | # '''PALETTE:''' van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schöffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; [[Study_Groups#EORTC|EORTC]] Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. Epub 2012 May 16. [https:// | + | # '''PALETTE:''' van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schöffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; [[Study_Groups#EORTC|EORTC]] Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. Epub 2012 May 16. [https://doi.org/10.1016/S0140-6736(12)60651-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22595799/ PubMed] [https://clinicaltrials.gov/study/NCT00753688 NCT00753688] |
− | ## '''Subgroup analysis:''' Kawai A, Araki N, Hiraga H, Sugiura H, Matsumine A, Ozaki T, Ueda T, Ishii T, Esaki T, Machida M, Fukasawa N. A randomized, double-blind, placebo-controlled, phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup. Jpn J Clin Oncol. 2016 Mar;46(3):248-53. Epub 2016 Feb 10. [https:// | + | ## '''Subgroup analysis:''' Kawai A, Araki N, Hiraga H, Sugiura H, Matsumine A, Ozaki T, Ueda T, Ishii T, Esaki T, Machida M, Fukasawa N. A randomized, double-blind, placebo-controlled, phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup. Jpn J Clin Oncol. 2016 Mar;46(3):248-53. Epub 2016 Feb 10. [https://doi.org/10.1093/jjco/hyv184 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4777611/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26864131/ PubMed] |
− | # '''SUCCEED:''' Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. Epub 2013 May 28. [https://doi.org/10.1200/JCO.2012.45.5766 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23715582 PubMed] NCT00538239 | + | # '''SUCCEED:''' Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. Epub 2013 May 28. [https://doi.org/10.1200/JCO.2012.45.5766 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23715582/ PubMed] [https://clinicaltrials.gov/study/NCT00538239 NCT00538239] |
− | # Kawai A, Araki N, Sugiura H, Ueda T, Yonemoto T, Takahashi M, Morioka H, Hiraga H, Hiruma T, Kunisada T, Matsumine A, Tanase T, Hasegawa T, Takahashi S. Trabectedin monotherapy after standard chemotherapy versus best supportive care in patients with advanced, translocation-related sarcoma: a randomised, open-label, phase 2 study. Lancet Oncol. 2015 Apr;16(4):406-16. Epub 2015 Mar 18. [https:// | + | # Kawai A, Araki N, Sugiura H, Ueda T, Yonemoto T, Takahashi M, Morioka H, Hiraga H, Hiruma T, Kunisada T, Matsumine A, Tanase T, Hasegawa T, Takahashi S. Trabectedin monotherapy after standard chemotherapy versus best supportive care in patients with advanced, translocation-related sarcoma: a randomised, open-label, phase 2 study. Lancet Oncol. 2015 Apr;16(4):406-16. Epub 2015 Mar 18. [https://doi.org/10.1016/S1470-2045(15)70098-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25795406/ PubMed] JapicCTI-121850 |
− | # '''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. [https:// | + | # '''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. [https://doi.org/10.1016/S1470-2045(16)30507-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27751846/ PubMed] [https://clinicaltrials.gov/study/NCT01900743 NCT01900743] |
[[Category:Soft tissue sarcoma regimens]] | [[Category:Soft tissue sarcoma regimens]] |
Latest revision as of 23:45, 30 June 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main STS page for regimens that include active anticancer treatment.
Neoadjuvant therapy
No neoadjuvant therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Awaiting publication (STRASS2) | 2020-2027 | Phase 3 (C) | 1a. AI 1b. EI |
TBD if different primary endpoint of DFS |
No systemic anticancer treatment before surgery.
Subsequent treatment
References
- STRASS2: NCT04031677
Adjuvant therapy
Observation
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Bramwell et al. 1994 (EORTC 62771) | 1977-1988 | Phase 3 (C) | CYVADIC | Inferior RFS |
Woll et al. 2012 (EORTC 62931) | 1995-2003 | Phase 3 (C) | AI | Did not meet primary endpoint of OS |
Gronchi et al. 2012 | 2002-2007 | Phase 3 (C) | EI | Non-inferior OS |
No further treatment.
References
- EORTC 62771: Bramwell V, Rouesse J, Steward W, Santoro A, Schraffordt-Koops H, Buesa J, Ruka W, Priario J, Wagener T, Burgers M, Van Unnik J, Contesso G, Thomas D, Van Glabbeke M, Markham D, Pinedo H. Adjuvant CYVADIC chemotherapy for adult soft tissue sarcoma--reduced local recurrence but no improvement in survival: a study of the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1994 Jun;12(6):1137-49. link to original article PubMed
- Pooled update: Le Cesne A, Ouali M, Leahy MG, Santoro A, Hoekstra HJ, Hohenberger P, Van Coevorden F, Rutkowski P, Van Hoesel R, Verweij J, Bonvalot S, Steward WP, Gronchi A, Hogendoorn PC, Litiere S, Marreaud S, Blay JY, Van Der Graaf WT. Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials. Ann Oncol. 2014 Dec;25(12):2425-32. Epub 2014 Oct 6. link to original article PubMed
- Gronchi A, Frustaci S, Mercuri M, Martin J, Lopez-Pousa A, Verderio P, Mariani L, Valagussa P, Miceli R, Stacchiotti S, Dei Tos AP, De Paoli A, Longhi A, Poveda A, Quagliuolo V, Comandone A, Casali PG, Picci P; Italian Sarcoma Group; Spanish Sarcoma Group. Short, full-dose adjuvant chemotherapy in high-risk adult soft tissue sarcomas: a randomized clinical trial from the Italian Sarcoma Group and the Spanish Sarcoma Group. J Clin Oncol. 2012 Mar 10;30(8):850-6. Epub 2012 Feb 6. link to original article PubMed EudraCT 2004-003979-36
- EORTC 62931: Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, Hoekstra HJ, Leahy M, Van Coevorden F, Verweij J, Hogendoorn PC, Ouali M, Marreaud S, Bramwell VH, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; NCIC Clinical Trials Group Sarcoma Disease Site Committee. Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol. 2012 Oct;13(10):1045-54. Epub 2012 Sep 4. link to original article PubMed NCT00002641
- Pooled update: Le Cesne A, Ouali M, Leahy MG, Santoro A, Hoekstra HJ, Hohenberger P, Van Coevorden F, Rutkowski P, Van Hoesel R, Verweij J, Bonvalot S, Steward WP, Gronchi A, Hogendoorn PC, Litiere S, Marreaud S, Blay JY, Van Der Graaf WT. Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials. Ann Oncol. 2014 Dec;25(12):2425-32. Epub 2014 Oct 6. link to original article PubMed
Locally advanced or metastatic disease
Best supportive care
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Le Cesne et al. 2021 (T-SAR) | 2015-01-26 to 2015-11-05 | Phase 3 (C) | Trabectedin | Inferior PFS |
No antineoplastic treatment.
References
- T-SAR: Le Cesne A, Blay JY, Cupissol D, Italiano A, Delcambre C, Penel N, Isambert N, Chevreau C, Bompas E, Bertucci F, Chaigneau L, Piperno-Neumann S, Salas S, Rios M, Guillemet C, Bay JO, Ray-Coquard I, Haddag L, Bonastre J, Kapso R, Fraslin A, Bouvet N, Mir O, Foulon S. A randomized phase III trial comparing trabectedin to best supportive care in patients with pre-treated soft tissue sarcoma: T-SAR, a French Sarcoma Group trial. Ann Oncol. 2021 Aug;32(8):1034-1044. Epub 2021 Apr 29. link to original article PubMed NCT02672527
Placebo
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Demetri et al. 2013 (SUCCEED) | 2007-2010 | Phase 3 (C) | Ridaforolimus | Inferior PFS |
van der Graaf et al. 2012 (PALETTE) | 2008-2010 | Phase 3 (C) | Pazopanib | Inferior PFS |
Kawai et al. 2015 | 2012-2014 | Randomized Phase 2 (C) | Trabectedin | Inferior PFS |
Mir et al. 2016 (REGOSARC) | 2013-08-05 to 2014-11-26 | Randomized Phase 2 (C) | Regorafenib | Inferior PFS1 |
1Reported efficacy in REGOSARC is for the leiomyosarcoma, synovial sarcoma, and other sarcoma cohorts; there was no significant difference in outcome for the liposarcoma cohort.
No active antineoplastic treatment.
References
- PALETTE: van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schöffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. Epub 2012 May 16. link to original article PubMed NCT00753688
- Subgroup analysis: Kawai A, Araki N, Hiraga H, Sugiura H, Matsumine A, Ozaki T, Ueda T, Ishii T, Esaki T, Machida M, Fukasawa N. A randomized, double-blind, placebo-controlled, phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup. Jpn J Clin Oncol. 2016 Mar;46(3):248-53. Epub 2016 Feb 10. link to original article link to PMC article PubMed
- SUCCEED: Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. Epub 2013 May 28. link to original article PubMed NCT00538239
- Kawai A, Araki N, Sugiura H, Ueda T, Yonemoto T, Takahashi M, Morioka H, Hiraga H, Hiruma T, Kunisada T, Matsumine A, Tanase T, Hasegawa T, Takahashi S. Trabectedin monotherapy after standard chemotherapy versus best supportive care in patients with advanced, translocation-related sarcoma: a randomised, open-label, phase 2 study. Lancet Oncol. 2015 Apr;16(4):406-16. Epub 2015 Mar 18. link to original article PubMed JapicCTI-121850
- 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 PubMed NCT01900743