Difference between revisions of "Soft tissue sarcoma - historical"

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[[#top|Back to Top]]
 
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. Is there a regimen missing from this list? See the [[Soft_tissue_sarcoma|main soft tissue sarcoma page]] for current regimens.
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the [[Soft_tissue_sarcoma|main soft tissue sarcoma page]] for current regimens.
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
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==Dacarbazine & Doxorubicin {{#subobject:9085a9|Regimen=1}}==
 
==Dacarbazine & Doxorubicin {{#subobject:9085a9|Regimen=1}}==
 
AD: '''<u>A</u>'''driamycin (Doxorubicin) & '''<u>D</u>'''acarbazine
 
AD: '''<u>A</u>'''driamycin (Doxorubicin) & '''<u>D</u>'''acarbazine
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<div class="toccolours" style="background-color:#eeeeee">
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<div class="toccolours" style="background-color:#ee6b6e">
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===Regimen {{#subobject:a9a5c2|Variant=1}}===
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===Regimen variant #1 {{#subobject:a9a5c2|Variant=1}}===
 
{| 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
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| style="background-color:#ffffbf" |Did not meet endpoints of RR/OS
 
| style="background-color:#ffffbf" |Did not meet endpoints of RR/OS
 
|-
 
|-
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|[https://academic.oup.com/jnci/article-abstract/83/13/926/988180 Zalupski et al. 1991]
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|}
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''<sup>1</sup>In SWOG S8616, although the experimental arm seemed to have superior TTP, this arm seemed to have superior OS.''
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<div class="toccolours" style="background-color:#b3e2cd">
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====Chemotherapy====
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*[[Dacarbazine (DTIC)]] 250 mg/m<sup>2</sup> IV once on day 1
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*[[Doxorubicin (Adriamycin)]] 60 mg/m<sup>2</sup> IV once on day 1
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'''21-day cycles'''
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</div></div><br>
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<div class="toccolours" style="background-color:#ee6b6e">
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===Regimen variant #2 {{#subobject:a9anc2|Variant=1}}===
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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!style="width: 20%"|Study
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!style="width: 20%"|Dates of enrollment
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 20%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
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|[https://doi.org/10.1093/jnci/83.13.926 Zalupski et al. 1991]
 
|1980-1986
 
|1980-1986
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
 
|[[#Dacarbazine_.26_Doxorubicin|Dacarbazine & Doxorubicin]]; CI
 
|[[#Dacarbazine_.26_Doxorubicin|Dacarbazine & Doxorubicin]]; CI
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS50%
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS50%
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|-
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|}
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<div class="toccolours" style="background-color:#b3e2cd">
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====Chemotherapy====
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*[[Dacarbazine (DTIC)]] 750 mg/m<sup>2</sup> IV once on day 1
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*[[Doxorubicin (Adriamycin)]] 60 mg/m<sup>2</sup> IV once on day 1
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'''21-day cycles'''
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</div></div><br>
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<div class="toccolours" style="background-color:#ee6b6e">
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===Regimen variant #3 {{#subobject:a9gdcz|Variant=1}}===
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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!style="width: 20%"|Study
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!style="width: 20%"|Dates of enrollment
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 20%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
 
|[https://doi.org/10.1200/JCO.1993.11.7.1276 Antman et al. 1993 (SWOG S8616)]
 
|[https://doi.org/10.1200/JCO.1993.11.7.1276 Antman et al. 1993 (SWOG S8616)]
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|-
 
|-
 
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''<sup>1</sup>In SWOG S8616, although the experimental arm seemed to have superior TTP, this arm seemed to have superior OS.''
 
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
*[[Dacarbazine (DTIC)]]
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*[[Dacarbazine (DTIC)]] 250 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 1000 mg/m<sup>2</sup>)
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*[[Doxorubicin (Adriamycin)]]
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*[[Doxorubicin (Adriamycin)]] 15 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 60 mg/m<sup>2</sup>)
 
'''21-day cycles'''
 
'''21-day cycles'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
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# '''SWOG S7613:''' Baker LH, Frank J, Fine G, Balcerzak SP, Stephens RL, Stuckey WJ, Rivkin S, Saiki J, Ward JH. Combination chemotherapy using adriamycin, DTIC, cyclophosphamide, and actinomycin D for advanced soft tissue sarcomas: a randomized comparative trial: a phase III, Southwest Oncology Group Study (7613). J Clin Oncol. 1987 Jun;5(6):851-61. [https://doi.org/10.1200/JCO.1987.5.6.851 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3295129/ PubMed]
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# '''SWOG S7613:''' Baker LH, Frank J, Fine G, Balcerzak SP, Stephens RL, Stuckey WJ, Rivkin S, Saiki J, Ward JH. Combination chemotherapy using adriamycin, DTIC, cyclophosphamide, and actinomycin D for advanced soft tissue sarcomas: a randomized comparative trial: a phase III, Southwest Oncology Group Study (7613). J Clin Oncol. 1987 Jun;5(6):851-61. [https://doi.org/10.1200/JCO.1987.5.6.851 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/3295129/ PubMed]
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# Zalupski M, Metch B, Balcerzak S, Fletcher WS, Chapman R, Bonnet JD, Weiss GR, Ryan J, Benjamin RS, Baker LH; [[Study_Groups#SWOG|SWOG]]. Phase III comparison of doxorubicin and dacarbazine given by bolus versus infusion in patients with soft-tissue sarcomas: a Southwest Oncology Group study. J Natl Cancer Inst. 1991 Jul 3;83(13):926-32. [https://academic.oup.com/jnci/article-abstract/83/13/926/988180 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/2067035/ PubMed]
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# Zalupski M, Metch B, Balcerzak S, Fletcher WS, Chapman R, Bonnet JD, Weiss GR, Ryan J, Benjamin RS, Baker LH; [[Study_Groups#SWOG|SWOG]]. Phase III comparison of doxorubicin and dacarbazine given by bolus versus infusion in patients with soft-tissue sarcomas: a Southwest Oncology Group study. J Natl Cancer Inst. 1991 Jul 3;83(13):926-32. [https://doi.org/10.1093/jnci/83.13.926 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/2067035/ PubMed]
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# '''SWOG S8616:''' Antman K, Crowley J, Balcerzak SP, Rivkin SE, Weiss GR, Elias A, Natale RB, Cooper RM, Barlogie B, Trump DL, Doroshow JH, Aisner J, Pugh RP, Weiss RB, Cooper BA, Clamond GH, Baker LH. An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. J Clin Oncol. 1993 Jul;11(7):1276-85. [https://doi.org/10.1200/JCO.1993.11.7.1276 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8315425/ PubMed]
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# '''SWOG S8616:''' Antman K, Crowley J, Balcerzak SP, Rivkin SE, Weiss GR, Elias A, Natale RB, Cooper RM, Barlogie B, Trump DL, Doroshow JH, Aisner J, Pugh RP, Weiss RB, Cooper BA, Clamond GH, Baker LH. An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. J Clin Oncol. 1993 Jul;11(7):1276-85. [https://doi.org/10.1200/JCO.1993.11.7.1276 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/8315425/ PubMed]
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==Doxorubicin & Olaratumab {{#subobject:31132d|Regimen=1}}==
 
==Doxorubicin & Olaratumab {{#subobject:31132d|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
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<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen {{#subobject:24a882|Variant=1}}===
 
===Regimen {{#subobject:24a882|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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| style="background-color:#1a9851" |Randomized Phase 2 (E-RT-esc)
 
| style="background-color:#1a9851" |Randomized Phase 2 (E-RT-esc)
 
|[[Soft_tissue_sarcoma#Doxorubicin_monotherapy|Doxorubicin]]
 
|[[Soft_tissue_sarcoma#Doxorubicin_monotherapy|Doxorubicin]]
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| style="background-color:#1a9850" |Superior OS
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| style="background-color:#1a9850" |Superior OS (primary endpoint)
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7139275/ Tap et al. 2020 (ANNOUNCE)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7139275/ Tap et al. 2020 (ANNOUNCE)]
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</div></div>
 
</div></div>
 
===References===
 
===References===
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# '''CP15-0806:''' Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R Jr, Conti I, Cosaert J, Schwartz GK. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97. Epub 2016 Jun 9. Erratum in: Lancet. 2016 Jul 30;388(10043):464. [https://doi.org/10.1016/S0140-6736(16)30587-6 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5647653/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27291997/ PubMed] [https://clinicaltrials.gov/study/NCT01185964 Clinical Trials Registry]
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# '''CP15-0806:''' Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R Jr, Conti I, Cosaert J, Schwartz GK. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97. Epub 2016 Jun 9. Erratum in: Lancet. 2016 Jul 30;388(10043):464. [https://doi.org/10.1016/S0140-6736(16)30587-6 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5647653/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27291997/ PubMed] [https://clinicaltrials.gov/study/NCT01185964 NCT01185964]
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# '''ANNOUNCE:''' Tap WD, Wagner AJ, Schöffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Pápai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL; ANNOUNCE Investigators. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1266-1276. [https://doi.org/10.1001/jama.2020.1707 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7139275/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32259228/ PubMed] [https://clinicaltrials.gov/study/NCT02451943 Clinical Trials Registry]
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# '''ANNOUNCE:''' Tap WD, Wagner AJ, Schöffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Pápai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL; ANNOUNCE Investigators. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1266-1276. [https://doi.org/10.1001/jama.2020.1707 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7139275/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32259228/ PubMed] [https://clinicaltrials.gov/study/NCT02451943 NCT02451943]
 
[[Category:Soft tissue sarcoma regimens]]
 
[[Category:Soft tissue sarcoma regimens]]
 
[[Category:Historical regimens]]
 
[[Category:Historical regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Soft tissue sarcomas]]
 
[[Category:Soft tissue sarcomas]]

Latest revision as of 23:40, 15 July 2024

Back to Top

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main soft tissue sarcoma page for current regimens.

2 regimens on this page
4 variants on this page


Locally advanced or metastatic disease, combination regimens

Dacarbazine & Doxorubicin

AD: Adriamycin (Doxorubicin) & Dacarbazine

Regimen variant #1

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Baker et al. 1987 (SWOG S7613) 1976-1979 Phase 3 (C) 1. AD & Cyclophosphamide
2. AD & Dactinomycin 		Did not meet endpoints of RR/OS

1In SWOG S8616, although the experimental arm seemed to have superior TTP, this arm seemed to have superior OS.

Chemotherapy

21-day cycles


Regimen variant #2

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Zalupski et al. 1991 1980-1986 Phase 3 (C) Dacarbazine & Doxorubicin; CI Did not meet primary endpoint of OS50%

Chemotherapy

21-day cycles


Regimen variant #3

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Antman et al. 1993 (SWOG S8616) 1987-1989 Phase 3 (C) MAID Seems to have superior OS1

Chemotherapy

  • Dacarbazine (DTIC) 250 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 1000 mg/m2)
  • Doxorubicin (Adriamycin) 15 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 60 mg/m2)

21-day cycles

References

  1. SWOG S7613: Baker LH, Frank J, Fine G, Balcerzak SP, Stephens RL, Stuckey WJ, Rivkin S, Saiki J, Ward JH. Combination chemotherapy using adriamycin, DTIC, cyclophosphamide, and actinomycin D for advanced soft tissue sarcomas: a randomized comparative trial: a phase III, Southwest Oncology Group Study (7613). J Clin Oncol. 1987 Jun;5(6):851-61. link to original article dosing details in abstract have been reviewed by our editors PubMed
  2. Zalupski M, Metch B, Balcerzak S, Fletcher WS, Chapman R, Bonnet JD, Weiss GR, Ryan J, Benjamin RS, Baker LH; SWOG. Phase III comparison of doxorubicin and dacarbazine given by bolus versus infusion in patients with soft-tissue sarcomas: a Southwest Oncology Group study. J Natl Cancer Inst. 1991 Jul 3;83(13):926-32. link to original article dosing details in abstract have been reviewed by our editors PubMed
  3. SWOG S8616: Antman K, Crowley J, Balcerzak SP, Rivkin SE, Weiss GR, Elias A, Natale RB, Cooper RM, Barlogie B, Trump DL, Doroshow JH, Aisner J, Pugh RP, Weiss RB, Cooper BA, Clamond GH, Baker LH. An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. J Clin Oncol. 1993 Jul;11(7):1276-85. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Doxorubicin & Olaratumab

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Tap et al. 2016 (CP15-0806) 2010-2013 Randomized Phase 2 (E-RT-esc) Doxorubicin Superior OS (primary endpoint)
Tap et al. 2020 (ANNOUNCE) 2015-2018 Phase 3 (E-esc) Doxorubicin Did not meet primary endpoint of OS

Chemotherapy

Targeted therapy

21-day cycles

Supportive therapy

References

  1. CP15-0806: Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R Jr, Conti I, Cosaert J, Schwartz GK. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97. Epub 2016 Jun 9. Erratum in: Lancet. 2016 Jul 30;388(10043):464. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01185964
  2. ANNOUNCE: Tap WD, Wagner AJ, Schöffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Pápai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL; ANNOUNCE Investigators. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1266-1276. link to original article link to PMC article PubMed NCT02451943
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