Soft tissue sarcoma - historical
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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 NCCN Guidelines. 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
- Dacarbazine (DTIC) 250 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 1
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
- Dacarbazine (DTIC) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 1
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
- 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 contains dosing details in abstract PubMed
- 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 contains dosing details in abstract PubMed
- 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 contains dosing details in manuscript 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
- Doxorubicin (Adriamycin) as follows:
- Cycles 1 to 8: 75 mg/m2 IV once on day 1
Targeted therapy
- Olaratumab (Lartruvo) 15 mg/kg IV once per day on days 1 & 8
21-day cycles
Supportive therapy
- CP15-0806, optional: Dexrazoxane (Zinecard) (dose not specified) IV once on day 1
References
- 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 contains dosing details in manuscript link to PMC article PubMed NCT01185964
- 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