Difference between revisions of "Soft tissue sarcoma"
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===Regimen {{#subobject:aea2c8|Variant=1}}=== | ===Regimen {{#subobject:aea2c8|Variant=1}}=== | ||
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EIA: '''<u>E</u>'''toposide, '''<u>I</u>'''fosfamide, '''<u>A</u>'''driamycin (Doxorubicin) | EIA: '''<u>E</u>'''toposide, '''<u>I</u>'''fosfamide, '''<u>A</u>'''driamycin (Doxorubicin) | ||
===Regimen {{#subobject:52e303|Variant=1}}=== | ===Regimen {{#subobject:52e303|Variant=1}}=== | ||
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EIA: '''<u>E</u>'''toposide, '''<u>I</u>'''fosfamide, '''<u>A</u>'''driamycin (Doxorubicin) | EIA: '''<u>E</u>'''toposide, '''<u>I</u>'''fosfamide, '''<u>A</u>'''driamycin (Doxorubicin) | ||
===Regimen {{#subobject:6d8a81|Variant=1}}=== | ===Regimen {{#subobject:6d8a81|Variant=1}}=== | ||
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===Regimen=== | ===Regimen=== | ||
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===Regimen {{#subobject:2ff0fe|Variant=1}}=== | ===Regimen {{#subobject:2ff0fe|Variant=1}}=== | ||
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===Regimen {{#subobject:2c183b|Variant=1}}=== | ===Regimen {{#subobject:2c183b|Variant=1}}=== | ||
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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
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===Regimen variant #1, 75 mg/m<sup>2</sup> {{#subobject:62faa6|Variant=1}}=== | ===Regimen variant #1, 75 mg/m<sup>2</sup> {{#subobject:62faa6|Variant=1}}=== | ||
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===Regimen variant #2, 80 mg/m<sup>2</sup> {{#subobject:fcfa1c|Variant=1}}=== | ===Regimen variant #2, 80 mg/m<sup>2</sup> {{#subobject:fcfa1c|Variant=1}}=== | ||
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===Regimen {{#subobject:a1dd30|Variant=1}}=== | ===Regimen {{#subobject:a1dd30|Variant=1}}=== | ||
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===Regimen variant #1, short infusion (Ifos 3) {{#subobject:89c8f1|Variant=1}}=== | ===Regimen variant #1, short infusion (Ifos 3) {{#subobject:89c8f1|Variant=1}}=== | ||
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===Regimen variant #2, continuous infusion (Ifos 9) {{#subobject:ad63a|Variant=1}}=== | ===Regimen variant #2, continuous infusion (Ifos 9) {{#subobject:ad63a|Variant=1}}=== | ||
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!style="width: 20%"|Years of enrollment | !style="width: 20%"|Years of enrollment | ||
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===Regimen {{#subobject:332a64|Variant=1}}=== | ===Regimen {{#subobject:332a64|Variant=1}}=== | ||
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===Regimen=== | ===Regimen=== | ||
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===Regimen {{#subobject:b5ff4e|Variant=1}}=== | ===Regimen {{#subobject:b5ff4e|Variant=1}}=== | ||
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===Regimen {{#subobject:33de2b|Variant=1}}=== | ===Regimen {{#subobject:33de2b|Variant=1}}=== | ||
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AD: '''<u>A</u>'''driamycin (Doxorubicin) & '''<u>D</u>'''acarbazine | AD: '''<u>A</u>'''driamycin (Doxorubicin) & '''<u>D</u>'''acarbazine | ||
===Regimen {{#subobject:a9a5c2|Variant=1}}=== | ===Regimen {{#subobject:a9a5c2|Variant=1}}=== | ||
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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
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===Regimen {{#subobject:2898f9|Variant=1}}=== | ===Regimen {{#subobject:2898f9|Variant=1}}=== | ||
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AIM: '''<u>A</u>'''driamycin (Doxorubicin), '''<u>I</u>'''fosfamide, '''<u>M</u>'''esna | AIM: '''<u>A</u>'''driamycin (Doxorubicin), '''<u>I</u>'''fosfamide, '''<u>M</u>'''esna | ||
===Regimen variant #1, 50/5000 {{#subobject:78d03a|Variant=1}}=== | ===Regimen variant #1, 50/5000 {{#subobject:78d03a|Variant=1}}=== | ||
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MAID: '''<u>M</u>'''esna, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>I</u>'''fosfamide, '''<u>D</u>'''acarbazine | MAID: '''<u>M</u>'''esna, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>I</u>'''fosfamide, '''<u>D</u>'''acarbazine | ||
===Regimen {{#subobject:156439|Variant=1}}=== | ===Regimen {{#subobject:156439|Variant=1}}=== | ||
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===Regimen {{#subobject:0dc9c2|Variant=1}}=== | ===Regimen {{#subobject:0dc9c2|Variant=1}}=== | ||
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Revision as of 02:41, 26 September 2020
Section editor | |
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Elizabeth J. Davis, MD Vanderbilt University Nashville, TN ![]() |
19 regimens on this page
28 variants on this page
|
Are you looking for a regimen but can't find it here? It is possible that we've moved it to the historical regimens page. If you still can't find it, please let us know so we can add it!.
Note: this page is for subtype-nonspecific soft tissue sarcoma regimens, some subtypes with very few subtype-specific regimens, as well as for sarcomas that are not readily categorized, e.g., alveolar soft part sarcoma. Please see the category page for links to other sarcoma types or use one of these links:
- Epithelioid sarcoma
- Gastrointestinal stromal tumor (GIST)
- Leiomyosarcoma
- Liposarcoma
- Rhabdomyosarcoma
Guidelines
ESMO
- 2014: Soft tissue and visceral sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
ESMO/EURACAN
- 2018: Casali et al. [Soft tissue and visceral sarcomas: ESMO–EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up https://www.esmo.org/Guidelines/Sarcoma-and-GIST/Soft-Tissue-and-Visceral-Sarcomas ]
NCCN
Neoadjuvant therapy
Epirubicin & Ifosfamide
back to top |
Regimen
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Gronchi et al. 2012 | Non-randomized portion of RCT | ||
Gronchi et al. 2017 (ISG-STS 1001) | Phase III (C) | Histotype-tailored therapy | Superior DFS |
Chemotherapy
- Epirubicin (Ellence) 60 mg/m2 IV once per day on days 1 & 2
- Ifosfamide (Ifex) 3000 mg/m2 IV once per day on days 1 to 3
Supportive medications
- Mesna (Mesnex) 1000 mg/m2 IV every 3 hours to every 4 hours on days 1 to 3
21-day cycle for 3 cycles
Subsequent treatment
- Gronchi et al. 2012: Surgery, then adjuvant EI x 2 versus no further treatment
- ISG-STS 1001: Surgery
References
- 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 contains verified protocol PubMed
- ISG-STS 1001: Gronchi A, Ferrari S, Quagliuolo V, Broto JM, Pousa AL, Grignani G, Basso U, Blay JY, Tendero O, Beveridge RD, Ferraresi V, Lugowska I, Merlo DF, Fontana V, Marchesi E, Donati DM, Palassini E, Palmerini E, De Sanctis R, Morosi C, Stacchiotti S, Bagué S, Coindre JM, Dei Tos AP, Picci P, Bruzzi P, Casali PG. Histotype-tailored neoadjuvant chemotherapy versus standard chemotherapy in patients with high-risk soft-tissue sarcomas (ISG-STS 1001): an international, open-label, randomised, controlled, phase 3, multicentre trial. Lancet Oncol. 2017 Jun;18(6):812-822. Epub 2017 May 9. link to original article contains protocol PubMed
EIA
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EIA: Etoposide, Ifosfamide, Adriamycin (Doxorubicin)
Regimen
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Issels et al. 2010 (EORTC 62961/ESHO 95) | Phase III (C) | EIA & regional hypertheremia | Seems to have inferior OS |
Chemotherapy
- Etoposide (Vepesid) 125 mg/m2 IV once per day on days 1 & 4
- Ifosfamide (Ifex) 1500 mg/m2 IV once per day on days 1 to 4
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
21-day cycle for 4 cycles
Subsequent treatment
- Surgery, then adjuvant RT, then adjuvant EIA x 4
References
- EORTC 62961/ESHO 95: Issels RD, Lindner LH, Verweij J, Wust P, Reichardt P, Schem BC, Abdel-Rahman S, Daugaard S, Salat C, Wendtner CM, Vujaskovic Z, Wessalowski R, Jauch KW, Dürr HR, Ploner F, Baur-Melnyk A, Mansmann U, Hiddemann W, Blay JY, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; European Society for Hyperthermic Oncology. Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study. Lancet Oncol. 2010 Jun;11(6):561-70. Epub 2010 Apr 29. link to original article link to PMC article contains verified protocol PubMed
- Update: Issels RD, Lindner LH, Verweij J, Wessalowski R, Reichardt P, Wust P, Ghadjar P, Hohenberger P, Angele M, Salat C, Vujaskovic Z, Daugaard S, Mella O, Mansmann U, Dürr HR, Knösel T, Abdel-Rahman S, Schmidt M, Hiddemann W, Jauch KW, Belka C, Gronchi A; European Organization for the Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group; European Society for Hyperthermic Oncology. Effect of neoadjuvant chemotherapy plus regional hyperthermia on long-term outcomes among patients with localized high-risk soft tissue sarcoma: the EORTC 62961-ESHO 95 randomized clinical trial. JAMA Oncol. 2018 Apr 1;4(4):483-492. link to original article link to PMC article PubMed
Adjuvant therapy
EIA
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EIA: Etoposide, Ifosfamide, Adriamycin (Doxorubicin)
Regimen
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Issels et al. 2010 (EORTC 62961/ESHO 95) | Phase III (C) | EIA & regional hypertheremia | Seems to have inferior OS |
Preceding treatment
- Neoadjuvant EIA x 4, then surgery, then adjuvant RT
Chemotherapy
- Etoposide (Vepesid) 125 mg/m2 IV once per day on days 1 & 4
- Ifosfamide (Ifex) 1500 mg/m2 IV once per day on days 1 to 4
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
21-day cycle for 4 cycles
References
- EORTC 62961/ESHO 95: Issels RD, Lindner LH, Verweij J, Wust P, Reichardt P, Schem BC, Abdel-Rahman S, Daugaard S, Salat C, Wendtner CM, Vujaskovic Z, Wessalowski R, Jauch KW, Dürr HR, Ploner F, Baur-Melnyk A, Mansmann U, Hiddemann W, Blay JY, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; European Society for Hyperthermic Oncology. Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study. Lancet Oncol. 2010 Jun;11(6):561-70. Epub 2010 Apr 29. link to original article link to PMC article contains verified protocol PubMed
- Update: Issels RD, Lindner LH, Verweij J, Wessalowski R, Reichardt P, Wust P, Ghadjar P, Hohenberger P, Angele M, Salat C, Vujaskovic Z, Daugaard S, Mella O, Mansmann U, Dürr HR, Knösel T, Abdel-Rahman S, Schmidt M, Hiddemann W, Jauch KW, Belka C, Gronchi A; European Organization for the Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group; European Society for Hyperthermic Oncology. Effect of neoadjuvant chemotherapy plus regional hyperthermia on long-term outcomes among patients with localized high-risk soft tissue sarcoma: the EORTC 62961-ESHO 95 randomized clinical trial. JAMA Oncol. 2018 Apr 1;4(4):483-492. link to original article link to PMC article PubMed
Observation
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Regimen
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Bramwell et al. 1994 (EORTC 62771) | Phase III (C) | CYVADIC | Inferior RFS |
Gronchi et al. 2012 | Phase III (C) | EI | Non-inferior OS |
Woll et al. 2012 (EORTC 62931) | Phase III (C) | AI | Did not meet primary endpoint of OS |
Pautier et al. 2012 (SARCGYN) | Phase III (C) | API | Seems to have inferior DFS |
Hensley et al. 2018 (GOG-0277) | Phase III (C) | GD, then Doxorubicin | Did not meet primary endpoint of OS |
No further treatment.
Preceding treatment
- Gronchi et al. 2012: Neoadjuvant EI x 3, then surgery
- EORTC 62931: Surgery +/- RT
- GOG-0277: Hysterectomy
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 contains verified protocol PubMed
- 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
- 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
- SARCGYN: Pautier P, Floquet A, Gladieff L, Bompas E, Ray-Coquard I, Piperno-Neumann S, Selle F, Guillemet C, Weber B, Largillier R, Bertucci F, Opinel P, Duffaud F, Reynaud-Bougnoux A, Delcambre C, Isambert N, Kerbrat P, Netter-Pinon G, Pinto N, Duvillard P, Haie-Meder C, Lhommé C, Rey A; GSF-GETO. A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide, and cisplatin followed by radiotherapy versus radiotherapy alone in patients with localized uterine sarcomas (SARCGYN study): a study of the French Sarcoma Group. Ann Oncol. 2013 Apr;24(4):1099-104. Epub 2012 Nov 8. link to original article PubMed
Locally advanced or metastatic disease, single-agent regimens
Cisplatin monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Blay et al. 2015 (EFC10145) | 2008-2012 | Phase III (C) | Cisplatin & Ombrabulin | Seems to have inferior PFS |
Note: PFS was very poor in both groups (less than 2 months); the difference was not considered clinically meaningful.
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
21-day cycles
References
- EFC10145: Blay JY, Pápai Z, Tolcher AW, Italiano A, Cupissol D, López-Pousa A, Chawla SP, Bompas E, Babovic N, Penel N, Isambert N, Staddon AP, Saâda-Bouzid E, Santoro A, Franke FA, Cohen P, Le-Guennec S, Demetri GD. Ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas after failure of anthracycline and ifosfamide chemotherapy: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 May;16(5):531-40. Epub 2015 Apr 8. link to original article contains protocol PubMed
Dacarbazine monotherapy
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Regimen
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Buesa et al. 1991 | Phase II | ||
García-Del-Muro et al. 2011 | Randomized Phase II (C) | Dacarbazine & Gemcitabine | Seems to have inferior OS |
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
- Buesa JM, Mouridsen HT, van Oosterom AT, Verweij J, Wagener T, Steward W, Poveda A, Vestlev PM, Thomas D, Sylvester R; EORTC Soft Tissue and Bone Sarcoma Group. High-dose DTIC in advanced soft-tissue sarcomas in the adult: a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group. Ann Oncol. 1991 Apr;2(4):307-9. link to original article contains verified protocol PubMed
- 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
Doxorubicin monotherapy
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Regimen variant #1, 75 mg/m2
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Mouridsen et al. 1987 (EORTC 62801) | 1980-1983 | Phase III (E-switch-ic) | Epirubicin | Did not meet primary endpoint of ORR |
Santoro et al. 1995 | 1985-1990 | Phase III (C) | 1. Doxorubicin & Ifosfamide 2. CYVADIC |
Did not meet endpoints of ORR/DOR/OS |
Nielsen et al. 1998 | NR | Phase III (C) | Epirubicin | Did not meet primary endpoint of ORR |
Lorigan et al. 2007 (EORTC 62971) | 1998-2001 | Phase III (C) | 1. Ifos 3 | Did not meet primary endpoint of PFS |
2. Ifos 9 | Did not meet primary endpoint of PFS | |||
Judson et al. 2014 (EORTC 62012) | 2003-2010 | Phase III (C) | Doxorubicin & Ifosfamide; intensified | Might have inferior OS |
Blay et al. 2014 (CR015769) | 2008-2012 | Phase III (C) | Trabectedin | Did not meet primary endpoint of PFS |
Ryan et al. 2016 (PICASSO III) | 2010-2012 | Phase III (C) | Doxorubicin & Palifosfamide | Did not meet primary endpoint of PFS |
Tap et al. 2016 (CP15-0806) | 2010-2013 | Randomized Phase II (C) | Doxorubicin & Olaratumab | Inferior OS |
Seddon et al. 2017 (GeDDiS) | 2010-2014 | Phase III (C) | Docetaxel & Gemcitabine | Might have superior PFS |
Tap et al. 2017 (TH CR-406/SARC021) | 2011-2014 | Phase III (C) | Doxorubicin & Evofosfamide | Did not meet primary endpoint of OS |
Tap et al. 2020 (ANNOUNCE) | 2015-2018 | Phase III (C) | Doxorubicin & Olaratumab | Did not meet primary endpoint of OS |
Note: in EORTC 62801, treatment was given until progression of disease, unacceptable toxicity, or cumulative doxorubicin dosage of 550 mg/m2, though the ultimate decision to stop treatment based on cumulative doxorubicin dosage was at the discretion of the treating physician. Patients in CR015769 had translocation-related sarcomas.
Chemotherapy
- Doxorubicin (Adriamycin) 75 mg/m2 IV bolus once on day 1
Supportive medications
- CP15-0806, optional: Dexrazoxane (Zinecard) (dose not specified) IV once on day 1
21-day cycle for up to 6 to 8 cycles (see note)
Regimen variant #2, 80 mg/m2
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Edmonson et al. 1993 | Phase III (C) | 1. Doxorubicin & Ifosfamide | Seems to have inferior ORR |
2. MAC | Might have inferior ORR |
Chemotherapy
- Doxorubicin (Adriamycin) 80 mg/m2 IV bolus once on day 1
21-day cycles
References
- EORTC 62801: Mouridsen HT, Bastholt L, Somers R, Santoro A, Bramwell V, Mulder JH, van Oosterom AT, Buesa J, Pinedo HM, Thomas D, Sylvester R; EORTC Soft Tissue and Bone Sarcoma Group. Adriamycin versus epirubicin in advanced soft tissue sarcomas: a randomized phase II/phase III study of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer Clin Oncol. 1987 Oct;23(10):1477-83. link to original article contains verified protocol PubMed
- Edmonson JH, Ryan LM, Blum RH, Brooks JS, Shiraki M, Frytak S, Parkinson DR. Randomized comparison of doxorubicin alone versus ifosfamide plus doxorubicin or mitomycin, doxorubicin, and cisplatin against advanced soft tissue sarcomas. J Clin Oncol. 1993 Jul;11(7):1269-75. link to original article contains protocol PubMed
- Santoro A, Tursz T, Mouridsen H, Verweij J, Steward W, Somers R, Buesa J, Casali P, Spooner D, Rankin E, Kirkpatrick A, van Glabbeke M, van Oosterom A; EORTC Soft Tissue and Bone Sarcoma Group. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1995 Jul;13(7):1537-45. link to original article PubMed
- Nielsen OS, Dombernowsky P, Mouridsen H, Crowther D, Verweij J, Buesa J, Steward W, Daugaard S, van Glabbeke M, Kirkpatrick A, Tursz T; EORTC soft tissue and bone sarcoma group. High-dose epirubicin is not an alternative to standard-dose doxorubicin in the treatment of advanced soft tissue sarcomas: a study of the EORTC soft tissue and bone sarcoma group. Br J Cancer. 1998 Dec;78(12):1634-9. link to PMC article PubMed
- Meta-analysis: Bramwell VH, Anderson D, Charette ML. Doxorubicin-based chemotherapy for the palliative treatment of adult patients with locally advanced or metastatic soft-tissue sarcoma: a meta-analysis and clinical practice guideline. Sarcoma. 2000;4(3):103-12. link to original article link to PMC article PubMed
- EORTC 62971: Lorigan P, Verweij J, Papai Z, Rodenhuis S, Le Cesne A, Leahy MG, Radford JA, Van Glabbeke MM, Kirkpatrick A, Hogendoorn PC, Blay JY; EORTC Soft Tissue and Bone Sarcoma Group. Phase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. J Clin Oncol. 2007 Jul 20;25(21):3144-50. link to original article contains verified protocol PubMed
- CR015769: Blay JY, Leahy MG, Nguyen BB, Patel SR, Hohenberger P, Santoro A, Staddon AP, Penel N, Piperno-Neumann S, Hendifar A, Lardelli P, Nieto A, Alfaro V, Chawla SP. Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas. Eur J Cancer. 2014 Apr;50(6):1137-47. Epub 2014 Feb 7. link to original article contains protocol PubMed NCT00796120
- EORTC 62012: Judson I, Verweij J, Gelderblom H, Hartmann JT, Schöffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litière S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. Epub 2014 Mar 5. link to original article PubMed NCT00061984
- 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. link to original article contains verified protocol link to PMC article PubMed
- PICASSO III: Ryan CW, Merimsky O, Agulnik M, Blay JY, Schuetze SM, Van Tine BA, Jones RL, Elias AD, Choy E, Alcindor T, Keedy VL, Reed DR, Taub RN, Italiano A, Garcia Del Muro X, Judson IR, Buck JY, Lebel F, Lewis JJ, Maki RG, Schöffski P. PICASSO III: A Phase III, Placebo-Controlled Study of Doxorubicin With or Without Palifosfamide in Patients With Metastatic Soft Tissue Sarcoma. J Clin Oncol. 2016 Nov 10;34(32):3898-3905. Epub 2016 Sep 30. link to original article PubMed NCT01168791
- TH CR-406/SARC021: Tap WD, Papai Z, Van Tine BA, Attia S, Ganjoo KN, Jones RL, Schuetze S, Reed D, Chawla SP, Riedel RF, Krarup-Hansen A, Toulmonde M, Ray-Coquard I, Hohenberger P, Grignani G, Cranmer LD, Okuno S, Agulnik M, Read W, Ryan CW, Alcindor T, Del Muro XFG, Budd GT, Tawbi H, Pearce T, Kroll S, Reinke DK, Schöffski P. Doxorubicin plus evofosfamide versus doxorubicin alone in locally advanced, unresectable or metastatic soft-tissue sarcoma (TH CR-406/SARC021): an international, multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1089-1103. Epub 2017 Jun 23. link to original article contains protocol PubMed NCT01440088
- 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 contains verified protocol PubMed ISRCTN07742377
- 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
Epirubicin monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Mouridsen et al. 1987 (EORTC 62801) | 1980-1983 | Phase III (E-switch-ic) | Doxorubicin | Did not meet primary endpoint of ORR |
Chemotherapy
- Epirubicin (Ellence) 75 mg/m2 IV bolus once on day 1
21-day cycle for up to 7 cycles (cumulative epirubicin dosage of 550 mg/m2) (though the ultimate decision to stop treatment based on cumulative epirubicin dosage was at the discretion of the treating physician)
References
- EORTC 62801: Mouridsen HT, Bastholt L, Somers R, Santoro A, Bramwell V, Mulder JH, van Oosterom AT, Buesa J, Pinedo HM, Thomas D, Sylvester R. Adriamycin versus epirubicin in advanced soft tissue sarcomas: a randomized phase II/phase III study of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer Clin Oncol. 1987 Oct;23(10):1477-83. link to original article contains verified protocol PubMed
Ifosfamide monotherapy
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Regimen variant #1, short infusion (Ifos 3)
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Lorigan et al. 2007 (EORTC 62971) | 1998-2001 | Phase III (E-switch-ic) | 1. Doxorubicin | Did not meet primary endpoint of PFS |
2. Ifos 9 | Did not meet primary endpoint of PFS |
Chemotherapy
- Ifosfamide (Ifex) 3000 mg/m2 IV over 4 hours on days 1 to 3, mixed with Mesna (Mesnex) in 1 liter of normal saline
Supportive medications
- Mesna (Mesnex) as follows:
- 600 mg/m2 IV bolus once on day 1, given immediately prior to mesna/ifosfamide infusion, then
- 1500 mg/m2 IV over 4 hours on days 1 to 3, given with Ifosfamide (Ifex), then
- 1200 mg/m2 IV twice per day on days 1 to 3, given at 4 and 8 hours after completion of ifosfamide and mesna
- An alternative is to use oral mesna instead of intravenous: Mesna (Mesnex) 1200 mg/m2 PO twice per day on days 1 to 3, given at 2 and 6 hours after completion of ifosfamide and mesna
- Sodium bicarbonate 150 mmol IV once per day on days 1 to 3
- Patient with somnolence or other signs of encephalopathy with ifosfamide received methylene blue 50 mg IV every 4 hours until resolution of symptoms. During cycles thereafter, patients would receive methylene blue 50 mg IV every 4 hours, starting 4 hours prior to ifosfamide on day 1, continuing until 72 hours after completion
21-day cycle for up to 6 cycles
Regimen variant #2, continuous infusion (Ifos 9)
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Lorigan et al. 2007 (EORTC 62971) | 1998-2001 | Phase III (E-esc) | 1. Doxorubicin | Did not meet primary endpoint of PFS |
2. Ifos 3 | Did not meet primary endpoint of PFS |
Chemotherapy
- Ifosfamide (Ifex) 3000 mg/m2/day IV continuous infusion over 72 hours, started on day 1, given with mesna (total dose per cycle: 9000 mg/m2)
- Each day's dose is mixed with mesna in 3 liters of normal saline
Supportive medications
- Mesna (Mesnex) as follows:
- 600 mg/m2 IV bolus once on day 1, immediately prior to mesna/ifosfamide infusion, then
- 3000 mg/m2/day IV continuous infusion over 72 hours, starting on day 1, given with Ifosfamide (Ifex), then
- 1800 mg/m2 IV over 12 hours once on day 4, starting after completion of ifosfamide and mesna
- An alternative is to use oral mesna instead of intravenous: Mesna (Mesnex) 1200 mg/m2 PO three times on day 4, given 0, 2, and 6 hours after completion of ifosfamide and mesna
- Sodium bicarbonate 150 mmol IV once per day on days 1 to 3
- Patient with somnolence or other signs of encephalopathy with ifosfamide received methylene blue 50 mg IV every 4 hours until resolution of symptoms. During cycles thereafter, patients would receive methylene blue 50 mg IV every 4 hours, starting 4 hours prior to ifosfamide on day 1, continuing until 72 hours after completion
21-day cycle for up to 6 cycles
Regimen variant #3
Study | Evidence |
---|---|
van Oosterom et al. 2002 | Phase II |
Chemotherapy
- Ifosfamide (Ifex) 3000 mg/m2 IV over 4 hours once per day on days 1 to 3, dissolved in 125 mL sterile water per 1000 mg of ifosfamide, mixed with Mesna (Mesnex) in an additional 1 liter of dextrose/saline
Supportive medications
- Mesna (Mesnex) as follows:
- 600 mg/m2 IV bolus once on day 1, immediately prior to mesna/ifosfamide infusion, then
- 1500 mg/m2 IV over 4 hours on days 1 to 3, given with Ifosfamide (Ifex), then
- 500 mg/m2 IV twice per day on days 1 to 3, given at 4 and 8 hours after completion of ifosfamide and mesna
- "Antiemetics were prescribed according to local conventions"
- 1 liter of fluid PO twice per day on days 1 to 3, taken 4 and 8 hours after completion of ifosfamide and mesna
21-day cycle for at least 2 cycles, except in cases of rapid disease progression
References
- van Oosterom AT, Mouridsen HT, Nielsen OS, Dombernowsky P, Krzemieniecki K, Judson I, Svancarova L, Spooner D, Hermans C, Van Glabbeke M, Verweij J; EORTC Soft Tissue and Bone Sarcoma Group. Results of randomised studies of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG) with two different ifosfamide regimens in first- and second-line chemotherapy in advanced soft tissue sarcoma patients. Eur J Cancer. 2002 Dec;38(18):2397-406 link to original article contains verified protocol PubMed content property of HemOnc.org
- EORTC 62971: Lorigan P, Verweij J, Papai Z, Rodenhuis S, Le Cesne A, Leahy MG, Radford JA, Van Glabbeke MM, Kirkpatrick A, Hogendoorn PC, Blay JY; EORTC Soft Tissue and Bone Sarcoma Group. Phase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. J Clin Oncol. 2007 Jul 20;25(21):3144-50. link to original article contains verified protocol PubMed
Pazopanib monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
van der Graaf et al. 2012 (PALETTE) | 2008-2010 | Phase III (E-RT-esc) | Placebo | Superior PFS |
Targeted therapy
- Pazopanib (Votrient) 800 mg PO once per day
Continued indefinitely
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 contains verified protocol 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
Placebo
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Demetri et al. 2013 (SUCCEED) | 2007-2010 | Phase III (C) | Ridaforolimus | Inferior PFS |
van der Graaf et al. 2012 (PALETTE) | 2008-2010 | Phase III (C) | Pazopanib | Inferior PFS |
Kawai et al. 2015 | 2012-2014 | Randomized Phase II (C) | Trabectedin | Inferior PFS |
Mir et al. 2016 (REGOSARC) | 2013-2014 | Randomized Phase II (C) | Regorafenib | Inferior PFS (*) |
No active antineoplastic treatment. Used as a comparator arm and here for reference purposes only. Note: 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.
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 contains verified protocol 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
- 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 contains protocol PubMed
- 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 NCT01900743
Regorafenib monotherapy
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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 NCT01900743
Temozolomide monotherapy
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Regimen variant #1, 5 out of 28 days
Study | Evidence |
---|---|
Talbot et al. 2003 | Phase II |
Note: patients on study could be reconsented to receive therapy beyond 1 year. Treatment given on an empty stomach, and doses rounded up if needed to next available dosage based on capsule doses.
Chemotherapy
- Temozolomide (Temodar) 200 mg/m2 PO once on day 1, then 12 hours later, 90 mg/m2 PO every 12 hours on days 1 to 5 (total of 10 doses per cycle)
Supportive medications
- Antiemetics "prescribed as clinically indicated by the treating physician"
28-day cycle for up to 13 cycles (1 year)
Regimen variant #2, 6 out of 9 weeks
Study | Evidence |
---|---|
Garcia del Muro et al. 2005 | Phase II |
Note: Initial dose used in the study was 75 mg/m2, but due to lack of toxicity, protocol was amended to use 100 mg/m2 doses.
Chemotherapy
- Temozolomide (Temodar) 100 mg/m2 PO once per day on days 1 to 42, no food 1 hour before and after temozolomide doses
Supportive medications
- "Antiemetics, mainly oral Metoclopramide (Reglan) and Ondansetron (Zofran), were prescribed as clinically indicated by the treating physician"
9-week cycle for up to 3 cycles
References
- Talbot SM, Keohan ML, Hesdorffer M, Orrico R, Bagiella E, Troxel AB, Taub RN. A phase II trial of temozolomide in patients with unresectable or metastatic soft tissue sarcoma. Cancer. 2003 Nov 1;98(9):1942-6. link to original article contains verified protocol PubMed
- Garcia del Muro X, Lopez-Pousa A, Martin J, Buesa JM, Martinez-Trufero J, Casado A, Poveda A, Cruz J, Bover I, Maurel J; Spanish Group for Research on Sarcomas. A phase II trial of temozolomide as a 6-week, continuous, oral schedule in patients with advanced soft tissue sarcoma: a study by the Spanish Group for Research on Sarcomas. Cancer. 2005 Oct 15;104(8):1706-12. link to original article contains verified protocol PubMed
Trabectedin monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kawai et al. 2015 | 2012-2014 | Randomized Phase II (E-esc) | Placebo | Superior PFS |
Chemotherapy
- Trabectedin (Yondelis) 1.2 mg/m2 IV continuous infusion over 24 hours, started on day 1
21-day cycles
References
- 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 contains protocol PubMed
Locally advanced or metastatic disease, combination regimens
Dacarbazine & Doxorubicin
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AD: Adriamycin (Doxorubicin) & Dacarbazine
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Baker et al. 1987 (SWOG S7613) | 1976-1979 | Phase III (C) | 1. AD & Cyclophosphamide 2. AD & Dactinomycin |
Did not meet endpoints of RR/OS |
Zalupski et al. 1991 | 1980-1986 | Phase III (C) | CI Dacarbazine & Doxorubicin | Did not meet primary endpoint of OS50% |
Antman et al. 1993 | 1987-1989 | Phase III (C) | MAID | Seems to have superior OS (*) |
Here for historic purposes. Note that in Antman et al. 1993, although the experimental arm seemed to have superior TTP, this arm seemed to have superior OS.
Chemotherapy
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 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 protocol PubMed
- 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 PubMed
Dacarbazine & Gemcitabine
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Regimen
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
García-Del-Muro et al. 2011 | 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
Study | Evidence | Comparator | Comparative Efficacy | |
---|---|---|---|---|
Seddon et al. 2017 (GeDDiS) | 2010-2014 | Phase III (E-switch-ic) | Doxorubicin | Might have inferior PFS |
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
References
- 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
Doxorubicin & Ifosfamide
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AIM: Adriamycin (Doxorubicin), Ifosfamide, Mesna
Regimen variant #1, 50/5000
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Le Cesne et al. 2000 (EORTC 62903) | Phase III (C) | AIM; 75/5000 | Did not meet primary endpoint of ORR |
Chemotherapy
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Ifosfamide (Ifex) 5000 mg/m2 IV once on day 1
21-day cycles
Regimen variant #2, 5-day course, lower dose doxorubicin - AI 75/10,000
Study | Evidence |
---|---|
Patel et al. 1998 | Pilot, <20 patients reported |
Chemotherapy
- Doxorubicin (Adriamycin) 25 mg/m2/day IV continuous infusion over 72 hours, started on day 1 (total dose per cycle: 75 mg/m2)
- Ifosfamide (Ifex) 2000 mg/m2 IV over 2 hours once per day on days 1 to 5
Supportive medications
- Mesna (Mesnex) 400 mg/m2 IV once on day 1, given simultaneously with the first dose of Ifosfamide (Ifex), then 1200 mg/m2/day IV continuous infusion over 120 hours
- Each day's dose is given in 2 liters of D5W with 100 mEq/L sodium acetate, 20 mEq/L potassium acetate, and 4 mEq/L magnesium sulfate
- If febrile neutropenia occurs, G-CSF is used in subsequent cycles
21-day cycle for up to 6 cycles
Regimen variant #3, 4-day course, higher dose doxorubicin - AI 90/10,000
Study | Evidence |
---|---|
Patel et al. 1998 | Pilot, <20 patients reported |
Chemotherapy
- Doxorubicin (Adriamycin) 30 mg/m2/day IV continuous infusion over 72 hours, started on day 1 (total dose per cycle: 90 mg/m2)
- Ifosfamide (Ifex) 2500 mg/m2 IV over 3 hours once per day on days 1 to 4
Supportive medications
- Mesna (Mesnex) 500 mg/m2 IV once on day 1, given simultaneously with the first dose of Ifosfamide (Ifex), then 1500 mg/m2/day IV continuous infusion over 96 hours
- Each day's dose is given in 2 liters of D5W with 100 mEq/L sodium acetate, 20 mEq/L potassium acetate, and 4 mEq/L magnesium sulfate
- G-CSF (type not specified) 5 mcg/kg (dose rounded to 300 or 480 mcg) SC once per day, starting on day 5, given until ANC is at least 10,000/uL
21-day cycle for up to 6 cycles
References
- Patel SR, Vadhan-Raj S, Burgess MA, Plager C, Papadopolous N, Jenkins J, Benjamin RS. Results of two consecutive trials of dose-intensive chemotherapy with doxorubicin and ifosfamide in patients with sarcomas. Am J Clin Oncol. 1998 Jun;21(3):317-21. link to original article contains verified protocol PubMed
- EORTC 62903: Le Cesne A, Judson I, Crowther D, Rodenhuis S, Keizer HJ, Van Hoesel Q, Blay JY, Frisch J, Van Glabbeke M, Hermans C, Van Oosterom A, Tursz T, Verweij J. Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: A trial of the European Organisation for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 2000 Jul;18(14):2676-84. link to original article contains protocol PubMed
Doxorubicin, Ifosfamide, RT
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AIM & RT: Adriamycin (Doxorubicin), Ifosfamide, Mesna, Radiation Therapy
Regimen
Study | Evidence |
---|---|
Venkatramani et al. 2015 (COG ARST0332 Arm D) | Phase IIIb |
Note: Regimen details are derived from the COG ARST0332 (NCT00346164) protocol.
Chemotherapy
- Doxorubicin (Adriamycin) as follows:
- Cycles 1 to 5: 37.5 mg/m2/day (maximum dose of 75 mg/day) IV continuous infusion over 48 hours, started on day 1 (total dose per cycle: 75 mg/m2)
- Doses are held when patients are receiving concurrent radiation therapy (for example, held during cycles 2 and 3, if radiation therapy is initiated with cycle 2). The missed doses are then administered in a different cycle, to maintain a total regimen dose of 375 mg/m2. If doses are held in 2 of 6 cycles, a doxorubicin-only "Cycle 7" may be given 21 days following cycle 6.
- Ifosfamide (Ifex) 3000 mg/m2 IV over 3 hours once per day on days 1 to 3
Supportive medications
- Mesna (Mesnex) 600 mg/m2 IV over 15 minutes once per day on days 1 to 3, given 15 minutes prior to each dose of Ifosfamide (Ifex), then at 3 hours, 6 hours, and 9 hours after start of Ifosfamide (Ifex)
- Hydration:
- Before first Ifosfamide (Ifex) infusion: D5 1/2 NS IV at rate of 200 mL/m2/hr IV until urine output > 2 mL/kg/hr
- With Ifosfamide (Ifex) infusion: D5 1/2 NS with 10 mEq KCL/L IV at rate of 125 mL/m2/hr IV beginning immediately after ifosfamide infusion and continuing until next ifosfamide dose, or until 24 hours after last dose.
- G-CSF (type not specified) 5 mcg/kg (max 480 mcg) SC once per day, starting on day 4, given until ANC is at least 2000/uL after nadir. Filgrastim should not be administered within 24 hours of chemotherapy.
21-day cycle for up to 6 cycles
Radiotherapy
- External beam radiotherapy beginning with cycle 2 (week 4)
Subsequent treatment
- Definitive resection of primary tumor after recovery from cycle 3 (week 13)
- Definitive resection of residual metastasis after completion of chemotherapy
References
- Abstract: Venkatramani R, Anderson JR, Million L, Coffin CM, McCarville B, Randall RL, et al. Risk-based treatment for synovial sarcoma in patients under 30 years of age: Children’s Oncology Group study ARST0332. J Clin Oncol [Internet]. 2015;33(15). link to original abstract contains protocol
Epirubicin & Ifosfamide
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Regimen
Study | Evidence |
---|---|
Reichardt et al. 1998 | Phase II |
Chemotherapy
- Epirubicin (Ellence) 45 mg/m2/day IV continuous infusion over 48 hours, started on day 2 (total dose per cycle: 90 mg/m2)
- Ifosfamide (Ifex) 2500 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 12,500 mg/m2)
- Each day's dose is mixed with mesna in 3 liters of "fluids with electrolytes"
Supportive medications
- Mesna (Mesnex) 1500 mg/m2 IV continuous infusion over 120 hours, started on day 1, given with Ifosfamide (Ifex) (total dose per cycle: 7500 mg/m2)
- G-CSF (type not specified) 5 mcg/kg SC once per day on days 6 to 15 or "until recovery of leukocytes"
- Ondansetron (Zofran) 8 to 24 mg/day (route not specified) prn nausea
- Dexamethasone (Decadron) (dose/schedule not specified) for antiemesis if necessary
21-day cycles
References
- Reichardt P, Tilgner J, Hohenberger P, Dörken B. Dose-intensive chemotherapy with ifosfamide, epirubicin, and filgrastim for adult patients with metastatic or locally advanced soft tissue sarcoma: a phase II study. J Clin Oncol. 1998 Apr;16(4):1438-43. link to original article contains verified protocol PubMed
Gemcitabine & Vinorelbine
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Regimen
Study | Evidence |
---|---|
Dileo et al. 2007 | Phase II |
Chemotherapy
- Gemcitabine (Gemzar) 800 mg/m2 IV over 90 minutes once per day on days 1 & 8
- Vinorelbine (Navelbine) 25 mg/m2 IV over 10 minutes once per day on days 1 & 8
21-day cycles
References
- Dileo P, Morgan JA, Zahrieh D, Desai J, Salesi JM, Harmon DC, Quigley MT, Polson K, Demetri GD, George S. Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas: results of a phase II trial. Cancer. 2007 May 1;109(9):1863-9. link to original article contains verified protocol PubMed
MAID
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MAID: Mesna, Adriamycin (Doxorubicin), Ifosfamide, Dacarbazine
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Antman et al. 1993 | 1987-1989 | Phase III (E-esc) | AD | Seems to have inferior OS (*) |
Fayette et al. 2009 | 1994-1997 | Phase III (C) | MAID]; higher-intensity | Did not meet primary endpoint of ORR |
Bui-Nguyen et al. 2011 | 2000-2008 | Non-randomized portion of RCT |
Note that in Antman et al. 1993, although this arm seemed to have superior TTP, the control arm seemed to have superior OS.
Chemotherapy
Supportive medications
References
- 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 PubMed
- Fayette J, Penel N, Chevreau C, Blay JY, Cupissol D, Thyss A, Guillemet C, Rios M, Rolland F, Fargeot P, Bay JO, Mathoulin-Pelissier S, Coindre JM, Bui-Nguyen B. Phase III trial of standard versus dose-intensified doxorubicin, ifosfamide and dacarbazine (MAID) in the first-line treatment of metastatic and locally advanced soft tissue sarcoma. Invest New Drugs. 2009 Oct;27(5):482-9. Epub 2009 Jan 16. link to original article PubMed
- Bui-Nguyen B, Ray-Coquard I, Chevreau C, Penel N, Bay JO, Coindre JM, Cupissol D, Italiano A, Bonichon F, Lotz JP, Thyss A, Jimenez M, Mathoulin-Pélissier S, Blay JY; GSF-GETO. High-dose chemotherapy consolidation for chemosensitive advanced soft tissue sarcoma patients: an open-label, randomized controlled trial. Ann Oncol. 2012 Mar;23(3):777-84. Epub 2011 Jun 7. link to original article PubMed
Dermatofibrosarcoma protuberans, all lines of therapy
Imatinib monotherapy
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Regimen variant #1, 400 mg/day
Study | Evidence |
---|---|
Rutkowski et al. 2010 (SWOG S0345) | Phase II, <20 pts |
Targeted therapy
- Imatinib (Gleevec) 400 mg PO once per day
48-week course
Regimen variant #2, 800 mg/day
Study | Evidence |
---|---|
Rutkowski et al. 2010 (EORTC 62027) | Phase II, <20 pts |
Targeted therapy
- Imatinib (Gleevec) 400 mg PO twice per day
Continued indefinitely, unless complete (R0) surgical resection became possible
References
- EORTC 62027; SWOG S0345: Rutkowski P, Van Glabbeke M, Rankin CJ, Ruka W, Rubin BP, Debiec-Rychter M, Lazar A, Gelderblom H, Sciot R, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze SM; EORTC Soft Tissue and Bone Sarcoma Group; SWOG. Imatinib mesylate in advanced dermatofibrosarcoma protuberans: pooled analysis of two phase II clinical trials. J Clin Oncol. 2010 Apr 1;28(10):1772-9. Epub 2010 Mar 1. link to original article contains verified protocol link to PMC article PubMed NCT00084630; NCT00085475
Desmoid tumors, all lines of therapy
Sorafenib monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gounder et al. 2018 (Alliance A091105) | 2014-2016 | Phase III (E-esc) | Placebo | Superior PFS |
Targeted therapy
- Sorafenib (Nexavar) 400 mg PO once per day
Continued indefinitely
References
- Alliance A091105: Gounder MM, Mahoney MR, Van Tine BA, Ravi V, Attia S, Deshpande HA, Gupta AA, Milhem MM, Conry RM, Movva S, Pishvaian MJ, Riedel RF, Sabagh T, Tap WD, Horvat N, Basch E, Schwartz LH, Maki RG, Agaram NP, Lefkowitz RA, Mazaheri Y, Yamashita R, Wright JJ, Dueck AC, Schwartz GK. Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med. 2018 Dec 20;379(25):2417-2428. link to original article contains protocol link to PMC article PubMed NCT02066181