Difference between revisions of "Soft tissue sarcoma"
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Revision as of 02:48, 23 January 2018
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Section editor | |
---|---|
James L. Chen, MD, MS Columbus, OH |
19 regimens on this page
28 variants on this page
|
Note: this page is for subtype-nonspecific soft tissue sarcoma 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.
Guidelines
ESMO
- 2014: Soft tissue and visceral sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
NCCN
Neoadjuvant therapy
Epirubicin & Ifosfamide
back to top |
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Gronchi et al. 2017 (ISG-STS 1001) | Phase III | Histotype-tailored therapy | Seems not superior |
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) with Ifosfamide (Ifex); abstract does not list dosage/schedule
21-day cycle for 3 cycles, followed by surgery
References
- 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
Locally advanced or metastatic disease, single-agent regimens
Cisplatin monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Blay et al. 2015 | 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
- 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 #1, 850 mg/m2
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Schöffski et al. 2016 | Phase III | Eribulin | Seems to have inferior OS |
Chemotherapy
- Dacarbazine (DTIC) 850 mg/m2 IV over 20 to 120 minutes once on day 1
21-day cycles
Regimen #2, 1000 mg/m2
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Demetri et al. 2015 | Phase III | Trabectedin | Inferior PFS |
Schöffski et al. 2016 | Phase III | Eribulin | Seems to have inferior OS |
Note: this is listed as a "starting dose" in Demetri et al. 2015, but no adjustment instructions were provided in the manuscript.
Chemotherapy
- Dacarbazine (DTIC) 1000 mg/m2 IV over 20 to 120 minutes once on day 1
21-day cycles
Regimen #3, 1200 mg/m2
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Buesa et al. 1991 | Phase II | ||
García-Del-Muro et al. 2011 | Randomized phase II | Dacarbazine & Gemcitabine | Seems to have inferior OS |
Schöffski et al. 2016 | Phase III | Eribulin | 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. High-dose DTIC in advanced soft-tissue sarcomas in the adult. A phase II study of the E.O.R.T.C. 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
- Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. Epub 2015 Sep 14. link to original article contains verified protocol link to PMC article PubMed
- Subgroup analysis: Hensley ML, Patel SR, von Mehren M, Ganjoo K, Jones RL, Staddon A, Rushing D, Milhem M, Monk B, Wang G, McCarthy S, Knoblauch RE, Parekh TV, Maki RG, Demetri GD. Efficacy and safety of trabectedin or dacarbazine in patients with advanced uterine leiomyosarcoma after failure of anthracycline-based chemotherapy: Subgroup analysis of a phase 3, randomized clinical trial. Gynecol Oncol. 2017 Sep;146(3):531-537. Epub 2017 Jun 24. PubMed
- Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. Epub 2016 Feb 10. link to original article PubMed
- Subgroup analysis: Demetri GD, Schöffski P, Grignani G, Blay JY, Maki RG, Van Tine BA, Alcindor T, Jones RL, D'Adamo DR, Guo M, Chawla S. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. 2017 Oct 20;35(30):3433-3439. Epub 2017 Aug 30. link to original article contains verified protocol PubMed
Doxorubicin monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Mouridsen et al. 1987 | Phase III | Epirubicin | Seems not superior |
Lorigan et al. 2007 | Phase III | Ifos 3 | Seems not superior |
Ifos 9 | Seems not superior | ||
Judson et al. 2014 (EORTC 62012) | Phase III | Intensified Doxorubicin & Ifosfamide | Might have inferior OS |
Tap et al. 2016 | Randomized Phase II | Doxorubicin & Olaratumab | Inferior OS |
Tap et al. 2017 (TH CR-406/SARC021) | Phase III | Doxorubicin & Evofosfamide | Seems not superior |
Seddon et al. 2017 (GeDDiS) | Phase III | Docetaxel & Gemcitabine | Might have superior PFS |
Chemotherapy
- Doxorubicin (Adriamycin) 75 mg/m2 IV bolus once on day 1
Supportive medications
- In Tap et al. 2016, Dexrazoxane (Zinecard) (dose not specified) could be used on day 1 of every cycle to reduce the potential for doxorubicin-related cardiotoxicity in cycles 5 to 8
21-day cycle for up to 6 to 8 cycles, until progression of disease, unacceptable toxicity, or patient refusal
Note: in Mouridsen et al. 1987, 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.
References
- Mouridsen HT, Bastholt L, Somers R, Santoro A, Bramwell V, Mulder JH, van Oosterom AT, Buesa J, Pinedo HM, Thomas D et al. 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
- 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
- Lorigan P, Verweij J, Papai Z, Rodenhuis S, Le Cesne A, Leahy MG, Radford JA, Van Glabbeke MM, Kirkpatrick A, Hogendoorn PC, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. 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
- 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
- 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 PubMed
- 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
- 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
Epirubicin monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Mouridsen et al. 1987 | Phase III | Doxorubicin | Seems not superior |
Chemotherapy
- Epirubicin (Ellence) 75 mg/m2 IV bolus once on day 1
21-day cycles, given until progression of disease, unacceptable toxicity, or 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
- Mouridsen HT, Bastholt L, Somers R, Santoro A, Bramwell V, Mulder JH, van Oosterom AT, Buesa J, Pinedo HM, Thomas D et al. 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 SD article contains verified protocol PubMed
Eribulin monotherapy
back to top |
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Schöffski et al. 2016 | Phase III | Dacarbazine | Seems to have superior OS |
Chemotherapy
- Eribulin (Halaven) 1.4 mg/m2 IV once per day on days 1 & 8
21-day cycles until progression
References
- Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. Epub 2016 Feb 10. link to original article contains protocol PubMed
- Subgroup analysis: Demetri GD, Schöffski P, Grignani G, Blay JY, Maki RG, Van Tine BA, Alcindor T, Jones RL, D'Adamo DR, Guo M, Chawla S. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. 2017 Oct 20;35(30):3433-3439. Epub 2017 Aug 30. link to original article contains verified protocol PubMed
Ifosfamide monotherapy
back to top |
Regimen #1, short infusion (Ifos 3)
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Lorigan et al. 2007 | Phase III | Doxorubicin | Seems not superior |
Ifos 9 | Seems not superior |
Chemotherapy
- Ifosfamide (Ifex) 3000 mg/m2 IV over 4 hours on days 1 to 3
- Each day's dose of ifosfamide is mixed together 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 together with Ifosfamide (Ifex), then
- 1200 mg/m2 IV two times 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 two times 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, progression of disease, unacceptable toxicity, or patient refusal
Regimen #2, continuous infusion (Ifos 9)
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Lorigan et al. 2007 | Phase III | Doxorubicin | Seems not superior |
Ifos 3 | Seems not superior |
Chemotherapy
- Ifosfamide (Ifex) 3000 mg/m2/day IV continuous infusion over 72 hours (total dose per cycle: 9000 mg/m2) on days 1 to 3, given together with mesna
- Each day's dose is mixed together 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 (total dose per cycle: 9000 mg/m2) on days 1 to 3, given together 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, progression of disease, unacceptable toxicity, or patient refusal
Regimen #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
- Each day's dose is dissolved in 125 mL sterile water per 1000 mg of ifosfamide, mixed together 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 together with Ifosfamide (Ifex), then
- 500 mg/m2 IV two times 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 two times 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; continued until disease progression or unacceptable toxicity or patient refusal
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
- Lorigan P, Verweij J, Papai Z, Rodenhuis S, Le Cesne A, Leahy MG, Radford JA, Van Glabbeke MM, Kirkpatrick A, Hogendoorn PC, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. 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 | Evidence | Comparator | Efficacy |
---|---|---|---|
van der Graaf et al. 2012 (PALETTE) | Phase III | Placebo | Superior PFS |
Chemotherapy
- Pazopanib (Votrient) 800 mg PO once per day
Given until progression of disease, unacceptable toxicity, withdrawal of consent, or death
References
- van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Sch?ffski 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
Placebo
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
van der Graaf et al. 2012 (PALETTE) | Phase III | Pazopanib | Inferior PFS |
Kawai et al. 2015 | Randomized Phase II | Trabectedin | Inferior PFS |
Mir et al. 2016 (REGOSARC) | Randomized Phase II | 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
- van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Sch?ffski 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
- 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
- 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
Regorafenib monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Mir et al. 2016 (REGOSARC) | Randomized Phase II | 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.
Chemotherapy
- Regorafenib (Stivarga) 160 mg PO once per day on days 1 to 21
28-day cycles
References
- 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
Temozolomide monotherapy
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Regimen #1
Study | Evidence |
---|---|
Talbot et al. 2003 | Phase II |
Chemotherapy
- Temozolomide (Temodar) 200 mg/m2 (doses rounded up if needed to next available dosage based on capsule doses) PO once on day 1, on an empty stomach; then 12 hours later, 90 mg/m2 PO once every 12 hours x 9 doses (total of 10 doses per cycle) on days 1 to 5, on an empty stomach
Supportive medications
- Antiemetics "prescribed as clinically indicated by the treating physician"
28-day cycles, given until progression of disease or 1 year; patients on study could be reconsented to receive therapy beyond 1 year
Regimen #2
Study | Evidence |
---|---|
Garcia del Muro et al. 2005 | Phase II |
Chemotherapy
- Temozolomide (Temodar) 100 mg/m2 PO once per day on days 1 to 42 (6 weeks), with no food 1 hour before and after temozolomide doses
- 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
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, progression of disease, or unacceptable toxicity
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 #1
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Demetri et al. 2015 | Phase III | Dacarbazine | Superior PFS |
Note: this is listed as a "starting dose," but no adjustment instructions were provided in the manuscript.
Chemotherapy
- Trabectedin (Yondelis) 1.5 mg/m2 IV continuous infusion over 24 hours, starting on day 1
Supportive medications
- Dexamethasone (Decadron) 20 mg IV once prior to trabectedin
21-day cycles
Regimen #2
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Kawai et al. 2015 | Randomized Phase II | Placebo | Superior PFS |
Chemotherapy
- Trabectedin (Yondelis) 1.2 mg/m2 IV continuous infusion over 24 hours, starting on day 1
21-day cycles
References
- Demetri GD, Chawla SP, von Mehren M, Ritch P, Baker LH, Blay JY, Hande KR, Keohan ML, Samuels BL, Schuetze S, Lebedinsky C, Elsayed YA, Izquierdo MA, Gómez J, Park YC, Le Cesne A. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol. 2009 Sep 1;27(25):4188-96. Epub 2009 Aug 3. link to original article 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
- Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. Epub 2015 Sep 14. link to original article contains verified protocol link to PMC article PubMed
- Subgroup analysis: Hensley ML, Patel SR, von Mehren M, Ganjoo K, Jones RL, Staddon A, Rushing D, Milhem M, Monk B, Wang G, McCarthy S, Knoblauch RE, Parekh TV, Maki RG, Demetri GD. Efficacy and safety of trabectedin or dacarbazine in patients with advanced uterine leiomyosarcoma after failure of anthracycline-based chemotherapy: Subgroup analysis of a phase 3, randomized clinical trial. Gynecol Oncol. 2017 Sep;146(3):531-537. Epub 2017 Jun 24. PubMed
Locally advanced or metastatic disease, combination regimens
AIM
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AIM: Adriamycin, Ifosfamide, Mesna
Regimen #1, 5-day course, lower dose doxorubicin - AI 75/10
Study | Evidence |
---|---|
Patel et al. 1998 | Pilot, <20 patients reported |
Chemotherapy
- Doxorubicin (Adriamycin) 25 mg/m2/day IV continuous infusion over 72 hours on days 1 to 3 (total dose per cycle: 75 mg/m2)
- Ifosfamide (Ifex) 2000 mg/m2 IV over 2 hours once per day on days 1 to 5 (total dose per cycle: 10,000 mg/m2)
Supportive medications
- Mesna (Mesnex) 400 mg/m2 IV once on day 1, given simultaneously with the first dose of Ifosfamide (Ifex)
- Mesna (Mesnex) 1200 mg/m2/day IV continuous infusion over 5 days on days 1 to 5 (total dose per cycle: 6000 mg/m2)
- 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 cycles, given until maximum response, 6 cycles of therapy, progression of disease, or unacceptable toxicity
Regimen #2, 4-day course, higher dose doxorubicin - AI 90/10
Study | Evidence |
---|---|
Patel et al. 1998 | Pilot, <20 patients reported |
Chemotherapy
- Doxorubicin (Adriamycin) 30 mg/m2/day IV continuous infusion over 72 hours on days 1 to 3 (total dose per cycle: 90 mg/m2)
- Ifosfamide (Ifex) 2500 mg/m2 IV over 3 hours once per day on days 1 to 4 (total dose per cycle: 10,000 mg/m2)
Supportive medications
- Mesna (Mesnex) 500 mg/m2 IV once on day 1, given simultaneously with the first dose of Ifosfamide (Ifex)
- Mesna (Mesnex) 1500 mg/m2/day IV continuous infusion over 4 days on days 1 to 4 (total dose per cycle: 6000 mg/m2)
- 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 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 cycles, given until maximum response, 6 cycles of therapy, progression of disease, or unacceptable toxicity
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
Dacarbazine & Gemcitabine
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
García-Del-Muro et al. 2011 | Randomized phase II | 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 over 3 hours (fixed-dose rate) once on day 1, given first
14-day cycle for 12 cycles, or longer per clinician discretion
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 #1, no prior radiation
Study | Evidence |
---|---|
Hensley et al. 2002 | Phase II |
Chemotherapy
- Docetaxel (Taxotere) 100 mg/m2 IV over 60 minutes once on day 8, given second
- Gemcitabine (Gemzar) 900 mg/m2 IV over 90 minutes once per day on days 1 & 8, given first
Supportive medications
- Dexamethasone (Decadron) 8 mg PO BID 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 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 (only one dose given)
21-day cycle for 6 to 8 cycles; Hensley et al. 2008 did not specify a maximum number of cycles
Regimen #2, patients who received prior radiation
Study | Evidence |
---|---|
Hensley et al. 2002 | Phase II |
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 BID on days 7-9 (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 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 (only one dose given)
21-day cycle for 6 to 8 cycles; Hensley et al. 2008 did not specify a maximum number of cycles
References
- Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31. link to original article contains verified protocol PubMed
- Hensley ML, Blessing JA, Mannel R, Rose PG. Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol. 2008 Jun;109(3):329-34. link to original article contains verified protocol link to PMC article PubMed
- 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
Doxorubicin & Olaratumab
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Tap et al. 2016 | Randomized Phase II | Doxorubicin | Superior OS |
Chemotherapy
- Doxorubicin (Adriamycin) as follows:
- Cycles 1 to 8: 75 mg/m2 IV once on day 1
- Olaratumab (Lartruvo) 15 mg/kg IV once per day on days 1 & 8
21-day cycles
Supportive medications
- In Tap et al. 2016, Dexrazoxane (Zinecard) (dose not specified) could be used on day 1 of every cycle to reduce the potential for doxorubicin-related cardiotoxicity in cycles 5 to 8
References
- 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 verified protocol PubMed
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 2 days on days 2 & 3 (total dose per cycle: 90 mg/m2)
- Ifosfamide (Ifex) 2500 mg/m2/day IV continuous infusion over 5 days on days 1 to 5 (total dose per cycle: 12,500 mg/m2)
- Each day's dose is mixed together with Mesna (Mesnex) in 3 liters of "fluids with electrolytes"
Supportive medications
- Mesna (Mesnex) 1500 mg/m2 IV continuous infusion over 5 days on days 1 to 5, given together with Ifosfamide (Ifex) (total dose per cycle: 7500 mg/m2)
- G-CSF 5 mcg/kg SC once per day on days 6 to 15 or "until recovery of leukocytes"
- Ondansetron (Zofran) 8-24 mg per day prn nausea
- Dexamethasone (Decadron) (dose/schedule not specified) for antiemesis if necessary
21-day cycles
References
- Reichardt P, Tilgner J, Hohenberger P, D?rken 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
Reference
- 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
Liposarcoma, all lines of therapy
Note: this will be moved to a histology-specific page, shortly.
Eribulin monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Schöffski et al. 2016 | Phase III | Dacarbazine | Superior OS (*) |
Efficacy is based on the 2017 subgroup analysis.
Chemotherapy
- Eribulin (Halaven) 1.4 mg/m2 IV once per day on days 1 & 8
21-day cycles until progression
References
- Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. Epub 2016 Feb 10. link to original article contains protocol PubMed
- Subgroup analysis: Demetri GD, Schöffski P, Grignani G, Blay JY, Maki RG, Van Tine BA, Alcindor T, Jones RL, D'Adamo DR, Guo M, Chawla S. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. 2017 Oct 20;35(30):3433-3439. Epub 2017 Aug 30. link to original article contains verified protocol PubMed
Rhabdomyosarcoma, all lines of therapy
Note: this will be moved to a histology-specific page, shortly.
VAC
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VAC: Vincristine, Actinomycin D, Cyclophosphamide
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Crist et al. 2001 (IRS-IV) | Phase III | VAI | Seems not superior |
VIE | Seems not superior |
To be completed
Chemotherapy
References
- Crist WM, Anderson JR, Meza JL, Fryer C, Raney RB, Ruymann FB, Breneman J, Qualman SJ, Wiener E, Wharam M, Lobe T, Webber B, Maurer HM, Donaldson SS. Intergroup rhabdomyosarcoma study-IV: results for patients with nonmetastatic disease. J Clin Oncol. 2001 Jun 15;19(12):3091-102. link to original article PubMed
VAI
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VAI: Vincristine, Actinomycin D, Ifosfamide
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Crist et al. 2001 (IRS-IV) | Phase III | VAC | Seems not superior |
VIE | Seems not superior |
To be completed
Chemotherapy
References
- Crist WM, Anderson JR, Meza JL, Fryer C, Raney RB, Ruymann FB, Breneman J, Qualman SJ, Wiener E, Wharam M, Lobe T, Webber B, Maurer HM, Donaldson SS. Intergroup rhabdomyosarcoma study-IV: results for patients with nonmetastatic disease. J Clin Oncol. 2001 Jun 15;19(12):3091-102. link to original article PubMed
VI, then VDC/IE, then VAC, then VI
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VI, then VDC/IE, then VAC, then VI: Vincristine & Irinotecan, followed by Vincristine, Doxorubicin, Cyclophosphamide alternating with Ifosfamide & Etoposide, followed by Vincristine, Actinomycin D, Cyclophosphamide, followed by Vincristine & Irinotecan
Regimen
Study | Evidence |
---|---|
Weigel et al. 2015 (COG ARST0431) | Phase II |
Note: this is a complicated 54-week regimen with no immediate plans to add it to HemOnc.org. Please refer to the original article.
References
- Weigel BJ, Lyden E, Anderson JR, Meyer WH, Parham DM, Rodeberg DA, Michalski JM, Hawkins DS, Arndt CA. Intensive multiagent therapy, including dose-compressed cycles of ifosfamide/etoposide and vincristine/doxorubicin/cyclophosphamide, irinotecan, and radiation, in patients with high-risk rhabdomyosarcoma: A report from the Children's Oncology Group. J Clin Oncol. 2016 Jan 10;34(2):117-22. Epub 2015 Oct 26. link to original article link to PMC article PubMed
VIE
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VIE: Vincristine, Ifosfamide, Etoposide
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Crist et al. 2001 (IRS-IV) | Phase III | VAC | Seems not superior |
VAI | Seems not superior |
To be completed
Chemotherapy
References
- Crist WM, Anderson JR, Meza JL, Fryer C, Raney RB, Ruymann FB, Breneman J, Qualman SJ, Wiener E, Wharam M, Lobe T, Webber B, Maurer HM, Donaldson SS. Intergroup rhabdomyosarcoma study-IV: results for patients with nonmetastatic disease. J Clin Oncol. 2001 Jun 15;19(12):3091-102. link to original article PubMed
Gastrointestinal stromal tumor (GIST), all lines of therapy
Please see the dedicated GIST page.