Soft tissue sarcoma

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Single-agent Regimens

Doxorubicin (Adriamycin)

Regimen

• Doxorubicin (Adriamycin) 75 mg/m2 IV day 1

21-day cycles, treatment was continued every 3 weeks until documented disease progression, unacceptable toxicity, or patient refusal, to a maximum of six cycles of chemotherapy

References

1. 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;4:103-112. link to original article contains protocol PubMed
2. Lorigan P, Verweij J, Papai Z, et al. 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;25:3144-3150. link to original article contains protocol PubMed

Epirubicin (Ellence)

Regimen

• Epirubicin (Ellence) 75 mg/m2 IV day 1

21-day cycles; treatment continued for 2-6 cycles, or until disease progression.

Reference

1. Mouridsen HT, Bastholt L, Somers R, 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;23:1477-1483. PubMed

Ifosfamide (Ifex)

Regimen

• Ifosfamide (Ifex) 3 g/m2 IV every 4 hours daily for 3 days
• Mesna (Mesnex) 600 mg/m2 IV directly prior to mesna/ifosfamide infusion
• Mesna (Mesnex) 1.5 g/m2 added to the ifosfamide/dextrose/saline solution

At 4 and 8 h after the end of infusion, patients received mesna 500 mg/m2 and 1 L of fluid orally.

21-day cycles; at least 2 cycles given, continued until disease progression or unacceptable toxicity or patient refusal

Reference

1. 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 protocol PubMed

Pazopanib (Votrient)

Regimen

• Pazopanib (Votrient) 800 mg po once daily

Treatment was continued until disease progression, unacceptable toxic effects, withdrawal of consent, or death.

Reference

1. 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. link to original article contains protocol PubMed

Combination regimens

AIM

AIM: Adriamycin, Ifosfamide, Mesna

Regimen

Protocol 1:

• Doxorubicin (Adriamycin) 25 mg/m2/day as a 24-hour continuous infusion on days 1-3 for a total dose of 75 mg/m2 over 72 hours
• Ifosfamide (Ifex) 2g/m2/day, infused over 2 hours each day for days 1-5, for a total dose of 10 g/m2/day
• Mesna (Mesnex) 400 mg/m2 IV simultaneously with the first dose of ifosfamide
• Mesna (Mesnex) 1,200 mg/m2 given in 2 L of D5W with 100 mEq/L sodium acetate, 20 mEq/L potassium acetate, and 4 mEq/L magnesium sulfate over 24 hours for 5 days.

Protocol 2:

• Doxorubicin (Adriamycin) 30 mg/m2/day as a 24-hour continuous infusion on days 1-3 for a total dose of 90 mg/m2 over 72 hours.
• Ifosfamide (Ifex) 2.5 g/m2/day, infused for 3 hours each day, for a total dose of 10 g/m2 over 4 days.
• Mesna (Mesnex) 500 mg/m2 IV with first dose of ifosfamide
• Mesna (Mesnex) 1,500 mg/m2 given in 2 L of D5W with 100 mEq/L sodium acetate, 20 mEq/L potassium acetate, and 4 mEq/L magnesium sulfate over 24 hours for 4 days.

21-day cycles, treatment was continued until maximum response or six cycles, progressive disease, or intolerable toxicity

Reference

1. 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. PubMed

Gemcitabine (Gemzar) & Docetaxel (Taxotere)

Regimen

• Gemcitabine (Gemzar) 900 mg/m2 IV days 1 & 8
• Docetaxel (Taxotere) 100 mg/m2 IV day 8

21 day cycle, completed until time of progression or development of unacceptable toxicity.

Reference

1. 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 protocol PubMed
2. 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 protocol PubMed

Epirubicin (Ellence) and Ifosfamide (Ifex)

Regimen

• Epirubicin (Ellence) 45 mg/m2 IV daily on days 2 & 3
• Ifosfamide (Ifex) 2.5 g/m2 IV daily, days 1-5
• Mesna (Mesnex) 1.5 g/m2 IV daily, days 1-5

3 week cycles

Reference

1. 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 protocol PubMed

GIST (Gastrointestinal Stromal Tumor)

Neoadjuvant

Imatinib (Gleevec)

Regimen #1

• Imatinib (Gleevec) 600 mg PO once daily

Preoperative administration was for 8-12 weeks, and stopped the day prior to surgery

Reference

1. Eisenberg BL, Harris J, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M. Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST): early results of RTOG 0132/ACRIN 6665. J Surg Oncol. 2009 Jan 1;99(1):42-7. link to original article contains protocol PubMed

Adjuvant

Imatinib (Gleevec)

Regimen #1

• Imatinib (Gleevec) 400 mg PO once daily

Imatinib was continued for 1-year postoperative

Regimen #2

• Imatinib (Gleevec) 400 mg PO once daily

Continued orally for 36 months, started within 12 weeks of surgery

References

1. Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, Blackstein ME, Blanke CD, von Mehren M, Brennan MF, Patel S, McCarter MD, Polikoff JA, Tan BR, Owzar K; American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Mar 28;373(9669):1097-104. link to original article contains protocol PubMed
2. Joensuu H, Eriksson M, Sundby Hall K, Hartmann JT, Pink D, Schütte J, Ramadori G, Hohenberger P, Duyster J, Al-Batran SE, Schlemmer M, Bauer S, Wardelmann E, Sarlomo-Rikala M, Nilsson B, Sihto H, Monge OR, Bono P, Kallio R, Vehtari A, Leinonen M, Alvegård T, Reichardt P. One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial. JAMA. 2012 Mar 28;307(12):1265-72. link to original article contains protocol PubMed

Metastatic or unresectable

Imatinib (Gleevec)

Regimen

• Imatinib (Gleevec) 400 mg PO once daily

Patients treated at 400 mg daily who showed disease progression were changed to high-dose imatinib, as listed below:

• Imatinib (Gleevec) 400 mg PO twice daily

Treatment was continued until disease progression or unacceptable toxicity

Reference

1. Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008 Feb 1;26(4):626-32. link to original article contains protocol PubMed