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.

References

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

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.

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

Doxorubicin (Adriamycin) & Ifosfamide (Ifex)

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

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.

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