Phase II trial of trofosfamide in patients with advanced pretreated soft tissue sarcomas.

Abstract

BACKGROUND:

The number of cytostatic agents effective in patients with advanced soft tissue sarcoma is limited. Trofosfamide, an alkylating agent, has been shown to be effective in several solid and haematological tumors.

PATIENTS AND METHODS:

Eighteen patients with a median age of 57 years (range, 27-78) were treated with oral trofosfamide 300 mg/d for 1 week followed by 150 mg/d given continuously to analyze the efficacy and toxicity of continuous low-dose oral trofosfamide. All had received at least one anthracycline-based chemotherapeutic regimen prior to trofosfamide.

RESULTS:

Nine patients (50%) achieved stable disease lasting for a median of 5.5+ months (range, 1-9+). The median time to progression was 10+ weeks (range, 4-37+) and the median survival 7+ months (range, 2-13+). Toxicity was mild, grade III degree toxicity was seen in 5 patients (28%): 3/2 patients with anemia/neutropenia and 2 patients with fatigue syndrome.

CONCLUSION:

No objective remission was observed with oral low-dose trofosfamide in heavily pretreated soft tissue sarcoma patients, but almost half of the patients achieved disease stabilisation for half a year. The moderate toxicity profile observed in this study allows the consideration of trofosfamide as a reasonable palliative treatment option for patients with soft tissue sarcoma.

• Authors: J T Hartmann, K Oechsle, F Mayer, L Kanz, C Bokemeyer
• Journal: Anticancer research (Anticancer Res) 2003 Mar-Apr Vol. 23 Issue 2C Pg. 1899-901 ISSN: 0250-7005 [Print] Greece
• PMID: 12820475 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Antineoplastic Agents, Alkylating
• Cyclophosphamide
• trofosfamide

Topics

• Administration, Oral
• Adult
• Aged
• Antineoplastic Agents, Alkylating (adverse effects, therapeutic use)
• Bone Neoplasms (drug therapy, secondary)
• Cyclophosphamide (adverse effects, analogs & derivatives, therapeutic use)
• Drug Administration Schedule
• Humans
• Liver Neoplasms (drug therapy, secondary)
• Lung Neoplasms (drug therapy, secondary)
• Lymphatic Metastasis
• Middle Aged
• Sarcoma (drug therapy, secondary)