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

TY - JOUR

T1 - Phase II trial of trofosfamide in patients with advanced pretreated soft tissue sarcomas

AU - Hartmann, J T

AU - Oechsle, K

AU - Mayer, F

AU - Kanz, L

AU - Bokemeyer, C

PY - 2003/6/25

Y1 - 2003/6/25

N2 - 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.

AB - 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.

KW - Administration, Oral

KW - Adult

KW - Aged

KW - Antineoplastic Agents, Alkylating

KW - Bone Neoplasms

KW - Cyclophosphamide

KW - Drug Administration Schedule

KW - Humans

KW - Liver Neoplasms

KW - Lung Neoplasms

KW - Lymphatic Metastasis

KW - Middle Aged

KW - Sarcoma

M3 - SCORING: Journal article

C2 - 12820475

VL - 23

SP - 1899

EP - 1901

JO - ANTICANCER RES

JF - ANTICANCER RES

SN - 0250-7005

IS - 2C

ER -