An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma.

Abstract

BACKGROUND:

The number of effective cytotoxic agents for the treatment of patients with metastatic adult type soft tissue sarcoma (STS) is limited, when patients have failed anthracyline-based chemotherapy. The aim of this trial was to evaluate the efficacy of gemcitabine in this setting.

METHODS:

Between August 2001 and March 2003 19 patients were eligible to enter. Gemcitabine was administered as a 30-minutes infusion at a dosage of 1 g/m2 on day 1, 8 and 15 every 4 weeks. All patients had progressive disease during (n = 12) or shortly after an anthracycline-based regimen (n = 3).

RESULTS:

Four of 19 patients did not start study treatment because of fulminant progression. Fifteen patients with a median age 47 years (32-72) were assessable. All patients had received at least one prior treatment regimen (range, 1-6) for metastatic disease containing anthracyclines (n = 15) and ifosfamide (n = 11). To date, a total of 72+ cycles have been applied (median; 3, 1-28+). Seven patients (47%) had progressive disease after completion of two cycles at the first response assessment. One patient (6%) attained a partial remission, and 7 patients (47%) achieved disease stabilisations. One patient is still on treatment after more than 2.5 years. The calculated progression-free rate at 3 and 6 months was 46.7% (CI(95%), 21.4-71.9) and 13.3% (CI(95%), (0-30.5). 95% of the cycles have been applied without any dose modification or treatment delay.

CONCLUSIONS:

Considering response and progression-free rate as the primary endpoints for phase II trials in pretreated STS, gemcitabine has moderate efficacy.

• Authors: J T Hartmann, K Oechsle, J Huober, A Jakob, M Azemar, M Horger, L Kanz, C Bokemeyer
• Journal: Investigational new drugs (Invest New Drugs) Vol. 24 Issue 3 Pg. 249-53 (May 2006) ISSN: 0167-6997 [Print] United States
• PMID: 16133789 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Antimetabolites, Antineoplastic
• Deoxycytidine
• Gemcitabine

Topics

• Adult
• Aged
• Antimetabolites, Antineoplastic (adverse effects, therapeutic use)
• Deoxycytidine (adverse effects, analogs & derivatives, therapeutic use)
• Disease-Free Survival
• Female
• Humans
• Male
• Middle Aged
• Sarcoma (drug therapy)
• Soft Tissue Neoplasms (drug therapy)
• Gemcitabine