Abstract
ABSTRACT:
BACKGROUND:
The long term outcome of advanced sarcoma patients treated with
trabectedin outside of clinical trials and the utility of maintenance
treatment has not been reported.
METHODS:
Between 2003
and 2008, patients with advanced sarcoma failing doxorubicin could be
treated within a compassionate use program (ATU, Temporary Use
Authorization) of trabectedin in France using the standard 3-weekly
regimen. Data from 181 patients (55%) were collected from 11 centres and
analyzed.
RESULTS:
Trabectedin was given in first,
second, third or fourth line in metastatic phase in 6%, 37%, 33% and 23%
of patients respectively. With a median follow-up of 6 years, median
PFS and OS were 3.6 months and 16.1 months respectively. The median
number of cycles was 3 (range 1--19). Best response were partial
response (PR, n = 18, 10%), stable disease (SD, n = 69, 39%) and
progressive disease (PD, n = 83, 46%), non evaluable (NE, n = 9, 5%).
Thirty patients (17%) had to be hospitalized for treatment- related side
effects. Independent prognostic factors in multivariate analysis (Cox
model) were myxoid LPS and line of trabectedin for PFS, and myxoid LPS
and retroperitoneal sarcomas for OS. Patients in PR or SD after 6 cycles
continuing treatment had a better PFS (median 5.3 vs 10.5 months, p =
0.001) and OS (median 13.9 vs 33.4 months, p = 0.009) as compared to
patients who stopped after 6 cycles.
CONCLUSIONS:
In this
compassionate use program, trabectedin yielded similar or better PFS
and OS than in clinical trials. Maintenance treatment beyond 6 cycles
was associated with an improved survival.
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