An open label, non-comparative phase II study of topotecan as salvage treatment for patients with soft tissue sarcoma.
BACKGROUND
The number of effective cytotoxic agents for the treatment of patients with metastatic soft tissue sarcoma (STS) is limited, especially when patients have failed anthracyline-based chemotherapy.


METHODS
Between 1999 and 2000 a total of 16 patients with histologically proven STS progressing during or after first-line anthracycline-based chemotherapy were entered into this open-label, noncomparative study. Topotecan was administered as a 30-min infusion at a dosage of 1.5 mg/m(2) on five consecutive days every 3 weeks. All patients had received an anthracycline- or ifosfamide-based first-line chemotherapy.


RESULTS
None of the 16 included patients achieved an objective response to topotecan. Six patients achieved stable disease (38%), lasting for at least 6 weeks in four patients (25%) and for less than 6 weeks in two patients (13%). Ten patients (62%) had progressive disease. The median time to progression was 79 days calculated from the start of topotecan therapy (range, 28-230). The treatment was well tolerated; however, both anemia and thrombopenia grade III/IV occurred in 25% of the patients as well as severe neutropenia in 69% of the patients. Nonhematologic toxicities grade III/IV such as diarrhea and severe bleeding occurred only in one patient each (6%).


CONCLUSIONS
Topotecan is well tolerated in anthracycline-resistant patients with metastatic STS, but no objective response has been observed in this trial.
Medizinische Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie, Robert-Roessle-Klinik, Helios-Klinikum Berlin, Universitätsklinikum Charité, Berlin, Germany.
Peter
P
Reichardt
Karin
K
Oechsle
Daniel
D
Pink
Carsten
C
Bokemeyer
F
F
Schneller
Rolf
R
Issels
Lothar
L
Kanz
Jörg Thomas
JT
Hartmann
D000328:Adult; D000368:Aged; D016001:Confidence Intervals; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D016879:Salvage Therapy / Q000379:methods*; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D019772:Topotecan / Q000008:administration & dosage* / Q000009:adverse effects
D019772:Topotecan