An open label, non-comparative phase II study of topotecan as salvage treatment for patients with soft tissue sarcoma

TY - JOUR

T1 - An open label, non-comparative phase II study of topotecan as salvage treatment for patients with soft tissue sarcoma

AU - Reichardt, Peter

AU - Oechsle, Karin

AU - Pink, Daniel

AU - Bokemeyer, Carsten

AU - Schneller, F

AU - Issels, Rolf

AU - Kanz, Lothar

AU - Hartmann, Jörg Thomas

PY - 2003/11

Y1 - 2003/11

N2 - 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.PATIENTS AND 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%).DISCUSSION: Topotecan is well tolerated in anthracycline-resistant patients with metastatic STS, but no objective response has been observed in this trial.

AB - 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.PATIENTS AND 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%).DISCUSSION: Topotecan is well tolerated in anthracycline-resistant patients with metastatic STS, but no objective response has been observed in this trial.

KW - Adult

KW - Aged

KW - Confidence Intervals

KW - Female

KW - Humans

KW - Infusions, Intravenous

KW - Male

KW - Middle Aged

KW - Nausea

KW - Salvage Therapy

KW - Sarcoma

KW - Survival Rate

KW - Topotecan

M3 - SCORING: Journal article

C2 - 14586217

VL - 21

SP - 481

EP - 486

JO - INVEST NEW DRUG

JF - INVEST NEW DRUG

SN - 0167-6997

IS - 4

ER -