An open label, non-comparative phase II study of topotecan as salvage treatment for patients with soft tissue sarcoma
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An open label, non-comparative phase II study of topotecan as salvage treatment for patients with soft tissue sarcoma. / Reichardt, Peter; Oechsle, Karin; Pink, Daniel; Bokemeyer, Carsten; Schneller, F; Issels, Rolf; Kanz, Lothar; Hartmann, Jörg Thomas.
In: INVEST NEW DRUG, Vol. 21, No. 4, 11.2003, p. 481-6.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -