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

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An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma. / Hartmann, J T; Oechsle, K; Huober, J; Jakob, A; Azemar, M; Horger, M; Kanz, L; Bokemeyer, C.

in: INVEST NEW DRUG, Jahrgang 24, Nr. 3, 05.2006, S. 249-53.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Hartmann, JT, Oechsle, K, Huober, J, Jakob, A, Azemar, M, Horger, M, Kanz, L & Bokemeyer, C 2006, 'An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma', INVEST NEW DRUG, Jg. 24, Nr. 3, S. 249-53. https://doi.org/10.1007/s10637-005-3537-1

APA

Hartmann, J. T., Oechsle, K., Huober, J., Jakob, A., Azemar, M., Horger, M., Kanz, L., & Bokemeyer, C. (2006). An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma. INVEST NEW DRUG, 24(3), 249-53. https://doi.org/10.1007/s10637-005-3537-1

Vancouver

Hartmann JT, Oechsle K, Huober J, Jakob A, Azemar M, Horger M et al. An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma. INVEST NEW DRUG. 2006 Mai;24(3):249-53. https://doi.org/10.1007/s10637-005-3537-1

Bibtex

@article{86e61caebdd14d379ff763e57154cdf4,
title = "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.",
keywords = "Adult, Aged, Antimetabolites, Antineoplastic, Deoxycytidine, Disease-Free Survival, Female, Humans, Male, Middle Aged, Sarcoma, Soft Tissue Neoplasms",
author = "Hartmann, {J T} and K Oechsle and J Huober and A Jakob and M Azemar and M Horger and L Kanz and C Bokemeyer",
year = "2006",
month = may,
doi = "10.1007/s10637-005-3537-1",
language = "English",
volume = "24",
pages = "249--53",
journal = "INVEST NEW DRUG",
issn = "0167-6997",
publisher = "Kluwer Academic Publishers",
number = "3",

}

RIS

TY - JOUR

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

AU - Hartmann, J T

AU - Oechsle, K

AU - Huober, J

AU - Jakob, A

AU - Azemar, M

AU - Horger, M

AU - Kanz, L

AU - Bokemeyer, C

PY - 2006/5

Y1 - 2006/5

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Antimetabolites, Antineoplastic

KW - Deoxycytidine

KW - Disease-Free Survival

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Sarcoma

KW - Soft Tissue Neoplasms

U2 - 10.1007/s10637-005-3537-1

DO - 10.1007/s10637-005-3537-1

M3 - SCORING: Journal article

C2 - 16133789

VL - 24

SP - 249

EP - 253

JO - INVEST NEW DRUG

JF - INVEST NEW DRUG

SN - 0167-6997

IS - 3

ER -