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A phase II trial of temozolomide as a 6-week, continuous, oral schedule in patients with advanced soft tissue sarcoma: a study by the Spanish Group for Research on Sarcomas.

BACKGROUNDThe objective of this study was to evaluate the activity and toxicity of temozolomide given as an extended schedule in patients with advanced sarcoma. METHODSForty-nine patients with pretreated soft tissue sarcoma (the STS arm) and 18 patients with previously untreated gastrointestinal str... Full description

Journal Title: Cancer October 15, 2005, Vol.104(8), pp.1706-1712
Main Author: Garcia Del Muro, Xavier
Other Authors: Lopez-Pousa, Antonio , Martin, Javier , Buesa, Jose M , Martinez-Trufero, Javier , Casado, Antonio , Poveda, Andres , Cruz, Josefina , Bover, Isabel , Maurel, Joan , Garcia Del Muro, Xavier
Format: Electronic Article Electronic Article
Language: English
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ID: ISSN: 0008-543X
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title: A phase II trial of temozolomide as a 6-week, continuous, oral schedule in patients with advanced soft tissue sarcoma: a study by the Spanish Group for Research on Sarcomas.
format: Article
creator:
  • Garcia Del Muro, Xavier
  • Lopez-Pousa, Antonio
  • Martin, Javier
  • Buesa, Jose M
  • Martinez-Trufero, Javier
  • Casado, Antonio
  • Poveda, Andres
  • Cruz, Josefina
  • Bover, Isabel
  • Maurel, Joan
  • Garcia Del Muro, Xavier
subjects:
  • Administration, Oral–Therapeutic Use
  • Adult–Analogs & Derivatives
  • Aged–Therapeutic Use
  • Antineoplastic Agents, Alkylating–Drug Therapy
  • Dacarbazine–Pathology
  • Drug Administration Schedule–Drug Therapy
  • Female–Secondary
  • Gastrointestinal Neoplasms–Drug Therapy
  • Humans–Secondary
  • Liver Neoplasms–Drug Therapy
  • Lung Neoplasms–Pathology
  • Male–Drug Therapy
  • Maximum Tolerated Dose–Pathology
  • Middle Aged–Pathology
  • Prognosis–Pathology
  • Sarcoma–Pathology
  • Soft Tissue Neoplasms–Pathology
  • Survival Rate–Pathology
  • Treatment Outcome–Pathology
  • Abridged
  • Antineoplastic Agents, Alkylating
  • Dacarbazine
  • Temozolomide
ispartof: Cancer, October 15, 2005, Vol.104(8), pp.1706-1712
description: BACKGROUNDThe objective of this study was to evaluate the activity and toxicity of temozolomide given as an extended schedule in patients with advanced sarcoma. METHODSForty-nine patients with pretreated soft tissue sarcoma (the STS arm) and 18 patients with previously untreated gastrointestinal stromal tumor (the GIST arm) were enrolled onto a 2-arm, multicenter, Phase II study between November 1999 and July 2001. Temozolomide was administered on a 6-week, continuous, oral schedule at a dose of 75 mg/m2 per day in 41 patients and, after an amendment, at a dose of 100 mg/m2 per day in 22 patients. RESULTSAmong 45 eligible patients in the STS arm, there were 7 partial responses, for an overall response rate of 15.5% (95% confidence interval [95% CI], 5-26%). Responses were seen in 5 of 11 patients who had gynecologic leiomyosarcoma. The median response duration was 12.5 months (range, 3.9-58.0 mos). In 4 patients, response lasted > 1 year, and 2 of those patients remained progression free for > 3 years. The median time to progression was 2.2 months (95% CI, 1.8-2.5 mos), and the median overall survival was 8.1 months (95% CI, 5.6-10.6 mos). Progression-free survival rates at 3 months and 6 months were 39.5% and 26%, respectively. In the GIST arm, no responses were noted. Grade 3-4 granulocytopenia, thrombocytopenia, and anemia were observed in 6 patients, 5 patients, and 7 patients, respectively. The most common nonhematologic toxicities were emesis and fatigue. CONCLUSIONSTemozolomide at the extended schedule was tolerated well and had activity in patients with pretreated soft tissue sarcomas, and especially among patients with gynecologic leiomyosarcoma.
language: eng
source:
identifier: ISSN: 0008-543X
fulltext: fulltext
issn:
  • 0008543X
  • 0008-543X
url: Link


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titleA phase II trial of temozolomide as a 6-week, continuous, oral schedule in patients with advanced soft tissue sarcoma: a study by the Spanish Group for Research on Sarcomas.
creatorGarcia Del Muro, Xavier ; Lopez-Pousa, Antonio ; Martin, Javier ; Buesa, Jose M ; Martinez-Trufero, Javier ; Casado, Antonio ; Poveda, Andres ; Cruz, Josefina ; Bover, Isabel ; Maurel, Joan ; Garcia Del Muro, Xavier
contributorGarcia Del Muro, Xavier (correspondence author) ; Garcia Del Muro, Xavier (record owner)
ispartofCancer, October 15, 2005, Vol.104(8), pp.1706-1712
identifierISSN: 0008-543X
subjectAdministration, Oral–Therapeutic Use ; Adult–Analogs & Derivatives ; Aged–Therapeutic Use ; Antineoplastic Agents, Alkylating–Drug Therapy ; Dacarbazine–Pathology ; Drug Administration Schedule–Drug Therapy ; Female–Secondary ; Gastrointestinal Neoplasms–Drug Therapy ; Humans–Secondary ; Liver Neoplasms–Drug Therapy ; Lung Neoplasms–Pathology ; Male–Drug Therapy ; Maximum Tolerated Dose–Pathology ; Middle Aged–Pathology ; Prognosis–Pathology ; Sarcoma–Pathology ; Soft Tissue Neoplasms–Pathology ; Survival Rate–Pathology ; Treatment Outcome–Pathology ; Abridged ; Antineoplastic Agents, Alkylating ; Dacarbazine ; Temozolomide
descriptionBACKGROUNDThe objective of this study was to evaluate the activity and toxicity of temozolomide given as an extended schedule in patients with advanced sarcoma. METHODSForty-nine patients with pretreated soft tissue sarcoma (the STS arm) and 18 patients with previously untreated gastrointestinal stromal tumor (the GIST arm) were enrolled onto a 2-arm, multicenter, Phase II study between November 1999 and July 2001. Temozolomide was administered on a 6-week, continuous, oral schedule at a dose of 75 mg/m2 per day in 41 patients and, after an amendment, at a dose of 100 mg/m2 per day in 22 patients. RESULTSAmong 45 eligible patients in the STS arm, there were 7 partial responses, for an overall response rate of 15.5% (95% confidence interval [95% CI], 5-26%). Responses were seen in 5 of 11 patients who had gynecologic leiomyosarcoma. The median response duration was 12.5 months (range, 3.9-58.0 mos). In 4 patients, response lasted > 1 year, and 2 of those patients remained progression free for > 3 years. The median time to progression was 2.2 months (95% CI, 1.8-2.5 mos), and the median overall survival was 8.1 months (95% CI, 5.6-10.6 mos). Progression-free survival rates at 3 months and 6 months were 39.5% and 26%, respectively. In the GIST arm, no responses were noted. Grade 3-4 granulocytopenia, thrombocytopenia, and anemia were observed in 6 patients, 5 patients, and 7 patients, respectively. The most common nonhematologic toxicities were emesis and fatigue. CONCLUSIONSTemozolomide at the extended schedule was tolerated well and had activity in patients with pretreated soft tissue sarcomas, and especially among patients with gynecologic leiomyosarcoma.
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titleA phase II trial of temozolomide as a 6-week, continuous, oral schedule in patients with advanced soft tissue sarcoma: a study by the Spanish Group for Research on Sarcomas.
descriptionBACKGROUNDThe objective of this study was to evaluate the activity and toxicity of temozolomide given as an extended schedule in patients with advanced sarcoma. METHODSForty-nine patients with pretreated soft tissue sarcoma (the STS arm) and 18 patients with previously untreated gastrointestinal stromal tumor (the GIST arm) were enrolled onto a 2-arm, multicenter, Phase II study between November 1999 and July 2001. Temozolomide was administered on a 6-week, continuous, oral schedule at a dose of 75 mg/m2 per day in 41 patients and, after an amendment, at a dose of 100 mg/m2 per day in 22 patients. RESULTSAmong 45 eligible patients in the STS arm, there were 7 partial responses, for an overall response rate of 15.5% (95% confidence interval [95% CI], 5-26%). Responses were seen in 5 of 11 patients who had gynecologic leiomyosarcoma. The median response duration was 12.5 months (range, 3.9-58.0 mos). In 4 patients, response lasted > 1 year, and 2 of those patients remained progression free for > 3 years. The median time to progression was 2.2 months (95% CI, 1.8-2.5 mos), and the median overall survival was 8.1 months (95% CI, 5.6-10.6 mos). Progression-free survival rates at 3 months and 6 months were 39.5% and 26%, respectively. In the GIST arm, no responses were noted. Grade 3-4 granulocytopenia, thrombocytopenia, and anemia were observed in 6 patients, 5 patients, and 7 patients, respectively. The most common nonhematologic toxicities were emesis and fatigue. CONCLUSIONSTemozolomide at the extended schedule was tolerated well and had activity in patients with pretreated soft tissue sarcomas, and especially among patients with gynecologic leiomyosarcoma.
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11Male–Drug Therapy
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18Treatment Outcome–Pathology
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titleA phase II trial of temozolomide as a 6-week, continuous, oral schedule in patients with advanced soft tissue sarcoma: a study by the Spanish Group for Research on Sarcomas.
authorGarcia Del Muro, Xavier ; Lopez-Pousa, Antonio ; Martin, Javier ; Buesa, Jose M ; Martinez-Trufero, Javier ; Casado, Antonio ; Poveda, Andres ; Cruz, Josefina ; Bover, Isabel ; Maurel, Joan ; Garcia Del Muro, Xavier
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2Aged–Therapeutic Use
3Antineoplastic Agents, Alkylating–Drug Therapy
4Dacarbazine–Pathology
5Drug Administration Schedule–Drug Therapy
6Female–Secondary
7Gastrointestinal Neoplasms–Drug Therapy
8Humans–Secondary
9Liver Neoplasms–Drug Therapy
10Lung Neoplasms–Pathology
11Male–Drug Therapy
12Maximum Tolerated Dose–Pathology
13Middle Aged–Pathology
14Prognosis–Pathology
15Sarcoma–Pathology
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atitleA phase II trial of temozolomide as a 6-week, continuous, oral schedule in patients with advanced soft tissue sarcoma: a study by the Spanish Group for Research on Sarcomas.
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abstractBACKGROUNDThe objective of this study was to evaluate the activity and toxicity of temozolomide given as an extended schedule in patients with advanced sarcoma. METHODSForty-nine patients with pretreated soft tissue sarcoma (the STS arm) and 18 patients with previously untreated gastrointestinal stromal tumor (the GIST arm) were enrolled onto a 2-arm, multicenter, Phase II study between November 1999 and July 2001. Temozolomide was administered on a 6-week, continuous, oral schedule at a dose of 75 mg/m2 per day in 41 patients and, after an amendment, at a dose of 100 mg/m2 per day in 22 patients. RESULTSAmong 45 eligible patients in the STS arm, there were 7 partial responses, for an overall response rate of 15.5% (95% confidence interval [95% CI], 5-26%). Responses were seen in 5 of 11 patients who had gynecologic leiomyosarcoma. The median response duration was 12.5 months (range, 3.9-58.0 mos). In 4 patients, response lasted > 1 year, and 2 of those patients remained progression free for > 3 years. The median time to progression was 2.2 months (95% CI, 1.8-2.5 mos), and the median overall survival was 8.1 months (95% CI, 5.6-10.6 mos). Progression-free survival rates at 3 months and 6 months were 39.5% and 26%, respectively. In the GIST arm, no responses were noted. Grade 3-4 granulocytopenia, thrombocytopenia, and anemia were observed in 6 patients, 5 patients, and 7 patients, respectively. The most common nonhematologic toxicities were emesis and fatigue. CONCLUSIONSTemozolomide at the extended schedule was tolerated well and had activity in patients with pretreated soft tissue sarcomas, and especially among patients with gynecologic leiomyosarcoma.
urlhttp://search.proquest.com/docview/68670937/
doi10.1002/cncr.21384
eissn10970142
date2005-10-15