A Two-Arm Phase II Study of Temozolomide in Patients with Advanced Gastrointestinal Stromal Tumors and Other Soft Tissue Sarcomas

Jonathan Trent, Jennifer Beach, Michael A. Burgess, Nicholas Papadopolous, Lei L. Chen, Robert S. Benjamin, Shreyaskumar R. Patel

Research output: Contribution to journalArticle

84 Citations (Scopus)

Abstract

BACKGROUND. The authors conducted a two-arm Phase II study of temozolomide to determine its efficacy and toxicity in patients with soft tissue sarcomas (STSs) who had received, had refused, or were not eligible for standard chemotherapy with doxorubicin and ifosfamide (Arm 1) and in patients with gastrointestinal stromal tumors (GISTs; Arm 2). Patients with GIST were eligible regardless of prior therapy before imatinib was available. METHODS. Sixty patients were enrolled in the current study, 19 of whom had GISTs and 41 of whom had other STSs. The patients received temozolomide at a dose of 85 mg/m2 orally for 21 days followed by 7 days without treatment. Standard radiographic imaging after every two cycles was used to assess the treatment response. RESULTS. Of the 39 patients in Arm 1, there was 1 complete response and 1 partial response of 39 evaluable patients, for a total response rate of 5% (95% confidence interval, 0-12%). The responses lasted 7 months and 8 months, respectively. In Arm 2, there was no response in 17 patients. The disease was stable in 22% of the patients with GISTs and 33% of the patients with other STSs. The median overall survival time was 26.4 months in patients with GISTs and 11 months in patients with other STSs. The median time to disease progression was 2.3 months in patients with GISTs and 3.3 months in patients with other STSs. Grade 3 and Grade 4 adverse effects (according to National Cancer Institute Common Toxicity Criteria) were rare and included fatigue (eight patients), anemia (six patients), constipation (four patients), neutropenia (four patients), and thrombocytopenia (four patients). CONCLUSIONS. The data from the current study suggest that temozolomide is well tolerated but has only minimal efficacy and a limited role in the treatment of patients with STSs.

Original languageEnglish
Pages (from-to)2693-2699
Number of pages7
JournalCancer
Volume98
Issue number12
DOIs
StatePublished - Dec 15 2003
Externally publishedYes

Fingerprint

temozolomide
Gastrointestinal Stromal Tumors
Sarcoma

Keywords

  • Clinical trial
  • Efficacy
  • Gastrointestinal stromal tumors (GIST)
  • Soft tissue sarcomas (STSs)
  • Temozolomide

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Trent, J., Beach, J., Burgess, M. A., Papadopolous, N., Chen, L. L., Benjamin, R. S., & Patel, S. R. (2003). A Two-Arm Phase II Study of Temozolomide in Patients with Advanced Gastrointestinal Stromal Tumors and Other Soft Tissue Sarcomas. Cancer, 98(12), 2693-2699. https://doi.org/10.1002/cncr.11875

A Two-Arm Phase II Study of Temozolomide in Patients with Advanced Gastrointestinal Stromal Tumors and Other Soft Tissue Sarcomas. / Trent, Jonathan; Beach, Jennifer; Burgess, Michael A.; Papadopolous, Nicholas; Chen, Lei L.; Benjamin, Robert S.; Patel, Shreyaskumar R.

In: Cancer, Vol. 98, No. 12, 15.12.2003, p. 2693-2699.

Research output: Contribution to journalArticle

Trent, J, Beach, J, Burgess, MA, Papadopolous, N, Chen, LL, Benjamin, RS & Patel, SR 2003, 'A Two-Arm Phase II Study of Temozolomide in Patients with Advanced Gastrointestinal Stromal Tumors and Other Soft Tissue Sarcomas', Cancer, vol. 98, no. 12, pp. 2693-2699. https://doi.org/10.1002/cncr.11875
Trent, Jonathan ; Beach, Jennifer ; Burgess, Michael A. ; Papadopolous, Nicholas ; Chen, Lei L. ; Benjamin, Robert S. ; Patel, Shreyaskumar R. / A Two-Arm Phase II Study of Temozolomide in Patients with Advanced Gastrointestinal Stromal Tumors and Other Soft Tissue Sarcomas. In: Cancer. 2003 ; Vol. 98, No. 12. pp. 2693-2699.
@article{a90d3a72e45a443db64c2b688959458c,
title = "A Two-Arm Phase II Study of Temozolomide in Patients with Advanced Gastrointestinal Stromal Tumors and Other Soft Tissue Sarcomas",
abstract = "BACKGROUND. The authors conducted a two-arm Phase II study of temozolomide to determine its efficacy and toxicity in patients with soft tissue sarcomas (STSs) who had received, had refused, or were not eligible for standard chemotherapy with doxorubicin and ifosfamide (Arm 1) and in patients with gastrointestinal stromal tumors (GISTs; Arm 2). Patients with GIST were eligible regardless of prior therapy before imatinib was available. METHODS. Sixty patients were enrolled in the current study, 19 of whom had GISTs and 41 of whom had other STSs. The patients received temozolomide at a dose of 85 mg/m2 orally for 21 days followed by 7 days without treatment. Standard radiographic imaging after every two cycles was used to assess the treatment response. RESULTS. Of the 39 patients in Arm 1, there was 1 complete response and 1 partial response of 39 evaluable patients, for a total response rate of 5{\%} (95{\%} confidence interval, 0-12{\%}). The responses lasted 7 months and 8 months, respectively. In Arm 2, there was no response in 17 patients. The disease was stable in 22{\%} of the patients with GISTs and 33{\%} of the patients with other STSs. The median overall survival time was 26.4 months in patients with GISTs and 11 months in patients with other STSs. The median time to disease progression was 2.3 months in patients with GISTs and 3.3 months in patients with other STSs. Grade 3 and Grade 4 adverse effects (according to National Cancer Institute Common Toxicity Criteria) were rare and included fatigue (eight patients), anemia (six patients), constipation (four patients), neutropenia (four patients), and thrombocytopenia (four patients). CONCLUSIONS. The data from the current study suggest that temozolomide is well tolerated but has only minimal efficacy and a limited role in the treatment of patients with STSs.",
keywords = "Clinical trial, Efficacy, Gastrointestinal stromal tumors (GIST), Soft tissue sarcomas (STSs), Temozolomide",
author = "Jonathan Trent and Jennifer Beach and Burgess, {Michael A.} and Nicholas Papadopolous and Chen, {Lei L.} and Benjamin, {Robert S.} and Patel, {Shreyaskumar R.}",
year = "2003",
month = "12",
day = "15",
doi = "10.1002/cncr.11875",
language = "English",
volume = "98",
pages = "2693--2699",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "12",

}

TY - JOUR

T1 - A Two-Arm Phase II Study of Temozolomide in Patients with Advanced Gastrointestinal Stromal Tumors and Other Soft Tissue Sarcomas

AU - Trent, Jonathan

AU - Beach, Jennifer

AU - Burgess, Michael A.

AU - Papadopolous, Nicholas

AU - Chen, Lei L.

AU - Benjamin, Robert S.

AU - Patel, Shreyaskumar R.

PY - 2003/12/15

Y1 - 2003/12/15

N2 - BACKGROUND. The authors conducted a two-arm Phase II study of temozolomide to determine its efficacy and toxicity in patients with soft tissue sarcomas (STSs) who had received, had refused, or were not eligible for standard chemotherapy with doxorubicin and ifosfamide (Arm 1) and in patients with gastrointestinal stromal tumors (GISTs; Arm 2). Patients with GIST were eligible regardless of prior therapy before imatinib was available. METHODS. Sixty patients were enrolled in the current study, 19 of whom had GISTs and 41 of whom had other STSs. The patients received temozolomide at a dose of 85 mg/m2 orally for 21 days followed by 7 days without treatment. Standard radiographic imaging after every two cycles was used to assess the treatment response. RESULTS. Of the 39 patients in Arm 1, there was 1 complete response and 1 partial response of 39 evaluable patients, for a total response rate of 5% (95% confidence interval, 0-12%). The responses lasted 7 months and 8 months, respectively. In Arm 2, there was no response in 17 patients. The disease was stable in 22% of the patients with GISTs and 33% of the patients with other STSs. The median overall survival time was 26.4 months in patients with GISTs and 11 months in patients with other STSs. The median time to disease progression was 2.3 months in patients with GISTs and 3.3 months in patients with other STSs. Grade 3 and Grade 4 adverse effects (according to National Cancer Institute Common Toxicity Criteria) were rare and included fatigue (eight patients), anemia (six patients), constipation (four patients), neutropenia (four patients), and thrombocytopenia (four patients). CONCLUSIONS. The data from the current study suggest that temozolomide is well tolerated but has only minimal efficacy and a limited role in the treatment of patients with STSs.

AB - BACKGROUND. The authors conducted a two-arm Phase II study of temozolomide to determine its efficacy and toxicity in patients with soft tissue sarcomas (STSs) who had received, had refused, or were not eligible for standard chemotherapy with doxorubicin and ifosfamide (Arm 1) and in patients with gastrointestinal stromal tumors (GISTs; Arm 2). Patients with GIST were eligible regardless of prior therapy before imatinib was available. METHODS. Sixty patients were enrolled in the current study, 19 of whom had GISTs and 41 of whom had other STSs. The patients received temozolomide at a dose of 85 mg/m2 orally for 21 days followed by 7 days without treatment. Standard radiographic imaging after every two cycles was used to assess the treatment response. RESULTS. Of the 39 patients in Arm 1, there was 1 complete response and 1 partial response of 39 evaluable patients, for a total response rate of 5% (95% confidence interval, 0-12%). The responses lasted 7 months and 8 months, respectively. In Arm 2, there was no response in 17 patients. The disease was stable in 22% of the patients with GISTs and 33% of the patients with other STSs. The median overall survival time was 26.4 months in patients with GISTs and 11 months in patients with other STSs. The median time to disease progression was 2.3 months in patients with GISTs and 3.3 months in patients with other STSs. Grade 3 and Grade 4 adverse effects (according to National Cancer Institute Common Toxicity Criteria) were rare and included fatigue (eight patients), anemia (six patients), constipation (four patients), neutropenia (four patients), and thrombocytopenia (four patients). CONCLUSIONS. The data from the current study suggest that temozolomide is well tolerated but has only minimal efficacy and a limited role in the treatment of patients with STSs.

KW - Clinical trial

KW - Efficacy

KW - Gastrointestinal stromal tumors (GIST)

KW - Soft tissue sarcomas (STSs)

KW - Temozolomide

UR - http://www.scopus.com/inward/record.url?scp=0344667592&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0344667592&partnerID=8YFLogxK

U2 - 10.1002/cncr.11875

DO - 10.1002/cncr.11875

M3 - Article

C2 - 14669291

AN - SCOPUS:0344667592

VL - 98

SP - 2693

EP - 2699

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 12

ER -