Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: a study of the european organization for research and treatment of cancer soft tissue and bone sarcoma group.

2.50
Hdl Handle:
http://hdl.handle.net/10541/85438
Title:
Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: a study of the european organization for research and treatment of cancer soft tissue and bone sarcoma group.
Authors:
Verweij, Jaap; Lee, Siow Ming; Ruka, W; Buesa, J; Coleman, R; Van Hoessel, R; Seynaeve, C; Di Paola, E D; Van Glabbeke, Martine M; Tonelli, D; Judson, Ian R
Abstract:
PURPOSE: To assess antitumor response and time to progression (TTP) with docetaxel compared with doxorubicin in first-line treatment of advanced and/or metastatic soft tissue sarcoma. PATIENTS AND METHODS: Patients with measurable soft tissue sarcoma lesions and adequate bone marrow, liver, and renal function were entered onto the study. They were randomized to either docetaxel 100 mg/m(2) given as a 1-hour intravenous infusion every 3 weeks or doxorubicin 75 mg/m(2) given as a bolus injection every 3 weeks. A maximum of seven cycles of treatment were scheduled. The study was designed as a randomized phase III study evaluating TTP by log-rank model. There was a clause for premature closure of the trial if fewer than five responses were observed among the first 25 assessable patients in the docetaxel treatment arm. RESULTS: Eighty-six patients were entered onto the study; 85 were assessable for toxicity and 83 for response. The rate of severe granulocytopenia was not significantly different between the two arms. Nausea (P =.001), vomiting (P <.001), and stomatitis (P =.005) were more common with doxorubicin therapy, whereas neurotoxicity was more frequent with docetaxel treatment. The response rate to doxorubicin therapy was 30% (95% confidence interval, 17% to 46%), whereas no responses to docetaxel therapy were seen (P <.001). In view of this, the trial was closed prematurely and the phase III study part was not conducted. CONCLUSION: Docetaxel is inactive in soft tissue sarcomas and cannot be recommended for further use in treatment of this disease.
Affiliation:
Department of Medical Oncology, Rotterdam Cancer Institute, and University Hospital Rotterdam, Nijmegen, the Netherlands.
Citation:
Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: a study of the european organization for research and treatment of cancer soft tissue and bone sarcoma group. 2000, 18 (10):2081-6 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
May-2000
URI:
http://hdl.handle.net/10541/85438
PubMed ID:
10811673
Type:
Article
Language:
en
ISSN:
0732-183X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorVerweij, Jaapen
dc.contributor.authorLee, Siow Mingen
dc.contributor.authorRuka, Wen
dc.contributor.authorBuesa, Jen
dc.contributor.authorColeman, Ren
dc.contributor.authorVan Hoessel, Ren
dc.contributor.authorSeynaeve, Cen
dc.contributor.authorDi Paola, E Den
dc.contributor.authorVan Glabbeke, Martine Men
dc.contributor.authorTonelli, Den
dc.contributor.authorJudson, Ian Ren
dc.date.accessioned2009-11-05T15:44:46Z-
dc.date.available2009-11-05T15:44:46Z-
dc.date.issued2000-05-
dc.identifier.citationRandomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: a study of the european organization for research and treatment of cancer soft tissue and bone sarcoma group. 2000, 18 (10):2081-6 J. Clin. Oncol.en
dc.identifier.issn0732-183X-
dc.identifier.pmid10811673-
dc.identifier.urihttp://hdl.handle.net/10541/85438-
dc.description.abstractPURPOSE: To assess antitumor response and time to progression (TTP) with docetaxel compared with doxorubicin in first-line treatment of advanced and/or metastatic soft tissue sarcoma. PATIENTS AND METHODS: Patients with measurable soft tissue sarcoma lesions and adequate bone marrow, liver, and renal function were entered onto the study. They were randomized to either docetaxel 100 mg/m(2) given as a 1-hour intravenous infusion every 3 weeks or doxorubicin 75 mg/m(2) given as a bolus injection every 3 weeks. A maximum of seven cycles of treatment were scheduled. The study was designed as a randomized phase III study evaluating TTP by log-rank model. There was a clause for premature closure of the trial if fewer than five responses were observed among the first 25 assessable patients in the docetaxel treatment arm. RESULTS: Eighty-six patients were entered onto the study; 85 were assessable for toxicity and 83 for response. The rate of severe granulocytopenia was not significantly different between the two arms. Nausea (P =.001), vomiting (P <.001), and stomatitis (P =.005) were more common with doxorubicin therapy, whereas neurotoxicity was more frequent with docetaxel treatment. The response rate to doxorubicin therapy was 30% (95% confidence interval, 17% to 46%), whereas no responses to docetaxel therapy were seen (P <.001). In view of this, the trial was closed prematurely and the phase III study part was not conducted. CONCLUSION: Docetaxel is inactive in soft tissue sarcomas and cannot be recommended for further use in treatment of this disease.en
dc.language.isoenen
dc.subjectSoft Tissue Canceren
dc.subject.meshAdult-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshAntineoplastic Agents, Phytogenic-
dc.subject.meshCross-Over Studies-
dc.subject.meshDisease Progression-
dc.subject.meshDoxorubicin-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshMale-
dc.subject.meshPaclitaxel-
dc.subject.meshSarcoma-
dc.subject.meshSoft Tissue Neoplasms-
dc.subject.meshSurvival Analysis-
dc.subject.meshTaxoids-
dc.subject.meshTreatment Outcome-
dc.titleRandomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: a study of the european organization for research and treatment of cancer soft tissue and bone sarcoma group.en
dc.typeArticleen
dc.contributor.departmentDepartment of Medical Oncology, Rotterdam Cancer Institute, and University Hospital Rotterdam, Nijmegen, the Netherlands.en
dc.identifier.journalJournal of Clinical Oncologyen

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