Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group.

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Hdl Handle:
http://hdl.handle.net/10541/99089
Title:
Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group.
Authors:
Santoro, A; Tursz, T; Mouridsen, H; Verweij, Jaap; Steward, William P; Somers, R; Buesa, J; Casali, P; Spooner, D; Rankin, Elaine M
Abstract:
PURPOSE: The aim of this trial was to compare the activity and toxicity of single-agent doxorubicin with that of two multidrug regimens in the treatment of patients with adult advanced soft tissue sarcomas. PATIENTS AND METHODS: This was a prospective randomized phase III trial performed by 35 cancer centers within the Soft Tissue and Bone Sarcoma Group of the European Organization for Research and Treatment of Cancer (EORTC). Six hundred sixty-three eligible patients were randomly allocated to receive either doxorubicin 75 mg/m2 (arm A), cyclophosphamide, vincristine, doxorubicin, and dacarbazine (CYVADIC) (arm B), or ifosfamide 5 g/m2 plus doxorubicin 50 mg/m2 (arm C). RESULTS: The overall response rate was 24% (95% confidence interval, 20.7% to 27.3%) among eligible patients and 26% among assessable patients. No statistically significant difference was detected among the three study arms in terms of response rate (arm A, 23.3%; arm B, 28.4%; and arm C, 28.1%), remission duration (median, 46 weeks on arm A, 48 weeks on arm B, and 44 weeks on arm C), or overall survival (median, 52 weeks on arm A, 51 weeks on arm B, and 55 weeks on arm C). The degree of myelosuppression was significantly greater for the combination of ifosfamide and doxorubicin than for the other two regimens. Cardiotoxicity was also more frequent in this arm, but other toxicities were similar. CONCLUSION: In advanced soft tissue sarcomas of adults, single-agent doxorubicin is still the standard chemotherapy against which more intensive or new drug treatments should be compared. Combination chemotherapy cannot be recommended outside a controlled clinical trial with the exclusion of some subsets of sarcoma patients for whom significant tumor volume reduction may be an important end point of a chemotherapy regimen.
Affiliation:
Divisione Oncologia Medica A, Istituto Nazionale Tumori, Milano, Italy.
Citation:
Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. 1995, 13 (7):1537-45 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
Jul-1995
URI:
http://hdl.handle.net/10541/99089
PubMed ID:
7602342
Type:
Article
Language:
en
ISSN:
0732-183X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorSantoro, Aen
dc.contributor.authorTursz, Ten
dc.contributor.authorMouridsen, Hen
dc.contributor.authorVerweij, Jaapen
dc.contributor.authorSteward, William Pen
dc.contributor.authorSomers, Ren
dc.contributor.authorBuesa, Jen
dc.contributor.authorCasali, Pen
dc.contributor.authorSpooner, Den
dc.contributor.authorRankin, Elaine Men
dc.date.accessioned2010-05-18T12:02:53Z-
dc.date.available2010-05-18T12:02:53Z-
dc.date.issued1995-07-
dc.identifier.citationDoxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. 1995, 13 (7):1537-45 J. Clin. Oncol.en
dc.identifier.issn0732-183X-
dc.identifier.pmid7602342-
dc.identifier.urihttp://hdl.handle.net/10541/99089-
dc.description.abstractPURPOSE: The aim of this trial was to compare the activity and toxicity of single-agent doxorubicin with that of two multidrug regimens in the treatment of patients with adult advanced soft tissue sarcomas. PATIENTS AND METHODS: This was a prospective randomized phase III trial performed by 35 cancer centers within the Soft Tissue and Bone Sarcoma Group of the European Organization for Research and Treatment of Cancer (EORTC). Six hundred sixty-three eligible patients were randomly allocated to receive either doxorubicin 75 mg/m2 (arm A), cyclophosphamide, vincristine, doxorubicin, and dacarbazine (CYVADIC) (arm B), or ifosfamide 5 g/m2 plus doxorubicin 50 mg/m2 (arm C). RESULTS: The overall response rate was 24% (95% confidence interval, 20.7% to 27.3%) among eligible patients and 26% among assessable patients. No statistically significant difference was detected among the three study arms in terms of response rate (arm A, 23.3%; arm B, 28.4%; and arm C, 28.1%), remission duration (median, 46 weeks on arm A, 48 weeks on arm B, and 44 weeks on arm C), or overall survival (median, 52 weeks on arm A, 51 weeks on arm B, and 55 weeks on arm C). The degree of myelosuppression was significantly greater for the combination of ifosfamide and doxorubicin than for the other two regimens. Cardiotoxicity was also more frequent in this arm, but other toxicities were similar. CONCLUSION: In advanced soft tissue sarcomas of adults, single-agent doxorubicin is still the standard chemotherapy against which more intensive or new drug treatments should be compared. Combination chemotherapy cannot be recommended outside a controlled clinical trial with the exclusion of some subsets of sarcoma patients for whom significant tumor volume reduction may be an important end point of a chemotherapy regimen.en
dc.language.isoenen
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshCyclophosphamide-
dc.subject.meshDacarbazine-
dc.subject.meshDose-Response Relationship, Drug-
dc.subject.meshDoxorubicin-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshIfosfamide-
dc.subject.meshLeukopenia-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshPrognosis-
dc.subject.meshProspective Studies-
dc.subject.meshRemission Induction-
dc.subject.meshSarcoma-
dc.subject.meshSurvival Analysis-
dc.subject.meshThrombocytopenia-
dc.subject.meshVincristine-
dc.titleDoxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group.en
dc.typeArticleen
dc.contributor.departmentDivisione Oncologia Medica A, Istituto Nazionale Tumori, Milano, Italy.en
dc.identifier.journalJournal of Clinical Oncologyen

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