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Randomized comparison of doxorubicin and vindesine to doxorubicin for patients with metastatic soft‐tissue sarcomas
Author(s) -
Borden Ernest C.,
Amato David A.,
Edmonson John H.,
Ritch Paul S.,
Shiraki Masanori
Publication year - 1990
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19900901)66:5<862::aid-cncr2820660509>3.0.co;2-r
Subject(s) - vindesine , doxorubicin , medicine , soft tissue sarcoma , sarcoma , soft tissue , oncology , toxicity , chemotherapy , surgery , gastroenterology , urology , pathology , cyclophosphamide , vincristine
Two treatment regimens for metastatic soft‐tissue sarcomas were compared in a randomized trial in the cooperative group setting. Histopathologic diagnosis was affirmed by pathology reference panel review in 72% of the 347 patients. In 21% of patients, the reference panel affirmed the diagnosis of soft‐tissue sarcoma but disagreed as to type; 7% of patients were ineligible based upon cell type. Of 298 patients evaluable, measurable tumor regression (partial or complete response) occurred in 17% of patients to doxorubicin (70 mg/m 2 intravenously) and 18% of patients to doxorubicin (70 mg/m 2 intravenously) and vindesine (3 mg/m 2 intravenously), each given every 3 weeks. No difference existed in complete response (4% for doxorubicin, 6% for doxorubicin and vindesine) or median survival (9.4 months for doxorubicin, 9.9 months for doxorubicin and vindesine). Overall, 60% of those patients on doxorubicin and vindesine and 46% on doxorubicin experienced a severe or worse toxicity of treatment ( P = 0.01). With greater toxicity and lack of any gains in efficacy, the results do not support use of the combination of doxorubicin and vindesine for metastatic soft‐tissue sarcomas.