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Cyvadic in advanced soft tissue sarcoma: A randomized study comparing two schedules: A study of the EORTC soft tissue and bone sarcoma group
Author(s) -
Pinedo H. M.,
Bramwell V. H. C.,
Mouridsen H. T.,
Somers R.,
Vendrik C. P. J.,
Santoro A.,
Buesa J.,
Wagener Th.,
van Oosterom A. T.,
van Unnik J. A. M.,
Sylvester R.,
de Pauw M.,
Thomas D.,
Bonadonna O.
Publication year - 1984
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(19840501)53:9<1825::aid-cncr2820530904>3.0.co;2-z
Subject(s) - medicine , nausea , vincristine , chemotherapy , regimen , sarcoma , cyclophosphamide , vomiting , soft tissue sarcoma , soft tissue , surgery , doxorubicin , gastroenterology , chemotherapy regimen , pathology
Two hundred forty‐six adults with advanced progressive soft tissue sarcoma received combination chemotherapy with cyclophosphamide, vincristine, Adriamycin (doxorubicin), and DTIC. They were randomly allocated to receive the four drugs simultaneously every 4 weeks (S 1 : CYVADIC), or pairs of drugs (S 2 : ADIC‐CYV) alternating at 4 weekly intervals. One hundred sixty‐two patients completed 8 weeks of chemotherapy, and were considered to be evaluable for response. There were 18 complete remissions and 25 partial remissions, an overall response rate of 26%, with a highly significant difference between the two arms in favor of S 1 (38% versus 14%, P = 0.001). There were no significant differences between S 1 and S 2 in terms of median duration of remissions (62 versus 39 weeks), and median survival of responders (85 versus 80 weeks) and of all evaluable patients (43 versus 45 weeks). Karnofsky index (KI) was the single most important prognostic factor. Patients with KI 90–100 showed a remission rate of 41% (56% on the S 1 regimen) in contrast with 14% in those with KI 50–80. No patient with a KI of 50 responded to chemotherapy. The main toxicities were nausea, vomiting, anorexia, alopecia and myelosuppression, but did not differ significantly between the two regimens. Our findings suggest that stratification according to KI is essential for studies on chemotherapy for advanced soft tissue sarcomas in order to make a valuable comparison of treatment results.