Abstract

The purpose of this study was to determine the efficacy and safety of the combination of 4'-Epi-DX and DDP as antitt~asur therapy of soft tissue sarcoma. Included were patients with age~ 60, performance status> 2 (WHO-scale), measurable ~ lesions, no signs of congestive heart failure, no previous cytotoyic treatment. Trea~nent plan: day ]: 4'-Epi-DX 45 mg/m 2 i.v.; day 2: 4'-Epi-DX 45 mg/~ i.v., 90rag DDP i.v. every 3-4 weeks, toxicity permitting. An escalation of 4'-Epi-DX was allowed (i0 mg/m 2) if WgC-usdir~2000/~ 3 and platelet-eadir~ 70.O00/mm 3. From If/ 1984-X/1985 27 pts. entered the study. 26 pie. were evaluable for response (i early denth) m~d all 27 pts. were evsluable for systemic toxicity. Response: Objektive reniseions were observed in i0 of 26 pta. = 38 %. There were 4 (1~ after 3-6 courses. Duration of response: median =6 + range 5+~ + months. PR was seen in 6 pts. after 2-4 courses. Duration of response (months): median=3,5 + range:2-7 +. NC was w~tched in 12 pte. after 3 courses. Duration of response: medians4,5 range:2-10 months. PPD w~us seen in 4 pts. Toxicity: H~totoxicity: 56 cycles in 15 p.ts. were evallmb!e for h~totoxicity (nsdir-valuea): WBL-depression grade 0 in 7 cycles, grade 1 in 7 cycles, grade 2 in 24 eyries, grade 3 in 17 cycles and grade 4 in 1 cycle; platelet-depreseiea grade 0 in 49 cycles, grade I in 3 cycles end grade 2 in 4 cycles. Organ-ralated toxicity: Neurotoxicity ~s observed in 4 pts. grade: 1,2,2,3. Alopecia was seen in all pts. (grade: median=B, range:l-3). 4 pts. refused further chemotherapy because of unmanageable nausea and vomiting. GheT.otherapy was finished in 1 pt. because of possibly beginning cardioeyopathy after i0 anurses. Another patient finished chemotherapy because of ototoxicity. Dose escalation according to protocol ~as done in n=34 courses of n=108 overall-courses. Dose reduction because of toxicity was done in n=12 courses.There was no difference in the rate of dose escalation in pts. with (1~ and PR as oomparad to pts. with NC and pPD. In conlusien: 4'-Epi-DX and DDP is effective in the treatment of advanced soft tissue sarcoma but the overall results don't seem to be better, than with established treatment. Toxicity is sometimes treatment limiting, but not definitively urmcceptable.

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