XXXX in the treatment of advanced @entity43 : a randomised co-operative multicentre phase III-study.

@entity43 @entity1 @entity137 @entity41 @entity5 @entity900 @entity786 @entity1311 @entity21193
BACKGROUND: In August 1988 a randomised phase III multicenter trial was started in order to compare @entity900 / @entity21193 (PT) with standard @entity900 / @entity786 (PC) in advanced @entity43 , aiming at lower @entity137 and maintained efficiency. @entity1 AND METHODS: Five hundred and nineteen @entity1 were enrolled into the protocol. Final evaluation after a median observation time of more than five years was made in July 1996 and included 398 eligible @entity1 , of whom 366 were evaluable regarding efficiency and 290 in respect of @entity137 . The @entity5 stages were classified as FIGO II in 53, FIGO III in 244 and FIGO IV in 68 @entity1 . The @entity1 were stratified regarding post-operative @entity5 burden. RESULTS: Hematological and gastrointestinal @entity137 WHO > = 3 were comparable between the two study arms though a significant difference could be demonstrated regarding alopecia (PT 8% vs. PC 47% after six cycles). The median time to progression as the main efficiency item was in favour of the study schedule (PT 20.6 vs. PC 15.1 months) while significant differences were neither observed in the whole study group nor in the analysed subgroups (R0, < 2 cm, > = 2 cm). The same held true for overall survival. CONCLUSION: PT may be recommended as a less toxic substitute for the former standard PC. After the acceptance of @entity1311 / @entity900 as a new standard, the role of @entity21193 should be investigated regarding adjuvant therapy in @entity1 without @entity41 , as a potential partner in triple or sequential treatment and in second-line treatment.
