XXXX with or without LAK cells in @entity1358 : a report of a European multicentre study.

@entity1 @entity99 @entity137 @entity417 @entity882 @entity66 @entity1358 @entity5041 @entity1017 @entity74 @entity3 @entity1011 @entity1199 @entity551
Between October 1987 and November 1988, 95 European @entity1 with @entity1358 have been treated with recombinant @entity1199 ( @entity5041 ) (EuroCetus) at 18 X 10(6) IU/m2/day (equivalent to 3 X 10(6) Cetus Units/m2/day) according to the West schedule in two trials. 1. Forty-two @entity1 received @entity5041 alone. Median time between initial diagnosis and @entity3 was three months. Eighty-one percent of the @entity1 had at least two involved sites at inclusion and 86% underwent prior nephrectomy. Twenty-seven @entity1 (64%) received two successive courses. Over 80% of the planned dose was administered in 69% and 44% of @entity1 during courses 1 and 2, respectively. Fever, @entity551 , @entity1017 , rise in @entity1011 level, @entity99 , @entity417 and @entity882 were commonly observed but resolved promptly after completion of therapy. No @entity137 was recorded. Two (6%) complete responses (CR), four (13%) partial responses (PR), four @entity66 ( @entity66 ) and 22 @entity74 ( @entity74 ) were observed. The response rate is 6/32 (19%); the median progression-free survival time is not reached at 218+ days (92-394). 2. Fifty-three @entity1 received @entity5041 with lymphokine-activated killer (LAK) cells. Median time from primary diagnosis to @entity3 was three months. Eighty-five percent of @entity1 had at least two involved sites though 73% had previously undergone nephrectomy. Forty @entity1 (75%) received two successive induction courses. Most @entity1 , i.e. respectively, 77% and 60%, were given at least 80% of the planned dose during courses 1 and 2. Median numbers of LAK cells infused were 13.1 and 11.6 X 10(9) nucleated cells per course, respectively. @entity137 was not different from that described above; no @entity137 occurred; five CR (10%), nine PR (18%), 11 @entity66 and 26 @entity74 were observed. The response rate is 14/51 (27%) and the median progression-free survival time is not reached at 7.2+ months (3-13.1). In conclusion, @entity5041 , with or without LAK cells, is obviously active on @entity1358 . The difference in response rate between the two trials is not statistically significant but has to be paralleled with the difference in dose received by the @entity1 rather than with the addition of a cellular therapy. @entity137 was always manageable and reversible. The association of @entity5041 with other lymphokines should represent a major issue to improve the response rate and will be considered in further European studies.
