@entity1358 -a randomized evaluation of XXXX vs @entity1199 , alpha-interferon (leucocyte) and @entity440 .

@entity1 @entity137 @entity440 @entity66 @entity13236 @entity5 @entity1358 @entity1199 @entity3027
@entity1358 ( @entity1358 ) has a poor prognosis. Conventional treatment strategies, including chemotherapy and hormonal therapy, have limited value. Although encouraging results have been achieved in terms of objective response using immunological manipulations, no conclusive studies yet exist with a controlled comparative evaluation of survival. Therefore, the present study was undertaken, which compared one of the present (and presumed best) treatments, @entity13236 ( @entity1199 / @entity3027 ) and @entity440 , with a control arm of @entity440 only. @entity440 has been shown to potentiate in vivo anti- @entity5 activity of @entity1199 , and because of its non-toxic behaviour it was included in both groups. The study was open, randomized and included seven institutions in Sweden. The @entity1 were stratified according to the different centres involved. An interim analysis was planned when a minimum of 100 @entity1 were evaluable. The 128 @entity1 finally included had a histologically documented metastatic @entity1358 , with a life expectancy of more than 3 months, a performance status WHO 0-2 and no prior chemo- or immunotherapy. Informed consent was obtained from each @entity1 . The @entity1 randomized to the control arm (n = 63) received only @entity440 40 mg p.o. daily for at least 1 year or until progression. The @entity1 (n = 65) randomized to biotherapy received subcutaneous recombinant @entity1199 , leucocyte @entity3027 in a treatment cycle of 42 days, as well as @entity440 p.o. In the absence of undue @entity137 or disease progression, these @entity1 received one additional treatment cycle of 42 days followed by maintenance treatment, consisting of 5 days therapy every 4 weeks, for 1 year, or until proven progression. Only two @entity1 in the @entity440 -only group received immunotherapy when the disease progressed, but without any beneficial effect. All @entity1 received appropriate local treatment when indicated. The interim analysis demonstrated no survival advantage for either group, and therefore further inclusion of @entity1 was stopped. The median follow-up was 11 months (range 0.4-48 months). The final survival analysis showed no significant differences between the two treatment arms in so far as comparison from the day of diagnosis of @entity66 , from the day of first evidence of metastatic spread, or from the onset of treatment. This was valid both when the evaluation was performed with regard to intention to treat and when the analysis was directed only to @entity1 that managed at least one treatment cycle (42 days) of @entity1199 / @entity3027 . The adverse effects were more pronounced in the @entity1199 / @entity3027 group. Although the number of @entity1 is limited, the results raise doubt concerning immunotherapy with @entity1199 and @entity3027 as a routine treatment in the management of advanced @entity1358 . The difference in cost of drugs and health care (drug costs per @entity1 : @entity1199 / @entity3027  27000 vs @entity440  360) as well as adverse effects caused by @entity1199 / @entity3027 are also factors of importance. The study emphasizes the need for more effort to find the 'optimal schedule' of immunotherapy, as well as the need for randomized controlled studies before approval of a new treatment in the routine setting.
