The role of XXXX in the first-line treatment of @entity1 with 'poor prognosis' @entity2971 ( @entity2971 ) undergoing sequential high dose chemotherapy.

@entity1 @entity137 @entity3136 @entity3549 @entity2971 @entity900 @entity1311 @entity6740 @entity2033 @entity2879 @entity281 @entity1260 @entity221
UNASSIGNED: 4633 Background: @entity1311 (T) has shown significant activity both in @entity900 -refractory and untreated @entity2971 @entity1 (pts). In order to determine the impact of T on survival (OS) and @entity137 the analysis compares the results of two prospective trials in pts with 'poor prognosis' @entity2971 . METHODS: In the first trial pts have received high dose @entity3549 chemotherapy ( @entity2033 - @entity3549 ) at dose level [ @entity2879 250 mg/sqm, @entity1260 2 g/sqm, @entity900 20 mg/sqm, d1-5, q d22] for 3 consecutive cycles as part of a phase I/II dose trial. Pts received G-CSF 5  g/kg s.c. from d+1 after treatment to leukocyte recovery >2000/ l and reinfusion of PBSC at day +2. The comparative trial consisted of pts treated in an identical fashion but additionally receiving T at a dose of 225 mg/sqm added on day 1 as a 3-h infusion prior to @entity900 ( @entity2033 - @entity3549 +T. RESULTS: 155 pts have been analyzed, 59 pts in @entity2033 - @entity3549 and 96 pts in @entity2033 - @entity3549 +T. 112 pts and 414 cycles are fully assessable for @entity137 , 152 pts for OS. Pts characteristics ( @entity2033 - @entity3549 compared to HDVIP+T): Median age 29 (16-42) vs. 31 yrs (18-54), mediastinal primary 11 vs. 24%, liver mets 40 vs. 40%, bone 7 vs. 4%, CNS 20 vs. 19%, elevated AFP, @entity6740 , LDH: 39 vs. 30%, 61 vs. 58% and 77 vs. 77%. Dose intensity of the 3- vs. 4-drug regimen achieved have been 98% and 95%. Median time to recovery of granulocytes and thrombocytes (>500/ l resp. >25.000 l) have been day 15 and 16 independent from the addition of T. Differences in grade III/IV @entity137 in favor of @entity2033 - @entity3549 were seen in terms of @entity3136 (14 vs. 49%), @entity221 (3 vs. 20%) and @entity281 (3 vs. 19%) (P.05). 88% of pts attained a favorable response (NED/CR/PRm-) to @entity2033 - @entity3549 compared to 67% in the @entity2033 - @entity3549 +T (P<.05). After a median follow up period of 34 mos (range, 9-78) and 16 (0-47) the calculated 3-yr OS rates were 69.9 (CI95%, 54.3-83.3) for @entity2033 - @entity3549 and 67.3% (56.3-78.3) for @entity2033 - @entity3549 +T (P=.3). Early death rate due to progression/ @entity137 was 3% in both trials. CONCLUSIONS: The addition of @entity1311 to @entity2033 - @entity3549 dose level 6 as first-line therapy was associated with a moderately elevated @entity137 . No substantial impact on survival can be anticipated for @entity2033 - @entity3549 +T. No significant financial relationships to disclose.
