Addition of @entity1259 as a third drug to @entity3003 - @entity1311 in first-line treatment of advanced @entity43 : a prospectively randomized gynecologic cancer intergroup trial by the Arbeitsgemeinschaft Gynaekologische Onkologie XXXX Study Group and the Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens.

@entity1 @entity43 @entity137 @entity390 @entity3003 @entity1259 @entity1311 @entity33 @entity18274 @entity281 @entity902
PURPOSE: Despite the progress that has been achieved, long-term survival rates in @entity1 with advanced @entity43 are still disappointing. One attempt to improve results could be the addition of non-cross-resistant drugs to @entity902 - @entity1311 combination regimens. Anthracyclines were among the candidates for incorporation as a third drug into first-line regimens. @entity1 AND METHODS: We performed a prospectively randomized phase III study comparing @entity3003 - @entity1311 (TC; area under the curve 5/175 mg/m2, respectively) with @entity1259 60 mg/m2 added to @entity18274 ( @entity18274 ) in previously untreated @entity1 with @entity43 . All drugs were administered intravenously on day 1 of a 3-week schedule for a planned minimum of six courses. RESULTS: Between November 1997 and February 2000, 1,282 @entity1 were randomly assigned to receive either TC (635 @entity1 ) or @entity18274 (647 @entity1 ), respectively. Grade 3/4 hematologic and some nonhematologic @entity137 ( @entity390 /emesis, @entity33 , and @entity281 ) occurred significantly more frequently in the @entity18274 arm. Accordingly, quality-of-life analysis showed inferiority of @entity18274 versus TC. Median progression-free survival time was 18.4 months for the @entity18274 arm and 17.9 months for the TC arm (hazard ratio [HR], 0.95; 95% CI, 0.83 to 1.07; P = .3342). Median overall survival time was 45.8 months for the @entity18274 arm and 41.0 months for the TC arm (HR, 0.93; 95% CI, 0.81 to 1.08; P = .3652). Similar nonsignificant differences were observed when strata were analyzed separately. CONCLUSION: Addition of @entity1259 to TC did not improve survival or time to treatment failure in @entity1 with @entity43 ; therefore, it cannot be recommended for clinical use in this population.
