Adjuvant @entity1205 plus XXXX in stage I/II @entity1149 ( @entity1149 ): Preliminary results of a randomized phase II pilot trial of the Central European Cooperative Oncology Group (CECOG).

@entity1 @entity1210 @entity137 @entity1149 @entity900 @entity1295 @entity1205 @entity2359 @entity34
UNASSIGNED: 7297 Background: Adjuvant chemotherapy treatment for early stage @entity1149 @entity1 is not yet standard practice. The aim of the present trial is to compare the activity, safety, and quality of life effects of adjuvant @entity1205 plus @entity900 versus observation only. METHODS: @entity1 with completely resected stage I-II @entity1149 , no prior chemotherapy and/or radiotherapy, and a WHO performance status of <= 2, were randomized to @entity1205 plus @entity900 , 75 mg/m(2) each, both on day 1, every 21 days for 6 cycles (arm A) versus observation only (arm B). Time-to-event endpoints were calculated using the Kaplan-Meier method and compared between arms using the log-rank test. The incidence of grade 3 and 4 @entity137 was compared using Pearson's chi-squared test. The primary objective is disease-free survival; secondary objectives are overall survival, treatment-related @entity137 , and quality of life. Planned recruitment is 80 @entity1 . RESULTS: From December 2001 to December 2003, 30 @entity1 were randomized to each arm. There were 22 males and 8 females in each arm. Arm A: 17 @entity1 had stage I and 13 @entity1 @entity34 ; arm B: 18 @entity1 had stage I and 12 @entity34 . Mean age (range) arm A was 58.1 years (44 - 77) and arm B was 56.9 (46 - 72). An interim analysis of @entity137 in the treatment arm after inclusion of 40 @entity1 (20 arm A; 20 arm B) revealed that 64% (13 of 20) experienced @entity1210 grade 3 or 4; 43% (9 of 20) peripheral @entity2359 2 or 3; and 50% (10 of 20) experienced @entity1295 grade 2 or 3. Furthermore a significant decrease in @entity1 ' quality of life was noted during the 5(th) and 6(th) chemotherapy cycles. Based on this analysis, a protocol amendment reduced the total number of cycles to 4, with a further 2 cycles administered at investigators' discretion. Current relapse rates and time to progression will be reported at the meeting. CONCLUSIONS: The administration of 4 cycles of @entity1205 plus @entity900 is feasible in the adjuvant setting for @entity1 with stage I/II @entity1149 . No significant financial relationships to disclose.
