Final results of the randomized phase II study of sequential docetaxel and irinotecan with infusion 5-fluorouracil/folinic acid in patients with advanced gastric cancer - GA-TAC.

4579 Background: The optimal chemotherapy combination in patients with metastatic gastric adenocarcinoma (GA) is yet to be determined. We compared two newer drugs, docetaxel (arm T) and irinotecan (arm C), in combination with infusion 5-Fu/lv sequentially and randomly assigned 81 patients to start with either of the two.,Patients with biopsy proven, previously untreated locally advanced or metastatic GA, measurable lesions (RECIST), good performance status (KPS ≤2), and adequate haematological, renal and liver functions were randomly assigned to start with four courses of docetaxel 45 mg/m2 (arm T) or irinotecan 180 mg/m (arm C) with 44h-infusion 5-Fu/lv (d1 q 2 w). Radiological evaluations were conducted at base line and after four courses, ie at the switch of combinations, and at 16 weeks, ie at the conclusion of the 2nd drug combination. Changes in the levels of 10 different tumour markers were similarly monitored as well as SAE (CTC-criteria) and QOL (EORTC QLQ-C30).,Presently, all patients are accrued and evaluated for response after 8 weeks' of treatment with either T or C and after completion of both combinations. CR, PR, SD, PD were seen in 0(2), 14(12), 13(7), 8(9) and 0(0), 17(17), 11(10), 9(5) cases after 8 weeks (16 weeks) in arm T and C, respectively (P>0.05). Median overall survival (OS) for both groups were 10.5 mos and there was no statistical difference between the survival curves of the two study arms (log-rank test: P>0.05).,This is the first randomised comparison of two of the newer drugs in GA-therapy. No statistical difference favouring either arm T or C was found with respect to RR or median OS. The median OS of > 10 mos indicates that the sequential adminstration of the two newer combinations is effective and similar as for the ECF/EOX-combinations. The final analyses of the secondary end points progression free survival, rates of SAE and differences in QOL will be presented at the meeting. No significant financial relationships to disclose.