A randomized phase II study of weekly docetaxel/cisplatin versus weekly docetaxel/oxaliplatin as first-line therapy for patients with advanced gastric cancer.

Docetaxel, in combination with cisplatin or oxaliplatin, has demonstrated efficacy in advanced gastric cancer (AGC). This randomized, non-comparative phase II trial evaluated two weekly docetaxel-based regimens to determine which is the most promising in terms of efficacy and safety as a front-line therapy in AGC. Chemotherapy-naïve patients with measurable unresectable and/or metastatic gastric adenocarcinoma were randomly assigned to receive docetaxel (35 mg/m(2)) weekly on days 1 and 8 of a 21-day cycle plus either cisplatin (60 mg/m(2) on day 1) (wDP) or oxaliplatin (120 mg/m(2) on day 1) (wDO). Of the 77 randomly assigned patients, 76 patients (38 per arm) received one of the study treatments. Overall, response rate (ORR) was 37 % for wDP and 41 % for wDO. Median progression-free survival (PFS) was 4.9 and 4.4 months for wDP and wDO, respectively, and median overall survival (OS) was 9.7 and 12.3 months, respectively. Exploratory analyses showed no significant difference between wDP and wDO in terms of ORR (P = 0.707), PFS (P = 0.324), or OS (P = 0.581). The main grade 3 or 4 toxicity in the wDP and wDO groups was neutropenia (47 % in both groups). wDO was less associated with nausea (66 vs. 82 %) and vomiting (39 vs. 63 %), but more associated with peripheral neuropathy (68 vs. 39 %) than wDP. Rates of overall grade 3 or 4 adverse events were similar (wDP 66 vs. wDO 68 %). wDP and wDO were found to be equally active and tolerable as front-line treatments in AGC.