Modified docetaxel, cisplatin, and 5-fluorouracil combination regimen and capecitabine maintenance in metastatic gastric cancer: toxicity and efficacy results.

Abstract

Little progress has been made, and there is an unmet medical need for treatment of metastatic gastric cancer (MGC). Docetaxel + cisplatin + 5-fluororacil (DCF) combination is an effective regimen with high rate of toxicity and is not well tolerated. We aimed to evaluate the efficacy and toxicity of a modified DCF (mDCF) combination regimen and capecitabine maintenance in MGC. Data of MGC patients were treated with first-line mDCF regimen (two weekly docetaxel 60mg/m2 day 1 iv, cisplatin 50mg/m2 day 1 iv, 5-fluouracil 400mg/m2 day 1 iv push, 2400mg/m2; day 1-day 2 iv infusion, leucovorin 400mg/m2 day 1 iv push) were recorded. Capecitabine maintenance was given as 2500mg/m2/ day 1-day 14 po, every 3weeks, to patients who do not have progressive disease and grade 3 treatment-related toxicity. A retrospective analysis was made. Forty patients were included. Mean age was 53 ± 11. Thirty-two patients had de novo metastasis. All patients' performance status was ECOG 1 or 2 (32/8). Median number of mDCF cycles given was 9 (min-max: 1-23). Overall response rate was 47.5%. Ten patients (25%) received capecitabine maintenance. Grade 3/4 toxicity was seen in 20 patients (50%). Hematologic grade 3/4 toxicity occurred in 13 patients (32.5%), and grade 3/4 neutropenia occurred in 11 patients (27.5%) and in 15 cycles. Nonhematologic grade 3/4 toxicity was seen in 7 patients (17.5%). Median follow-up time was 17.2months. Median time to progression (TTP) was 10.8 ± 1.9months (95% CI: 6.89-14.64). Median overall survival was 14.7 ± 1.73months (95% CI: 11.30-18.10). mDCF protocol was a tolerable chemotherapy regimen for the first-line treatment of MGC with higher ORR and longer TTP compared to standard DCF protocol. Capecitabine maintenance might increase TTP.