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

Abstract

Background 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. Method Data of MGC patients were treated with first-line mDCF regimen (two weekly docetaxel 60 mg/m(2) day 1 iv, cisplatin 50 mg/m(2) day 1 iv, 5-fluouracil 400 mg/m(2) day 1 iv push, 2400 mg/m(2); day 1-day 2 iv infusion, leucovorin 400 mg/m(2) day 1 iv push) were recorded. Capecitabine maintenance was given as 2500 mg/m(2)/ day 1-day 14 po, every 3 weeks, to patients who do not have progressive disease and grade 3 treatment-related toxicity. A retrospective analysis was made. Results 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 17.2 months. Median time to progression (TTP) was 10.8 +/- 1.9 months (95% CI: 6.89-14.64). Median overall survival was 14.7 +/- 1.73 months (95% CI: 11.30-18.10). Conclusions 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.