Phase I/II study of a combination of docetaxel, capecitabine, and cisplatin (DXP) as first-line chemotherapy in patients with advanced gastric cancer.

摘要: This study was conducted to determine the optimal dosage of docetaxel-capecitabine-cisplatin (DXP) regimen and evaluate its efficacy safety in patients with advanced gastric cancer. Patients or esophagogastric junctional adenocarcinoma received capecitabine (days 1–14) intravenous docetaxel cisplatin (day 1) every 3 weeks. In phase I study, 15 were treated 4 different dose levels. Asthenia neutropenic fever dose-limiting toxicities. For II 1,125 mg/m2 initially recommended 60 mg/m2 cisplatin. However, frequent modifications at this level resulted a final 937.5 mg/m2 capecitabine. Among 40 enrolled complete 23 partial responses observed, presenting objective response rate 68%. Ten achieving good disappearance distant metastases underwent surgery, pathologic identified. After median follow-up 83.7 months (range, 20.2–86.5) surviving patients, overall survival 14.4 months progression-free 7.6 months. The most grade 3/4 adverse events neutropenia (62.5%) asthenia (37.5%). per cent experienced fever, one case sepsis-induced death. DXP displays considerable antitumor activity, may thus present effective first-line treatment for Further investigation both neoadjuvant settings is warranted.