Combination docetaxel (Taxotere), fluorouracil, and leucovorin (TFL), as first-line chemotherapy in advanced gastric cancer: a Hellenic Cooperative Oncology Group phase II study

We assessed the efficacy and safety profile of a docetaxel (Taxotere; Sanofi-Aventis, France), fluorouracil (FU), and leucovorin (LV) combination (TFL), as first-line chemotherapy in patients with advanced gastric cancer. Fifty-eight patients with advanced gastric cancer were entered in this phase II study. The chemotherapy regimen (TFL) was administered in an outpatient setting as follows: docetaxel 7 mg/m2 on day 1 and FU 50 mg/m2 and LV 30 mg/m2 on days 1 to 3, every 3 weeks for six cycles. On an intent-to-treat basis, 4 complete (7%) and 11 partial responses (19%) were observed, with an objective overall response rate of 26%; in addition, 22 patients (38%) had stable and 15 (26%) had progressive disease. For 6 (10%) patients, response could not be evaluated. Responses were noted at all metastatic sites. With a median follow-up of 55 months, median survival was 9 months; median time to progression, 5.9 months; and median duration of response, 10 months. Toxicity was manageable and no toxic death was reported. Neutropenia was the most frequent severe toxicity and occurred in 30% of the patients. The main non-hematologic toxicities were alopecia (76%), diarrhea (30%), and stomatitis (30%). The results of this phase II study seem to indicate that the TFL regimen has moderate activity in patients with advanced gastric cancer, with acceptable toxicity.