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


METHODS
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.


RESULTS
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%).


CONCLUSIONS
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.
Oncology Department, Hippokration General Hospital, 108, Vas.Sofias Avenue, Athens, Greece.
Pavlos
P
Papakostas
Dimitrios
D
Tsavdaridis
Paris
P
Kosmidis
Haralabos P
HP
Kalofonos
Athanassios
A
Sakantamis
Dimitrios
D
Janinis
Dimosthenis
D
Skarlos
Dimitrios
D
Bafaloukos
Aristotelis
A
Bamias
Nikos
N
Xiros
George
G
Fountzilas
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000556:secondary; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
D043823:Taxoids; D000077143:Docetaxel; D002955:Leucovorin; D005472:Fluorouracil