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.
Papakostas
Pavlos
P
Oncology Department, Hippokration General Hospital, 108, Vas.Sofias Avenue, Athens, Greece.
Tsavdaridis
Dimitrios
D
Kosmidis
Paris
P
Kalofonos
Haralabos P
HP
Sakantamis
Athanassios
A
Janinis
Dimitrios
D
Skarlos
Dimosthenis
D
Bafaloukos
Dimitrios
D
Bamias
Aristotelis
A
Xiros
Nikos
N
Fountzilas
George
G
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