A pilot clinical trial of postoperative intensive weekly chemotherapy using cisplatin, epi-doxorubicin, 5-fluorouracil, 6S-leucovorin, glutathione and filgrastim in patients with resected gastric cancer.
OBJECTIVE
The study was performed to assess the feasibility and activity of an intensive chemotherapeutic regimen as adjuvant treatment for patients with resected gastric cancer at high risk of recurrence (pT(2)N(1-2); pT(3-4)N(any) M0).


METHODS
Starting 21 to 28 days after potentially curative surgery for primary gastric cancer, 25 patients received 8 weekly cycles of cisplatin 40 mg/m2, 5-fluorouracil 500 mg/m2, epidoxorubicin 35 mg/m2, 6S-stereoisomer of leucovorin at a dose of 250 mg/m2, and glutathione at a dose of 1.5 g/m2. From the day after to the day before each cycle of chemotherapy, filgrastim was administered by subcutaneous injection at a dose of 5 microg/kg.


RESULTS
After a median follow-up of 33 months, 80% of the patients were alive and disease-free. Five patients had relapsed: three in the liver, one in the peritoneum and one in the lymph nodes. Toxicity was mild: five patients experienced WHO grade III toxicity (three leukopenia, two thrombocytopenia); no toxic deaths occurred.


CONCLUSIONS
Intensive weekly chemotherapy is a feasible postoperative treatment option for patients with resected gastric cancer at high risk of relapse. These data, together with recent results in advanced disease, make this approach of interest for the development of new programs of adjuvant therapy in this setting.
Section of Experimental Oncology, Ospedale S. Salvatore, Pesaro, Italy.
F
F
Graziano
N
N
Cardarelli
M
M
Marcellini
E T
ET
Menichetti
G
G
Catalano
S
S
Cascinu
D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D000069585:Filgrastim; D005472:Fluorouracil / Q000008:administration & dosage; D005978:Glutathione / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D004317:Doxorubicin; D005978:Glutathione; D000069585:Filgrastim; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil