title: Dose escalation and split course of 4-epidoxorubicin in combination chemotherapy (FEM II) of advanced gastric carcinoma. A phase-II trail of the 'Chemotherapiegruppe Gastrointestinaler Tumoren (CGT)'.
abstract: In a phase II trial 46 patients with advanced gastric carcinoma were treated with FEM combination chemotherapy (5-fluorouracil, 4-epidoxorubicin and mitomycin C) in which 4-epidoxorubicin was administered by escalated dose and split course (FEM II). Twenty-nine patients with measurable disease were evaluable for response. One complete remission and 7 partial remissions were achieved, suggesting an overall response rate of 28%; 2 minimal responses (7%) and 9 patients with no change were observed (31%); 10 patients had tumor progression (34%). Median survival time for all patients was 6.2 months, for patients with CR + PR + MR 16.2 months, for patients with no change 8.4 months, and with tumor progression 3.5 months. WHO grade 2 and 3 leukopenia appeared in 6%, thrombocytopenia in 0% and alopecia in 27% of the patients after the first cycle. Nausea and vomiting grade 2 and 3 were seen in 21%. Comparing these results with our earlier data achieved with FEM I, FEM II showed a tendency towards better response and survival, and subjective toxicity (nausea/vomiting) was significantly reduced. Therefore, in our opinion FEM II is preferable for practical use.
authors.affiliation: Onkologisches Zentrum, Universität Heidelberg, Fakultät für Klinische Medizin, FRG.
authors.forename: W
authors.initials: W
authors.lastname: Queisser
authors.forename: H
authors.initials: H
authors.lastname: Flechtner
authors.forename: M E
authors.initials: ME
authors.lastname: Heim
authors.forename: K
authors.initials: K
authors.lastname: Kabelitz
authors.forename: B
authors.initials: B
authors.lastname: Massner
authors.forename: L
authors.initials: L
authors.lastname: Edler
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004341:Drug Evaluation; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005743:Gastrectomy; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin; D008937:Mitomycins / Q000008:administration & dosage; D015337:Multicenter Studies as Topic; D009362:Neoplasm Metastasis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery
chemical_list: D008937:Mitomycins; D015251:Epirubicin; D016685:Mitomycin; D005472:Fluorouracil