Combination 5-fluorouracil (FU), folinic acid (FA), and alpha-interferon 2B in advanced gastric cancer: results of a phase II trial.
BACKGROUND
Based on encouraging treatment results with FU/FA or FU/IFN in gastrointestinal tract cancer, a phase II study was conducted to evaluate the effects and toxicity of combination FU/FA/IFN in patients (pts) with inoperable/metastatic gastric cancer.


METHODS
IFN 6 M.U. s.c. 1 x/week, FU 500 mg/m2 bolus i.v. 1 x/week and FA 500 mg/m2 1 x/week as a 2-hour infusion. Of 72 treated pts, 72 (22 females, 50 males) are evaluable for response and toxicity. Median age was 55.6 years (28-80), and median Karnofsky performance status was 80% (70-100). Sites of measurable disease were inoperable primary tumors/local recurrence (18), liver metastasis (22), lymph nodes (31) and peritoneum (20). One pt had bone marrow metastasis and another had paraneoplastic hyperfibrinolytic coagulopathy.


RESULTS
10/72 pts had complete response, 20/72 pts partial response, 40/72 pts tumor stabilization and 2/72 pts progressive disease. The median duration of response (CR/PR) was 9 months, the median progression-free interval 6 months, the median survival time was 9 months, and for responding patients (CR/PR) 12.5 months.


RESULTS
1/72 pts had WHO grade 4 toxicity (diarrhea), 5/72 pts had WHO grade 3 toxicity (nausea 1, diarrhea 4). Except for 1 treatment-limiting grade 4 toxicity, no modifications of dose or schedule due to toxicity were required. Thirty-six of 44 pts experienced a significant reduction in tumor-related pain under treatment.


CONCLUSIONS
Biochemical modulation of FU with FA and IFN is effective in advanced gastric cancer. Moderate toxicity, outpatient treatment setting and high rates of amelioration tumor-related pain contribute to an effective palliation.
Jäger
E
E
II. Medizinische Klinik, Krankenhaus Nordwest, Frankfurt, Germany.
Bernhard
H
H
Klein
O
O
Wächter
B
B
Theiss
F
F
Dippold
W
W
Meyer zum Büschenfelde
K H
KH
Knuth
A
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D059408:Pain Management; D010166:Palliative Care; D011788:Quality of Life; D011994:Recombinant Proteins; D012074:Remission Induction; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome
D007155:Immunologic Factors; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D002955:Leucovorin; D005472:Fluorouracil