S. Kikuyama et al., PHASE-II STUDY OF 5-FLUOROURACIL, PIRARUBICIN AND LOW-DOSE CONSECUTIVE ADMINISTRATION OF CISPLATIN FOR ADVANCED AND RECURRENT GASTRIC-CANCER, Japanese Journal of Clinical Oncology, 28(5), 1998, pp. 314-317
Background: The FAP regimen was modified and low-dose consecutive dail
y administration of cisplatin (CDDP) and continuous infusion of 5-fluo
rouracil (5-FU) and pirarubicin were employed to reduce the toxicity a
nd achieve synergy. Patients with advanced and recurrent gastric cance
r were treated with this regimen as early phase II trial and its effic
acy and toxicity were assessed. Methods: Twenty-nine patients with adv
anced or recurrent gastric cancer were treated with intravenous 5-FU,
360 mg/m(2), continuous infusion, on days 1-5 and 8-12, CDDP, 10 mg/bo
dy, drip infusion, on days 1-5 and 8-12 and pirarubicin, 20 mg/body, o
n days 1 and 8, which was repeated every 4 weeks. Results: One complet
e (CR) and 10 partial (PR) responses were observed, Eleven patients sh
owed no change (NC) and seven had progressive disease (PD), The overal
l response rate (CR and PR) was 37.9%. The response rates of lymph nod
e metastatic lesions and primary gastric lesions were 47 and 44%, resp
ectively. The major toxicity was bone marrow suppression, which was we
ll tolerated. Grade 3/4 nausea/vomiting did not occur. The median surv
ival of all patients was 30 weeks, that of those who responded was 48
weeks and that of those showing NC or PD was 24 weeks. Conclusions: Th
is modified FAP regimen was considered useful with a moderate response
and less severe toxicity, but further investigation is necessary.