TY - JOUR
T1 - Epidoxorubicin and double biochemical 5-fluorouracil modulation with folinic acid and human lymphoblastoid interferon in advanced gastric carcinoma
T2 - A multicentric phase II study of the Southern Italy Oncology Group (GOIM)
AU - Colucci, Giuseppe
AU - Maiello, Evaristo
AU - Gebbia, Vittorio
AU - Cifarelli, Rosaria Alba
AU - Biglietto, Maria
AU - Pedicini, Antonio
AU - Durini, Ernesto
AU - Giuliani, Francesco
AU - Gebbia, Nicolò
PY - 1996/7
Y1 - 1996/7
N2 - In our previous randomized trial of advanced gastric cancer patients, the addition of epirubicin (EPI) to 5-fluorouracil (FU) with folinic acid (FA) resulted in an improved response rate and survival in the responder patients. Preclinical studies also showed an enhancement of FU and anthracyclines with interferon. To evaluate the possibility of human lymphoblastoid interferon (IFN) to enhance the therapeutic activity of the FA-FU + EPI combination regimen, 39 advanced gastric cancer patients received: FU at 375 mg/m
2 i.v. immediately after FA (I-isomer form) at 100 mg/m
2 i.v. for 5 consecutive days; EPI at 60 mg/m
2 i.v. on day 1, and IFN 3 MU s.c. for 7 consecutive days, starting 2 days before the FA-FU administration. Thirty-seven patients were evaluable for response and toxicity. Twelve partial responses were observed with an overall response rate of 32% (95% CI, 17-48%). The median response duration was 6 months, and the median survival time was 8 months. Toxicity was mild and no grade 4 side effects or treatment-related deaths were observed. However, the addition of IFN to the FA-FU + EPI regimen did not improve response, duration of response or survival.
AB - In our previous randomized trial of advanced gastric cancer patients, the addition of epirubicin (EPI) to 5-fluorouracil (FU) with folinic acid (FA) resulted in an improved response rate and survival in the responder patients. Preclinical studies also showed an enhancement of FU and anthracyclines with interferon. To evaluate the possibility of human lymphoblastoid interferon (IFN) to enhance the therapeutic activity of the FA-FU + EPI combination regimen, 39 advanced gastric cancer patients received: FU at 375 mg/m
2 i.v. immediately after FA (I-isomer form) at 100 mg/m
2 i.v. for 5 consecutive days; EPI at 60 mg/m
2 i.v. on day 1, and IFN 3 MU s.c. for 7 consecutive days, starting 2 days before the FA-FU administration. Thirty-seven patients were evaluable for response and toxicity. Twelve partial responses were observed with an overall response rate of 32% (95% CI, 17-48%). The median response duration was 6 months, and the median survival time was 8 months. Toxicity was mild and no grade 4 side effects or treatment-related deaths were observed. However, the addition of IFN to the FA-FU + EPI regimen did not improve response, duration of response or survival.
KW - Fluorouracil
KW - Folinic acid
KW - Gastric carcinoma
KW - Interferon
UR - http://www.scopus.com/inward/record.url?scp=0030004762&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0030004762&partnerID=8YFLogxK
M3 - Article
C2 - 8692529
AN - SCOPUS:0030004762
VL - 53
SP - 269
EP - 274
JO - Oncology
JF - Oncology
SN - 0030-2414
IS - 4
ER -