Pegylated liposomal doxorubicin, 5-fluorouracil and cisplatin versus mitomycin-C, 5-fluorouracil and cisplatin for advanced gastric cancer: a randomized phase II trial.
OBJECTIVE
Clinical data suggested that a regimen incorporating doxorubicin to 5-fluorouracil (5-FU) and cisplatin may be more effective but probably quite toxic for advanced gastric cancer patients. With the aim to maintain efficacy while reducing toxicity, we compared the activity and safety of a combination of 5-FU, cisplatin and pegylated liposomal doxorubicin with a combination of 5-FU, cisplatin and mitomycin-C.


METHODS
Seventy-eight patients were randomised to receive 5-FU (400 mg/m(2) bolus, 600 mg/m(2) 22 h continuous infusion day 1 and 2) and cisplatin (50 mg/m(2) day 1) every 2 weeks, combined either with pegylated liposomal doxorubicin (20 mg/m(2) day 1 every two weeks) (arm A) or mitomycin-C (7 mg/m(2) every 6 weeks) (arm B).


RESULTS
The overall response rate was 64.1% in arm A and 38.5% in arm B (P = 0.041). The median time to tumour progression and overall survival were 7.93 and 5.14 months (P = 0.04) and 12.1 and 8.3 months (P = 0.02) in arm A and B, respectively. Fourteen patients in arm A and 18 patients in arm B experienced a grade 3/4 toxic effect.


CONCLUSIONS
A combination of pegylated liposomal doxorubicin, cisplatin and 5-FU can be safely administered in gastric cancer patients with a promising efficacy profile.
Cascinu
Stefano
S
Clinica di Oncologia Medica, AO Ospedali Riuniti, Università Politecnica delle Marche, Via Conca, 60020 Ancona, Italy. cascinu@yahoo.com
Galizia
Eva
E
Labianca
Roberto
R
Ferraù
Francesco
F
Pucci
Francesca
F
Silva
Rosa Rita
RR
Luppi
Gabriele
G
Beretta
Giordano Domenico
GD
Berardi
Rossana
R
Scartozzi
Mario
M
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000009:adverse effects / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D013270:Stomach; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D016685:Mitomycin; D004317:Doxorubicin; D002945:Cisplatin; D005472:Fluorouracil