Pegylated liposomal doxorubicin, 5-fluorouracil and cisplatin versus mitomycin-C, 5-fluorouracil and cisplatin for advanced gastric cancer: a randomized phase II trial.

Author(s): Cascinu S, Galizia E, Labianca R, Ferrau F, Pucci F, Silva RR, Luppi G, Beretta GD, Berardi R, Scartozzi M

Affiliation(s): Clinica di Oncologia Medica, AO Ospedali Riuniti, Universita Politecnica delle Marche, Via Conca, 60020 Ancona, Italy. cascinu@yahoo.com

Publication date & source: 2011-07, Cancer Chemother Pharmacol., 68(1):37-43. Epub 2010 Sep 7.

Publication type: Clinical Trial, Phase II; Comparative Study; Multicenter Study; Randomized Controlled Trial

PURPOSE: 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. PATIENTS AND 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.