TY - JOUR
T1 - Safety of cisplatin combined with continuous 5-FU versus bolus 5-FU and leucovorin, in metastatic gastrointestinal cancer (FFCD 9404 randomised trial)
AU - Duffour, Jacqueline
AU - Bouché, Olivier
AU - Rougier, Philippe
AU - Milan, Chantal
AU - Bedenne, Laurent
AU - Seitz, Jean François
AU - Buecher, Bruno
AU - Legoux, Jean Louis
AU - Ducreux, Michel
AU - Vetter, Denis
AU - Raoul, Jean Luc
AU - François, Eric
AU - Ychou, Marc
PY - 2006/9/1
Y1 - 2006/9/1
N2 - Background: The objective of this phase III study was to compare the safety and efficacy of FLP (modulation of 5-FU (Fluorouracil) by folinic acid or leucovorin (LV) and cisplatin vs. FP (5-FU combined with Cisplatin) as a first line chemotherapy in advanced oesophageal, gastric and pancreatic cancer. Patients and Methods: 232 patients with measurable lesions were randomised to receive at the first cycle either FP (arm A: 5-FU 800 mg/m2/d in continuous infusion 5 days and cisplatin 100 mg/m2 on day 1 or 2), or FLP (arm B: LV, 100 mg/m2/d in bolus 5 days, followed by 5-FU 350 mg/m2/d in 1 h infusion 5 days and cisplatin 100 mg/m2 on day 1 or 2). In case of no grade 3-4 haematological and diarrhoea toxicity, the dose of 5-FU was increased to 1,000 mg/m2/d and 400 mg/m 2/d in the two arms respectively, for the subsequent cycles until disease progression. Results: The distribution of primary tumours was: 19 squamous cell carcinoma of the oesophagus, 19 oesophageal adenocarcinoma, 91 gastric and 97 pancreatic adenocarcinoma. Safety remained acceptable and comparable in the two arms except for the severe grade 3-4 mucositis, which was lower in arm B (4.5 vs. 16.4%, p<0.009). Efficacy in terms of tumour response and survival was similar in the two arms, showing an objective response rate (after external review) of 18.6% (95% confidence interval (CI) 11.4-25.8%) in arm A vs. 15% (95% CI 8.5-21.6%) in arm B, an overall median survival of 24 weeks in arm A vs. 24.7 in arm B (p=0.83) and a progression-free median survival of 12.4 weeks vs. 12.1 in arms A and B, respectively (p=0.91). Conclusion: The FLP regimen is substantially equivalent to FP in terms of safety and quality of life, as well as for antitumour efficacy in these carcinomas; the only slight advantage of FLP in this study concerns mucositis. Based on these results, FLP could be used as an alternative to FP when appropriate.
AB - Background: The objective of this phase III study was to compare the safety and efficacy of FLP (modulation of 5-FU (Fluorouracil) by folinic acid or leucovorin (LV) and cisplatin vs. FP (5-FU combined with Cisplatin) as a first line chemotherapy in advanced oesophageal, gastric and pancreatic cancer. Patients and Methods: 232 patients with measurable lesions were randomised to receive at the first cycle either FP (arm A: 5-FU 800 mg/m2/d in continuous infusion 5 days and cisplatin 100 mg/m2 on day 1 or 2), or FLP (arm B: LV, 100 mg/m2/d in bolus 5 days, followed by 5-FU 350 mg/m2/d in 1 h infusion 5 days and cisplatin 100 mg/m2 on day 1 or 2). In case of no grade 3-4 haematological and diarrhoea toxicity, the dose of 5-FU was increased to 1,000 mg/m2/d and 400 mg/m 2/d in the two arms respectively, for the subsequent cycles until disease progression. Results: The distribution of primary tumours was: 19 squamous cell carcinoma of the oesophagus, 19 oesophageal adenocarcinoma, 91 gastric and 97 pancreatic adenocarcinoma. Safety remained acceptable and comparable in the two arms except for the severe grade 3-4 mucositis, which was lower in arm B (4.5 vs. 16.4%, p<0.009). Efficacy in terms of tumour response and survival was similar in the two arms, showing an objective response rate (after external review) of 18.6% (95% confidence interval (CI) 11.4-25.8%) in arm A vs. 15% (95% CI 8.5-21.6%) in arm B, an overall median survival of 24 weeks in arm A vs. 24.7 in arm B (p=0.83) and a progression-free median survival of 12.4 weeks vs. 12.1 in arms A and B, respectively (p=0.91). Conclusion: The FLP regimen is substantially equivalent to FP in terms of safety and quality of life, as well as for antitumour efficacy in these carcinomas; the only slight advantage of FLP in this study concerns mucositis. Based on these results, FLP could be used as an alternative to FP when appropriate.
KW - 5-fluorouracil
KW - Cisplatin
KW - Gastrointestinal cancer
KW - Metastases
UR - http://www.scopus.com/inward/record.url?scp=33750831270&partnerID=8YFLogxK
M3 - Article
C2 - 17094417
AN - SCOPUS:33750831270
SN - 0250-7005
VL - 26
SP - 3877
EP - 3883
JO - Anticancer Research
JF - Anticancer Research
IS - 5 B
ER -