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Phase II study of irinotecan with bolus and high dose infusional 5-FU and folinic acid (modified de Gramont) for first or second line treatment of advanced or metastatic colorectal cancer

Leonard, P; Seymour, MT; James, R; Hochhauser, D; Ledermann, JA; (2002) Phase II study of irinotecan with bolus and high dose infusional 5-FU and folinic acid (modified de Gramont) for first or second line treatment of advanced or metastatic colorectal cancer. BRIT J CANCER , 87 (11) 1216 - 1220. 10.1038/sj.bjc.6606641.

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Abstract

We investigated the activity of irinotecan given with a more convenient modified bimonthly de Gramont regimen of bolus and infusional 5-fluorouracil [IrMdG] in advanced or metastatic colorectal cancer in the first and second line setting, Irinotecan 180 mg m(-2) was infused over 90 min. L-folinic acid 175 mg or d,1 folinic acid 350 mg was given over 2 h followed by a bolus of 5-fluorouracil (400 mg m(-2)) and a 46 h continuous infusion of 5-fluorouracil (2.4-2.8 g m(-2)). Forty-six previously untreated patients (Group A) and 36 who had received 5-fluorouracil for metastatic disease (Group B) were recruited. Seventy-eight patients were evaluable for response. A partial response was seen in 13 out of 43 (30% [95%CI 28.1 - 31.9%]) in Group A and 8/35 (23% [95% CI 17.9 - 28.1%]) in Group B. 40% (95%CI 38.1 - 41.9%) of Group A and 26% (95% Cl 20.9 - 31.1%) of Group B patients achieved disease stabilisation. The median progression free survival from the start of this treatment was 7 months (95% CI 4.4 - 9.6 months) in Group A and 5 months (95% CI 2.8 - 7.2 months) in Group B. Median overall survival was 14 months (95% CI 9.0 - 18.9) in Group A and 11 months (95% CI 5.9 - 16.1) in Group B. Grade 3 - 4 toxicity in both treatment groups were similar, leucopenia 17% and diarrhoea 7 - 8%. Grade 3 - 4 mucositis was not seen and severe alopecia affected only three patients. IrMdG is an active and well-tolerated regimen for both the first and second line treatment of advanced colorectal cancer. (C) 2002 Cancer Research UK.

Type: Article
Title: Phase II study of irinotecan with bolus and high dose infusional 5-FU and folinic acid (modified de Gramont) for first or second line treatment of advanced or metastatic colorectal cancer
DOI: 10.1038/sj.bjc.6606641
Keywords: colorectal cancer, irinotecan, 5-fluorouracil (5-FU), irinotecan and 5-FU combination therapy, MULTICENTER RANDOMIZED-TRIAL, BIMONTHLY LEUCOVORIN, CPT-11 IRINOTECAN, FLUOROURACIL, 5-FLUOROURACIL, REGIMEN, OXALIPLATIN, CARCINOMA
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > CRUK Cancer Trials Centre
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Oncology
URI: http://discovery.ucl.ac.uk/id/eprint/120013
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