Randomized adjuvant study comparing two schemes of 5-fluorouracil and leucovorin in stage B2 and C colon adenocarcinoma: Study design and preliminary safety results

André, Thierry; Colin, Philippe; Louvet, Christophe; Gamelin, Érick; Bouché, Olivier; Achille, Emmanuel; Colbert, N; Boaziz, C.; Piedbois, Pascal; Tubiana-Mathieu, Nicole; Boutan-Laroze, Arnaud; Flesch, M.; Billiau, V.; Buyse, Marc

doi:10.1016/s0093-7754(01)90250-7

Cited by 13 publications

(3 citation statements)

References 19 publications

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“…A French study coordinated by GERCOR (Groupe d'Etude et de Recherche Clinique en Oncologie Radiotherapies) compared 2-weekly infused 5-FU/FA with bolus 5-FU/FA and a second randomisation to either 24 or 36 weeks of treatment. With 905 patients recruited, treatment was less toxic in the infused 5-FU/FA arm with significantly lower incidence of grades 3 and 4 neutropenia, diarrhoea and mucositis (Po0.001) (Andre et al, 2001). This is consistent with our study in which PVI 5-FU resulted in much better toxicity profile.…”

Section: Discussionsupporting

confidence: 90%

Twelve weeks of protracted venous infusion of fluorouracil (5-FU) is as effective as 6 months of bolus 5-FU and folinic acid as adjuvant treatment in colorectal cancer

et al. 2003

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We performed a multicentre randomised trial to compare the efficacy and toxicity of 12 weeks of 5-fluorouracil (5-FU) delivered by protracted intravenous infusion (PVI 5-FU) against the standard bolus regimen of 5-FU and folinic acid (5-FU/FA) given for 6 months as adjuvant treatment in colorectal cancer. A total of 716 patients with curatively resected Dukes' B or C colorectal cancer were randomised to 5-FU/FA (5-FU 425 mg m À2 i.v. and FA 20 mg m À2 i.v. bolus days 1 -5 every 28 days for 6 months) or to PVI 5-FU alone (300 mg m À2 day for 12 weeks). With a median follow-up of 19.8 months, 133 relapses and 77 deaths have been observed. Overall survival did not differ significantly (log rank P ¼ 0.764) between patients receiving 5-FU/FA and PVI 5-FU (3-year survival 83.2 vs 87.9%, respectively). Patients in the 5-FU/FA group had significantly worse relapse-free survival (RFS, log rank P ¼ 0.023) compared to those receiving PVI 5-FU (3-year RFS, 68.6 vs 80%, respectively). Grades 3 -4 neutropenia, diarrhoea, stomatitis and severe alopecia were significantly less (Po0.0001) and global quality of life scores significantly better (Po0.001) for patients in the PVI 5-FU treatment arm. In conclusion, infused 5-FU given over 12 weeks resulted in similar survival to bolus 5-FU and FA over a 6 month period, but with significantly less toxicity.

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Section: Discussionsupporting

confidence: 90%

Twelve weeks of protracted venous infusion of fluorouracil (5-FU) is as effective as 6 months of bolus 5-FU and folinic acid as adjuvant treatment in colorectal cancer

et al. 2003

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“…Use of radiation therapy in rectal cancer, and the patients keeping a diary may have increased the number of reported events in the present series. We administered 5-FU as true boluses with an approximate injection time of 3 min, which may be associated with more adverse events than short (about 15 min) infusions (Andre et al, 2001). We also included VAD-related adverse effects, though they were infrequent in comparison to some other series (Carde et al, 1989;Gleeson et al, 1993;Kock et al, 1998).…”

Section: Discussionmentioning

confidence: 99%

Lactobacillus supplementation for diarrhoea related to chemotherapy of colorectal cancer: a randomised study

et al. 2007

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5-Fluorouracil (5-FU)-based chemotherapy is frequently associated with diarrhoea. We compared two 5-FU-based regimens and the effect of Lactobacillus and fibre supplementation on treatment tolerability. Patients diagnosed with colorectal cancer (n ¼ 150) were randomly allocated to receive monthly 5-FU and leucovorin bolus injections (the Mayo regimen) or a bimonthly 5-FU bolus plus continuous infusion (the simplified de Gramont regimen) for 24 weeks as postoperative adjuvant therapy. On the basis of random allocation, the study participants did or did not receive Lactobacillus rhamnosus GG supplementation (1 -2 Â 10 10 per day) and fibre (11 g guar gum per day) during chemotherapy. Patients who received Lactobacillus had less grade 3 or 4 diarrhoea (22 vs 37%, P ¼ 0.027), reported less abdominal discomfort, needed less hospital care and had fewer chemotherapy dose reductions due to bowel toxicity. No Lactobacillus-related toxicity was detected. Guar gum supplementation had no influence on chemotherapy tolerability. The simplified de Gramont regimen was associated with fewer grade 3 or 4 adverse effects than the Mayo regimen (45 vs 89%), and with less diarrhoea. We conclude that Lactobacillus GG supplementation is well tolerated and may reduce the frequency of severe diarrhoea and abdominal discomfort related to 5-FU-based chemotherapy.

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“…Since no data showing su- perior efficacy or better tolerability of the NSABP regimen exist, for economical reasons, it should no longer be used for the few patients who are candidates for treatment with 5-FU/LV only. Instead, modern regimens, such as the 5-FU prodrug capecitabine, should clearly be preferred for this group of patients [13]. This oral fluoropyrimidine has been compared to the MAYO-Clinic regimen in a prospective randomized trial; it was not shown to be inferior with respect to efficacy and was associated with significantly fewer serious adverse events [14,15].…”

Section: Sensitivity Analysesmentioning

confidence: 99%

Adjuvant Chemotherapy for Colon Cancer – Analysis of Treatment Costs from the Perspective of Statutory Sickness Funds

Görner¹,

Riemer-Hommel²

2008

Z Gastroenterol

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From a health insurance perspective, substantial cost savings may be realised through the use of established chemotherapy regimens, if most patients are treated in the outpatient setting. In the outpatient setting, costs for drug prices are the main cost driver, so further savings could be realised for third-party payers if prices of chemotherapeutic drugs are reduced. For economic reasons, patients who are candidates for bolus 5-FU regimens, should not be treated according to the NSABP protocol. The MAYO-Clinic protocol is a low cost regimen in both settings, but for medical reasons alternative therapies such as capecitabine or infusional 5 FU protocols must be preferred in patients unable to tolerate the new standard FOLFOX-4.

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Randomized adjuvant study comparing two schemes of 5-fluorouracil and leucovorin in stage B2 and C colon adenocarcinoma: Study design and preliminary safety results

Cited by 13 publications

References 19 publications

Twelve weeks of protracted venous infusion of fluorouracil (5-FU) is as effective as 6 months of bolus 5-FU and folinic acid as adjuvant treatment in colorectal cancer

Twelve weeks of protracted venous infusion of fluorouracil (5-FU) is as effective as 6 months of bolus 5-FU and folinic acid as adjuvant treatment in colorectal cancer

Lactobacillus supplementation for diarrhoea related to chemotherapy of colorectal cancer: a randomised study

Adjuvant Chemotherapy for Colon Cancer – Analysis of Treatment Costs from the Perspective of Statutory Sickness Funds

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