Phase III trial of bolus 5-fluorouracil (5-FU)/folinic acid (FA) (MAYO) vs. weekly oxaliplatin (OXA) plus high dose 24h 5-FU infusion/FA in patients with advanced colorectal cancer (CRC)

Grothey, Axel; Buechele, T.; Kroening, Hendrik; Ridwelski, K.; Reichardt, Peter; Kretzschmar, Albrecht; Clemens, M.; Schmoll, H.-J.

doi:10.1016/s0959-8049(01)81446-5

Cited by 90 publications

(65 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…However, in contrast to studies with the FOLFOX-6 regimen, where 21% of patients reported functional impairment caused by sensory neuropathy with a median administered oxaliplatin dose of 900 mg m À2 (Louvet et al, 2002a), the intensity of neuropathy observed in our trial, where the median dose of oxaliplatin was 800 mg m À2 , did not exceed mild to moderate grades. This observation corresponds well with the recently reported low rate of severe neuropathy with the weekly FUFOX regimen in stage IV colorectal cancer (Grothey et al, 2002). These observations indicate that weekly application of lower doses of oxaliplatin may have advantages compared with biweekly oxaliplatin-regimens in terms of neurotoxicity.…”

Section: Efficacysupporting

confidence: 91%

“…Compared with the other oxaliplatin/5-FU regimens studied in gastric cancer, the rate of severe diarrhoea was relatively high (17%) in our study. However, this is comparable with recently reported findings with the FUFOX regimen in metastatic colorectal cancer, where grade 3/4 diarrhoea affected 21% of patients (Grothey et al, 2002). It would be worthwhile to investigate whether administering a lower dose of FA, which can itself cause diarrhoea, would reduce this rate.…”

Section: Efficacysupporting

confidence: 89%

“…The weekly application of oxaliplatin plus infusional 5-FU/FA (FUFOX), as proposed by the Arbeitsgemeinschaft Internistische Onkologie (AIO), has proven to be highly effective in first-line metastatic colorectal cancer. The AIO FUFOX regimen is also associated with an acceptable toxicity profile, with a particularly low rate of sensory neuropathy (Grothey et al, 2002).…”

mentioning

confidence: 99%

See 2 more Smart Citations

Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer

et al. 2005

View full text Add to dashboard Cite

Oxaliplatin plus fluorouracil/folinic acid (5-FU/FA) every 2 weeks has shown promising activity in advanced gastric cancer. This study assessed the efficacy and safety of weekly oxaliplatin plus 5-FU/FA (FUFOX regimen) in the metastatic setting. Patients with previously untreated metastatic gastric cancer received oxaliplatin (50 mg m À2 ) plus FA (500 mg m À2 , 2-h infusion) followed by 5-FU (2000 mg m À2 , 24-h infusion) given on days 1, 8, 15 and 22 of a 5-week cycle. The primary end point of this multicentre phase II study was the response rate according to RECIST criteria. A total of 48 patients were enrolled. Median age was 62 years and all patients had metastatic disease, with a median number of three involved organs. The most common treatment-related grade 3/4 adverse events were diarrhoea (17%), deep vein thrombosis (15%), neutropenia (8%), nausea (6%), febrile neutropenia (4%), fatigue (4%), anaemia (4%), tumour bleeding (4%), emesis (2%), cardiac ischaemia (2%) and pneumonia (2%). Grade 1/2 sensory neuropathy occurred in 67% of patients but there were no episodes of grade 3 neuropathy. Intent-to-treat analysis showed a response rate of 54% (95% CI, 39 -69%), including two complete responses. At a median follow-up of 18.1 months (range 11.2 -26.2 months), median survival is 11.4 months (95% CI, 8.0 -14.9 months) and the median time to progression is 6.5 months (95% CI, 3.9 -9.2 months). The weekly FUFOX regimen is well tolerated and shows notable activity as first-line treatment in metastatic gastric cancer.

show abstract

Section: Efficacysupporting

confidence: 91%

Section: Efficacysupporting

confidence: 89%

mentioning

confidence: 99%

See 1 more Smart Citation

Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer

et al. 2005

View full text Add to dashboard Cite

show abstract

“…Although the Tournigand trial (Tournigand et al, 2001) reported impressive median survival, this may have been because of patient selection as a first-line single-agent control arm was not included. Two further trials reported at ASCO this year (Goldberg et al, 2002;Grothey et al, 2002) do not clarify the situation owing to their design, for example comparing infusional 5FU/FA+oxaliplatin with bolus 5FU/FA+irinotecan.…”

Section: External Evidencementioning

confidence: 99%

Combination chemotherapy for advanced colorectal cancer

2003

View full text Add to dashboard Cite

“…This combination achieves response rates of 18 -22% and overall survivals of 12 -15 months (de Gramont et al, 2000;Maiello et al, 2000). Combinations using newer agents such as irinotecan and oxaliplatin achieve higher response rates of up to 50% and longer median overall survivals (Douillard et al, 2000;Saltz et al, 2000;Grothey et al, 2002). However, the newer agents, especially in combination with 5FU/FA, are associated with greater toxicity, which may be severe and dose-limiting.…”

mentioning

confidence: 99%

Combination chemotherapy in advanced gastrointestinal cancers: ex vivo sensitivity to gemcitabine and mitomycin C

et al. 2003

View full text Add to dashboard Cite

Advanced or metastatic disease is common in both oesophagogastric and colorectal cancers, with poor 5-year survival despite palliative chemotherapy. We have investigated the sensitivity of gastrointestinal tumours to gemcitabine in combination with mitomycin C (GeM), using a modified ex vivo ATP-based tumour chemosensitivity assay (ATP-TCA). Tumour material from 41 colorectal and 22 oesophagogastric cancers were assessed. The GeM combination showed variable but definite activity in most of the samples tested. The results show that GeM achieves 495% inhibition at concentrations within the range achievable clinically in 60% of colorectal tumours (21 out of 35) and 38% of oesophagogastric tumours (five out of 13) tested. We did not identify any significant difference in sensitivity using concurrent or sequential exposure of tumour-derived cells to these two drugs. The results from this study suggest that GeM may be a useful combination in the treatment of advanced gastrointestinal malignancy.

show abstract

Phase III trial of bolus 5-fluorouracil (5-FU)/folinic acid (FA) (MAYO) vs. weekly oxaliplatin (OXA) plus high dose 24h 5-FU infusion/FA in patients with advanced colorectal cancer (CRC)

Cited by 90 publications

References 0 publications

Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer

Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer

Combination chemotherapy for advanced colorectal cancer

Combination chemotherapy in advanced gastrointestinal cancers: ex vivo sensitivity to gemcitabine and mitomycin C

Contact Info

Product

Resources

About