Quality of life and survival with continuous hepatic-artery floxuridine infusion for colorectal liver metastases

Allen-Mersh, T G; Earlam, S; Fordy, C; Abrams, Keith R.; Houghton, Janet A.

doi:10.1016/s0140-6736(94)90750-1

Cited by 502 publications

(172 citation statements)

References 22 publications

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“…In the UK HAPT study (Allen-Mersh, 1994), patients were randomized to receive intra-arterial fluorouracildeoxyuridine (FUDR) via a totally implantable infusion device (Infusaid) or best supportive care; in the latter group, 20% of patients received systemic chemotherapy as palliation. Survival was significantly longer in the HAC group (median survival 405 vs 226 days).…”

Section: Discussionmentioning

confidence: 99%

A phase II study of regional 2-weekly 5-fluorouracil infusion with intravenous folinic acid in the treatment of colorectal liver metastases

Howell

McArdle²,

Kerr³

et al. 1997

Br J Cancer

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Summary Forty patients with unresectable colorectal metastases confined to the liver were evaluated in a phase 11 study. 5-Fluorouracil (5-FU) was delivered via a surgically placed hepatic artery catheter. Patients received folinic acid (200 mg m-2) intravenously over 2 h followed by a loading dose of intra-arterial 5-FU (400 mg m-2) over 15 min, then 5-FU (1600 mg m-2) by intra-arterial infusion over the following 22 h. This was repeated on day 2 and the whole schedule was repeated every 2 weeks. Response was assessed after six treatments. The median follow-up was 17 months. Overall response rate was 46% with 8% complete response. Estimated median survival is 19 months. Site of progression was the liver alone in 55%, liver and lung in another 16% and 29% in other sites. Eight patients experienced grade 3 or 4 toxicity. The response rate of this regimen compares favourably with reported trials of intra-arterial FUDR, and our schedule is currently being compared with a similar schedule of intravenous 5-FU and folinic acid in a randomized Medical Research Council trial (CR05).Keywords: colorectal cancer; liver metastases; chemotherapy; infusion intra-arterial Colorectal cancer is the second most common cause of cancer deaths in the UK. Approximately half of the patients undergoing apparently curative resection will die within 5 years because of recurrent disease, mostly with liver metastases; in 30% of these patients the liver will be the only site affected. Few patients are suitable for surgical treatment, most having multiple metastases affecting both lobes. Unfortunately, the results of conventional systemic chemotherapy have been disappointing. For example, single-agent 5-flourouracil (5-FU) has a response rate of approximately 10% (Blijham et al, 1996). Furthermore, although the addition of folinic acid (FA) to 5-FU has resulted in higher response rates, there remains doubt as to whether this translates into a survival benefit (Advanced Colorectal Cancer Meta-analysis Project, 1992).As most cytotoxic drugs have a steep dose-response curve, it is a basic pharmacokinetic principle that if one can increase drug delivery to a tumour then increased response rates can be achieved (Gamelin et al, 1995). An alternative approach to the therapy of liver metastases is therefore to deliver the drug intra-arterially. In the case of patients with liver metastases the arterial route of delivery is particularly appropriate as it has been shown that established liver metastases over 1 cm in diameter are mainly supplied by the hepatic artery (Breedis, 1954).We report our experience of an intra-arterial 5-FU-based regimen in patients with unresectable colorectal liver metastases. In this study, we combined three factors that, on the basis of pharmacological studies, have been shown to offer a therapeutic advantage, namely intra-arterial administration, infusional rather Received 17 February 1997 Revised 9 April 1997 Accepted 29April 1997 Correspondence to: JD Howell than bolus 5-FU therapy and modulation of 5-FU by high-dose ...

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Section: Discussionmentioning

confidence: 99%

A phase II study of regional 2-weekly 5-fluorouracil infusion with intravenous folinic acid in the treatment of colorectal liver metastases

Howell

McArdle²,

Kerr³

et al. 1997

Br J Cancer

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“…5-Fluorouracil (5-FU) is one of the cytostatic agents that, as a single agent (but in combination with folinic acid), produces response rates averaging 20% (Skibber et al, 2000); irinotecan, raltitrexed and oxaliplatin have in some studies achieved similar response rates (Cunningham et al, 1995;Becouarn et al, 1998;Diaz-Rubio et al, 1998;Saltz et al, 2000). 5-Fluorouracil leads to a modest survival benefit when compared to approaches such as best supportive care (Nodic Gastrointestinal Tumor Adjuvant Therapy Group, 1992;Allen-Mersh et al, 1994;Hafstrom et al, 1994). Moreover, chemotherapy delays the occurrence or progression of symptoms by 6 months and improves symptoms without severe toxicity in 40% (Nordic Gastrointestinal Tumor Adjuvant Therapy Group, 1992;Glimelius, 1993;Allen-Mersh et al, 1994).…”

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confidence: 99%

“…5-Fluorouracil leads to a modest survival benefit when compared to approaches such as best supportive care (Nodic Gastrointestinal Tumor Adjuvant Therapy Group, 1992;Allen-Mersh et al, 1994;Hafstrom et al, 1994). Moreover, chemotherapy delays the occurrence or progression of symptoms by 6 months and improves symptoms without severe toxicity in 40% (Nordic Gastrointestinal Tumor Adjuvant Therapy Group, 1992;Glimelius, 1993;Allen-Mersh et al, 1994). Standard palliative therapy is based on 5-FU/folinic acid combinations, with or without irinotecan or oxaliplatin, given intravenously.…”

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confidence: 99%

EORTC Early Clinical Studies Group early phase II trial of S-1 in patients with advanced or metastatic colorectal cancer

et al. 2003

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Cancer of the colon and rectum is one of the most frequent malignancies both in the US and Europe. Standard palliative therapy is based on 5-fluorouracil/folinic acid combinations, with or without oxaliplatin or irinotecan, given intravenously. Oral medication has the advantage of greater patient convenience and acceptance and potential cost savings. S-1 is a new oral fluorinated pyrimidine derivative. In a nonrandomised phase II study, patients with advanced/metastatic colorectal cancer were treated with S-1 at 40 mg m À2 b.i.d. for 28 consecutive days, repeated every 5 weeks, but by amendment the dose was reduced to 35 mg m À2 during the study because of a higher than expected number of severe adverse drug reactions. In total 47 patients with colorectal cancer were included. In the 37 evaluable patients there were nine partial responses (24%), 17 stable diseases (46%) and 11 patients had progressive disease (30%). Diarrhoea occurred frequently and was often severe: in the 40 and 35 mg m À2 group, respectively, 38 and 35% of the patients experienced grade 3 -4 diarrhoea. The other toxicities were limited and manageable. S-1 is active in advanced colorectal cancer, but in order to establish a safer dose the drug should be subject to further investigations.

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“…They had a total of 614 patients comparing chemotherapy to an initial observation arm in patients with metastatic colorectal cancer (Hine and Dykes, 1984;Nordic Gastrointestinal Tumour Adjuvant Therapy Group (NGTATG), 1992;Rougier et al, 1992;Scheithauer et al, 1993;Allen-Mersh et al, 1994;Hafstrom et al, 1994;Glimelius et al, 1995). These are listed in Table 1, along with a brief description of treatment schedules.…”

Section: Trials Selectedmentioning

confidence: 99%

Survival benefit of chemotherapy in metastatic colorectal cancer: a meta-analysis of randomized controlled trials

2000

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SummaryTo estimate the magnitude of benefit of chemotherapy in prolonging survival for patients with metastatic colorectal cancer, a metaanalysis of randomized controlled trial was performed. A systematic search was performed to identify randomized trials comparing chemotherapy with observation or supportive care alone. Trials were assessed for quality of reporting, publication bias and heterogeneity. Relative risks for outcomes from published data were pooled using a random-effects model. Seven trials with 614 patients were included. All trials used fluoropyrimidine-based chemotherapy, through a variety of routes and schedules, including intravenous, intra-portal and hepatic arterial infusion. Compared with the 'no-chemotherapy' arm, chemotherapy significantly reduced 1-year mortality (risk ratio 0.69; 95% confidence interval (CI) 0.60-0.81, P < 0.00001). The mortality at 2 years was not significantly different (risk ratio 0.93; 95% CI 0.87-1.00, P = 0.053). Between-trial comparisons demonstrated benefit with a variety of routes and schedules. Chemotherapy significantly prolongs 1-year survival for patients with metastatic colorectal cancer, and should be offered to those with good performance status.

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Quality of life and survival with continuous hepatic-artery floxuridine infusion for colorectal liver metastases

Cited by 502 publications

References 22 publications

A phase II study of regional 2-weekly 5-fluorouracil infusion with intravenous folinic acid in the treatment of colorectal liver metastases

A phase II study of regional 2-weekly 5-fluorouracil infusion with intravenous folinic acid in the treatment of colorectal liver metastases

EORTC Early Clinical Studies Group early phase II trial of S-1 in patients with advanced or metastatic colorectal cancer

Survival benefit of chemotherapy in metastatic colorectal cancer: a meta-analysis of randomized controlled trials

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