A prospective randomized comparison of protracted infusional 5-fluorouracil with or without weekly bolus cisplatin in metastatic colorectal carcinoma: a Mid-Atlantic Oncology Program study

Article Abstract:

Previous research has indicated that the slow, continuous infusion of 5-fluorouracil in the treatment of advanced colorectal cancer is more effective in producing responses than is the administration of the drug in single boluses. While a response rate of 30 percent was observed among the patients given protracted infusional 5-fluorouracil (PIF) and only a seven percent response rate observed among the patients receiving bolus injections, the advantage in response rate did not produce a statistically significant improvement in survival. While the PIF patients achieved greater survival at 18 and 24 months, the difference did not achieve statistical significance. In order to fine-tune the chemotherapeutic treatment of advanced colorectal cancer, the researchers have now evaluated the effects of adding a weekly bolus of cisplatin to the continuous infusion of 5-fluorouracil. A total of 184 patients with advanced metastatic colorectal cancer, never treated before with chemotherapy, were given the protracted infusion of 5-fluorouracil at 300 milligrams per meter squared of body area per day for 10 weeks. The patients were randomly assigned to receive or not receive cisplatin in addition to this treatment; each week, some patients also received a bolus of 20 milligrams per meter squared cisplatin. Of the patients who were fully evaluable for response and survival, 85 received both drugs while 83 received 5-fluorouracil alone. The results were almost identical for the two groups. Thirty-five percent of the patients in the 5-fluorouracil-only arm responded to treatment; 33 percent of those receiving both drugs responded. Likewise, the median survival of the patients receiving 5-fluorouracil was 11.8 months; for the patients receiving 5-fluorouracil and cisplatin, the median survival was 11.3 months. The results indicate that the addition of cisplatin to the chemotherapeutic regimen provides no benefit to the patients. The authors suggest that research efforts might be better spent determining dosage schedules of 5-fluorouracil which provide maximum effect. (Consumer Summary produced by Reliance Medical Information, Inc.)

Usage, Intravenous therapy

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Treatment of patients with advanced colorectal cancer with cisplatin, 5-fluorouracil, and leucovorin

Article Abstract:

The response of colorectal cancer to chemotherapy is generally disappointing. Many alternative chemotherapeutic strategies have been tried, but with quite limited success. One alternative treatment strategy is the addition of leucovorin to chemotherapy with 5-fluorouracil. Leucovorin is metabolized to 5,10-methylenetetrahydrofolate, which inhibits the enzyme thymidylate synthase; this inhibition increases the effectiveness of the 5-fluorouracil. Nevertheless, complete remissions with this protocol have been rare, and the partial responses have been short-lasting. Furthermore, the gastrointestinal toxicity has been considerable and may result in life-threatening diarrhea in elderly patients. It might be possible to improve the success of this chemotherapeutic regimen by adding another chemotherapeutic agent that is known to increase the effectiveness of 5-fluorouracil. Cisplatin is such a drug; and a study of 59 patients with advanced inoperable colorectal cancer was devised to evaluate the effectiveness of the combination of cisplatin, 5-fluorouracil, and leucovorin. Of the 59 patients treated, three achieved complete responses and 17 had partial responses for an objective response rate of 34 percent. An additional 16 patients had their disease stabilized. The average survival was just short of one year. At one year, 40 percent of the patients were alive, and 15 percent were alive at two years. The toxicity of the chemotherapeutic regimen was moderate, and no cases of life-threatening toxicity were encountered. The results indicate that the combined regimen of cisplatin, 5-fluorouracil, and leucovorin is well-tolerated, safe, and effective in treating patients with advanced colorectal cancer. (Consumer Summary produced by Reliance Medical Information, Inc.)

Dosage and administration, Leucovorin, Folinic acid

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Continuous infusion 5-fluorouracil plus weekly cisplatin for pancreatic carcinoma: a Mid-Atlantic Oncology Program study

Article Abstract:

Adenocarcinoma (cancer) of the pancreas affects close to 30,000 Americans each year, and about 25,000 of these will die of this disease. Unfortunately, for the patients whose cancer is not detected early enough for surgery to be an option, the prospects are bleak. Effective chemotherapy does not exist. Several agents are known which can yield a response rate between 10 and 20 percent; one of these is 5-fluorouracil. However, attempts to improve this performance by using combination chemotherapy have not yet led to a consistently superior regimen. Several experiments have suggested that cisplatin may exert additive effects with 5-fluorouracil, so an attempt was made to evaluate a treatment protocol using these two agents. The 5-fluorouracil was administered to 56 patients with pancreatic cancer in a slow continuous infusion for 10 weeks. This treatment was augmented by small weekly doses of cisplatin. After two weeks of rest, the 10-week cycle began again. Eight patients achieved responses to therapy; the responses were complete for two patients. The median duration of the response was 5.8 months, which, although short, is superior to the results reported for other chemotherapeutic regimens. Similarly, 26 percent of the patients were alive after one year, an improvement over the survival published in other reports of pancreas cancer. While these results seem to indicate that the combination of continuous 5-fluorouracil and weekly cisplatin may be an improvement over existing chemotherapeutic protocols, it cannot be ruled out that the patients in the present study were more robust to start with than the patients who participated in previous studies reporting inferior results. (Consumer Summary produced by Reliance Medical Information, Inc.)

Pancreatic cancer

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