A Prospective Randomized Trial of Continuous Infusion 5-Fluorouracil (5-FU) Versus 5-FU Plus Cisplatin in Patients with Advanced Colorectal Cancer A Trial of the Spanish Cooperative Group for Digestive Tract Tumor Therapy (T.T.D.)

Dı́az-Rubio, Eduardo; Jimeno, J.; Antón, A.; Aranda, Enrique; Sánchez, Juan Cristóbal; Massuti, B.; Cruz-Hernández, Juan J.; Carrato, Alfredo; Martin, Mike G.; Belon, J.; González, Rosendo Bugarín; Millà, A.; Sanchiz, F.; Balañá, C.; Lizón, J.; Díaz-Faes, J; Alonso, A.; A, Navarrete; Ortiz, J.; Camps, Carme; Moral, F. del

doi:10.1097/00000421-199202000-00011

Cited by 16 publications

(9 citation statements)

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“…In these studies, the mean response rates achieved by patients who had previously received chemotherapy were 3% and 2% for CDDP and CBDCA, respectively. Moreover, combination treatment with 5-FU and cisplatin did not produce a greater response rate than that observed with 5-FU given as a single agent [10].…”

Section: Discussionmentioning

confidence: 72%

Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines

Machover¹,

Dı́az-Rubio²,

Gramont³

et al. 1996

Annals of Oncology

355

126

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SummaryBackground: Oxaliplatin (L-OHP) is a platinum complex that possesses activity against human and murine cells in vitro and in vivo, including colorectal carcinoma-derived cell lines, and cells that have been selected for resistance to cisplatin. We report two consecutive phase II trials of L-OHP for treatment of patients with advanced colorectal carcinoma.Patients and methods: Fifty-eight patients were entered in study I, and 51 patients in study II. All of the patients had tumor progression when they were treated, prior to their enrolment, with a fluoropyrimidine-containing regimen. In both trials treatment consisted of L-OHP, 130 mg/m 2 , by i.v. infusion for two hours; the treatment was repeated every 21 days.Results: Response to therapy: Study I: Fifty-five patients were assessed for response. The response rate was 11% (95% CI, 0.03-0.19). Study II: All 51 patients were assessed for response. The response rate was 10% (95% CI, 0.017-0.18).

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Section: Discussionmentioning

confidence: 72%

Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines

Machover¹,

Dı́az-Rubio²,

Gramont³

et al. 1996

Annals of Oncology

355

126

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“…In the rst study, with 122 patients, uorouracil:cisplatin provided a signicantly greater objective response rate (25% vs 3%; p ¾ 0.001) with increased toxicity, but no improvement in overall survival (10 vs 12 months) (106). In the second trial, 160 patients were entered (107). The overall response rates in the combination and in the single arm were 18% and 23%, respectively.…”

Section: Fluorouracil In Combination With Cisplatinmentioning

confidence: 99%

A Systematic Overview of Chemotherapy Effects in Colorectal Cancer

et al. 2001

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A systematic review of chemotherapy trials in several tumour types was performed by The Swedish Council of Technology Assessment in Health Care (SBU). The procedures for the evaluation of the scientific literature are described separately (Acta Oncol 2001; 40: 155-65). This synthesis of the literature on adjuvant and palliative therapy with cytostatics for colorectal cancer is based on 208 scientific articles, including eight meta-analyses and 162 randomised studies. These studies involve approximately 126,800 patients. The conclusions reached can be summarized into the following points: The benefit of postoperative adjuvant chemotherapy with fluorouracil and levamisole in patients with colon cancer stage Dukes' C was demonstrated more than ten years ago in two phase III trials. There was a reduction of recurrence from 56% to 39% and reduction of death from 51% to 40% after more than five years of follow-up. Although this combination has been widely accepted as standard adjuvant treatments for stage Dukes' C colon cancer, there is still debate on whether adjuvant treatment with fluorouracil alone would be equally efficacious. Several phase III trials with postoperative adjuvant chemotherapy with fluorouracil and leucovorin in patients with colon cancer stage Dukes' C have demonstrated a similar statistically significant improvement in disease-free and overall survival in comparison with a control arm. Six months of treatment with fluorouracil and leucovorin is as efficient as twelve months of fluorouracil and levamisole. This treatment is, thus, recommended for routine use. No convincing benefit from adjuvant chemotherapy is proven in colon cancer stage Dukes' B although some randomised trials have shown the same relative survival gain as seen in stage Dukes' C. There is less knowledge on survival benefits from adjuvant chemotherapy for Dukes' stage B and C rectal cancer. In small randomised trials, postoperative radiochemotherapy has, however, improved survival to the same extent as chemotherapy in colon cancer Dukes' stage C. A meta-analysis of nine randomised trials revealed a small but statistically significant benefit in five-year survival and a reduction in the risk of death for the patients receiving immediate postoperative portal vein infusion compared with controls. At present, however, the use of portal vein infusion or intraperitoneal therapy outside of a research trial cannot be recommended in the light of the limited effects. This conclusion is further supported by similarly limited effects in two recently reported very large European multicentre trials. In advanced colorectal cancer, chemotherapy may prolong survival, decrease tumour-related symptoms, improve general well-being or maintain it at a high level for a longer time period compared with best supportive care. These effects have been seen using systemic chemotherapy and using regional chemotherapy in patients with metastases limited to the liver. Subjective responses and quality of life improvements are seen more frequently than objective tu...

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“…In a randomized study Scheithauer et al have seen a higher response rate and a longer time to progression or death with the combination of cisplatin, 5FU and leucovorin compared to fluorouracil and leucovorin: the response rate was 28% and 19% and the time to progression or death was 5.2 and 8.5 months, respectively 15 . Another study carried out by Diaz-Rubio et al 16 failed to demonstrate any advantage for the addition of cisplatin to continuous-infusion 5FU.…”

Section: Discussionmentioning

confidence: 93%

A Phase II Trial of Carboplatin, Methotrexate and Fluorouracil in Fluorouracil-Pretreated Colorectal Cancer

Pronzato

Botto²,

Ghio³

et al. 1998

Journal of Chemotherapy

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5-Fluorouracil and leucovorin combination is the most commonly applied chemotherapy treatment for colorectal cancer patients, both in the adjuvant setting and for advanced disease. Patients resistant or refractory to the 5-fluorouracil-leucovorin combination have been treated in this phase II trial with carboplatin plus methotrexate and fluorouracil in sequence. Twenty patients with measurable lesions from advanced colorectal cancer were entered in the trial. The treatment plan was carboplatin 300 mg/m2 day 1, methotrexate 40 mg/m2 day 1, fluorouracil 600 mg/m2 day 2, every 21 days. Two patients with liver metastasis had a partial response. Median survival was 12 months (range 4-24). Toxicity was acceptable and no patient had to be hospitalized because of the treatment. In this set of patients activity of the new combination is marginal.

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A Prospective Randomized Trial of Continuous Infusion 5-Fluorouracil (5-FU) Versus 5-FU Plus Cisplatin in Patients with Advanced Colorectal Cancer A Trial of the Spanish Cooperative Group for Digestive Tract Tumor Therapy (T.T.D.)

Cited by 16 publications

References 0 publications

Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines

Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines

A Systematic Overview of Chemotherapy Effects in Colorectal Cancer

A Phase II Trial of Carboplatin, Methotrexate and Fluorouracil in Fluorouracil-Pretreated Colorectal Cancer

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