Randomized study of continuous infusion fluorouracil versus fluorouracil plus cisplatin in patients with metastatic colorectal cancer.

Kemeny, Nancy E.; Israel, Karla Cristina Petruccelli; Niedzwiecki, Donna; Chapman, Douglass; Botet, José; Minsky, Bruce D.; Vinciguerra, Vincent; Rosenbluth, Richard; Bosselli, B; Cochran, Craig

doi:10.1200/jco.1990.8.2.313

Cited by 94 publications

(30 citation statements)

References 14 publications

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“…The combination chemotherapy of cisplatin and 5-FU has been proven to have synergic antitumor effect in many experimental and clinical studies (17,18). However, the optimal sequence for the administration of these drugs has yet to be determined.…”

Section: Discussionmentioning

confidence: 99%

S-1 Plus Cisplatin Combination Chemotherapy in Patients with Advanced Non–Small Cell Lung Cancer

Ichinose

Yoshimori

Sakai

et al. 2004

Clinical Cancer Research

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Purpose: To evaluate the efficacy and toxicity of a novel combination chemotherapeutic regimen including cisplatin with an oral anticancer agent, S-1 that consisted of tegafur, 5-chloro-2, 4-dihydroxypyridine, and potassium oxonate, for non-small-cell lung cancer (NSCLC) patients.Experimental Design: In this phase II trial, patients with locally advanced and metastatic NSCLC were treated with the oral administration of S-1 at 40 mg/m 2 twice a day for 21 consecutive days while cisplatin (60 mg/m 2 ) was administered intravenously on day 8. This schedule was repeated every 5 weeks.Results: Of 56 patients enrolled in the study, 55 patients were eligible and analyzed. The median number of cycles administered was 3 (range, 1-12 cycles). Among these 55 patients, one complete response and 25 partial responses were observed with an overall response rate of 47% (95% confidence interval, 34 -61%). The median survival time was 11 months and the 1-year survival rate was 45%. Hematologic toxicities of grades 3 and 4 included neutropenia (29%) and anemia (22%). No grade 4 nonhematologic toxicity was observed. Grade 3 toxicity included anorexia (13%), vomiting (7%), or diarrhea (7%).Conclusions: S-1 plus cisplatin combination chemotherapy showed a promising effectiveness with acceptable toxicity rates in patients with advanced NSCLC. These results warrant further investigations of this regimen including a randomized controlled trial for its use as a first line treatment for NSCLC.

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Section: Discussionmentioning

confidence: 99%

S-1 Plus Cisplatin Combination Chemotherapy in Patients with Advanced Non–Small Cell Lung Cancer

Ichinose

Yoshimori

Sakai

et al. 2004

Clinical Cancer Research

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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).…”

Section: Fluorouracil In Combination With Cisplatinmentioning

confidence: 99%

A Systematic Overview of Chemotherapy Effects in Colorectal Cancer

Ragnhammar¹

2001

Acta Oncologica

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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 scienti c 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 scienti c 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 bene t of postoperative adjuvant chemotherapy with uorouracil 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 ve 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 uorouracil alone would be equally ef cacious. Several phase III trials with postoperative adjuvant chemotherapy with uorouracil and leucovorin in patients with colon cancer stage Dukes' C have demonstrated a similar statistically signi cant improvement in disease-free and overall survival in comparison with a control arm. Six months of treatment with uorouracil and leucovorin is as ef cient as twelve months of uorouracil and levamisole. This treatment is, thus, recommended for routine use. No convincing bene t 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 bene ts 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 signi cant bene t in ve-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 tumour remissions. Altho...

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“…The combination of fluorouracil with leucovorin is nowadays the more or less accepted standard treatment, but the optimum treatment schedule still has to be defined (Moertel, 1994). Cisplatin as a single agent at standard doses is inactive in colorectal cancer (DeSimone et al, 1986) but in combination with fluorouracil a modest activity has been reported (Posner et al, 1987; LoRuss et al, 1989;Kemeny et al, 1990). Etoposide as a single agent given intravenously is inactive in colorectal cancer (Perry et al, 1976;Douglass et al, 1979).…”

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confidence: 99%

Phase II study of a short course of weekly high-dose cisplatin combined with long-term oral etoposide in metastatic colorectal cancer

Planting

Burg²,

Bent³

et al. 1996

Br J Cancer

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Summary In a phase I study of weekly administered cisplatin combined with oral etoposide, we observed a partial response in 4 out of 11 patients with metastatic colorectal cancer. Subsequently, we performed a phase II study to investigate the activity of this combination as first-line treatment in this disease. Fourteen patients with metastatic colorectal cancer were enrolled in this study. The poor prognosis for numerous patients with metastatic colorectal cancer is an incentive for oncologists to explore new treatments for this disease. The combination of fluorouracil with leucovorin is nowadays the more or less accepted standard treatment, but the optimum treatment schedule still has to be defined (Moertel, 1994). Cisplatin as a single agent at standard doses is inactive in colorectal cancer (DeSimone et al., 1986) but in combination with fluorouracil a modest activity has been reported (Posner et al., 1987; LoRuss et al., 1989;Kemeny et al., 1990). Etoposide as a single agent given intravenously is inactive in colorectal cancer (Perry et al., 1976;Douglass et al., 1979). As colorectal tumours are in general slow growing, a more prolonged administration of cytotoxic drugs may be advantageous. Oral etoposide can be given over a long period of time with acceptable toxicity (Greco et al., 1990). Activity of oral etoposide has been shown in small-cell and non-small-cell lung cancer, germ cell tumours and breast cancer. In a phase I study of weekly cisplatin combined with oral etoposide a partial response was observed in 4 out of 11 patients with metastatic colorectal cancer, most of them pretreated with fluorouracil (Planting et al., 1995 During treatment patients had weekly physical examinations and assessment of toxicity, weekly full blood counts and estimation of electrolytes, calcium and magnesium and creatinine clearance. Neurological examination including VPT was repeated after the cisplatin treatment period. Response to treatment was assessed 2 weeks after the last cisplatin administration. The standard WHO criteria were used for evaluation of response and toxicity (WHO, 1979). Treatment ScheduleCisplatin was administered at a dose of 70 mg m-2 on days 1, 8 and 15 and days 29, 36 and 43; oral etoposide was administered at a dose of 50 mg daily on days 1 -15 and days 29 -43. During cisplatin administration patients were hospitalised for 24 h. The treatment regimen consisted of prehydration with 1000 ml dextrose saline + 20 mmol potassium chloride + 1 g magnesium sulphate over 4 h; cisplatin powder was dissolved in 250 ml 3% sodium chloride and administered over 3 h followed by post-hydration with 2 1 of dextrose saline + 40 mmol potassium chloride + 2 g magnesium sulphate over 8 h. The anti-emetic regimen consisted of 8 mg ondansetron slow i.v. bolus directly before the start of the cisplatin infusion and was repeated if necessary.In this study dose reductions were not allowed. If at the day of planned cisplatin administration WBC was <2.5 x 109 1-1 and/or platelets were <75 x 109 -1 treatment was postpone...

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Randomized study of continuous infusion fluorouracil versus fluorouracil plus cisplatin in patients with metastatic colorectal cancer.

Cited by 94 publications

References 14 publications

S-1 Plus Cisplatin Combination Chemotherapy in Patients with Advanced Non–Small Cell Lung Cancer

S-1 Plus Cisplatin Combination Chemotherapy in Patients with Advanced Non–Small Cell Lung Cancer

A Systematic Overview of Chemotherapy Effects in Colorectal Cancer

Phase II study of a short course of weekly high-dose cisplatin combined with long-term oral etoposide in metastatic colorectal cancer

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