Seminars in oncology
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Seminars in oncology · Feb 1999
ReviewCombining new agents with anthracyclines in metastatic breast cancer: an overview of recent findings.
Historically, doxorubicin has been the most effective single agent in metastatic breast cancer, and the combination of doxorubicin with other active agents (as in the 5-fluorouracil/doxorubicin/cyclophosphamide protocol) has improved patient outcome. Results from phase II and several recent phase III studies provide evidence that new agents are also highly active in the treatment of metastatic breast cancer and suggest that they would be active in combination regimens with the anthracyclines. ⋯ Studies to date indicate that this high response rate is achieved without accompanying cardiotoxicity. Several other new agents, notably, paclitaxel, vinorelbine, and gemcitabine, also have been evaluated in combination with the anthracyclines.
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Seminars in oncology · Feb 1999
Randomized Controlled Trial Multicenter Study Clinical TrialA phase III study of irinotecan (CPT-11) versus best supportive care in patients with metastatic colorectal cancer who have failed 5-fluorouracil therapy. V301 Study Group.
In a prospective multicenter trial, 279 patients with metastatic colorectal cancer who had failed 5-fluorouracil therapy were randomized 2:1 to receive either best supportive care (BSC) plus treatment with the topoisomerase I inhibitor, irinotecan (CPT-11; Rhône-Poulenc Rorer, Antony, France), at a dose of 350 mg/m2 every 3 weeks or BSC alone. Overall survival, the primary end point of the study, was significantly improved in patients receiving the irinotecan treatment. Only 14% of patients receiving BSC alone were alive at 1 year compared with 36% in the irinotecan group. ⋯ Appreciable deterioration in global quality of life (50% reduction from baseline) occurred significantly later in the irinotecan-treated patients than in the controls. Additionally, quality of life analyses of all symptoms, except diarrhea, mean scores were significantly in favor of patients assigned to irinotecan treatment than those assigned to BSC. This is the first time that the benefit of second-line chemotherapy has been demonstrated by a randomized controlled trial in advanced colorectal cancer.
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Seminars in oncology · Feb 1999
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialIrinotecan versus infusional 5-fluorouracil: a phase III study in metastatic colorectal cancer following failure on first-line 5-fluorouracil. V302 Study Group.
In a multicenter phase III trial, 267 patients with nonbulky metastatic colorectal cancer who had failed first-line 5-fluorouracil (5-FU) therapy were randomized to receive second-line treatment with either the new topoisomerase agent, irinotecan (Rhône-Poulenc Rorer, Antony, France), or a high-dose infusional 5-FU regimen. Patients treated with irinotecan survived significantly longer than those treated with infusional 5-FU. The 1-year survival rate was 45% for patients receiving irinotecan compared with 32% for patients receiving 5-FU. ⋯ Overall, mean global quality of life scores were similar in the two arms of the study throughout the period of treatment and follow-up, demonstrating that the more effective disease control achieved by irinotecan at least maintains quality of life. Indeed, deterioration in quality of life (defined as >50% decrease from baseline score) occurred significantly later in irinotecan-treated patients. In light of these data, irinotecan should be considered the reference treatment for patients with 5-FU-refractory advanced colorectal cancer.
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Seminars in oncology · Feb 1999
ReviewSetting a new standard--irinotecan (Campto) in the second-line therapy of colorectal cancer: final results of two phase III studies and implications for clinical practice.
The final results of two very important randomized trials of irinotecan (Campto, Rhône-Poulenc Rorer, Antony, France) as second-line treatment for patients with advanced colorectal cancer are presented. In one trial, the new topoisomerase inhibitor was compared with best supportive care; in the other, its use was compared with the strategy of high-dose 5-fluorouracil (5-FU) infusion. ⋯ In the comparison with infusional 5-FU, the more effective antitumor activity of irinotecan may have helped maintain quality of life. These results have implications for clinical practice: following failure on 5-FU, irinotecan must now be considered the best available option for treatment.