Seminars in oncology
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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 · Dec 1998
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialPhase III studies of single-agent docetaxel in patients with metastatic breast cancer who have progressed despite previous chemotherapy regimens: preliminary results.
A recent large phase III trial has for the first time demonstrated that choice of treatment can influence survival duration in patients with metastatic breast cancer who have progressed despite previous anthracycline-containing therapy. In a multicenter study, patients who received docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) experienced a longer median survival time (II.4 months v 8.7 months; P = .0097) as well as a longer time to progression (19 weeks v II weeks; P < .001) and higher overall response rate (30% v II.6%; P < .0001) than patients receiving treatment with mitomycin C and vinblastine. The toxicity profile was manageable and tolerable for both arms. ⋯ In this study, the duration of survival was not influenced by treatment. However, the higher response rate with docetaxel was achieved without the risk of potentially fatal cardiac toxicity seen in some patients who received doxorubicin. To date, docetaxel is the only single agent shown to have a potential superior activity when compared with doxorubicin in patients with progressive metastatic disease.
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Seminars in oncology · Oct 1998
Randomized Controlled Trial Comparative Study Clinical TrialDocetaxel versus doxorubicin in patients with metastatic breast cancer who have failed alkylating chemotherapy: a preliminary report of the randomized phase III trial. 303 Study Group.
Three hundred twenty-six patients who had failed prior alkylating agents, given either as adjuvant therapy or therapy for advanced breast cancer or both, were randomly assigned to treatment with up to seven cycles of doxorubicin 75 mg/m2 or docetaxel (Taxotere, Rhône-Poulenc Rorer, Antony, France) 100 mg/m2 given every 3 weeks. The two arms of the study were well-matched for age, performance status, previous therapy, and the nature of the metastatic disease. Forty-seven percent of the docetaxel-treated patients and 49% of the doxorubicin-treated patients were defined as having disease that showed primary or secondary resistance. ⋯ Overall median time to response was 12 weeks with docetaxel and 23 weeks with doxorubicin. Febrile neutropenia, grade 3/4 nausea and vomiting, and cardiotoxicity were significantly more common among the doxorubicin-treated patients, while diarrhea grade 3-4, skin toxicity, neurologic toxicity, fluid retention, and allergy of any grade were significantly more likely in the docetaxel-treated patients. This study demonstrates for the first time the superiority in terms of response rate of a taxoid over an anthracycline in the treatment of advanced breast cancer.
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Seminars in oncology · Oct 1998
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy of paclitaxel or doxorubicin used as single agents in advanced breast cancer: a literature survey.
The anthracyclines are among the most active agents in the treatment of breast cancer. In recent years, the taxoids have produced promising results as single agents in breast cancer. ⋯ Based on the known activity of doxorubicin and the single-agent phase II results of paclitaxel, two phase III randomized trials comparing these drugs as monotherapy in first-line, with crossover on progression, were conducted by the European Organization for Research and Treatment of Cancer and the Intergroup. The preliminary results of these studies were presented at international congresses and will be discussed here.