Seminars in oncology
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Seminars in oncology · Dec 2000
Multicenter Study Clinical TrialRituximab as first-line systemic therapy for patients with low-grade lymphoma.
Rituximab (Rituxan; Genentech, Inc, South San Francisco, CA and IDEC Pharmaceutical Corporation, San Diego, CA), the first monoclonal antibody available for the systemic treatment of cancer, yields a 48% response rate in patients with refractory low-grade non-Hodgkin's lymphoma. This preliminary report describes the use of rituximab, instead of standard chemotherapy, in 39 previously untreated patients with stages II-IV low-grade non-Hodgkin's lymphoma All patients received rituximab 375 mg/m2 by intravenous infusion for 4 consecutive weeks and were evaluated for response at week 6. Patients with stable disease or an objective response received repeat 4-week courses at 6-month intervals, for a maximum of four treatment cycles. ⋯ Treatment was well tolerated. The high level of activity suggests that initial treatment with rituximab is a reasonable option in this group of patients, and that repeat maintenance courses at 6-month intervals are feasible and well tolerated. Further follow-up evaluation is necessary to determine the merits of this approach compared with traditional chemotherapeutic treatment.
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Seminars in oncology · Oct 1999
Multicenter Study Clinical TrialRituximab in indolent lymphoma: the single-agent pivotal trial.
Rituximab (Rituxan; IDEC Pharmaceuticals, San Diego, CA, and Genentech, Inc, San Francisco, CA) is a chimeric anti-CD20 monoclonal antibody that targets mature B cells and most B-cell malignancies. Rituximab was the first monoclonal antibody to be approved for therapeutic use for any malignancy. ⋯ The overall results of the trial have been previously reported; additional aspects of the trial (eg, pharmacokinetics) have been reported separately as well. The current report includes an update, expansion, and synthesis of data from the single-agent pivotal trial of rituximab.
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Seminars in oncology · Oct 1999
Multicenter Study Clinical TrialCHOP plus rituximab chemoimmunotherapy of indolent B-cell lymphoma.
Indolent (low-grade) B-cell lymphomas are responsive to single-agent and combination chemotherapy agents, but unfortunately possess an incurable, relapsing nature. Novel agents and innovative treatment approaches need to be evaluated in these patients, with the ultimate goals of maintaining good quality of life and prolonging overall survival. Novel combinations of chemotherapeutic agents, monoclonal antibodies (both unlabeled and radiolabeled), and anti-idiotypic vaccine therapies are currently being evaluated. ⋯ A 95% overall response (55%, complete remission; 40%, partial remission) rate using strict definitions for complete remission and extensive staging studies was achieved in a 40-patient intent-to-treat group. In addition, seven of seven patients with follicular histologies achieving complete remission also had clearing of BCL-2 (chromosome 14;18 translocation) positivity from blood and marrow by sensitive polymerase chain reaction assay, suggesting the eradication of subclinical minimal residual disease. Based on its single-agent efficacy, excellent toxicity profile, and ability to be successfully combined with combination chemotherapy (ie, CHOP), rituximab is currently undergoing extensive investigation in a large number of worldwide clinical trials to determine its optimal use in the treatment of CD20-positive neoplasms.
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Seminars in oncology · Jun 1999
Multicenter Study Clinical TrialOverview of docetaxel (Taxotere)/cisplatin combination in non-small cell lung cancer.
Cisplatin-based chemotherapy is effective in non-small cell lung cancer (NSCLC), although it prolongs survival only modestly. Single-agent docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) is highly active against NSCLC. The activity and tolerability of two docetaxel/ cisplatin regimens were therefore investigated in two multicenter phase II studies, one in Australia and one in France. ⋯ Other severe toxicities were rare, with severe stomatitis and severe neurosensory side effects reported in 2% and 1%, respectively, of treated patients. No severe fluid retention occurred. Docetaxel/cisplatin, administered as two different schedules, is well tolerated and exhibits efficacy in the range of the most established combinations in the treatment of advanced NSCLC.
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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.