Journal of clinical oncology : official journal of the American Society of Clinical Oncology
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Phase III double-blind comparison of dolasetron mesylate and ondansetron and an evaluation of the additive role of dexamethasone in the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapy.
To compare the efficacy of dolasetron and ondansetron in controlling nausea and vomiting in the first 24 hours; to evaluate the efficacy when dexamethasone is added to either drug in the first 24 hours; and to extend these comparisons over 7 days in patients receiving moderately emetogenic chemotherapy. ⋯ At the doses used, dolasetron was significantly less effective than ondansetron at controlling nausea and vomiting in the first 24 hours in patients receiving moderately emetogenic chemotherapy, but there was no demonstrable difference between both drugs over 7 days. The addition of dexamethasone significantly improved the efficacy of both drugs in the first 24 hours and over 7 days.
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To evaluate the objective tumor response rate and toxicities of patients with metastatic colorectal carcinoma treated with irinotecan hydrochloride (CPT-11). ⋯ According to the study design, CPT-11 showed promising activity in chemotherapy-naive patients with advanced colorectal carcinoma and modest activity in patients with prior 5-FU exposure. The toxicity with this schedule appears manageable with appropriate dose modification for individual patient tolerance and an intensive loperamide regimen for the management of diarrhea. Care should be taken when treating patients with prior pelvic radiotherapy because of the increased risk of neutropenia.
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Randomized Controlled Trial Clinical Trial
Phase III placebo-controlled trial of capsaicin cream in the management of surgical neuropathic pain in cancer patients.
A minority of cancer survivors develops long-term postsurgical neuropathic pain. Based on evidence that capsaicin, the pungent ingredient in hot chili peppers, might be useful for treating neuropathic pain, we developed the present clinical trial. ⋯ A topical capsaicin cream decreases postsurgical neuropathic pain and, despite some toxicities, is preferred by patients over a placebo by a three-to-one margin among those expressing a preference.
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Clinical Trial
Phase II trial of 9-aminocamptothecin administered as a 72-hour continuous infusion in metastatic colorectal carcinoma.
The camptothecin derivative irinotecan has demonstrated clinical activity in metastatic colorectal carcinoma in both chemotherapy-naive and fluorouracil-refractory patients. 9-Aminocamptothecin (9-AC; NSC 603071), another camptothecin derivative, was selected for clinical development based on preclinical activity, including cures in human tumor xenografts resistant to standard anticancer agents. We report a phase II trial of 9-AC in patients with previously untreated metastatic colorectal carcinoma. ⋯ At the dose and schedule used in this trial, 9-AC lacked antitumor activity in metastatic colorectal cancer. 9-AC infusion schedules of longer duration are currently being investigated in this disease.
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Practice Guideline Guideline
Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer. Adopted on May 16, 1997 by the American Society of Clinical Oncology.
The primary objective was to determine clinical practice guidelines for the diagnostic evaluation, treatment, and follow-up care of patients with surgically unresectable stage III and IV non-small-cell lung cancer (NSCLC). These guidelines are intended for use by oncologists in the care of patients outside of clinical trials. ⋯ In patients without evidence of extrathoracic cancer, a chest x-ray and chest computed axial tomography (CAT) scan are recommended to stage locoregional disease, with biopsy of mediastinal lymph nodes found on CAT scan to be greater than 1 cm in shortest transverse diameter. Pretreatment bone scan and head CAT scan are recommended only when signs or symptoms of disease are present. If a patient is otherwise potentially resectable, a biopsy should be performed of a radiographically documented isolated adrenal or hepatic mass to rule out metastatic disease. Chemotherapy, ideally a platinum-based regimen, is appropriate for selected patients who have a good performance status with both unresectable, locally advanced, and metastatic NSCLC. A detrimental effect on survival was observed with older alkylating agent-based regimens. In patients with unresectable stage III NSCLC, two or more cycles of cisplatin-based chemotherapy with or followed by radiation has been proven to enhance survival; ongoing maintenance chemotherapy is of unproven benefit. Chemotherapy should be administered for no more than eight cycles in patients with stage III or IV NSCLC. Initial treatment with an investigational agent is appropriate, provided a standard regimen is then given if the disease does not respond after two cycles. Delaying chemotherapy until symptoms develop may negate the survival benefits of treatment. There is no current evidence that either confirms or refutes that second-line chemotherapy improves survival in patients with nonresponding or progressive NSCLC. NSCLC histologic type is not an important prognostic factor in these patients, and the role of newer prognostic factors (eg, p53 mutation) in clinical decision-making is investigational. Radiation should be included as part of the standard treatment for selected patients with unresectable stage III NSCLC, whose performance status and pulmonary function are adequate. Definitive-dose thoracic radiotherapy should be no less than 60 Gy in 1.8- to 2-Gy fractions. Local symptoms from primary or metastatic NSCLC can be relieved by judicious use of radiotherapy. (ABSTRACT TRUNCATED)