Journal of clinical oncology : official journal of the American Society of Clinical Oncology
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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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Clinical Trial Controlled Clinical Trial
Effect of amifostine on toxicities associated with sequential chemotherapy and radiation therapy for unresectable non-small-cell lung cancer: results of a phase II trial.
To determine the effect of amifostine on the safety and efficacy of induction chemotherapy with high-dose cisplatin and vinblastine followed by large-field thoracic irradiation to 60 Gy in patients with stage IIIA or IIIB non-small-cell lung cancer (NSCLC). ⋯ Amifostine can be administered safely with high-dose cisplatin, vinblastine, and radiation therapy for NSCLC. The response rate and survival data provide no evidence that amifostine impairs response to treatment. Amifostine appears to reduce cisplatin-related nephrotoxicity and radiation-induced esophagitis.
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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)
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Double-blind, multicenter, randomized trial to compare the effect of two doses of adrenocorticotropic hormone versus placebo in controlling delayed emesis after high-dose cisplatin in adult patients with cancer.
To compare, in a double-blind, placebo-controlled, randomized trial, the efficacy of two different doses of the depot formulation of adrenocorticotropic hormone (ACTH) in controlling delayed emesis after cisplatin. ⋯ ACTH reduces the incidence and severity of delayed vomiting and nausea after cisplatin. A dose of 2 mg 24 hours after cisplatin is better than one of 1 mg. Whether the activity of ACTH is mediated only by adrenal corticosteroids needs to be verified.
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Multicenter Study Comparative Study Clinical Trial
Low risk of secondary leukemias after chemotherapy without mechlorethamine in childhood Hodgkin's disease. German-Austrian Pediatric Hodgkin's Disease Group.
In the last two decades, it has become evident that secondary leukemias after Hodgkin's disease (HD) are mainly caused by the treatment with alkylating agents, especially mechlorethamine. Since 1978, the German-Austrian trials for childhood HD have used combined chemoradiotherapy without mechlorethamine. ⋯ The observed risk of SHM is smaller than in other studies (adults and children) in which chemotherapy with mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) was given. This difference can be attributed to the lower cumulative doses of alkylating agents, the absence of mechlorethamine in the chemotherapy, and the small number of patients who needed salvage therapy in the presented cohort. In general, differences in the incidence of SHM after HD reflect complex differences between treatment strategies.