American journal of clinical oncology
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Am. J. Clin. Oncol. · Apr 1994
Randomized Controlled Trial Comparative Study Clinical TrialA randomized double-blind trial of ondansetron alone versus in combination with dexamethasone versus in combination with dexamethasone and lorazepam in the prevention of emesis due to cisplatin-based chemotherapy.
To compare the effectiveness and side effects of antiemetic regimens using ondansetron alone (O) versus ondansetron plus dexamethasone (OD) versus ondansetron plus dexamethasone plus lorazepam (ODA) in the prevention of emesis induced by cisplatin-based chemotherapy. ⋯ Ondansetron was very effective in the prevention of nausea and vomiting during the acute phase after cisplatin administration. In treating delayed nausea and vomiting, although the results of three regimens were still disappointing, the combination of ondansetron plus dexamethasone or plus lorazepam provided superior results. Patients who received the lorazepam-containing regimen appeared more comfortable and less restless than those who were given other regimens.
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Am. J. Clin. Oncol. · Apr 1994
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy of oral ondansetron, a selective antagonist of 5-HT3 receptors, in the treatment of nausea and vomiting associated with cyclophosphamide-based chemotherapies. Ondansetron Study Group.
We evaluated the efficacy and safety of oral ondansetron, a selective antagonist of 5-HT3 receptors, for the treatment of nausea and vomiting associated with cyclophosphamide-based chemotherapy (> 500 mg/m2). In this trial 324 chemotherapy-naive cancer patients, mostly females with breast cancer, were randomized to receive either placebo or ondansetron 1 mg, 4 mg, or 8 mg three times per day for 3 days. There were no differences in the doses of cyclophosphamide, doxorubicin, and methotrexate between the study groups. ⋯ A higher incidence of headaches and gastrointestinal complaints (constipation, abdominal pain) were observed in the three ondansetron groups. In conclusion, oral ondansetron is an effective and well-tolerated antiemetic treatment in the management of cancer patients receiving ambulatory cyclophosphamide-based chemotherapy. These results support the view that serotonin and 5-HT3 receptors play an important role in cyclophosphamide-induced nausea and vomiting.
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Am. J. Clin. Oncol. · Aug 1993
Randomized Controlled Trial Clinical TrialAn analysis of radiotherapy data from the CNS cancer consortium's randomized prospective trial comparing AZQ to BCNU in the treatment of patients with primary malignant brain tumors. The CNS cancer consortium.
The CNS Cancer Consortium has conducted a phase III study comparing diaziquone (AZQ) with carmustine (BCNU) in the treatment of adults with primary anaplastic glial brain tumors. Patients eligible for this study were 18 years of age or older at the time of biopsy, subtotal resection, or gross total resection of an anaplastic glial brain tumor. Within 3 weeks of surgery, patients received whole brain radiotherapy at 1.7 to 2 Gy per fraction to a total whole brain dose of 42-48 Gy. ⋯ Two-year Kaplan-Meier survival was 22% in the AZQ-treated patients and 25% in BCNU-treated patients. In an analysis of radiotherapy administered we found that, within the range of doses required for this study, there was no influence of whole brain dose, boost dose, total dose, or size of the boost field on survival. The institution providing radiotherapy (teaching hospital vs nonteaching facility) did not influence survival.
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Am. J. Clin. Oncol. · Jun 1993
Review Clinical TrialClinical experience with interstitial thermoradiotherapy for localized implantable pelvic tumors.
Twenty-six patients (20 females, 6 males) with localized tumors of the pelvis, including 3 primary advanced (PRIM), 7 persistent (PERS), 10 recurrent (REC), and 6 metastatic (MET) tumors, were treated with a combination of low-dose rate (LDR) iridium 192 interstitial radiotherapy (IRT), interstitial 915 MHz microwave hyperthermia (IHT), and external beam radiotherapy (RT). Histological diagnoses were squamous cell carcinoma in 13 (50%), adenocarcinoma in 12 (46%) and soft tissue sarcoma in 1 (4%) lesion. Tumor sites were cervix in 8 (31%), colorectum in 6 (23%), vagina in 4 (15%), anus in 3 (12%), ovary in 2 (8%), and other sites in 3 (12%) lesions. ⋯ Factors influencing initial (3 months FU) and long-term tumor response (12 months FU) included tumor class, tumor volume, total radiation dose, and thermal parameters with "good quality of heating" (TQ 41 degrees C > or = 75%) and high minimum tumor temperature (Tmin(av) > or = 41 degrees C). Treatment toxicity was acceptable: whereas 8 (31%) patients experienced acute side effects, which subsided within weeks, 7 (27%) developed long-term complications. Thermal damage was associated with IHT treatments exceeding maximum average temperatures of > or = 44 degrees C and maximum peak temperatures of > or = 45 degrees C.
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Am. J. Clin. Oncol. · Jun 1993
Comparative StudyResource utilization. High dose rate versus low dose rate brachytherapy for gynecologic cancer.
A comparative analysis of anesthesia use, perioperative morbidity and mortality, capital, and treatment cost of high dose rate versus low dose rate intracavitary brachytherapy for gynecologic malignancy is presented. To assess current anesthesia utilization, application location, and high dose rate afterloader availability for gynecologic brachytherapy in private and academic practices, a nine-question survey was sent to 150 radiotherapy centers in the United States, of which 95 (63%) responded. Of these 95 respondents, 95% used low dose rate brachytherapy, and 18% possessed high dose rate capability. ⋯ Capital investment, maintenance requirements, and depreciation costs for high dose rate capability are reviewed. Application of the defined "revenue-cost ratio" formula demonstrates the importance of high application numbers and consistent reimbursement for parity in high dose rate operation. Logically, inadequate third-party reimbursement (e.g., Medicare) reduces high dose rate parity and threatens the future availability of high dose rate technology.