Comparison of the serum neutralization test and a competitive enzyme-linked immunosorbent assay for the detection of antibodies to vesicular stomatitis virus New Jersey and vesicular stomatitis virus Indiana.
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A competitive enzyme-linked immunosorbent assay (C-ELISA) for the detection of antibodies against vesicular stomatitis virus New Jersey (VSV-NJ) and vesicular stomatitis virus Indiana (VSV-IN) was compared with the serum neutralization test (SNT) using 1,106 serum samples obtained from dairy cattle on sentinel study farms in the Poas region of Costa Rica. Kappa coefficients between the C-ELISA and the SNT were 0.8871 (95% confidence interval [CI]: 0.8587-0.9155) and 0.6912 (95% CI: 0.6246-0.7577) for the VSV-NJ and VSV-IN tests, respectively. These results indicate good to excellent agreement between the 2 tests under these conditions. (+info)
Mouth-washings with recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) do not improve grade III-IV oropharyngeal mucositis (OM) in patients with hematological malignancies undergoing stem cell transplantation. Results of a randomized double-blind placebo-controlled study.
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We investigated whether daily oral washings with recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) solution improved grade III-IV oropharyngeal mucositis (OM) in patients with hematological malignancies undergoing stem cell transplantation. Forty-one consecutive patients (21 males and 20 females, median age (range) 44 (16-69) years) were prospectively randomized to perform daily mouth-washes with either a 400 microg rhGM- CSF (Molgramostin, Schering-Plough) solution (group A, n = 18) or with a saline solution (group B, n = 23). Primary end-points were the intensity of OM, night rest quality and characteristics of food intake. Secondary end-points were need for and duration of parenteral nutrition, oral and intravenous analgesic requirements, incidence of viral or fungal oral infections and development of neutropenic fever. No differences were found between the placebo and rhGM-CSF-treated groups regarding overall duration of OM, maximum grade, reduction in at least one grade of OM (nine patients (56%) in group A vs 13 patients (68%) in group B), reduction of spontaneous or swallowing-induced pain, improvement in oral food intake, use of parenteral nutrition or use of systemic analgesics. In conclusion, mouth-washings with a 400 microg of rhGM-CSF solution do not improve severe OM in hematological patients undergoing stem cell transplantation. (+info)
Phase I evaluation of prolonged-infusion gemcitabine with irinotecan for relapsed or refractory leukemia or lymphoma.
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PURPOSE: To estimate the maximum-tolerated duration of infusion of gemcitabine at 10 mg/m(2)/min in combination with irinotecan at 40 mg/m(2) daily for 3 days in the treatment of relapsed or refractory acute leukemia or lymphoma. PATIENTS AND METHODS: Patients with leukemia or lymphoma were escalated in separate strata. Stratum I consisted of 11 patients, median age of 47 years (range, 18 to 68 years), with relapsed or refractory leukemia. Stratum II contained nine patients, median age of 48 years (range, 39 to 68 years), who had refractory non-Hodgkin's lymphoma. Patients received irinotecan at 40 mg/m(2) daily for 3 days, beginning just before the first dose of gemcitabine. Gemcitabine was given at 10 mg/m(2)/min, with the total duration adjusted following a modified continuous reassessment model. RESULTS: Severe myelosuppression and stomatitis/esophagitis were the most serious hematologic and nonhematologic toxicities. Several patients developed febrile neutropenia, nausea, or vomiting. In both strata, the maximum recommended duration of infusion of gemcitabine was 12 hours delivered at 10 mg/m(2)/min (7,200 mg/m(2)). The overall response rate for one cycle of this therapy in this phase I trial for patients with leukemia was 18% (95% confidence interval, 8% to 45%), and for those with lymphoma, 33% (95% confidence interval, 17% to 66%). CONCLUSION: A prolonged infusion of gemcitabine at 10 mg/m(2)/min for 12 hours with 3 days of irinotecan at 40 mg/m(2)/d is a tolerable induction regimen for patients with acute leukemia or lymphoma. Stomatitis/esophagitis should be anticipated; however, this regimen may induce responses in patients with difficult-to-treat hematologic malignancies. (+info)
Phase I and pharmacokinetic study of DX-8951f (exatecan mesylate), a hexacyclic camptothecin, on a daily-times-five schedule in patients with advanced leukemia.
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PURPOSE: DX-8951f is a novel hexacyclic camptothecin-analogue topoisomerase I inhibitor with both in vitro antileukemic activity and myelosuppression as a dose-limiting toxicity in solid tumor Phase I studies. DX-8951f is active in a human acute myeloid leukemia (AML) severe combined immunodeficient mouse model. In a leukemia Phase I study, we investigated the toxicity profile and pharmacokinetics of DX-8951f in patients with primary refractory or relapsed AML or acute lymphocytic leukemia, myelodysplastic syndromes, or chronic myelogenous leukemia in blastic phase (CML-BP). EXPERIMENTAL DESIGN: DX-8951f was given as an i.v. infusion over 30 min daily for 5 or 7 days. The starting dose was 0.6 mg/m(2)/day for 5 days (3.0 mg/m(2)/course). Courses were given every 3-4 weeks according to toxicity and antileukemic efficacy. RESULTS: Twenty-five patients (AML, 21 patients; myelodysplastic syndrome, 1 patient; acute lymphocytic leukemia, 2 patients; CML-BP, 1 patient) were treated. Stomatitis was the dose-limiting toxicity, occurring in two of two patients treated at 1.35 mg/m(2)/day for 5 days, two of three treated at 1.2 mg/m(2)/day for 5 days, and one of six treated at 0.9 mg/m(2)/day for 7 days. The recommended Phase II dose was 0.9 mg/m(2)/day for 5 days. The pharmacokinetics of DX-8951 was linear and well fit by a two-compartment model. CONCLUSIONS: Phase II studies are warranted to further define the activity of DX-8951f in patients with hematological malignancies. (+info)
Angular stomatitis and riboflavin status among adolescent Bhutanese refugees living in southeastern Nepal.
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BACKGROUND: Between 1990 and 1993, fear of ethnic persecution led 83,000 ethnic Nepalese to flee from Bhutan to refugee camps in Nepal, where they remained at the time of this study. Reported cases of angular stomatitis (AS), ie, thinning or fissuring at the mouth angles, increased 6-fold from December 1998 to March 1999, from 5.5 to 35.6 cases per 1000 per month. This increase came after the removal of a fortified cereal from rations. OBJECTIVES: The main objectives were to assess the prevalence of AS and of low concentrations of riboflavin, folate, vitamin B-12, and iron by using biochemical measures; to determine whether riboflavin status was associated with AS; and to assess the potential of AS as a screening measure for low riboflavin concentrations. DESIGN: In October 1999, we performed a survey among a random sample of 463 adolescent refugees in which we conducted interviews and physical examinations and obtained blood specimens for riboflavin assessment. Riboflavin status was assessed with the erythrocyte glutathione reductase (EC 1.6.4.2) activity coefficient. After we excluded those adolescents who had taken vitamins during the past month, 369 were eligible for analyses. RESULTS: AS was common (26.8%; 95% CI: 22.3, 31.3), the prevalence of low riboflavin concentrations was high (85.8%; 80.7, 90.9), and riboflavin status was associated with AS. Adolescents with AS had significantly lower riboflavin concentrations than did adolescents without AS (P = 0.02). The adjusted odds ratio for AS and low riboflavin concentrations was 5.1 (1.55, 16.5). CONCLUSION: Globally, riboflavin deficiency is rare. Its emergence in food-dependent populations can be a harbinger of other B-vitamin deficiencies. (+info)
Long-term results of reirradiation for patients with recurrent rectal carcinoma.
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BACKGROUND: The current study was conducted to assess the long-term results of reirradiation in patients with recurrent rectal carcinoma. METHODS: One hundred and three patients with recurrent adenocarcinoma of the rectum underwent reirradiation with concurrent 5-fluorouracil-based chemotherapy. The initial radiation dose to the pelvis ranged from 3000 to 7400 centigrays (cGy) with a median dose of 5040 cGy. The median time from initial treatment to recurrence was 19 months. Irradiation techniques consisted of two lateral fields with/without a posterior pelvic field to include recurrent tumor with a margin of 2-4 cm only. The reirradiation doses ranged from 1500 to 4920 cGy with a median dose of 3480 cGy. Total cumulative doses ranged from 7060 to 1080 cGy with a median total dose of 8580 cGy. After the reirradiation, 34 patients also underwent surgical resection for residual disease. Fourteen patients underwent pelvic exenteration, 11 patients underwent abdominoperineal resection, 4 patients underwent transanal transabdominal proctosigmoidectomy, 2 patients underwent full thickness local excision, and 3 patients underwent a Hartmann resection. RESULTS: Follow-up ranged from 3 84 months with a median follow-up of 2 years. The median survival for the whole group was 26 months and the 5-year actuarial survival rate was 19%. The median interval and 5-year survival rate of patients undergoing surgical resection after reirradiation was 44 months and 22% compared with 14 months and 15% for patients treated with reirradiation only (P = 0.001). Treatment was generally well tolerated. Fifteen patients required a treatment break and early termination of treatment for Grade 3 and higher diarrhea, moist desquamation, or mucositis. Late complications were seen in 22 patients, including persistent severe diarrhea in 18 patients with 10 patients requiring long-term parental support, small bowel obstruction was seen in 15 patients, fistula formation in 4 patients, and coloanal stricture in 2 patients. There was no difference in incidence of acute or long-term complications by the total radiation dose delivered. CONCLUSIONS: In patients with recurrent rectal carcinoma, high doses of reirradiation can be delivered with acceptable risks without prohibitive long-term side effects. Surgical salvage and long-term survival of patients are possible. (+info)
Prevention of oral mucositis and oral candidiasis for patients with cancer treated with chemotherapy: cochrane systematic review.
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The objectives of this study were to determine whether oral prophylactic agents are superior to placebo or no treatment on the incidence of oral mucositis and oral candidiasis for patients with cancer. A Cochrane systematic review was conducted of randomized trials of oral (and topical) prophylactic agents for mucositis and oral candidiasis, anywhere in the world, among patients with cancer (excluding head and neck) who were receiving chemotherapy. Eleven studies were included in the meta-analysis for mucositis. Of the six prophylactic agents used for mucositis, only one--ice chips--was effective (relative risk 0.57, 95% CI 0.43 to 0.77). Fifteen studies were included in the meta-analysis for oral candidiasis. There is evidence that antifungal agents that are partially or fully absorbed from the gastrointestinal tract prevent oral candidiasis and that the partially absorbed agents may be more effective than the fully absorbed agents. The RR for partially absorbed agents was 0.13 (95% CI 0.06 to 0.27). In conclusion, there is weak and unreliable evidence that ice chips prevent mucositis. There is evidence that prophylactic use of antifungal agents, which are absorbed or partially absorbed from the gastrointestinal tract, reduce the clinical signs of oral candidiasis. (+info)
Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system.
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PURPOSE: Mucositis occurs in almost all patients treated with radiotherapy for head and neck cancer. The aim of this multicenter, double-blind, prospective, randomized trial was to evaluate the clinical efficacy of an economically viable antimicrobial lozenge (bacitracin, clotrimazole, and gentamicin [BcoG]) in the alleviation of radiation-induced mucositis in patients with head and neck cancer. PATIENTS AND METHODS: One hundred thirty-seven eligible patients were randomized to treatment with either antimicrobial lozenge (69 patients) or placebo lozenge (68 patients). The primary end point of the study was the time to development of severe mucositis from the start of radiotherapy. Secondary end points included severity and duration of mucositis, pain measurement, radiation therapy interruption, and quality of life. Mucositis was scored using a validated mucositis scoring system. RESULTS: Toxicity profiles were similar between the two arms of the study. The median time to development of severe mucositis from the start of radiotherapy was 3.61 weeks on BCoG and 3.96 weeks on placebo (P =.61). There were no statistically significant differences between the arms in the extent of severe mucositis as measured by physician, in oral toxicities as recorded by patients, or in radiotherapy delays. CONCLUSION: This study was conducted on the basis of a pilot study that demonstrated the BCoG lozenge to be tolerable and microbiologically efficacious. A validated mucositis scoring system was used. However, in this group of patients treated with conventional radiotherapy, the lozenge did not impact significantly on the severity of mucositis. Whether such a lozenge would be beneficial in treatment situations where rate of severe mucositis is higher (ie, in patients treated with unconventional fractionation or with concomitant chemotherapy) is unknown. (+info)