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PubMedDate not supplied

A comparison of voice quality ratings made by Japanese and American listeners using the GRBAS scale.

The GRBAS scale is a widely used method for perceptual evaluation of voice quality. Two linguistically diverse groups of listeners (Japanese and American) rated 35 voice samples using the GRBAS scale. The ratings obtained from the two groups were compared to determine if the different linguistic background affected the use of the GRBAS scale. Results show that there are no significant differences between the Japanese and American listeners in the use of the Grade, Roughness and Breathiness scales. Ratings on the Asthenia and Strain scales, however, were different between the two groups of listeners. Despite these discrepancies, the GRBAS scale may be an excellent tool for perceptual evaluation of voice quality by linguistically diverse groups.

Adolescent↗

PubMed2003

Second-line treatment of advanced gastric cancer with oxaliplatin plus raltitrexed.

BACKGROUND: Treatment with oxaliplatin plus raltitrexed has demonstrated an encouraging therapeutic index in patients with advanced colorectal cancer and malignant pleural mesothelioma. The aim of this multi-institutional study was to determine the antitumor potential of this combination in patients with metastatic gastric cancer failing prior palliative first-line chemotherapy, and to reconfirm its favorable toxicity profile. PATIENTS AND METHODS: 21 patients with metastatic gastric cancer, who progressed while on or within 6 months after discontinuing palliative first-line chemotherapy, participated in this study. They received raltitrexed 3,0 mg/m(2) and oxaliplatin 130 mg/m(2) both given intravenously on day 1 every 3 weeks. RESULTS: One patient achieved a partial response, 6 had stable disease, and 14 patients progressed. Median progression-free and overall survival from the onset of salvage chemotherapy was 2.0 and 4.5 months, respectively. Hematologic adverse reactions, specifically neutropenia and anemia were common, though generally mild to moderate with only 3 patients experiencing grade 3/4 toxicity. The most frequent non-hematologic adverse events included nausea/emesis, asthenia, and transient elevation of liver functional parameters, again with grade 3 symptoms occurring only in a minority of patients. CONCLUSION: Despite reproducibility of a favorable toxicity profile of oxaliplatin + raltitrexed, our data suggest that this combination regimen has no substantial antitumor activity in patients with progressive, chemotherapeutically pretreated metastatic gastric cancer.

Adult↗

PubMedDate not supplied

Changes in teachers' voice quality during a working day with and without electric sound amplification.

The present study investigated changes in the voice quality of teachers during a working day (a). in ordinary conditions and (b). when using electrical sound amplification while teaching. Classroom speech of 5 teachers was recorded with a portable DAT recorder and a head-mounted microphone during the first and the last lesson of a hard working day first in ordinary conditions and the following week using amplification. Long-term average spectrum and sound pressure level (SPL) analyses were made. The subjects' comments were gathered by questionnaire. Voice quality was evaluated by 2 speech trainers. With amplification, SPL was lower and the spectrum more tilted. Voice quality was evaluated to be better. The subjects reported less fatigue in the vocal mechanism. Spectral tilt decreased and SPL increased during the day. There was a tendency for perceived asthenia to decrease. No significant changes were observed in ordinary conditions. The acoustic changes seem to reflect a positive adaptation to vocal loading. Their absence may be a sign of vocal fatigue.

Amplifiers, Electronic↗

PubMed2004

Can we prevent a second 'Gulf War syndrome'? Population-based healthcare for chronic idiopathic pain and fatigue after war.

In the 1991 Gulf War less than 150 of nearly 700,000 deployed US troops were killed in action. Today, however, over 1 in 7 US veterans of the war has sought federal healthcare for related-health concerns, and fully 17% of UK Gulf War veterans describe themselves as suffering from the 'Gulf War syndrome', a set of poorly defined and heterogeneous ailments consisting mainly of chronic pain, fatigue, depression and other symptoms. Even though over 250 million dollars of federally funded medical research has failed to identify a unique syndrome, the debate regarding potential causes continues and has included oil well smoke, contagious infections, exposure to chemical and biological warfare agents, and posttraumatic stress disorder. Historical analyses completed since the Gulf War have found that postwar syndromes consisting of chronic pain, fatigue, depression and other symptoms have occurred after every war in the 20th century. These syndromes have gone by a variety of names such as Da Costa's syndrome, irritable heart, shell shock, neurocirculatory asthenia, and battle fatigue. Though the direct causes of these syndromes are typically elusive, it is clear that war sets in motion an undeniable cycle of physical, emotional, and fiscal consequences for war veterans and for society. These findings lead to important healthcare questions. Is there a way to prevent or mitigate subsequent postwar symptoms and associated depression and disability? We argue that while idiopathic symptoms are certain to occur following any war, a population-based approach to postwar healthcare can mitigate the impact of postwar syndromes and foster societal, military, and veteran trust. This article delineates the model, describes its epidemiological foundations, and details examples of how it is being adopted and improved as part of the system of care for US military personnel, war veterans and families. A scientific test of the model's overall effectiveness is difficult, yet healthcare systems for combatants and their families are already being put to pragmatic tests as troops return from war in Iraq and Afghanistan and from other military challenges.

Chronic Disease↗

PubMed2004

The burden of anaemia in patients with cancer.

Anaemia is highly prevalent in patients with cancer, and its incidence and severity depend on many factors, such as type of anti-cancer therapy. The decreased oxygen capacity of blood resulting from anaemia affects virtually every organ and tissue system in the body, manifesting in numerous signs and symptoms that include fatigue, dyspnoea, palpitations, tachycardia, asthenia, anorexia, cold hypersensitivity and general weakness. Anaemia related to cancer may also cause cognitive dysfunction, leading to decreased mental alertness, poor concentration and memory problems. There is a close association between anaemia and overall quality of life (QoL) variables, and anaemia is an adverse prognostic factor in patients with cancer. Since anaemia can seriously compromise the QoL of cancer patients and is associated with decreased overall survival time, there is a strong need for effective and well-tolerated treatment strategies. Erythropoietic agents have been proven to be safe, well-tolerated and effective in the management of anaemia in patients with cancer. Epoetin therapy reduces transfusion requirements and increases haemoglobin levels in patients with solid tumours and haematological malignancies.

Anemia, Hypochromic↗

PubMed2005

A phase II trial of raltitrexed (Tomudex) in advanced pancreatic and biliary carcinoma.

PURPOSE: To evaluate the impact of raltitrexed (Tomudex) on the quality of life in a multicenter, phase II study in advanced pancreatic and biliary carcinomas. PATIENTS AND METHODS: Forty-six patients with advanced, histologically proven pancreatic (n = 37, 80.4%) or biliary (n = 9, 19.6%) carcinoma received 3 mg/m2 raltitrexed intravenously once every 3 weeks. For the quality of life assessments, EORTC QLQ-C30 was used, and the evaluation of the clinical benefit was performed according to the 4 criteria of the clinical benefit response. All patients were assessed for safety, and 41 patients were evaluable for objective response. RESULTS: Patients (63% male/37% female) had a mean age of 61.2 years, 71.7% had a PS of 0-1, 78.3% had metastatic disease, and 63% had at least 2 tumoral sites. A total of 176 cycles were administered with a mean of 4 cycles per patient (range 1-12). Three out of 43 patients evaluable for EORTC QLQ-C30 (7.0%; CI(95%) 1.4-19.0%) had a quality of life improvement. Thirty-two patients fulfilled the 4 criteria required to evaluate the clinical benefit response; 5 were responders (15.6%; CI(95%) 5.3-32.8%); 1 patient was a good responder based on both the EORTC questionnaire and the clinical benefit response. Forty-one patients were assessable for response, 3 responded to treatment (response rate: 6.5 %; CI(95%) 1.3-17.9%). Median survival was 4.6 months (CI(95%) 2.9-8.2 months), the 1-year survival rate was 21.8%. The most common grade 3-4 toxicities were neutropenia (8%), leukopenia (8%), thrombopenia (6%), anemia (6%), liver enzyme elevations (11%), asthenia (9%), vomiting (9%), abdominal pain (7%), and phlebitis (6%). One treatment-related death occurred (neutropenic sepsis). CONCLUSION: Raltitrexed appeared to be generally well tolerated and showed a clinical benefit response and/or quality of life improvement in a limited number of patients.

Antimetabolites, Antineoplastic↗

PubMed2005

Weekly docetaxel in pretreated metastatic breast cancer patients: a phase I-II study.

OBJECTIVE: We conducted a phase I-II study to determine the maximum tolerated dose (MTD), toxicity and activity of weekly docetaxel administration in pretreated metastatic breast cancer patients. METHODS: In phase I, cohorts of 3 women with pretreated metastatic breast cancer were treated with a 1-hour infusion of docetaxelat 30, 35, 40 mg/m2/week after premedication with two doses of dexamethazone 8 mg 12 h apart. Subsequently, a cohort of 28 women was treated at the MTD for 24 consecutive weeks in a phase II setting and was assessed for toxicity and activity. RESULTS: Three patients were treated at each of the first two dose levels; 9 patients were treated at the 3rd level (40 mg/m2/week). Dose-limiting toxicities (DLTs) were experienced at that level by 2/6 patients of the first two accrued groups and in 2/3 patients of the 3rd (confirmation) group, thus establishing the subsequent phase II dose at 35 mg/m2/week. Two out of 28 evaluable patients (7.1%, 95% CI 0-16.7) showed complete responses, whereas 8 (28.6%, 95% CI 11.8-45.3) showed partial responses, and an objective response rate of 35.7% (95% confidence interval, CI 18-53.5%). In addition, 8 patients (28.6%) had stable disease. The median time to progression and overall survival were 5 (range 1-15) and 15 months (95% CI 7-23), respectively. One patient experienced 1 episode of grade 3 neutropenia. Severe asthenia was the main reason for interruption of chemotherapy (10 patients, 35.5%). CONCLUSIONS: In pretreated metastatic breast cancer patients, the sustained weekly administration of docetaxel, even though it demonstrated an activity similar to a 3-weekly schedule could not be maintained for the planned 24 weeks due to the progressive emergence of nonhematological side effects that approached DLTs.

Adolescent↗

PubMed2005

Continuous infusion of oxaliplatin plus chronomodulated capecitabine in 5-fluorouracil- and irinotecan-resistant advanced colorectal cancer patients.

OBJECTIVES: The aim of the study was to define the feasibility and efficacy of Xelox (capecitabine and oxaliplatin) administered through a new and original schedule in advanced pretreated colorectal cancer (CRC) patients. METHODS: 36 metastatic CRC patients resistant at least to a previous 5-fluorouracil- and irinotecan-based chemotherapy line were included in the study. TREATMENT: Oxaliplatin 70 mg/m2 as continuous infusion for 12 h (8.00 a.m. to 8.00 p.m.) on days 1, 8 plus chronomodulated capecitabine 1,750 mg/m2/day per os (8.00 a.m. 25% of total dose; 6.00 p.m. 25% of total dose; 11.00 p.m. 50% of total dose), on days 1-14 every 21 days. 16 (44.4%) patients had previously received only 1 chemotherapy line for metastatic disease and 20 patients (55.6%) 2 chemotherapy lines. Moreover, 12 patients (33.3%) progressed after a first or second line of oxaliplatin-based regimen as well. RESULTS: Most frequent related G3-4 adverse reactions were diarrhea (11.6%), nausea/vomiting (8.3%), neuropathy (8.3%), mucositis (8.3%), asthenia (16.7%) and hand-foot syndrome (5.5%). G3-4 anemia, leucopenia and liver toxicities were not observed. The overall response rate was 30.6% (11/36 patients). Disease stabilization was observed in 13 patients (36.1%) and progression in 12 patients (34.3%). Between the 12 oxaliplatin-resistant patients, the overall response rate was 25% (3 patients); 6 patients (54.5%) obtained a stable disease, and only 3 patients (25%) progressed. The median overall survival was 11.3 months (95% confidence interval 7.0-15.7 months), the median response duration 2.8 months (95% confidence interval 1.2-5.6 months) and the median time to progression 6.7 months (95% confidence interval 5.7-6.3 months). The 1-year survival rate was 53.8%. CONCLUSIONS: The high overall tumor growth control, the remarkable median time to progression and overall survival and the good safety profile are of particular interest for patients with heavy pretreated metastatic CRC.

Adult↗

PubMed2005

Combination of irinotecan (CPT-11) plus 5-fluorouracil and leucovorin (FOLFIRI regimen) as first line treatment for elderly patients with metastatic colorectal cancer: a phase II trial.

PURPOSE: To evaluate the efficacy and tolerance of irinotecan (CPT-11) in combination with bolus and continuous infusion of 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFIRI regimen) as first-line treatment of elderly patients with metastatic colorectal cancer (MCC). METHODS: Thirty consecutive, previously untreated patients with metastatic colorectal cancer, aged (median 76 years; range 70-84) were enrolled. The performance status (WHO) was 0 in 8, 1 in 16 and 2 in 6 patients; 19 (63%) patients had prior surgery and 8 (27%) adjuvant chemotherapy. CPT-11 (180 mg/m(2) as a 90 min i.v. infusion) was administered on day 1, LV (200 mg/m(2) as a 2-hour i.v. infusion), 5-FU (400 mg/m(2)/d i.v. bolus followed by 600 mg/m(2)/d as a 22-hour i.v. continuous infusion) were given on days 1 and 2 every 2 weeks. RESULTS: Complete response was achieved in one (3.3%) patient and partial response in 10 (33.3%) (overall response rate: 36.6%; 95% C.I.: 26.6-48.4%); 11 (36.6%) patients had stable disease and, 8 (26.6%) disease progression. The median duration of response was 7.5 months and the median time to disease progression 7.0 months. After a median follow-up period of 17 months, the median overall survival was 14.5 months. Main toxicities were: grade 3-4 neutropenia (n = 6; 20%), grade 3 thrombocytopenia (n = 1; 3.3%), grade 2 anemia (n = 9; 30%), grade 3-4 diarrhea (n = 5; 17%) and grade 3 asthenia (n = 3; 10%). There was one treatment-related death due to neutropenic sepsis. CONCLUSIONS: The FOLFIRI combination is an active regimen with manageable toxicity as front-line treatment in patients above 70 years of age.

Aged↗

PubMed2005

A dose escalation study of pegylated liposomal Doxorubicin (caelyx) in combination with capecitabine (xeloda) in patients with refractory solid tumors.

OBJECTIVE: Pegylated liposomal doxorubicin (PLD) and capecitabine (CAP) have separately shown significant antitumor activity in a wide range of solid tumors. A phase I study was conducted in order to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of their combination in patients with refractory solid tumors. PATIENTS AND METHODS: Fifteen patients with histologically confirmed inoperable solid neoplasms were enrolled. The patients' median age was 65 years, 10 were male, and 12 had a performance status score (WHO) of 0-1. PLD was administered on day 1 as a 1-hour intravenous infusion at escalated doses ranging from 35 to 40 mg/m(2). CAP was administered on days 1-14 per os, at escalated doses ranging from 1,600 to 1,800 mg/m(2), given as two daily divided doses. Treatment was repeated every 3 weeks. RESULTS: At the dose of PLD 40 mg/m(2) and CAP 1,800 mg/m(2), all 3 enrolled patients presented DLTs [2 patients grade 3 palmar-plantar erythrodysesthesia (PPE) and 1 patient grade 3 asthenia] and thus, the recommended MTD for future phase II studies is PLD 40 mg/m(2) and CAP 1,700 mg/m(2). A total of 57 treatment cycles were administered. Grade 2/3 neutropenia complicated 9 (17%) cycles and 1 patient was hospitalized for febrile neutropenia. There was no septic death. The main nonhematologic toxicity was PPE grade 2 in 3 (19%) patients and grade 3 in 4 (27%). PPE was the reason of treatment interruption for 3 patients. Other toxicities were mild and easily manageable. Two patients (16%) with partial response suffering from gastric cancer and 5 patients with (42%) stable disease were observed among 12 evaluable patients. CONCLUSIONS: The results of this phase I study demonstrate that PLD and CAP can be combined at clinically effective and relevant doses. However, PPE is a common side effect and further investigation is warranted to define its precise role in the treatment of solid malignancies.

Adult↗

PubMed2006

Salvage chemotherapy with gemcitabine and oxaliplatin in heavily pretreated patients with metastatic breast cancer: a multicenter phase II study.

PURPOSE: It was the aim of this study to evaluate the activity and tolerance of gemcitabine and oxaliplatin in pretreated metastatic breast cancer patients. METHODS: Thirty-one patients who had disease relapse or progression after completion of an anthracycline- and/or taxane-based front-line regimen were treated with gemcitabine 1,500 mg/m(2) on days 1 and 8 as a 30-min intravenous infusion and oxaliplatin 130 mg/m(2) on day 8 as a 4-hour intravenous infusion, in cycles of 21 days. RESULTS: Complete response occurred in 1 patient (3%) and partial response in 4 patients (13%) (overall response rate 16%; 95% confidence interval 3.2-29.1). Nine patients (29%) had stable disease and 17 (55%) progressive disease. Three partial responses (13%) were achieved among 23 patients receiving the regimen as third-line treatment. The median duration of response was 6 months (range 3-44.8), the median time to tumor progression 4.6 months (range 0.8-43.8), and the median survival 14.4 months (range 2.1-44.8). Grade 3 and 4 neutropenia occurred in 14 patients (45%), grade 3 and 4 thrombocytopenia in 6 patients (20%), and grade 2 and 3 asthenia in 4 patients (13%). There was no episode of febrile neutropenia. CONCLUSION: The gemcitabine-oxaliplatin combination is a relatively active and well-tolerated salvage regimen in patients with heavily pretreated metastatic breast cancer.

Aged↗

PubMed1975

Correlation of symptoms in pre-menstrual tension to oestrogen and progesterone concentrations in blood plasma. A preliminary study.

15 women with premenstrual tension are rated in four symptom groups, anxiety-tension, asthenia-depression, irritability-explosiveness and feelings of swelling. The ratings of anxiety and irritability were also added to a separate group. Ratings were then correlated to plasma oestrogen and progesterone levels and oestrogen/progesterone ratios. There was a significant correlation between oestrogen levels and the anxiety, irritability, anxiety + irritability and depression groups. A correlation was also found between oestrogen/progesterone ratios and anxiety. No significant correlation was found between progesterone levels and symptom ratings.

Adult↗

PubMed1989

Safety of fenofibrate--US and worldwide experience.

Fenofibrate is a fibric acid derivative with enhanced potency and specificity of action on lipids. Preclinical toxicology reveals minimal toxic effects; dose-related changes occurred seldom, with only hepatic effects in rodents (mainly enzyme changes), some renal effects in dogs, and no reactions in monkeys. Teratogenicity tests were negative, and mutagenicity was not associated with fenofibrate. Carcinogenicity was evident in rodents with liver carcinoma at doses of 12 or 40 times the human dose, but cancer has not been associated with fenofibrate in over 10 years of clinical research and use. European experience with fenofibrate involved 7,145 patients in short- and long-term clinical trials, plus 10 years of marketing experience with a patient exposure of 6 million patient-years. Adverse effects were relatively low in frequency (6%) in the European clinical trials and manifested as gastrointestinal effects, muscle pain, skin problems, and sweating or dizziness. Short- and long-term fenofibrate studies revealed basically the same scope and frequency of adverse effects. Experience in US clinical trials mirrored the European experience; three types of adverse effects occurred more commonly in fenofibrate patients versus placebo: skin reactions, neurologic effects, and musculoskeletal reactions. Laboratory tests were mildly abnormal for liver function, leukocytes, and hemoglobin; these reactions were significant enough to be considered adverse drug experiences only occasionally. Hepatobiliary tests for lithogenicity showed an increase in cholesterol saturation, but gallstones seldom have been associated with fenofibrate. Postmarketing, open experiences in Europe over 10 years have been consistent with the study results. The rate of reactions has been low (about 115/year or a 0.3% incidence rate). The reactions noted in these spontaneous reports were hepatic, renal, gallstones, cutaneous, hematologic, sexual asthenia, and weight loss. In general, fenofibrate can be considered a safe and well-tolerated lipid-lowering drug that has been scrutinized extensively for safety in clinical research and during an already long marketing period in Europe.

Clinical Trials as Topic↗

PubMed1985

Bromocriptine treatment in tall adolescents: two years of clinical experience.

34 adolescents referred for excessive height prediction (HP) (11 boys with HP greater than 196 cm, 23 girls with HP greater than 180 cm) were treated for 9-15 months with bromocriptine (5-7.5 mg/day). Minor and transient side effects were observed in 20% of the subjects at the beginning of the treatment. Treatment had to be stopped in 1 boy complaining of asthenia and headache. Puberty developed normally, 19 girls experienced menarche during treatment and 1 continued regular menses. Bromocriptine treatment induced: (1) a significant decrease (p less than 0.001) in growth velocity from (mean +/- SEM) 8.6 +/- 0.4 to 5.3 +/- 1.5 cm/year in boys and from 7.1 +/- 0.2 to 4.6 +/- 0.6 cm/year in girls; (2) a twofold mean increase in skeletal maturation rate. Adult HP was reduced significantly from 202 +/- 1.4 to 195.4 +/- 1.2 cm in boys, and from 184 +/- 0.7 to 179.8 +/- 0.7 in girls. These results confirm our previous report suggesting that bromocriptine is a valuable alternative to sex steroid treatment in order to limit the final height in excessively tall adolescents.

Adolescent↗

PubMed1985

Transmission of Mycobacterium tuberculosis with renal allografts.

Disseminated tuberculosis occurred in 2 allograft recipients of kidneys procured on the same donor. Both recipients were treated by low dose prednisolone and azathioprine, and one of them was on a special protocol including antilymphocyte globulins as rejection prophylaxis. None of them experienced acute rejection. The early posttransplant period was uneventful except for the occurrence of mild viral infections in both cases (herpes simplex virus in case 1 and cytomegalovirus in case 2). 2 and 6 months after transplantation, respectively, patient 1 developed acute fever, asthenia, and disorientation while patient 2 presented with spiking fever and miliary pneumonitis. Mycobacterium tuberculosis grew in the urine of both recipients in the absence of clinical genitourinary symptoms. The two mycobacterial species had the same bacteriologic characteristics and the same antibiotic sensitivity. As the recipients had no evidence of a previous history of active tuberculosis, it is suggested, as for some other infectious agents, that mycobacterium was transmitted along with the transplanted kidneys.

Azathioprine↗

PubMed1979

[High-dosage gestagen treatment in the therapy of advanced breast cancer].

The results obtained with a new hormonal treatment schedule involving the administration of medroxyprogesterone acetate in single and total doses never before used in the treatment of advanced breast cancer are reported. The results concern 100 patients, 13 of which in premenopause and 87 in postmenopause stage. 79 patients were treated with a single daily dose of 1500 mg i.m. for 30 days, subdivided into 2 equal doses administered at intervals of 12 hours, while 21 patients were treated with a dose of 2000 mg/day using the same modalities. In the 13 premenopausal patients, complete or partial objective remission was observed in 12/13 (92%) of cases, while the disease advanced in one of the patients (8%). Of the 87 postmenopausal patients, complete or partial objective remission was observed in 40/87 (46%) of cases, minimal remission in 9/87 (10%), while 18/87 (21%) remained stationary. The disease advanced in 20/87 (23%) of patients. In patients where metastasis mainly affected the bones and soft tissues complete or partial remission occurred in 41/52 (79%) of cases. Those where visceral metastasis was prevalent showed remission in 3/33 (9%) of cases. Median duration of remission was 6 months (range: 3--27). A significant reduction of pain was noticed in 68/74 (92%) of cases, of dyspnea in 20/25 (80%), of anorexia in 45/53 (85%), of asthenia in 49/70 (70%) and of restriction of movement in 24/39 (62%). On the basis of the present results, treatment with massive doses of medroxyprogesterone acetate should be considered: a) as first therapeutic measure in the treatment of postmenopausal patients with prevalent lesions in soft tissues and bones; b) as a subject of a particular study in premenopausal patients with breast cancer in an advanced stage, and c) as a possible alternative to polychemotherapy in the treatment of micrometastasis following mastectomy.

Breast Neoplasms↗

PubMedDate not supplied

Home treatment with interleukin 2 and beta-interferon in patients with colorectal cancer and hepatocellular carcinoma.

Biological response modifiers have been extensively investigated in the management of patients with cancer, but few data are available on tumors of the gastrointestinal tracts. To evaluate the feasibility and activity of the combination of interleukin 2 (IL-2) and beta-interferon (beta-IFN), 15 patients with colorectal cancer and 10 patients with hepatocellular carcinoma were treated with the following outpatient schedule: beta-IFN 3 x 10(6) U i.m. 3 times weekly from day 1 to day 14; IL-2 4.5 x 10(6) U s.c. every 12 for 5 consecutive days a week from day 7 to day 21, the cycles being repeated every 28 days. All of the patients had been previously treated with chemotherapy; 7 unresectable locally advanced, and 18 had metastatic disease. All of the treatment courses were administered in an outpatient setting. No grade 4 side effects were recorded. The worst side effects were grade 3 fever (4 patients) and asthenia (2 patients) requiring treatment discontinuation in 4 cases. Twenty-four patients were evaluated for response (14 with colorectal cancer and 10 with hepatocellular carcinoma). One partial response, 4 stable disease, 9 progressive disease were recorded among the colorectal patients; 4 stable disease and 6 progressive disease among the hepatocellular carcinoma patients. The median duration of stable disease was 3 months for hepatocellular carcinoma and 4 months for colorectal cancer patients. Our results suggest that the schedule is feasible in an outpatient setting. Its limited hematological toxicity makes it suitable to be combined with cytotoxic drugs.

Adult↗

PubMed1990

Single-dose fosfomycin trometamol versus multiple-dose cotrimoxazole in the treatment of lower urinary tract infections in general practice. Multicenter Group of General Practitioners.

A randomized trial, comparing a single dose treatment of fosfomycin trometamol (FT, 3 g) versus a 3-times daily regimen of cotrimoxazole (CTX, 960 mg) was carried out in women with uncomplicated urinary tract infections. Of 36 evaluable patients, 19 were treated with FT and 17 with TMP. The bacteriological results after 4 weeks of follow-up were in the FT group (n = 19): cure in 17 (89%), and failure in 2 (11%). For the CTX group (n = 17) the results were cure in 13 (76%), and failure in 4 (24%). Adverse events were reported in 3 patients on FT (2 diarrhoea, 1 epigastralgia) and in 2 on CTX (1 stain rash, 1 asthenia).

Bacteriuria↗