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At least 865 records · Page 48Linked to original sources
PubMed1992

Oral granisetron--simple and effective: a preliminary report. The Granisetron Study Group.

This randomised, double-blind, study was carried out in 930 patients in order to examine the efficacy and safety of oral granisetron in the dose range 0.25, 0.5, 1.0 and 2.0 mg twice daily. Oral granisetron was administered for either 7 or 14 days according to the chemotherapy regimen used. A total of 930 patients were enrolled into this study in order to be able to detect a difference of 15% between groups (80% power). The preliminary results showed that at 7 days efficacy was significantly greater for 1.0 mg b.d. (58.5%) than for 0.25 mg b.d. (43.7%) and indicated that, of the doses examined, the 1.0 mg b.d. dose was optimal in patients receiving moderately emetogenic chemotherapy. In agreement with this there were more withdrawals from the 0.25 and 0.5 mg groups due to lack of efficacy. The adverse events most frequently reported (in greater than 5% of patients) were constipation, headache, abdominal pain, fever, leucopenia and asthenia. The latter three are recognised side effects of the primary disease and of chemotherapy. The incidence of headache was similar to that seen in previous granisetron studies. Abdominal pain may have been related to constipation. The incidence of constipation (25.9%) was higher than that reported in previous granisetron studies but was not dose related. Thus oral granisetron at 1.0 mg twice daily is an effective antiemetic, offering a convenient dosing regimen without significant adverse events.

Administration, Oral↗
PubMed1994

A randomised trial of MACC chemotherapy with or without lonidamine in advanced non-small cell lung cancer. Cuneo Lung Cancer Study Group (CuLCaSG)

Combination chemotherapy with anti-proliferative agents is the usual treatment for patients with advanced non-small cell lung cancer (NSCLC), good performance status and no major clinical contraindications. Lonidamine (LND), a new drug with an innovative mechanism of action, might potentiate anti-cancer activity of conventional cytotoxic drugs, with no increase of specific toxicity. Following a pilot study of feasibility, we now report the results of a randomised trial evaluating MACC chemotherapy, as originally described, versus the same regimen+LND. 151 patients with advanced NSCLC were assigned at random to the two treatment arms. LND 150 mg was given orally three times daily. Treatment was continued until progression of disease, unacceptable toxicity or refusal by the patient (median number of cycles of MACC, three for both arms; median duration of LND administration, 8 weeks in the arm concerned). Actual dose intensities (DI) of MACC and LND were, respectively, 100 and 83% of those intended (median values). There was a negative correlation between duration of chemotherapy and the DI of MACC reached in each patient, but no correlation between the duration of treatment with LND and its DI. DIs of LND and MACC were not correlated with each other. In all, 15 objective responses (one complete and four partial responses in the MACC group, 10 partial responses in patients on MACC+LND) were observed. Median progression-free survivals were 20 weeks (confidence interval, CI 14-22) for the group on LND and 17 weeks (CI 12-17) for the control group (non-significant difference). Median overall survivals were, respectively, 30 weeks (CI 23-40) and 27 weeks (CI 22-34), P = non-significant. Toxicity was as expected by the use of MACC, and similar in both arms, except for more severe anaemia and gastric toxicity in the group on MACC+LND. Other uncommon side-effects, seen only in this latter group, were mild to moderate and reversible and included myalgia, asthenia, testicle pain, headache, visual troubles, incubi and dizziness. Subjective tolerance to the treatment, and perception of physical and psychological well-being were rated similarly by patients of both groups. MACC plus LND is a moderately active regimen in advanced NSCLC, with a foreseeable and reversible toxicity of low-medium grade. Potential enhancements of anti-tumour efficacy of chemotherapy, and possible host survival benefits derived from the use of LND are not substantiated by the results of this trial.

Adult↗
PubMed1994

Activity of docetaxel (Taxotere) in small cell lung cancer. The Early Clinical Trials Group of the EORTC.

Docetaxel (Taxotere) is a new cytotoxic compound with a broad spectrum of activity in preclinical studies. This paper reports a phase II trial in patients with previously-treated small cell carcinoma of the lung. 34 patients received 100 mg/m2 of docetaxel in an intravenous infusion given over 1 h every 21 days. Seven partial responses were reported (25% of 28 evaluable patients). Duration of response was 3.5-12.6 months. Toxicities were predominantly neutropenia, alopecia and asthenia. Docetaxel is a new compound with activity in previously-treated patients with small cell lung cancer, and is suitable for evaluation in combination with other cytotoxic drugs active in this disease.

Adult↗
PubMed1994

Docetaxel (Taxotere) in advanced malignant melanoma: a phase II study of the EORTC Early Clinical Trials Group.

The antitumour activity of docetaxel was investigated in patients with advanced malignant melanoma. Docetaxel, 100 mg/m2, intravenous, over 60 min, was administered every 3 weeks. Response evaluation was performed after two cycles. No prophylactic treatment with steroids or antihistamines was given. 38 patients were included, 36 were eligible and evaluable for toxicity and 30 patients were evaluable for response. The main haematological toxicity was neutropenia [17 patients with common toxicity criteria (CTC) grade 4 and 11 CTC grade 3] with nadir after 5-8 days and rapid recovery. The most frequent non-haematological toxicity was generalised alopecia (83% of the patients). Asthenia, malaise and fatigue were also seen in 58%. Skin toxicity was also frequent. Hypersensitivity reactions (erythematous rash, urticaria, blood pressure changes and tachycardia), seen in 42% of the patients, were mild to moderate. Oedema was registered in one fifth of the patients and developed after four or more treatment cycles. The overall response rate in the evaluable patients was 17% (five partial responders). We conclude that docetaxel has activity in advanced malignant melanoma.

Adult↗
PubMed1995

Early clinical studies with docetaxel. Docetaxel Investigators Group.

Docetaxel has been evaluated in six phase I studies involving a total of 234 patients with a wide variety of tumour types (50% had breast or ovarian cancer). The aims of these studies were to determine the optimal dosage schedule of docetaxel for use in subsequent phase II studies, and to characterise the pharmacokinetic and tolerability profiles of docetaxel. Intravenous (i.v.) doses of docetaxel (5-115 mg/m2) were administered in various treatment schedules for a total of 790 courses. Cycles were repeated every 2-3 weeks. Dose-dependent neutropenia was the major dose-limiting adverse effect of docetaxel. Other adverse events reported included hypersensitivity, fluid retention, skin reactions, asthenia and alopecia. Anaphylactoid reactions occurred rarely. No abnormal cardiac activity was detected, and neurological adverse events were mild. Docetaxel 100 mg/m2 administered as a 1 h i.v. infusion every 3 weeks combined acceptable tolerability with complete neutropenic recovery. This dosage schedule was thus considered to be optimal for further investigation in phase II studies.

Antineoplastic Agents, Phytogenic↗
PubMed1995

Effects of intrapleural mitoxantrone and mepacrine on malignant pleural effusion--a randomised study.

30 patients with malignant pleuritis were randomised to be treated, either with intrapleural instillation of mepacrine chloride or with mitoxantrone. The patients were evaluated with chest X-ray and a symptom questionnaire during a follow-up period of 12 weeks. Mitoxantrone levels in the pleural space and plasma were measured at different time points in some of the patients. High concentrations of mitoxantrone were found in the pleural fluid while the plasma concentrations were low, giving a plasma/intracavity ratio generally of less than 1:60. The chest X-rays showed excellent results for both treatment modalities. However, the patients treated with mepacrine chloride experienced greater discomfort with fever and pain, and those treated with mitoxantrone reported significantly less dyspnoea and less asthenia after 4 weeks. We conclude that both treatments are equally effective in preventing the recurrence of malignant effusion. However, mitoxantrone seems to have further advantages when it comes to improving the quality of life.

Adult↗
PubMed2005

Feasibility and clinical outcome of laparoscopic colorectal resection for endometriosis.

OBJECTIVE: This study was undertaken to evaluate the feasibility and complications of laparoscopic segmental colorectal resection for endometriosis and its efficacy on gynecologic and digestive symptoms. STUDY DESIGN: After magnetic resonance imaging and rectal endoscopic sonographic evaluation of symptomatic colorectal endometriosis, 40 consecutive women requiring colorectal resection were included in this study. Symptom questionnaires were completed before and after the procedure. Perioperative complications and linear intensity scores for several gynecologic and digestive symptoms were recorded. RESULTS: Thirty-six women (90%) underwent laparoscopic segmental colorectal resection and 4 required laparoconversion. Major complications occurred in 4 cases (10%), including 3 rectovaginal fistulae and 1 pelvic abscess. Transient urinary dysfunction occurred in 7 women (17.5%). Median follow-up after colorectal resection was 15 months (3-22 months). Median overall preoperative and postoperative pain scores were 8 +/- 1 (range 4-10) and 2 +/- 2 (0-10), respectively ( P < .0001). Nonmenstrual pelvic pain ( P = .0001), dysmenorrhea ( P < .0001), dyspareunia ( P = .0001), and pain on defecation ( P < .0005) were improved by colorectal resection. Lower back pain and asthenia were not improved. CONCLUSION: Our results suggest that laparoscopic segmental colorectal resection for endometriosis is feasible but carries a risk of major postoperative complications. Colorectal resection improved gynecologic and digestive symptoms, and the overall pain score.

Adult↗
PubMed2005

Efficacy and safety of sildenafil citrate in men with erectile dysfunction and chronic heart failure.

Chronic heart failure (CHF) is an increasingly common cardiovascular disorder. Many patients who have CHF report moderate to marked decreases in the frequency of sexual activity, and up to 75% of patients report erectile dysfunction (ED). There are few controlled clinical data on the efficacy and safety of sildenafil citrate in men who have ED and CHF; thus, we evaluated these parameters in patients who had stable CHF. This was a double-blind, placebo-controlled, flexible-dose study. Men who had ED and stable CHF were randomized to receive sildenafil or placebo for 12 weeks. Primary outcomes were questions 3 and 4 of the International Index of Erectile Function. Secondary outcomes included the 5 functional domains of the International Index of Erectile Function, 2 global efficacy assessment questions, intercourse success rate, the Erectile Dysfunction Inventory of Treatment Satisfaction, and the Life Satisfaction Checklist. By week 12, patients who received sildenafil (n = 60) showed significant improvements on questions 3 and 4 compared with patients who received placebo (n = 72; p <0.002). Larger percentages of patients who received sildenafil reported improved erections (74%) and improved intercourse (68%) compared with patients who received placebo (18% and 16%, respectively). Intercourse success rates were 53% among patients who received sildenafil and 20% among those who received placebo. Patients who received sildenafil were highly satisfied with treatment and their sexual life compared with patients who received placebo. Sixty percent of patients who received sildenafil and 48% of patients who received placebo developed adverse events, including transient headache, facial flushing, respiratory tract infection, and asthenia. The incidence of events related to cardiovascular effects was low. Sildenafil is an effective and well-tolerated management of ED in men who have mild to moderate CHF.

Adult↗
PubMed2004

[Neutropenia and fever after aorto-coronary bypasses].

Plasma-derived products are often used in cardiac surgery. We report the case of a patient developing an infection due to Parvovirus B19 after coronary artery bypass. Symptoms were fever, asthenia, anemia, and pancreatitis. This infection can be transmitted from plasma-derived product, like fibrin sealant (used for hemostasis during surgery). Parvovirus B19 is resistant to existing virus-inactivating techniques. The patient had to leave our hospital after symptomatic treatment which has significantly increased the length to stay.

Coronary Artery Bypass↗
PubMed2004

[Sheehan's syndrome: an erratic diagnosis in the early postpartum].

Post-partum pituitary necrosis (Sheehan's syndrome) is a rare complication of the post-partum haemorrhage. The diagnosis can be erratic and often delayed. We report the case of a patient who had headaches and meningitis signs few hours after a post-partum haemorrhage. Magnetic Resonance Imaging (MRI) performed at day 2 showed a specific hypophysitis. The onset of asthenia, loss of weight, polyuro-polydipsy, persistent amenorrhoea and absence of lactation led to hormonal investigation. This permitted to diagnose global antehypopituitarism associated with diabetes insipidus. Progressive pituitary atrophy due to necrosis was found using MRI follow-up over 1 year. Our report summarises pathophysiological features of Sheehan's syndrome and early clinical and biological signs are discussed. MRI of the sellar region may be useful to early suspect the diagnosis.

Adult↗
PubMed2004

Effects of Siberian ginseng (Eleutherococcus senticosus maxim.) on elderly quality of life: a randomized clinical trial.

An unspecific feeling of fatigue and asthenia often pushes elderly patients to require any form of help even from non medically trained people. Traditional Chinese medicine suggest that Siberian ginseng could act as safe "adaptogenic" substance. Our aim was thus to test the effect of a middle term Eleutherococcus senticosus Maxim. (Araliaceae) administration on elderly, health related quality of life (HRQOL). 20 elderly hypertensive and digitalized volunteers (age >/= 65 years) were randomized in a double -blind manner to E. senticosus dry extract 300 mg/day (n = 10) or placebo (n = 10) for 8 weeks. The short form-36 health survey version 2 (SF-36v2), a validated general health status questionnaire, was used to access HRQOL at baseline and at 4 and 8 weeks. There were no significant differences in baseline demographics and SF-36v2 scores between the groups. At each visit, controls of digitalemia and blood pressure level were carried out. After 4 weeks of therapy, higher scores in social functioning (p = 0.02) scales were observed in patients randomized to E. senticosus; these differences did not persist to the 8-week time point. No adverse event has been observed in both groups of patients. No significant difference in both blood pressure control and digitalemia was observed in both treatment groups. Subjects give E. senticosus (70%) were more likely to state that they received active therapy than subjects given placebo (20%; p < 0.05). In conclusion, E. senticosus safely improves some aspects of mental health and social functioning after 4 weeks of therapy, although these differences attenuate with continued use.

Aged↗
PubMed2005

High doses of pergolide improve clinical global impression in advanced Parkinson's disease:- a preliminary open label study.

We evaluated the efficacy and safety of high-dose pergolide treatment in patients with moderate to severe Parkinson's disease (PD) in an open-label multicenter clinical trial. The primary objective was to assess the amount of reduction in levodopa, the improvement in Unified Parkinson's Disease Rating Scale (UPDRS) and adverse reactions. We treated 32 patients with PD presenting with motor fluctuations. Pergolide treatment started with a dose escalation period of 12 weeks followed by a 12-week continuation period. Pergolide doses were increased up to a maximum of 12 mg/day in combination with a simultaneous decrease of levodopa doses in 100mg steps. Levodopa was reduced from 500 mg/day (median) to 250 mg/day. Mean UPDRS part III improved significantly (p=0.01). Clinical global impression improved significantly after 24 weeks (p<0.01). Most frequent adverse events were hallucinations, asthenia, anxiety, abdominal pain, and peripheral edema. Twenty-two patients finished the complete study according to protocol. A possible relationship to the study medication was assumed for two serious adverse events reporting psychosis. We conclude that high doses of pergolide are efficacious in advanced stages of PD if given in appropriate regimens.

Adult↗
PubMedDate not supplied

Alterations of lipid profile in endurance over-trained subjects.

BACKGROUND: We tested the hypothesis that endurance over-training could alter the favorable effects of well-tolerated training on lipid profile. METHODS: At weeks 1, 6, 15, 26, 36, and 47 of the training program, blood was drawn to test lipid profile of 20 endurance-trained rowers. Diet and caloric intake were controlled. RESULTS: Over-training was diagnosed in five subjects (loss of performance, asthenia, sleep disturbance...) at week 15 and lipid profile of well-trained and over-trained subjects were compared. Training improved cholesterolemic profile and lowered insulin resistance (HOMA-IR: -39 +/- 9%; p=0.02), and triglycerides concentration (-30 +/- 6%; p=0.05) in rowers who did not change to demonstrate over-training. Plasma LPL (+29 +/- 11%; p=0.01) and hepatic lipase (+5 +/- 3%; p=0.01) activities increased in this group suggesting higher TG utilization and turnover. After week 15 and regarding the well-trained condition for the five over-trained subjects, VLDL-TG (-13 +/- 7 %; p=0.03) and Apo-C(3) (-31 +/- 13%; p=0.01) concentrations decreased, while insulin resistance (+17 +/- 7%; p=0.03) and glycerol concentration (+17 +/- 3%; p=0.01) increased and hepatic lipase activity decreased (-14 +/- 4%; p=0.01). CONCLUSION: Over-training was accompanied by alterations in the lipid profile, which appeared to be the consequence of over-training.

Adult↗
PubMed2004

Molecular mechanisms involved in muscle wasting in cancer and ageing: cachexia versus sarcopenia.

The aim of the present review is to summarize and evaluate the different mechanisms and catabolic mediators involved in cancer cachexia and ageing sarcopenia since they may represent targets for future promising clinical investigations. Cancer cachexia is a syndrome characterized by a marked weight loss, anorexia, asthenia and anemia. In fact, many patients who die with advanced cancer suffer from cachexia. The degree of cachexia is inversely correlated with the survival time of the patient and it always implies a poor prognosis. Unfortunately, at the clinical level, cachexia is not treated until the patient suffers from a considerable weight loss and wasting. At this point, the cachectic syndrome is almost irreversible. The cachectic state is often associated with the presence and growth of the tumour and leads to a malnutrition status due to the induction of anorexia. In recent years, age-related diseases and disabilities have become of major health interest and importance. This holds particularly for muscle wasting, also known as sarcopenia, that decreases the quality of life of the geriatric population, increasing morbidity and decreasing life expectancy. The cachectic factors (associated with both depletion of fat stores and muscular tissue) can be divided into two categories: of tumour origin and humoural factors. In conclusion, more research should be devoted to the understanding of muscle wasting mediators, both in cancer and ageing, in particular the identification of common mediators may prove as a good therapeutic strategies for both prevention and treatment of wasting both in disease and during healthy ageing.

Aging↗
PubMed2005

The pivotal role of cytokines in muscle wasting during cancer.

The cachectic syndrome, characterized by a marked weight loss, anorexia, asthenia and anemia, is invariably associated with the presence and growth of the tumour and leads to a malnutrition status due to the induction of anorexia or decreased food intake. In addition, the competition for nutrients between the tumour and the host leads to an accelerated catabolic state, which promotes severe metabolic disturbances in the host, including hypermetabolism, which leads to an increased energetic inefficiency. Although the search for the cachectic factor(s) started a long time ago, and although many scientific and economic efforts have been devoted to its discovery, we are still a long way from knowing the whole truth. Present investigation is devoted to unrevealing the different signaling pathways (particularly transcriptional factors) involved in muscle wasting. The main aim of the present review is to summarize and evaluate the different molecular mechanisms and catabolic mediators involved in cancer cachexia since they may represent targets for future promising clinical investigations.

Animals↗
PubMed2005

The pivotal role of cytokines in muscle wasting during cancer.

The cachectic syndrome, characterized by a marked weight loss, anorexia, asthenia and anemia, is invariably associated with the presence and growth of the tumour and leads to a malnutrition status due to the induction of anorexia or decreased food intake. In addition, the competition for nutrients between the tumour and the host leads to an accelerated catabolic state, which promotes severe metabolic disturbances in the host, including hypermetabolism, which leads to an increased energetic inefficiency. Although the search for the cachectic factor(s) started a long time ago, and although many scientific and economic efforts have been devoted to its discovery, we are still a long way from knowing the whole truth. Present investigation is devoted to unrevealing the different signaling pathways (particulary transcriptional factors) involved in muscle wasting. The main aim of the present review is to summarize and evaluate the different molecular mechanisms and catabolic mediators involved in cancer cachexia since they may represent targets for future promising clinical investigations.

Animals↗
PubMed2005

First-line chemotherapy with docetaxel and cisplatin in metastatic breast cancer.

The purpose of this study was to evaluate the efficacy and tolerance of combined treatment with docetaxel-cisplatin as first-line chemotherapy in patients with metastatic breast cancer (MBC). Consecutive eligible chemonaive patients received docetaxel 75 mg/m(2) on day 1 and cisplatin 75 mg/m(2) on day 2 every 3 weeks for 6 cycles, with prophylactic recombinant human granulocyte colony-stimulating factor (rHuG-CSF) on days 4-11. Thirty-two patients (64%) had received prior adjuvant chemotherapy; these included 16 (32%) who had received anthracyclines. In 50 evaluable patients with a median age (range) of 56 (31-72) years, the overall response rate was 68% (95% CI, 55-81%), with 7 (14%) complete and 27 (54%) partial responses. Stable and progressive disease was observed in 10 (20%), and 6 (12%) patients, respectively. The median duration of response was 10 months, and the median time to progression was 39 weeks. Grade 3/4 hematological toxicity included--neutropenia in 9 patients (18%), anemia in 2 (4%) and thrombocytopenia in 1 (2%). One patient (2%) with febrile neutropenia required hospitalization. Grade 3/4 nonhematological toxicities included nausea/vomiting in 18%, nephrotoxicity in 14%, asthenia (4%), and neurotoxicity (2%). Toxicity was common in older patients (>56 years). There were no treatment-related deaths. A combination of docetaxel-cisplatin with rHuG-CSF support is well tolerated and effective as first-line chemotherapy in MBC.

Adult↗
PubMed2005

Cryptic 5' MLL gene insertion in an X-chromosome in acute myeloblastic leukemia.

Band 11q23 is known to be involved in translocations and insertions with a variety of partner chromosomes. They lead to MLL rearrangement, resulting in fusion with numerous genes. We report here on a 43-year-old man presenting with asthenia and pancytopenia who was diagnosed with acute myeloblastic leukemia FAB-M5. Conventional cytogenetic techniques showed a del(11)(q21). Using a specific probe for fluorescent in situ hybridization, the MLL gene was found to be disrupted, with the 5' region being inserted into the X-chromosome (around bands q24 approximately q25), as confirmed by whole X-chromosome painting. The accumulating data on acute myeloblastic leukemia demonstrate that the 5'-MLL insertion in an X-chromosome is a rare but recurrent abnormality associated with leukemia, not only in infants, but also in adults.

Adult↗