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PubMed1999

Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group.

The aim of this study was to compare the efficacy and tolerability of docetaxel to methotrexate and 5-fluorouracil in advanced breast cancer after anthracycline failure. A randomised multicentre trial was conducted in 283 patients with advanced breast cancer who had failed previous anthracycline treatment. Docetaxel at a dose of 100 mg/m2 every 3 weeks (n = 143) was compared with sequential methotrexate and 5-fluorouracil (MF; n = 139) given at day 1 and 8 every 3 weeks at dosages of 200 mg/ m2 and 600 mg/m2, respectively. After progression, crossover to the alternative treatment group was recommended. There was a significantly higher overall response rate in the docetaxel 42% (CR 8% + PR 34%) than in the MF arm 21% (CR 3% + PR 18%) (P < 0.001). The median time to progression (TTP) was 6.3 months in the docetaxel arm and 3.0 months in the MF arm (P < 0.001). Docetaxel also had a significantly higher response rate of 27% following crossover compared with MF (12%). Significantly more side-effects (leucopenia, infections, neuropathy, oedema, asthenia, skin, nail changes, alopecia) were seen in the docetaxel than in the MF group. However, grade 3 and 4 side-effects were infrequent with both drugs, with the exception of fatigue, alopecia and infections. Median overall survival (OS) including crossover phase was 10.4 months in the docetaxel and 11.1 months in the MF arm (P = 0.79). Based on the response rate and the primary endpoint of TTP, docetaxel is superior to sequential methotrexate and 5-fluorouracil in advanced breast cancer after anthracycline failure.

Adult↗
PubMed1999

Decreased toxicity and increased efficacy of cancer chemotherapy using the pineal hormone melatonin in metastatic solid tumour patients with poor clinical status.

Melatonin (MLT) has been proven to counteract chemotherapy toxicity, by acting as an anti-oxidant agent, and to promote apoptosis of cancer cells, so enhancing chemotherapy cytotoxicity. The aim of this study was to evaluate the effects of concomitant MLT administration on toxicity and efficacy of several chemotherapeutic combinations in advanced cancer patients with poor clinical status. The study included 250 metastatic solid tumour patients (lung cancer, 104; breast cancer, 77; gastrointestinal tract neoplasms, 42; head and neck cancers, 27), who were randomized to receive MLT (20 mg/day orally every day) plus chemotherapy, or chemotherapy alone. Chemotherapy consisted of cisplatin (CDDP) plus etoposide or gemcitabine alone for lung cancer, doxorubicin alone, mitoxantrone alone or paclitaxel alone for breast cancer, 5-FU plus folinic acid for gastro-intestinal tumours and 5-FU plus CDDP for head and neck cancers. The 1-year survival rate and the objective tumour regression rate were significantly higher in patients concomitantly treated with MLT than in those who received chemotherapy (CT) alone (tumour response rate: 42/124 CT + MLT versus 19/126 CT only, P < 0.001; 1-year survival: 63/124 CT + MLT versus 29/126 CT only, P < 0.001). Moreover, the concomitant administration of MLT significantly reduced the frequency of thrombocytopenia, neurotoxicity, cardiotoxicity, stomatitis and asthenia. This study indicates that the pineal hormone MLT may enhance the efficacy of chemotherapy and reduce its toxicity, at least in advanced cancer patients of poor clinical status.

Adult↗
PubMed1987

Cancer cachexia.

Cancer cachexia is a complex syndrome that includes host tissue wasting, anorexia, asthenia, and abnormal host intermediary metabolism. It is present in approximately 50% of cancer patients during treatment and nearly 100% of treated cancer patients at death. Cachexia has a detrimental impact on cancer therapy. The central problem of cancer cachexia is that energy balance is not maintained, and the host has a relative hypophagia which results in host tissue wasting. The tumor by its nature and obligate growth can continue to consume glucose, amino acids, and lipids at the expense of the host. This produces abnormal host intermediary metabolism including elevated glucose production and recycling, decreased muscle protein synthesis, and increased muscle and fat breakdown. The exact mechanisms of cancer cachexia have been only partially elucidated. The identification of signal molecules like cachectin which mediate these changes may be on the horizon. Nutritional support can reverse some of the derangements seen with cachexia, and there is evidence that functional lean body mass or body cell mass can be restored in some (but not all) patients. However, nutritional support has not yet improved response to chemotherapy or radiation therapy, nor has it improved host tolerance of chemotherapy. It has improved operative mortality and morbidity in cachectic cancer patients undergoing major surgical procedures. Optimum host nutritional support appears to be dependent on high insulin concentrations in both humans and rats. Insulin and exercise may be methods to preserve host lean tissue and feed the host rather than the tumor. Future studies depend on better definition of tumor-bearing host metabolism, altering the relationship between neoplasm and host to preferentially feed the host, and making the neoplasm more susceptible to effective treatment.

Animals↗
PubMed2003

An open-label study of levetiracetam at individualised doses between 1000 and 3000 mg day(-1) in adult patients with refractory epilepsy.

BACKGROUND: The novel antiepileptic drug (AED) levetiracetam (LEV, Keppra) is indicated as adjunctive therapy for partial epilepsy. The primary aim of this study was to measure the safety and tolerability of LEV individualised dosing in a heterogeneous refractory epilepsy population. METHODS: LEV was evaluated in a 10- to 16-week open-label, multicentre study in adult patients with epilepsy refractory to previous treatment with at least two AEDs. Individualised LEV doses up to 3000 mg x day(-1) were determined in an initial up-titration phase, and optimal doses were administered as adjunctive treatment during an 8- to 10-week evaluation period. Concomitant AEDs and their doses could not be changed during the study. Safety and tolerability were monitored by expression of adverse events as well as by retention rate. The effect of LEV on concomitant AED concentration was also studied. Efficacy was assessed using global clinical evaluation (GCE) scores, seizure frequency, and >or=50% responder rate. RESULTS: LEV therapy was initiated in 219 patients; 183 had localisation-related epilepsy and 37 had generalised epilepsy. In one patient, epileptic syndrome was defined as both localisation-related and generalised. About 81.7% (179/219) continued and completed treatment throughout the study, and 79% (172/219) chose to continue LEV in a follow-up study. The most common adverse events were asthenia, dizziness, and somnolence. Most adverse events occurred during up-titration. LEV treatment did not alter the concentration of concomitant AEDs. LEV improved GCE scores in 79.5% (152/191) of patients. LEV reduced the median total seizure frequency of all patients from a median of 2.25 seizures per week at baseline (n=219) to 1.10 seizures per week during the evaluation period (n=191 patients with at least one seizure count during evaluation). The >or=50% responder rate was 48.2% for all seizure types, 49.4% for partial-onset, and 51.4% for generalised-onset seizures. Throughout the evaluation period (i.e. from the start of the evaluation period until completion or early discontinuation), 26/191 (13.6%) had a 100% reduction in total seizure frequency, while in a follow-up study, 10.5% (18/172) were seizure-free for at least 6 months and 6.4% (11/172) were seizure-free for at least 1 year. CONCLUSION: LEV was well tolerated, as evidenced by limited adverse event reporting and the high retention rate, and appeared effective in both generalised and partial epilepsy.

Adolescent↗
PubMed2003

Neurorrhaphy of the recurrent laryngeal nerve.

BACKGROUND: It has been controversial to anastomose the severed recurrent laryngeal nerve after transection because when severed recurrent nerves are directly anastomosed, the vocal cords do not regain normal movements and are fixed in the median. The objective of this study was to learn whether direct neurorrhaphy is necessary if the recurrent laryngeal nerve is severed during thyroid or parathyroid surgery. STUDY DESIGN: From 1998 to 2001, 12 patients who had a complete recurrent laryngeal nerve injury during thyroid or parathyroid surgery were enrolled into this study. Eight had primary repair of the nerve; four did not have repair because of cancer invasion. Patients were followed with laryngoscopic or laryngovideostroboscopic examination at 3 months and 6 months postoperatively. Subjective ratings of aspiration and voice quality were based on patient reports. Perceptual voice quality was rated according to grade, roughness, breathiness, asthenia, and strain (GRBAS) scales. If a patient's voice quality, aspiration, and GRBAS scales did not improve at 6 months postoperatively, medialization laryngoplasty was considered. RESULTS: Eight patients with immediate repair showed improved voice quality, aspiration, GRBAS scales, and maximum phonation time at 6 months after surgery. A significant decrease of glottal gap was also noted in patients with neurorrhaphy but not in four patients without neurorrhaphy. Medialization laryngoplasty was performed in all four patients without neurorrhaphy in the followup period. Immobilization of the vocal cord was noted in all of them, but only one in the neurorrhaphy group had an atrophy of the cord; all four patients without neurorrhaphy had atrophy. CONCLUSIONS: Neurorrhaphy of the recurrent laryngeal nerve is a simple and effective procedure to improve voice quality, aspiration, GRBAS scales, glottal gap, and maximum phonation time by preventing atrophy of the vocal cord.

Adult↗
PubMedDate not supplied

[Effectiveness and safety of imatinib in seven gastrointestinal stromal tumor cases].

OBJECTIVE: To measure the effectiveness and safety of imatinib for gstrointestinal stromal tumors (GISTs). METHOD: A retrospective study from 1993 through June 2005 by identifying all patients diagnosed with GIST by the Pathology Department. The medical records of those treated with imatinib were reviewed. Demographic, diagnostic, therapeutic, and outcome-related data were collected. RESULTS: Twenty-five patients were identified, 7 of them treated with imatinib. Total responses were 4/7; 2/7 cases were complete responses, and 2/7 were partial responses. Mean actuarial disease-free survival was 10 months, and overall survival was 44 months. Adverse reactions (ARs) reported included: 33% (5) gastrointestinal events, 40% (6) dermatologic events and/or edema, 14% (2) blood toxicity, and 13% (2) asthenia. In all, 2/7 patients experienced no imatinib-related toxicity. CONCLUSIONS: In our experience, imatinib is an effective, well tolerated therapy for malignant [c-Kit (CD117)-positive], non-resectable and/or metastatic GIST.

Adult↗
PubMed2002

Clinical and epidemiologic trends in HIV/AIDS patients in a hospital setting of Yaoundé, Cameroon: a 6-year perspective.

OBJECTIVES: In order to appreciate the impact of the HIV/AID pandemic in Yaound , Cameroon, an evaluation of the clinical and epidemiologic trends in HIV/AIDS patients was undertaken in a hospital setting. METHODS: A rapid assessment method was used to collect data. Patient record examination, interviews and direct observation were employed. RESULTS: Of 875 cases studied in the hospital during a 6-year period, 43.7% were males and 56.3% females. A total of 5.4% of all the cases were seen in 1993 compared to 30.5% in 1998. The number of admissions per patient ranged from 0 to 4, with a median duration of admission of 14 days (range 0-343 days). The 25-44-year age group was mostly affected (63.4% cases) and 10.1% were in the 0-14-year age group. About 27% of cases died in hospital, mainly between 1996 and 1997. The predominant clinical manifestations included persistent fever and diarrhea, excessive weight loss, chronic cough and profound asthenia. Opportunistic infections and cancers also formed part of the picture. CONCLUSIONS: The increasing clinical and epidemiologic trends of the HIV/AIDS pandemic within the hospital show the devastation and socio-economic impact, especially on the Cameroonian youth and women. Intense public health measures must be put in place to educate and cater for the vulnerable groups in society.

AIDS-Related Opportunistic Infections↗
PubMed2003

When and how should we screen for hereditary hemochromatosis?

Hemochromatosis is the clinical expression of iron overload and occurs as hereditary and secondary variants. In hereditary hemochromatosis, an inborn error in iron metabolism results in excess absorption of dietary iron, which gradually accumulates in the liver, pancreas, and heart. The most common form of hereditary hemochromatosis is related to homozygosity for the C282Y mutation in the HFE gene. Early diagnosis is essential because hereditary hemochromatosis is common, severe, and treatable. Early manifestations consist of asthenia, arthralgia, and serum transferrin saturation elevation. The C282Y mutation should be looked for to confirm the diagnosis in the patient and family members. Measurement of serum transferrin saturation followed by genetic testing in individuals with values above 45% is a reasonable screening strategy.

Genetic Predisposition to Disease↗
PubMed2003

Cancer cachexia: the molecular mechanisms.

Cancer cachexia is a syndrome characterised by a marked weight loss, anorexia, asthenia and anaemia. In fact, many patients who die with advanced cancer suffer from cancer cachexia. The cachectic state 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 starvation 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. The main aim of the present review is to summarise and evaluate the different catabolic mediators (both humoural and tumoural) involved in cancer cachexia since they may represent targets for future promising clinical investigations.

Animals↗
PubMed2003

Catabolic mediators as targets for cancer cachexia.

The cachexia syndrome, characterized by a marked weight loss, anorexia, asthenia and anaemia, is invariably associated with the growth of a tumour and leads to a malnutrition status caused by the induction of anorexia or decreased food intake. In addition, the competition for nutrients between the tumour and the host results in an accelerated catabolism state, which promotes severe metabolic disturbances in the patient. The search for the cachectic factor(s) started a long time ago, and many scientific and economic efforts have been devoted to its discovery, but we are still a long way from a complete answer. The present review aims to evaluate the different molecular mechanisms and catabolic mediators (both humoural and tumoural) that are involved in cancer cachexia and to discuss their potential as targets for future clinical investigations.

Animals↗
PubMed2006

[Constrictive pericarditis as the first sign of lung cancer].

Symptoms such as cough and hemoptysis in patients with lung cancer can be the consequence of local bronchopulmonary disease, tumor growth that leads to compression of surrounding structures, distant metastases, diverse systemic effects (anorexia, asthenia, weight loss), or paraneoplastic syndromes associated with tumor production of certain hormones. Approximately 10% of patients are asymptomatic at diagnosis. We report the case of a 77-year-old man with dyspnea, pleuritic chest pain, and lower limb edema. The patient died within a few days. The cause of the clinical picture was constrictive pericarditis secondary to metastases from lung carcinoma.

Aged↗
PubMed2000

Recurrent cholestasis and hypereosinophilia in a young female.

A 22-year-old female presented, in December 1998, with asthenia, itching and hypereosinophilia. In January 1997, due to the same clinical picture, the patient had inappropriately been diagnosed elsewhere to have an "idiopathic eosinophilic syndrome" and complete remission was obtained after short-term steroid treatment. Upon admission, physical examination was negative and blood tests revealed absolute eosinophilia [42%, i.e., 3,800 of 9,600 white blood cells], aspartate aminotransferase 4 x upper limits of normal, alanine aminotransferase 5 x upper limits of normal and alkaline phosphatase 2 x upper limits of normal. Both liver biopsy and endoscopic retrograde cholangiopancreatography findings were totally consistent with primary sclerosing cholangitis, while all known causes of hypereosinophilia and alteration in liver function tests were carefully excluded. The clinical course was characterized by complete clinical and biochemical normalization in absence of any treatment and further follow-up was completely negative.

Adult↗
PubMed2001

Acute cholestatic hepatitis induced by bupropion prescribed as pharmacological support to stop smoking. A case report.

We report the first case of acute cholestatic hepatitis induced by bupropion. This antidepressant was taken by a 49-year-old female as adjuvant treatment to stop smoking. After 20 days of bupropion, the patient presented a symptomatology characterized by asthenia, nausea and scleral icterus and biochemical analyses showed a dramatic increase in direct bilirubin (up to 28 mg/dl) and transaminases (up to 68-fold normal limits). Antinuclear antibodies were positive (title = 1:80; speckled pattern). Biochemical analyses and antinuclear antibodies were normal two years earlier. The histology showed a pattern of acute hepatitis with involvement of bile ducts and with features of centrolobular cholestasis. Treatment with methylprednisolone was commenced and continued for 20 days. Liver enzymes and bilirubin returned to normal within two months of withdrawal of bupropion and remained normal during the 4-month follow-up. Antinuclear antibodies also became negative. Other causes of liver damage were excluded. Considering the clinical diagnostic scale for hepatotoxic adverse drug reaction, our patient showed a score compatible with the final diagnosis of bupropion-related cholestatic hepatitis.

Acute Disease↗
PubMed2003

Comparison between methotrexate and azathioprine in the treatment of chronic active Crohn's disease: a randomised, investigator-blind study.

BACKGROUND AND AIMS: The efficacy of azathioprine in the treatment of chronic active Crohn's disease is well established. However, this drug has a long onset of action. Methotrexate has also been shown to be effective in chronic active Crohn's disease. The aim of this study was to evaluate the efficacy and safety of methotrexate in comparison with azathioprine, and to establish whether methotrexate has a shorter onset of action in this setting. METHODS: Patients with chronic active Crohn's disease were admitted to this investigator-blind study. Chronicity was defined as the need for steroid therapy of > or = 10 mg/day for at least 4 months during the preceding 12 months, with at least one attempt to discontinue treatment. The disease had to be clinically active at entry, with a Crohn's Disease Activity Index of > or = 200. Six patients treated with azathioprine and methotrexate, respectively, were found to have enterocutaneous and perianal fistulas. At entry, all patients received prednisolone (40 mg once a day) which was tapered over a period of 12 weeks unless their clinical condition deteriorated. All patients were randomised to receive i.v. methotrexate 25 mg/week, or oral azathioprine 2 mg/kg per day, for a 6-month follow-up period. After the first 3 months, methotrexate was switched to oral administration maintaining the same dose. The primary efficacy outcome considered was the proportion of patients entering first remission after 3 and 6 months of therapy. Clinical remission was defined as the lack of need for steroid treatment and a Crohn's Disease Activity Index score of < or = 150 points at each scheduled visit. RESULTS: In the 54 patients (26 F, 28 M, mean age 34 years, range 18-60) randomly assigned to methotrexate (n=27) or azathioprine (n=27), no statistically significant difference was found between the two treatment regimens with respect to remission rate after 3 (methotrexate 44%, azathioprine 33%, p=0.28, (95% CI, 0.369-0.147), and 6 months (methotrexate 56%, azathioprine 63%, p=0.39, 95% CI, 0.187-0.335), respectively. Six patients withdrew from therapy due to adverse events: 3/27 (11%) in methotrexate and 3/27 (11%) in azathioprine. Drug-related adverse events (asthenia, nausea and vomiting) that did not require withdrawal from therapy were more frequent in the methotrexate group (azathioprine: 2/27 (7%); methotrexate: 12/27 (44%), p=0.00009). The frequency of these adverse events was comparable during the intravenous or oral administration of the drug. CONCLUSIONS: This study confirms that methotrexate is effective in inducing remission in patients with chronic active Crohn's disease, therapeutic efficacy being comparable, but not faster, than that of azathioprine.

Adult↗
PubMed1999

Dercum's disease (adiposis dolorosa).

Dercum's disease (adiposis dolorosa) is a rare condition characterized by progressively painful fatty deposits, usually, in menopausal women with obesity, asthenia and mental phenomena. We report a case of a 48-year-old woman with recurrent neck swelling and pain in the neck and parotid region, and a review of management of this uncommon problem.

Adipose Tissue↗
PubMed1999

Infusion reactions associated with the therapeutic use of monoclonal antibodies in the treatment of malignancy.

With the FDA approval of Rituximab in 1998 for the treatment of lymphoma, and Trastuzumab in 1999 for the treatment of breast cancer, monoclonal antibodies were officially added to the therapeutic armamentarium against malignancy. Most of the side effects associated with these agents are due to antigen-antibody interactions on specific cells and tissues. One of the most predictable side effects of these products is a constellation of various systemic effects including flu-like symptoms such as headache, fever, sweats, skin rash, shortness of breath, hypotension, nausea, and asthenia that occurs with the first infusion of such products. Rarely severe hypotension, bronchospasm, and hypoxia and even death have occurred. The pathophysiology of these reactions appears to be secondary to the release of cytokines as the antibodies bind do circulating antigen-expressing cells that are then removed in the reticuloendothelial system of the lungs, spleen and liver. In patients with large numbers of antigen-dense cells that have a high mitotic index, such as prolymphocytic leukemia, mantle cell lymphoma, or lymphosarcoma cell leukemia, there is a risk of true tumor lysis syndrome. One should be particularly cautious when treating patients with high numbers of circulating antigen-expressing cells in the setting of underlying cardiovascular or respiratory disease.

Antibodies, Monoclonal↗
PubMed2001

Phase 1 study of N1-N11-diethylnorspermine (DENSPM) administered TID for 6 days in patients with advanced malignancies.

UNLABELLED: This was a dose escalation Phase 1 trial designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of DENSPM. METHODS: Adult patients with refractory solid tumors were treated with DENSPM administered by intravenous infusion in 100 ml of normal saline over 30 minutes. The daily dose of DENSPM was divided into three equal doses administered approximately every eight hours for six days. Courses were repeated every 28 days. RESULTS: Twenty-eight patients were enrolled in the study. Dose levels of DENSPM explored were 25 mg/m2/day (3 patients), 50 mg/m2/day (9 patients), 60 mg/m2/day (5 patients), 75 mg/m2/day (6 patients), 94 mg/m2/day (3 patients) and 118 mg/m2/day (2 patients). The DLT for DENSPM was central nervous system toxicity characterized by aphasia, ataxia, dizziness, vertigo and slurred speech occurring at dose levels > or = 94 mg/m2/day, which was also the MTD. SAFETY: The most frequent drug-related adverse events were asthenia (9 patients), injection site reaction (6 patients) and anemia (6 patients). One patient was removed from the study due to CNS toxicity. There were no treatment-related deaths. No trends were observed regarding hematologic toxicities, biochemical changes or changes in vital signs. EFFICACY: Nineteen of the 28 patients enrolled in the study were assessed for response. No objective responses were observed. Five patients had stable disease as the best response to therapy. CONCLUSIONS: Because the DLT was CNS and because of the relatively low doses that could be safely administered on this schedule as compared with a once-a-day schedule, this regimen was not recommended for Phase 2.

Adult↗
PubMed1997

Phase II trial of the oral platinum complex JM216 in non-small-cell lung cancer: an EORTC early clinical studies group investigation.

BACKGROUND: JM216 is a new oral platinum complex with dose-limiting toxicity myelosuppression, now undergoing phase II evaluation. PATIENTS AND METHODS: JM216 was evaluated as first line therapy in non-small-cell lung cancer. Seventeen patients received 120 mg/m2/day for five days repeated every three weeks. RESULTS: Toxicity was manageable, the commonest side-effects being nausea, vomiting, diarrhoea, constipation and asthenia. Myelososuppression was generally grade < 2 and there were no cases of neutropenic sepsis or bleeding. Thirteen patients were fully evaluable for response. No sustained objective responses were reported. One patient was reported as stable disease had a partial response after three courses but was progressing again after four. An additional five patients had stable disease (46.2%). CONCLUSIONS: Although some patients may have had useful palliation, JM216 did not appear to have significant antitumour activity in non-small-cell lung cancer.

Administration, Oral↗