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PubMed2000

[Raltitrexed-induced skin reaction].

BACKGROUND: Raltitrexed (Tomudex(R)) is a thymine synthetase inhibitor used for first line treatment of metastatic colorectal cancer. Skin reactions were reported in the preclinical trials but have never been documented in clinical practice. We report the first two cases. CASE REPORTS: Two patients, aged 75 and 65 years, were given raltitrexed for adenocarcinoma of the rectum for the first case and of the sigmoid for the second. Both developed a skin reaction 5 and 7 days after onset of treatment. These patients had erythromatous edematous and purpuric skin reactions associated with asthenia, diarrhea and moderate fever. The skin lesions were painful and pseudo-cellulitic. They were generalized in the first case and localized on the legs in the second. The reactions subsided in both cases 15 days after drug withdrawal after a desquamation phase. CONCLUSION: We report the first two cases of raltitrexed-induced pseudo-cellulitic skin reactions.

Aged↗
PubMedDate not supplied

[Combination of 5-Fluorouracil and folinic acid--is it still the standard therapy for advanced colorectal carcinoma?].

After a long period in which the only therapeutic approach for the management of colorectal cancer was the optimization of fluoropyrimidine-based chemotherapy, the last few years have seen the emergence of newly active chemotherapeutic agents endowed with novel mechanisms of action, such as oxaliplatin (OHP), irinotecan (CPT11), raltitrexed and oral 5-fluorouracil (5-FU) pro-drugs which can offer new therapeutic possibilities. The availability of these different classes of cytotoxic agents has introduced the possibility of combination chemotherapy. The most widely studied combinations are 5-FU/folinic acid (FA)/CPT11 and 5-FU/FA/OHP, both of which have been tested in two randomized studies. These trials consistently demonstrated that the addition of CPT11 or OHP to widely accepted infusional/bolus 5-FU/FA regimens is superior to the same 5-FU/FA schedule alone in term of response rate (rate of about > 50%) and time to progression. It's worth nothing that both trials with the combination of 5-FU/FA/CPT11 showed a significant survival benefit. Toxicity profiles were more pronounced with the combination therapies but the quality of life evaluation showed that the combinations had no negative impact on the evolution of the global health status over time. A current ongoing randomized study compares 5-FU/FA/CPT11 with 5-FU/FA/OHP in order to identify the best first-line chemotherapy. Preliminary results in terms of objective response and toxicity are similar for both treatments. Raltitrexed is a thymidilate synthase inhibitor with activity comparable to 5-FU and a convenient administration schedule. In our institution, we performed a phase II single center trial to assess the efficacy of the combination of raltitrexed and CPT11. The principal aim of the study was the overall response rate. We observed a very promising 51% overall response rate. Most relevant side effects were diarrhea in about 20% of patients, asthenia and vomiting. Two recent studies have assessed the efficacy and tolerability of raltitrexed-OHP combination therapy. The results showed that the combination is active (ORR: 46-62%) and tolerable. Promising results have also been obtained in phase I studies with the OHP/CPT11 combination. All these data need to be confirmed in phase II-III clinical trials. In conclusion, combination therapy with CPT11 plus 5-FU/FA produces a 2-3 month survival advantage over 5-FU/FA alone and represents the new reference in the first-line chemotherapy of colorectal cancer. The association of 5-FU/FA and OHP improves response rates and progression-free survival. The increase in toxicity of these combinations is predictable and reversible and does not compromise quality of life. These important data suggest that there is now a limited role for single-agent first-line chemotherapy of metastatic colorectal cancer.

Antimetabolites, Antineoplastic↗
PubMed2001

Rationale and dose-finding studies of the combination of irinotecan and a taxane on a weekly schedule.

Cisplatin (Platinol)-based chemotherapy has been the standard systemic therapy for both non-small-cell and small-cell lung cancer for the past 2 decades, though the efficacy and benefit remain modest. Recently, several novel agents have been introduced that have single-agent activity comparable to cisplatin and offer the possibility of improved therapy for lung cancer. Camptothecin and taxane derivatives are associated with both different mechanisms of action and nonhematologic toxicities, and have demonstrated additive or synergistic activity when used in combination in preclinical studies. We review pertinent clinical studies of these agents in lung cancer and present our experience in combining irinotecan (Camptosar, CPT-11) with taxanes on a weekly schedule in dose-finding and efficacy studies. When chemotherapy is delivered for 4 consecutive weeks followed by a 2-week rest, hematologic toxicity is dose limiting and most prominent during weeks 3 and 4. Dose intensification is feasible if the schedule is modified so the chemotherapy is given on days 1 and 8, with cycles repeated every 3 weeks. The most common nonhematologic toxicities remain asthenia, neuropathy, and diarrhea. Future studies will explore and better define the role of these drug combinations in the treatment of lung cancer.

Adult↗
PubMed2001

[Palpable mantel cell lymphoma in the breast].

BACKGROUND: Extranodal involvement is not unusual in mantle cell lymphoma (MCL) which accounts for 6% of non-Hodgkin's lymphomas. Simultaneous localization in the eyelid and in the breast, as observed in our case, is however exceptional. CASE REPORT: Chronic lymphoid leukemia (CLL) was suspected in a 71-year-old woman with asthenia, a cervical and axillary nodal enlargement and elevated lymphocyte count. Blood immunoflow cytometry analysis, occurrence of rapidly growing tumors involving the two breasts and eyelids and cytogenetic and molecular features led to the diagnosis of MCL. A very good partial remission was obtained with second-line polychemotherapy composed of cytarabin, cisplatin and dexamethasone, but lasted only 3 months after the end of 6 cycles. DISCUSSION: Primary breast and eyelid lymphomas are rare. Such localizations are exceptional in MCL and are signs of aggressive disease. Before extra-nodal involvement, MCL may simulate banal CLL. Therefore, systematic immunohistochemistry and if necessary molecular analysis are useful for early diagnosis of MCL. Prognosis is particularly poor. Conventional chemotherapy cannot provide cure of MCL and median survival is 48 months. For this reason, high-dose chemotherapy with stem cell graft has to be discussed in young patients. MCL is currently characterized by Bcl1 rearrangement, t(11-14) translocation and cyclin D1 overexpression among small B-cell lymphomas in recent REAL- and WHO-classifications.

Aged↗
PubMed2000

[Clinical course of chronic bronchitis in Chernobyl wreckers].

AIM: To characterize clinical symptoms of chronic bronchitis (CB) in Chernobyl wreckers. MATERIAL AND METHODS: 71 CB male Chernobyl wreckers exposed to low-dose radiation and 43 control patients were examined and treated in a specialized hospital in 1988-1996. Clinical features of CB were investigated by clinical (complaints, history, objective examination), laboratory (total blood count, biochemical and immunological blood picture, coagulogram) and instrumental (fibrobronchoscopy, x-ray, radiometry, spirography) findings with further statistical processing. RESULTS: Chernobyl wreckers more frequently had neurocirculatory asthenia and hemoptysis. The latter was caused by bronchial mucosa atrophy. In chronic non-obstructive bronchitis they exhibited mild bronchoobstruction on the distal level. Laboratory indices showed no essential changes. CONCLUSION: Chernobyl wreckers have a more severe course of CB.

Adolescent↗
PubMed2001

Rare side-effects of fenofibrate.

Fibrates are widely prescribed as hypolipidemic drugs and are considered as safe. We report the case of a 69 year-old woman who probably developed a major allergic reaction following a Fenofibrate prescription (generic form) of 300 mg per day. Clinical features included asthenia, hyperthermia (40.5 degrees C) and slight muscular pain. Biological abnormalities were mildly elevated muscular enzymes and pancytopenia rapidly developed. All bacteriologic, virologic, immune and radiologic investigations were normal. Evolution was spontaneously favorable with Fenofibrate withdrawal. This is the first reported case of major fever and pancytopenia following a Fenofibrate prescription. Adverse effects of Fenofibrate are briefly reviewed and their usual favorable outcomes following drug removal are outlined.

Aged↗
PubMed2001

Docetaxel/gemcitabine: salvage chemotherapy in anthracycline-pretreated patients with advanced breast cancer.

Docetaxel (Taxotere) and gemcitabine (Gemzar) are active agents against breast cancer. Several phase I studies evaluated different schedules of their combination and clearly demonstrated that docetaxel and gemcitabine can be safely combined in either an every 3-week schedule or in a weekly and biweekly schedule. The toxicity profiles of these combinations were mainly grade 3 and 4 neutropenia and asthenia. Phase I studies also suggested that the docetaxel/gemcitabine combinations are active regimens in pretreated patients with advanced breast cancer. Three phase II studies of patients previously treated with anthracycline-based chemotherapy reported a mean objective response rate of 46% and a mean overall survival of 13.5 months. Two of these trials enrolled patients with anthracycline-resistant or anthracycline-refractory disease; the objective responses using docetaxel/gemcitabine combination were 36% to 55% and 54%, respectively. It is noteworthy that objective responses were also achieved with this regimen in some patients who progressed while receiving taxane-based, front-line chemotherapy. These efficacy results were obtained with a mild toxicity profile. Adverse events were of short duration and easily manageable. Further studies are needed to evaluate this combination as front-line chemotherapy as well as second-line in well-defined subgroups of patients with advanced breast cancer. Furthermore, the combination should be compared with other more standard or investigational regimens.

Antibiotics, Antineoplastic↗
PubMed2000

[Long-term safety of using tiagabine in epilepsy].

Tiagabine (TGB) is a novel antiepileptic drug efficacious for the treatment of partial epilepsies. The aim of that work is short presentation of current data concerning long-term safety of TGB. Tolerance to TGB does not develop with long-term therapy. Idiosyncratic reaction and changes in haematology and chemistry values have not been associated with TGB therapy. The most common adverse effects are dizziness, asthenia, nervousness, tremor, diarrhoea and depression. The current data do not show any evidence of relationship between visual field constriction and TGB treatment. No adverse effects on cognitive abilities have been found. There are contradictory data concerning tiagabine-induced nonconvulsive status epilepticus. Because of high safety and efficacy TBG is an important new antiepileptic drug for the treatment of intractable partial epilepsies.

Animals↗
PubMed2001

ALK positive lymphohistiocytic variant of anaplastic large cell lymphoma in an adult.

BACKGROUND AND OBJECTIVES: The lymphohistiocytic (LH) variant of anaplastic large cell lymphoma (ALCL) has, for a long time, been considered typical of children and adolescents. The aim of this study is a detailed characterization of a case of this peculiar ALCL subtype affecting an adult patient. DESIGN AND METHODS: A 36-year old male presented with diffuse adenopathy and systemic symptoms (high fever, anorexia, asthenia); a diagnosis of CD30+/ALK+ ALCL, LH variant, was morphologically suspected and corroborated by immunohistochemistry that was crucial for the definitive diagnosis and subtyping. RESULTS: The neoplastic population consisted of cells highly variable in size and shape but more often isolated and largely obscured by a predominant reactive cellular infiltrate of histiocytes and plasma cells. The lymphoma cells exhibited a null non-B non-T antigenic profile, but reacted strongly for the Ber-H2/CD30, EMA, ALKc anti-TIA-1 monoclonal antibodies. The patient underwent chemotherapy plus bone marrow transplantation and, one year after diagnosis, he is well and in complete remission. INTERPRETATION AND CONCLUSIONS: Our findings provide additional evidence that: a) ALK+ lymphoma represents a single disease with a broad spectrum of morphology; b) clinicians and pathologists should be aware of the possible occurrence of LH variant of ALK+ ALCL also in adults in whom a favorable response to therapy may be expected despite systemic disease and an aggressive clinical presentation.

Adult↗
PubMed1998

Alpha-blocker therapy for benign prostatic hyperplasia: a comparative review.

In the past decade there has been a shift in the primary approach to therapy for BPH, from surgical intervention to pharmacotherapy. Therapies with alpha-blockers, particularly long-acting selective alpha1-adrenoreceptor antagonists, has proven effective, and hence has become a popular treatment option. In randomized controlled trials, 3 alpha-adrenoreceptor antagonists -terazosin, doxazosin, and tamsulosin -have been shown to significantly improve both the mean peak urinary flow and the severity of BPH-related symptoms. There are no currently published trials comparing the clinical efficacy of these drugs. Reports from non-comparative trials suggest that the effects on symptoms and flow rates are similar. However, side effects, such as postural hypotension, asthenia, and dizziness may be less with tamsulosin. Use of tamsulosin is associated with loss of ejaculation in 4.5% of men. Until differences in efficacy are demonstrated, the choice of alpha-blocker will depend on tolerance for side effects and convenience of administration.

Journal Article↗
PubMedDate not supplied

A phase II study of subcutaneous low-dose interleukin-2 plus erythropoietin in metastatic renal cell carcinoma progressing on interleukin-2 alone.

OBJECTIVE: The activation of angiogenesis has been proven to suppress the anti-cancer immunity. The evidence of abnormally high pretreatment blood levels of vascular endothelial growth factor (VEGF), which is the main angiogenic factor, has appeared to predict resistance to IL-2 immunotherapy of metastatic renal cell carcinoma (RCC). Therefore, the control of VEGF secretion could influence the efficacy of IL-2. Recent data suggest that erythropoietin (EPO) may modulate VEGF secretion and IL-2 biological activity. On this basis, a study was planned with subcutaneous (s.c.) low-dose IL-2 plus EPO in metastatic RCC, which had progressed on IL-2 alone (6 million IU/day for 6 days/week for 4 weeks). METHODS: Patients received IL-2 at the same dose as the previous cycle, plus EPO (10,000 3 times/week until the end of IL-2 therapy. Serum levels of VEGF were measured by enzyme immunoassay on venous blood samples collected at weekly intervals. The study included 12 evaluable metastatic RCC patients. RESULTS: The treatment was well-tolerated and most patients referred a relief of IL-2-induced asthenia. A partial response (PR) and 4 stable diseases (SD) were achieved on IL-2 plus EPO, whereas the other 7 patients had a progressive disease (PD). Hemoglobin mean levels were significantly higher on IL-2 plus EPO than during the previous therapy with IL-2 alone in the same patients. In the same way, mean lymphocyte increase was higher on IL-2 plus EPO than on IL-2 alone, even though this difference was not significant. Finally, VEGF increase was significantly lower on IL-2 plus EPO than during IL-2 alone. CONCLUSION: This preliminary study shows that the concomitant administration of EPO may allow a control of the neoplastic growth in advanced cancer patients progressing on IL-2 alone, reduce the subjective toxicity, prevent hemoglobin decrease and counteract IL-2-related VEGF increase.

Aged↗
PubMed2001

[Depression in cancer patients. Early recognition--adequate treatment].

During or following chemotherapy, cancer patients frequently suffer from depression, asthenia and lassitude, which may have an unfavorable effect on the course of the disease. Psychotherapeutic interventions and psychopharmaceuticals can significantly ameliorate these symptoms and thus improve the patient's quality of life. Over the long term, the general practitioner has a key diagnostic and therapeutic function. While monitoring the further course of the patient, he can recognize the signs of depression and call in specialist help.

Ambulatory Care↗
PubMed2001

A multi-institutional phase ii study of SU101, a platelet-derived growth factor receptor inhibitor, for patients with hormone-refractory prostate cancer.

In a multi-institutional Phase II trial, we evaluated the efficacy of a platelet-derived growth factor receptor (PDGF-r) inhibitor, SU101, in patients with hormonerefractory prostate cancer. The patients received a 4-day i.v. loading dose of SU101 at 400 mg/m(2) for 4 consecutive days, followed by 10 weekly infusions at 400 mg/m(2). The primary study end points were a decline in prostate-specific antigen (PSA) and a decrease in measurable tumor. Secondary end points were time to progression and an effect on pain as measured by the Brief Pain Survey. Expression of PDGF-r was examined in both metastatic and archival primary prostate tumor samples. Forty-four patients were enrolled at four centers. The median age was 72 years, the median PSA was 223 ng/ml, and 21 patients had at least one prior chemotherapy. Thirty-nine patients are evaluable for PSA, and three patients demonstrated a PSA decline >50% from baseline (55-99.9% decrease). The median time to progression was 90 days. Of 19 patients evaluable for measurable disease, 1 patient had a partial response. Nine of 35 evaluable patients had significant improvement in pain. The most frequent adverse events were asthenia (75%), nausea (55%), anorexia (50%), and anemia (41%). PDGF-r expression was detected in 80% of the metastases and 88% of primary prostate cancers. The results of this trial may warrant further clinical studies with other PDGF-r inhibitors.

Aged↗
PubMedDate not supplied

[Clinical aspects of AIDS at the Calmette hospital in Phnom Penh, Kingdom of Cambodia A report on 356 patients hospitalized in the Medicine "B" Department of the Calmette Hospital].

A study on AIDS subjects carried out at the Calmette Hospital in Phnom-Penh between the 1st January 97 and the 30th December 98. The objective of this study was to describe the most frequent clinical manifestations as well as the opportunistic infections according to the 1993 CDC classification (purely clinical classification). Three hundred and fifty six AIDS patients hospitalized in medicine B were included in our study. A complete file was prepared for each subject, specifying his/her social and family situation, profession, sexual behavior and history. The clinical condition was specified and the paraclinical examinations were recorded. The average age was 35 years with 250 men and 106 women, i.e. a M/F sex ratio of 2.4. The majority of male contaminations were due to sexual relationships with multiple partners, 82%, and women with a single partner was of 78%. The use of condoms was of 60% (versus 40% occasional); the extent of drug-addiction was 1.12% (4 cases). A history of STD was found in 56% of cases. The presenting symptoms most frequently found were asthenia, anorexia, fever and weight-loss. In decreasing order, the clinical manifestations often associated were: weight-loss > 10% or a catechetic condition 58.70% (209/356), fever > 38 degrees C >1 month 53% (189/356), diarrhea (> one month) 41.60% (148/356). The most frequent opportunistic infections were: oral candidiasis 51.40% (183/356) and 40% are oro-oesophageal (oral candidiasis + dysphagia or odynphagia), pulmonary and extrapulmonary tuberculoses (TB) 43.50% (155/356) (pulmonary TB in 65.16%, TB of the lymph nodes 23.22% and disseminated TB and cerebral TB 11.61%), cryptococcal meningitis 11.80% (42/356) and pneumocystosis 6.50% (23/356), CMV retinitis 1.12% (4/356). The other opportunistic manifestations such as toxoplasmosis and Kaposis sarcoma are much more rarely encountered due to the difficulties of the paraclinical diagnosis. The mortality in the department was of 17.40% (62/356). In conclusions, tuberculosis is the most frequent of the opportunistic infections in Cambodia. Cryptococcal meningitis is in 3rd place for opportunistic infections. It is the first diagnosis that should be evoked in a meningeal irritation.

AIDS-Related Opportunistic Infections↗
PubMed2001

Phase 2 and 3 clinical trial of oral bexarotene (Targretin capsules) for the treatment of refractory or persistent early-stage cutaneous T-cell lymphoma.

OBJECTIVES: To determine the safety and efficacy of oral bexarotene (Targretin capsules; Ligand Pharmaceuticals Incorporated, San Diego, Calif). DESIGN: The effects of 2 randomized doses of 6.5 mg/m(2) per day (with crossover for progression) vs 650 mg/m(2) per day (later modified to 300 mg/m(2) per day) were evaluated in an open-label, multicenter, phase 2 and 3 study conducted between February 1997 and November 1998. SETTING: Eighteen international cutaneous T-cell lymphoma clinics at academic referral centers. PATIENTS: Fifty-eight patients with biopsy-proven stage IA through IIA cutaneous T-cell lymphoma that was refractory to (or patients were intolerant of) treatment or had reached at least a 6-month response plateau under at least 2 forms of prior therapy (median of 3.5 prior therapies). INTERVENTION: Bexarotene (Targretin capsules) administered once daily with meal for 16 weeks or longer. MAIN OUTCOME MEASURES: Primary end point classification of overall response rate of complete and partial remissions determined by either the Physician's Global Assessment of Clinical Condition or the objective Composite Assessment of Index Lesion Severity. Body surface area, time to response, duration of disease control, time to disease progression, individual index lesion signs and symptoms, and quality of life parameters were secondary outcomes. RESULTS: Responses (> or = 50% improvement) were seen in 3 (20%) of 15 patients with an initial dose at 6.5 mg/m(2) per day (95% confidence interval [CI], 0%-40%), 15 (54%) of 28 patients at 300 mg/m(2) per day (95% CI, 35%-72%), and 10 (67%) of 15 patients at above 300 mg/m(2) per day (95% CI, 43%-91%). The rate of progressive disease was 47%, 21%, and 13% at the same dose levels, respectively. Eight (73%) of 11 patients crossing over from 6.5 mg/m(2) per day to higher doses subsequently responded. The median duration of response from start of therapy could not be estimated for the 15 patients at 300 mg/m(2) per day owing to low relapse rates in 2 patients (13%); at higher doses it was 516 days. The following drug-related adverse effects were reversible and treatable: hypertriglyceridemia (46 patients [79%]), hypercholesterolemia (28 patients [48%]), headache (27 patients [47%]), central hypothyroidism (23 patients [40%]), asthenia (21 patients [36%]), and leukopenia (16 patients [28%]). No cases of drug-related neutropenic fever, sepsis, or death occurred. Pancreatitis occurred in 3 patients with triglyceride levels higher than 14.69 mmol/L (1300 mg/dL), all of whom were taking 300 mg/m(2) or more of oral bexarotene per day. CONCLUSIONS: Bexarotene (Targretin capsules) (the first retinoid X receptor-selective rexinoid) was well tolerated and effective as an oral treatment for 15 (54%) of 28 patients with refractory or persistent early-stage cutaneous T-cell lymphoma at doses of 300 mg/m(2) per day. Hypertriglyceridemia and hypothyroidism require monitoring but are reversible and manageable with concomitant medication.

Administration, Oral↗
PubMed2000

[Current role of antidopaminergic drugs in pediatrics].

The treatment of gastrointestinal disorders in pediatrics is based on the use of prokinetic agents; amongst these prokinetic compounds, cholinomimetic drugs and dopamine antagonists (metoclopramide, domperidone) are principally available. Metoclopramide is an antidopaminergic benzamide with mainly antiemetic effects, due to the interaction with dopamine receptors in the central trigger zone. Another effect is to enhance the transit of material through the gastrointestinal tract. Disadvantages in the use of metoclopramide are neurological effects (asthenia, sleepiness), extrapyramidal dyskinetic reactions and/or neuroendocrine side effects (galactorrhea). Domperidone is a pure dopaminantagonist that accelerates gastric emptying. It is useful in the treatment of acute nausea and vomiting caused by different agents. There are adverse effects only if it is used in parenteral way.

Child↗
PubMed2001

A phase II trial of the cyclin-dependent kinase inhibitor flavopiridol in patients with previously untreated stage IV non-small cell lung cancer.

PURPOSE: Flavopiridol is a potent cyclin-dependent kinase inhibitor with preclinical activity against non-small cell lung cancer (NSCLC), inhibiting tumor growth in vitro and in vivo by cytostatic and cytotoxic mechanisms. A Phase II trial was conducted to determine the activity and toxicity of flavopiridol in untreated patients with metastatic NSCLC. EXPERIMENTAL DESIGN: A total of 20 patients were treated with a 72-h continuous infusion of flavopiridol every 14 days at a dose of 50 mg/m(2)/day and a concentration of 0.1-0.2 mg/ml. Dose escalation to 60 mg/m(2)/day was permitted if no significant toxicity occurred. Response was initially assessed after every two infusions; patients treated longer than 8 weeks were then assessed after every four infusions. Plasma levels of flavopiridol were measured daily during the first two infusions to determine steady-state concentrations. RESULTS: This study was designed to evaluate a total of 45 patients in two stages. However, because no objective responses were seen in the first 20 patients, the early-stopping rule was invoked, and patient accrual was halted. In four patients who received eight infusions, progression was documented at 15, 20, 40, and 65 weeks, respectively. The most common toxicities included grade 1 or 2 diarrhea in 11 patients, asthenia in 10 patients, and venous thromboses in 7 patients. The mean +/- SD steady-state concentration of drug during the first infusion was 200 +/- 89.9 nM, sufficient for cytostatic effects in in vitro models. CONCLUSIONS: At the current doses and schedule, flavopiridol does not have cytotoxic activity in NSCLC, although protracted periods of disease stability were observed with an acceptable degree of toxicity.

Aged↗