Linfoma anaplásico de células grandes asociado a implante mamario. Reporte de un caso y revisión de la literatura. / Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Argentinian case

El linfoma anaplásico de células grandes asociado a implantes mamarios LACG-AI o BIA-ALCL, abreviatura en inglés de "Breast Implant Associated-Anaplastic Large Cell Lymphoma", es una nueva entidad reconocida por la OMS desde el 2016, de rara incidencia y que aún plantea muchos interrogantes. Desde su primera mención en 1997 (J. Keech - B. Creech) su incidencia ha ido en aumento. En julio de 2020, 953 casos en el mundo según el Registro de la Sociedad Americana de Cirujanos Plásticos (PROFILE), y las publicaciones se multiplican exponensialmente año a año demostrando el interés que suscita. Se ha descripto una fuerte asociación con las superficies texturizadas de los implantes mamarios y con el tipo de material (mayor textura "grado 4" y cubierta de poliuretano mayor riesgo) llegando a describirse tasas tan altas omo 1/2830 en Australia/Nueva Zelanda. Su presentación clínica en casi el 75% es bajo la forma de un seroma tardío y el tiempo de exposición promedio ronda entre los 7 a 11 años. El diagnóstico histo-patológico integra el examen morfológico con la caracterización molecular, visualizándose grandes célular anaplásicas CD30 (+), ALK (-). El tratamiento quirúrgico, capsulectomía bilateral en estadios tempranos es el gold standard. Su pronóstico es excelente con exérsis completas. Objetivo: actualizar la información sobre esta novel enfermedad y comentar un caso propio que presenta todas las características descriptas en la literatura, siendo el 14° registrado en Argentina

The anaplastic large cell lymphoma associated with breast implants, LACCG-AI o BIA-ALCL abbreviation in English, is an entity recognized by the WHO since 2016 of rare incidence and that still raises many questions. Since its firts mention in 1997 (J. Keech - B. Creech) its incidence has been increasing, In july 2020, 953 cases in the world according to the Registry of the America Society of Plastic Surgeons (PROFILE), and the publications multiply exponentially year after year, demonstrating the interest it arouses, A strong association has been described with the textured surfaces of breast implants and with the type of material (greater texture "grade 4" and higher risk polyurethane cover), reaching rates as high as 1/2830 in Australia / New Zealand. Its clinical presentation in almost 75% is in the form of a late seroma and the average exposure time is between 7 to 11 years. The pathological anatomical diagnosis integrates the morphological examination with the molecular characterization, visualizing large anaplastic CD30 (+), ALK (-) cells. Surgical treatment, bilateral capsulectomy in early stages, is the gold standard. Her prognosis is excellent with complete exeresis. Objetive: to update the information on this novel disease and comment on an own case that presents all the characteristics described in the literature, the 14th being registered in Argentina

[Development, implementation, and analysis of a "collaborative decision-making for reasonable care" document in pediatric palliative care]. / Élaboration, mise en place et analyse d'une fiche de traçabilité « décisions concertées ­ soins raisonnables ¼ en soins palliatifs pédiatriques.

INTRODUCTION: In France, a legal framework and guidelines state that decisions to limit treatments (DLT) require a collaborative decision meeting and a transcription of decisions in the patient's file. The do-not-attempt-resuscitation order involves the same decision-making process for children in palliative care. To fulfill the law's requirements and encourage communication within the teams, the Resource Team in Pediatric Palliative Care in Aquitaine created a document shared by all children's hospital units, tracing the decision-making process. This study analyzed the decision-making process, quality of information transmission, and most particularly the relevance of this new "collaborative decision-making for reasonable care" card. MATERIAL AND METHODS: Retrospective study evaluating the implementation of a traceable document relating the DLT process. All the data sheets collected between January and December 2013 were analyzed. RESULTS: A total of 58 data sheets were completed between January and December 2013. We chose to collect the most relevant data to evaluate the relevance of the items to be completed and the transmission of the document, to draw up the patients' profile, and the contents of discussions with families. Of the 58 children for whom DLT was discussed, 41 data sheets were drawn up in the pediatric intensive care unit, seven in the oncology and hematology unit, five in the neonatology unit, four in the neurology unit, and one in the pneumology unit. For 30 children, one sheet was created, for 11 children, two sheets and for two children, three sheets were filled out. Thirty-nine decisions were made for withholding lifesaving treatment, 11 withdrawing treatment, and for five children, no limitation was set. Nine children survived after DLT. Of the 58 data sheets, only 31 discussions with families were related to the content of the data sheet. Of the 14 children transferred out of the unit with a completed data sheet, it was transmitted to the new unit for 11 children (79%). DISCUSSION: The number of data sheets collected in 1 year shows the value of this document. The participation of several pediatric specialities' referents in its creation, then its progressive presentation in the children's hospital units, were essential steps in introducing and establishing its use. Items describing the situation, management proposals, and adaptation of the children's supportive care were completed in the majority of cases. They correspond to a clinical description, the object of the discussion, and the daily caregiver's practices, respectively. On the other hand, discussions with families were related to the card's contents in only 53% of the cases. This can be explained by the time required to complete the DLT process. It is difficult for referring doctors to systematically, faithfully, and objectively transcribe discussions with parents. Although this process has been used for a long time in intensive care units, this document made possible an indispensable formalisation in the decision-making process. In other pediatric specialities, the sheet allowed introducing the palliative approach and was a starter and a tool for reflection on the do-not-attempt-resuscitation order, thus suggesting the need for anticipation in these situations. CONCLUSION: With the implementation of this new document, the DLT, data transmission, and continuity of care conditions were improved in the children's hospital units. Sharing this sheet with all professionals in charge of these children would support homogeneity and quality of management and care for children and their parents.

High prevalence of chitotriosidase deficiency in Peruvian Amerindians exposed to chitin-bearing food and enteroparasites.

The human genome encodes a gene for an enzymatically active chitinase (CHIT1) located in a single copy on Chromosome 1, which is highly expressed by activated macrophages and in other cells of the innate immune response. Several dysfunctional mutations are known in CHIT1, including a 24-bp duplication in Exon 10 causing catalytic deficiency. This duplication is a common variant conserved in many human populations, except in West and South Africans. Thus it has been proposed that human migration out of Africa and the consequent reduction of exposure to chitin from environmental factors may have enabled the conservation of dysfunctional mutations in human chitinases. Our data obtained from 85 indigenous Amerindians from Peru, representative of populations characterized by high prevalence of chitin-bearing enteroparasites and intense entomophagy, reveal a very high frequency of the 24-bp duplication (47.06%), and of other single nucleotide polymorphisms which are known to partially affect enzymatic activity (G102S: 42.7% and A442G/V: 25.5%). Our finding is in line with a founder effect, but appears to confute our previous hypothesis of a protective role against parasite infection and sustains the discussion on the redundancy of chitinolytic function.

Effect of macrophage depletion on viral DNA rebound following antiretroviral therapy in a murine model of AIDS (MAIDS).

In the attempt to eradicate HIV-1 infection, a strategy to eliminate macrophages, one of the most important cellular reservoirs in sustaining virus replication during HAART, could be of great benefit in the suppression of viral rebound. Aware of the ability of clodronate to cause macrophage depletion, the effect of the administration of clodronate encapsulated in erythrocytes on disease progression and on viral rebound was evaluated in a murine model of AIDS (MAIDS). One group of LP-BM5 retroviral complex-infected C57BL/6 mice received oral administrations of azidothymidine and dideoxyinosine daily for 12 weeks; two other groups received in addition, either clodronate-loaded erythrocytes or free clodronate at 7-10 day intervals. At the end of the treatment, the three groups maintained parameters characterizing disease progression similar to those of uninfected mice and showed a significantly lower level of BM5d DNA than infected mice in all organs and cells tested. To assess the viral rebound, some animals were left for an additional 4 month period without any treatment. After this time, the BM5d DNA content in blood leukocytes increased in all groups, but the group having received clodronate-loaded erythrocytes, in addition to transcriptase inhibitors, showed a significant delay in viral rebound.

Genetic relationships among species of Contracaecum Railliet & Henry, 1912 and Phocascaris Höst, 1932 (Nematoda: Anisakidae) from pinnipeds inferred from mitochondrial cox2 sequences, and congruence with allozyme data.

The genetic relationships among 11 taxa, belonging to the genus Contracaecum (C. osculatum A, C. osculatum B, C. osculatum (s.s.), C. osculatum D, C. osculatum E, C. osculatum baicalensis, C. mirounga, C. radiatum, C. ogmorhini (s.s.), C. margolisi) and Phocascoris (Phocoscris cystophorae), parasites as adults of seals, were inferred from sequence analysis 1519 bp) of the mitochondrial cytochrome c oxidase subunit II (mtDNA cox2) gene. Phylogenetic analyses obtained from Parsimony (MP) and Neighbour-Joining (NJ) K2P distance values generated similar topologies, each well supported at major nodes. All analyses delineated two main clades: the first encompassing the parasites of the phocid seals, i.e. the C. osculatum species complex, C. osculatum boicolensis, C. mirounga and C. radiatum, with the latter two species forming a separate subclade; the second including the parasites of otarids, i.e. C. ogmorhini (s.s.) and C. margolisi. An overall high congruence between mtDNA inferred tree topologies and those produced from nuclear data sets (20 allozyme loci) was observed. Comparison of the phylogenetic hypothesis here produced for Controcaecum spp. plus Phocascaris with those currently available for their definitive hosts (pinnipeds) suggests parallelism between hosts and parasite phylogenetic tree topologies.

Inhibition of murine AIDS by pro-glutathione (GSH) molecules.

Antioxidant molecules can be used both to replenish the depletion of reduced glutathione (GSH) occurring during HIV infection, and to inhibit HIV replication. The purpose of this work was to assess the efficacy of two pro-GSH molecules able to cross the cell membrane more easily than GSH. We used an experimental animal model consisting of C57BL/6 mice infected with the LP-BM5 viral complex; the treatments were based on the intramuscular administration of I-152, a pro-drug of N-acetylcysteine and S-acetyl-beta-mercaptoethylamine, and S-acetylglutathione, an acetylated GSH derivative. The results show that I-152, at a concentration of 10.7 times lower than GSH, caused a reduction in lymph node and spleen weights of about 55% when compared to infected animals and an inhibition of about 66% in spleen and lymph node virus content. S-acetylglutathione, at half the concentration of GSH, caused a reduction in lymph node weight of about 17% and in spleen and lymph node virus content of about 70% and 30%, respectively. These results show that the administration of pro-GSH molecules may favorably substitute for the use of GSH as such.

[Endoscopic resection of a gastric haemangioma: case report]. / Resezione endoscopica di un emangioma dello stomaco: a proposito di un caso clinico.

Gastric haemangiomas are an infrequent histological type of gastrointestinal benign tumors. Diagnosis is based on imaging but only pathological examination can give certainty. Endoscopic resection, according some specific criteria, is the gold standard procedure. Authors present a case of cavernous haemangioma diagnosed and treated by endoscopic procedure.

Antiviral and immunomodulatory properties of new pro-glutathione (GSH) molecules.

Reduced glutathione (GSH) is present in millimolar concentrations in mammalian cells. It is involved in many cellular functions such as detoxification, amino acid transport, production of coenzymes, and the recycling of vitamins E and C. GSH acts as a redox buffer to preserve the reduced intracellular environment. Decreased glutathione levels have been found in numerous diseases such as cancer, viral infections, and immune dysfunctions. Many antioxidant molecules, such as GSH and N-acetylcysteine (NAC), have been demonstrated to inhibit in vitro and in vivo viral replication through different mechanisms of action. Accumulating evidence suggests that intracellular GSH levels in antigen-presenting cells such as macrophages, influence the Th1/Th2 cytokine response pattern, and more precisely, GSH depletion inhibits Th1-associated cytokine production and/or favours Th2 associated responses. It is known that GSH is not transported to most cells and tissues in a free form. Therefore, a number of different approaches have been developed in the last years to circumvent this problem. This review discusses the capacity of some new molecules with potent pro-GSH effects either to exert significant antiviral activity or to augment GSH intracellular content in macrophages to generate and maintain the appropriate Th1/Th2 balance. The observations reported herein show that pro-GSH molecules represent new therapeutic agents to treat antiviral infections and Th2-mediated diseases such as allergic disorders and AIDS.

The treatment of fistulae and ureteral stenosis after kidney transplantation.

INTRODUCTION: The incidence of urological complications after kidney transplantation varies from 3% to 14%, with a probable loss of the graft in 10% to 15% of cases and a mortality rate of up to 15%, despite improvements in prevention, diagnosis, and treatment as well as the use of new immunosuppressive therapies. Urinous fistulae, which are considered early complications of transplantation, are due to ischemic damage or necrosis generally occurring in the distal third of the ureter. Preservation of accessory arteries to the lower portion of the kidney is important, as they may constitute the blood supply of this segment of the collecting system or ureter. Their ligation may lead to necrosis and urinary fistulae. Ureteral stenosis, as late complication, is related to a pathology of the ureter itself, to infections, to abscesses, to fibrosis, and to ischemia. An early endoscopic approach permits resolution in 70% of cases. The aim of this retrospective study was to determine incidence and treatment of these complications. MATERIALS AND METHODS: From 1991 to 2004 we performed 453 kidney transplantations both from cadaveric and living donors. In 199 patients we performed a transvesical ureteroneocystostomy (UNCS), and in 260, an extravesical UNCS. RESULTS: The nine patients who showed fistulae (1.9%) underwent surgical treatment. In eight we used a direct ureteral reimplantation, and in one, a Boari flap technique. Nephrectomy was necessary in four patients, including two who died of septic complications. In all 26 cases of ureteral stenosis (5.6%), we used an endourological approach (anterograde or retrograde), with surgical treatment afterward in 11 patients (42%) nine direct reimplants, one anastomosis to the native ureter (transplantation from a living donor), and in one case a Boari flap technique four patients who underwent surgical treatment showed progressive damage to graft function. CONCLUSIONS: In all patients who showed fistulae we suggest surgical review: for patients with ureteral stenosis, we suggest first an endourological approach and only when it is not successful do we consider surgical treatment.

[Association between breast and colorectal cancer and polyps. Screening and epidemiological study]. / Associazione tra cancro della mammella e polipi e cancro del colon-retto. Studio epidemiologico e di screening.

BACKGROUND: Studies regarding the associations between different types of cancer in the same patient are very few and not always come to the same conclusions. Several hypothesis are suggested and particularly genetic and socioeconomical ones seem to offer an interpretation of this issue. Early detection of a second neoplasm allows to improve prognosis and survival. The knowledge of correlations between tumors help to select a population, with a high risk to develop a second cancer, to be included in a screening program. Nowadays thanks to early detection of breast cancer, ten years survival is more than 75%. Women who had breast cancer now live longer and so could have a higher risk to develop a second cancer. METHODS: From September 1998 to September 1999 in our Department 71 patients operated for breast cancer, underwent screening colonscopy. No patients refused to be included in the study. Mean age was 61 years (range 36-87). Each patient had a clinician interview in order to explain the goals of the study. RESULTS: Results show that among all patients 3 (4.2%) presented a history of colon cancer, 18.3% (13 cases) presented large bowel polyps. In 84.60% patients (11 cases) polyps were found not over 40 cm. This study shows that 93% of patients (66 cases) had a relative with cancer history. CONCLUSIONS: Our results compared with those of other authors seem to show an increased risk for breast cancer patients in developing polyps or colon cancer, so we suggest to insert sigmoidoscopy in standard follow-up of breast cancer patients.

Nerve growth factor and neuropeptides circulating levels in systemic sclerosis (scleroderma).

OBJECTIVE: To determine the circulating levels of nerve growth factor (NGF), neuropeptide Y (NPY), and vasoactive intestinal peptide (VIP) in systemic sclerosis (SSc), and to correlate these levels with clinical and laboratory features. METHODS: Forty four patients with SSc were evaluated for circulating NGF (immunoenzymatic assay), NPY and VIP (radioimmunoassay), anticentromere and antitopoisomerase I autoantibodies, lung disease (pulmonary function tests with carbon monoxide transfer factor (TLCO), ventilation scintiscan with 99mTc DTPA radioaerosol, high resolution computed tomography (HRCT), pulmonary pressure (echo colour Doppler)), heart disease (standard and 24 ECG, echocardiography), cutaneous involvement (skin score), joint involvement (evidence of tender or swollen joints, or both), peripheral nervous system (PNS) involvement (electromyography), rheumatoid factor, angiotensin converting enzyme (fluorimetric method), von Willebrand factor (ELISA), and erythrocyte sedimentation rate (ESR) (Westergren). RESULTS: Circulating NGF levels in SSc were significantly increased compared with controls (p<0.00001) and significantly higher in the diffuse than in the limited subset of patients (p<0.01). Patients with articular disease had significantly higher levels of NGF. A significant indirect correlation between NGF levels and TLCO was detected (p<0.01), but no correlation was found between NGF and HRCT, DTPA, skin score, PNS involvement and angiotensin converting enzyme and von Willebrand factor levels, antitopoisomerase or anticentromere antibodies, and ESR. NGF levels increased progressively as the disease worsened. Similarly, VIP circulating levels were significantly increased in patients with SSc (p<0.001), whereas the increase of NPY levels did not reach statistical significance. However, both neuropeptides, following the same trend as NGF, increased as the disease worsened (skin score and lung disease). CONCLUSIONS: The increase of NGF and VIP in patients with SSc, the former in the diffuse subset of the disease, and in patients with prominent articular disease, may suggest a link between neurotransmitters and the disease pathogenesis. Neuropeptide circulating levels seem to increase only in patients with the most severe disease.

Duodenal ulcer relapse is not always associated with recurrence of H. pylori infection: a prospective three-year follow-up study.

BACKGROUND: Long-term data concerning the reappearance of Helicobacter pylori infection and duodenal ulcer (DU) recurrence after successful eradication are still few and conflicting. Inadequate histological assessment or use of indirect tests for the determination of H. pylori and bias in the selection of patients to be controlled can influence reported results. The aim of this study was to determine the rate of recurrence of H. pylori infection and ulcer relapse in a population of cured DU patients followed up for 3 years irrespective of their symptomatology. METHODS: Between 1992 and 1994, 126 patients with DU disease were treated with double or triple therapy. Patients using nonsteroidal antiinflammatory drugs or aspirin or receiving maintenance antisecretory therapy were excluded. H. pylori infection was assessed by three bioptic tests from both the antrum and the body (culture, urease, histopathological examination). After 2 months from cessation of treatment, DU had healed and H. pylori infection was cured in 102 of 126 patients (81%). These patients were endoscopically followed up after 1 and 3 years, respectively, and were advised to contact us at symptom recurrence. At 1 and 3 years, we studied 95 (93.2%) and 79 (77.4%) patients, respectively, of the 102 who were cured. The other patients were untraceable or refused endoscopy because they were asymptomatic. RESULTS: After 1 year, no patient had H. pylori recurrence, whereas three patients had a relapse of DU without evidence of infection. After 3 years, recurrence of H. pylori occurred in six patients (annual rate, 2.5%), DU relapsed in five H. pylori-positive patients (6.3%) and in two H. pylori-negative patients (annual rate, 1.9%). Fasting gastrin and acid secretion values studied in all relapsed patients were within the normal range except for one H. pylori-positive patient. CONCLUSIONS: Recurrence of H. pylori infection is very low where treatment is effective, but a DU relapse, not related to acid hypersecretion, can occur in a small percentage of cured patients.

[Cystic polyps of the stomach: review of our case series]. / Polipi cistici dello stomaco: revisione della nostra casistica.

The Authors report their experience with gastric polyps based upon 3,384 endoscopies performed from October 1992 to August 1995. The incidence of cystic polyps with respect to the examinations performed and to the number of gastric polyps found was 0.45% and 21.3% respectively. The cases were taken into account with respect to sex, age, number of lesions, location, size and association to Gardner's syndrome. A comparison between the observed cases and a comprehensive review of the relevant Literature was performed.

[Large cystic polyps of the stomach]. / Un caso di polipi cistici gastrici permagni.

The Authors report the case of a 83 year old woman with large cystic polyps of the stomach. Gastric cystic polyps are polypoid lesions which may develop following functional disorders such as increased mucosal stimulation by gastrin, or excessive retention of gastric secretions. The incidence of these polyps is variable, depending on their being underestimated since they are not always macroscopically visible. The case here reported is very interesting not only for the number of lesions (over 50), but also for their size (5-25 mm in diameter).

Modulation of human lymphoblastoid interferon activity by melatonin in metastatic renal cell carcinoma. A phase II study.

BACKGROUND: Numerous attempts to identify active cytotoxic agents for the treatment of metastatic renal cell carcinoma (RCC) have proved disappointing. However, several recent developments in biologic therapy of neoplastic disease have substantially improved the prospects for the treatment of advanced RCC. Melatonin (MLT), a hormone regulated by the pineal gland, has been shown to act on the immune system by causing the release of cytokines from activated T-cell populations. METHODS: A series of 22 patients with documented progressing RCC entered a trial in which the authors studied the effect of a long term regimen (12 months) with human lymphoblastoid interferon (IFN), 3 mega units (MU) intramuscularly 3 times per week, and MLT, 10 mg orally every day. RESULTS: Twenty-one patients were evaluable for response and toxicity. There were seven remissions (33%): three complete, involving lung and soft tissue and four partial, with a median duration at the time of this writing of 16 months. Nine patients achieved stable disease, and five progressed. General toxicity was mild. Fever, chills, arthralgias, and myalgias occurred rarely. Leukopenia and hepatic enzyme elevation were modest and always reversible. CONCLUSIONS: Response rate and toxic effects observed during this study warrant additional randomized studies to define the role of MLT's concomitant administration in the clinical response to IFN in metastatic RCC.

[Gastric xanthomatosis in a patient with severe lipid metabolic disorder]. / Xantomatosi gastrica in paziente con grave dismetabolismo lipidico.

Gastric xanthomas are rare in routine endoscopy, generally ranging from to 2 to 5 mm in diameter, mostly isolated, but in some cases multiple. Their nature has not yet been cleared. In fact, even if they have histochemical characteristics similar to cutaneous xanthelasmas, they are not generally considered closely related to lipid metabolism disorders. The Authors report a case with some peculiarities regarding number, location and dimension of the gastric xanthomas, and point out the possibility of a metabolic disorder in their aetiopathogenesis.

Cyclophosphamide, epidoxorubicin and Carboplatin as treatment for advanced-carcinoma of the bladder - a phase-ii study.

In advanced carcinoma of the bladder, the M-VAC chemotherapy schedule can yield positive results, but at the cost of very high toxicity. Recent studies have shown epidoxorubicin and to a lesser degree, carboplatin to be active against urothelial tumors, with cardiac, haematological and renal toxicity lower than that observed with CISCA or M-VAC chemotherapy regimens. In this study, we determined the toxicity and efficacy of cyclophosphamide 400 mg/m(2), epidoxorubicin 75 mg/m(2) and carboplatin 300 mg/m(2) in a 28-day course. From February 1990 to December 1991, we enrolled 33 advanced bladder cancer patients (25 males, 8 females), mean age 63 years. 31 patients were evaluable for toxicity and response. The major disease localizations were: locoregional 15 (48%), lymph nodes 6 (20%), liver 5 (16%), lung 3 (10%) and bone 2 (6%). A total of 186 cycles of therapy were administered, with a mean of 5.4 per patient. Six patients (19%) had a complete response (CR): 2 locoregional, 3 lymph node and 1 lung. Eleven patients (36%) had a partial response (PR), for an overall response rate of 55%. The median duration of response was 53 weeks and median survival for the entire group of patients was 40 weeks. No delays or interruptions due to sepsis occurred during therapy; haematological, cardiac and renal toxicity were below WHO grade 3. The efficacy of this chemotherapy regimen proved to be comparable to that of more aggressive schedules, while its toxicity was markedly lower.

[Staplers and pulmonary surgery]. / Staplers e chirurgia polmonare.

The Authors report their experience with staplers (model T.A. 30) in lung surgery: 152 stapled sutures were, in fact, performed in the IV Surgical Department of the University "La Sapienza" of Rome, during the period 1980/90. The use of staplers assures a perfect closure and prevents granulomas due to suture materials in typical as well as atypical lung resections.

Monotherapy with nilutamide, a pure nonsteroidal antiandrogen, in untreated patients with metastatic carcinoma of the prostate. The Italian Prostatic Cancer Project.

A total of 26 previously untreated patients with metastatic carcinoma of the prostate received the pure nonsteroidal antiandrogen nilutamide as a single agent. Objective response rate was 38.5 +/- 18.7% (95% confidence interval). Median progression-free survival and median survival were 9 and 23 months, respectively. Of 13 patients with progression on antiandrogen 5 showed an additional objective response to a second-line endocrine treatment. The drug was generally well tolerated, except for 2 patients who discontinued treatment because of moderate gastrointestinal symptoms. Approximately a third of the patients complained of decreased adaptation to darkness. An electroretinogram and dark adaptation test revealed the presence of functional damage and visual complaints reversed in all patients on cessation of therapy. The other most frequent side effects were slight nausea (26.9% of the patients) and alcohol intolerance (19.2%). A nonsignificant increase in testosterone levels was shown within 1 month of treatment, after which the levels remained stable. Approximately half of the sexually active men claimed maintenance of libido and sexual potency during treatment. A slightly significant increase in hemoglobin was observed during the long term, suggesting the occurrence of a trophic effect by androgens on erythropoiesis. The results indicate that nilutamide as a single agent has an acceptable toxicity and a moderate activity, and may maintain sexual interest in a discrete number of cases. Whether monotherapy with nonsteroidal antiandrogens offers a valid option in the palliation of advanced disease remains to be seen in comparative prospective trials.