Prevalence and Factors Associated with Stress, Anxiety and Depression amongst Primary Care Patients with Hepatitis B and C Infections in Nigeria.

BACKGROUND: Globally, more than 350 million people live with viral hepatitis, out of which over 20 million are in Nigeria. The prevalence of anxiety, depression and stress among patients with viral hepatitis in the primary care setting is not well established. OBJECTIVES: The objectives of this study were to determine the prevalence and factors associated with depression, anxiety and stress among hepatitis patients in a primary care clinic in North Central Nigeria using the Patient Health Questionnaire (PHQ2), Generalized Anxiety Disorder (GAD 2) and Kessler 6 scales respectively. METHODS: This cross-sectional study was carried out among Hepatitis B and C patients attending the Hepatitis Clinic of the Family Medicine Department, Federal Medical Centre Keffi. A total of 123 participants were recruited using a simple random sampling technique. Their sociodemographic and clinical data were collected after which they were screened for depression, anxiety and stress. Data collected was analysed using IBM SPSS. RESULTS: The mean age of study participants was 38.9±11.6 years. Most of them had hepatitis B infection (89.7%) and were on antiviral medications or liver supplements (45.2%). The prevalence of anxiety, depression and stress among them were found to be 18.9%, 25% and 77.6% respectively. Illness duration and medication use were found to be significantly associated with both depression and stress among them. CONCLUSION: The prevalence of anxiety, depression and stress is high among adult primary care patients with viral hepatitis in FMC Keffi.

CONTEXTE: À l'échelle mondiale, plus de 350 millions de personnes vivent avec les hépatites virales, dont plus de 20 millions au Nigeria. La prévalence de l'anxiété, de la dépression et du stress chez les patients atteints d'hépatite virale dans le cadre des soins primaires n'est pas bien établie. OBJECTIFS: Cette étude visait à déterminer la prévalence et les facteurs associés à la dépression, à l'anxiété et au stress chez les patients atteints d'hépatite dans une clinique de soins primaires dans le centre-nord du Nigeria en utilisant les échelles du Questionnaire de Santé Patient (PHQ2), du Trouble Anxieux Généralisé (GAD 2) et de Kessler 6 respectivement. MÉTHODES: Cette étude transversale a été réalisée parmi les patients atteints d'hépatite B et C fréquentant la clinique d'hépatite du département de médecine familiale du Centre Médical Fédéral de Keffi. Un total de 123 participants ont été recrutés à l'aide d'une technique d'échantillonnage aléatoire simple. Leurs données sociodémographiques et cliniques ont été recueillies, après quoi ils ont été dépistés pour la dépression, l'anxiété et le stress. Les données collectées ont été analysées à l'aide d'IBM SPSS. RÉSULTATS: L'âge moyen des participants à l'étude était de 38,9±11,6 ans. La plupart d'entre eux étaient atteints d'une infection par l'hépatite B (89,7 %) et prenaient des médicaments antiviraux ou des compléments hépatiques (45,2 %). La prévalence de l'anxiété, de la dépression et du stress parmi eux s'est avérée être respectivement de 18,9 %, 25 % et 77,6 %. La durée de la maladie et l'utilisation de médicaments ont été significativement associées à la dépression et au stress chez ces patients. CONCLUSION: La prévalence de l'anxiété, de la dépression et du stress est élevée parmi les patients adultes en soins primaires atteints d'hépatite virale au FMC Keffi. MOTS-CLÉS: Prévalence et facteurs, stress, anxiété, dépression, patients atteints d'hépatite B et C.

Renal tolerance of cisplatin in patients more than 80 years old.

PURPOSE: Assessment of cisplatin (CDDP) tolerance in patients more than 80 years old in good general condition who may benefit from CDDP-based treatment. PATIENTS AND METHODS: Data on 35 patients older than 80 years who received one to six chemotherapy cycles (median, three cycles; total number of cycles, 98) including CDDP (60 to 100 mg/m2) were analyzed retrospectively. Before treatment, all patients had normal renal function as defined by serum creatinine (SC) levels below 132 mumol/L. Renal function was evaluated by measurement of SC and creatinine clearance (CC) before and after each course of chemotherapy. CC was calculated according to the Cockroft and Gault formula, where CC = (140 - age) x weight kg/0.814 x SC mumol/L. Renal toxicity was evaluated by the difference between prechemotherapy SC and the maximum SC level observed (delta SC) and by the difference between prechemotherapy CC and the minimal CC observed after treatment with CDDP (delta CC). The evolution of SC and CC during repeated courses of CDDP was analyzed, as were any extrarenal toxicities. RESULTS: Renal function remained stable in 19 patients (54%) with delta SC less than 18 mumol/L and 18 of 35 patients (51%) with delta CC less than 9 mL/min. A slight deterioration in renal function was observed in 13 patients (37%) with delta SC greater than 18 mumol/L and less than 60 mumol/L, and with a delta CC greater than 11 mL/min and less than 21 mL/min. In three patients (9%), delta SC was greater than 60 mumol/L (71, 73, 115 mumol/L) and delta CC was greater than 21 mL/min (25, 26, 36 mL/min). There were no cases of severe renal insufficiency, clinical ototoxicity, or neurotoxicity > or = grade 2. Treatment was terminated after one or two courses in three patients because of grade 2 or 3 hematologic toxicity and in two patients for grade 3 nausea or vomiting. CONCLUSION: CDDP at moderate doses can reasonably be administered to patients older than 80 years who may benefit from antineoplastic chemotherapy.

Interleukin-2 and lymphokine-activated killer cells in 15 children with advanced metastatic neuroblastoma.

A phase II trial using interleukin-2 (IL2) and lymphokine-activated killer (LAK) cells was carried out in an attempt to treat children with end-stage neuroblastoma. Fifteen patients (median age, 7 years) were enrolled in the study. Twelve were in relapse after massive chemotherapy and autologous bone marrow transplantation (ABMT), and three had a primary refractory disease after conventional chemotherapy. IL2 was administered as an 18 x 10(6) IU/m2/d continuous infusion. One course consisted of a double 5-day treatment period separated by a 6-day break. Cytapheresis to harvest LAK progenitor cells was performed during the rest period. After a 4-day in vitro culture, LAK cells were reinjected during the second cycle of therapy. A phenotypic and functional analysis of immunologic parameters was conducted along with the therapeutic protocol. Toxicity was significant with two toxic deaths (cardiotoxicity and respiratory distress). The reinfusion of large amounts of LAK cells was clearly involved in one case, but this particularly severe toxicity has to be related to the patient's status (ie, heavy pretreatment). No significant clinical response was seen. The immunologic monitoring showed phenotypic and functional modifications in these patients before initiation of treatment and an unexpected absence of evolution of these parameters during IL2 therapy. Although the origin of these immune dysfunctions is not clear, they could be involved in the failure of IL2 therapy. Future studies of IL2 therapy in neuroblastoma should be undertaken earlier in the course of the disease.

A phase-II study of adoptive immunotherapy with continuous infusion of interleukin-2 in children with advanced neuroblastoma. A report on 11 cases.

Nine children with poor prognosis neuroblastoma have been treated by continuous infusion of IL-2 and autologous LAK cells, as described previously by West et al. in adult patients. Six patients were in relapse after high-dose chemotherapy and autologous BMT and three presented with primary refractory disease after conventional therapy. Although patients were very young (median age 6 years; average weight 17 kg), infusion of IL-2, cytapheresis and reinjection of LAK cells appeared feasible with the usual and transient complications observed with IL-2. Haematological toxicity, although reversible, was more important than usually described and due to the presence of bone-marrow metastases in 8 of the 9 patients. Life-threatening toxicity was observed in only one of the admission centres and was probably due to the rapid reinjection of a very large number of activated cells. Two patients presenting with very active disease after high-dose chemotherapy and autologous or allogeneic BMT received IL-2 alone, at 120 days and at 90 days after the graft. The reactivation of grade-II GVHD was the major complication in the patient treated after an allograft, whereas no BMT-related toxicity was observed in the patient treated after the autologous BMT. Immunological modifications induced by IL-2 were very different between these patients. As expected, a preferential outgrowth of NK cells with both NK and LAK activity was observed in the patient treated just after the autograft. In contrast, in the patient treated after an allograft and in the 9 patients in relapse, T lymphocytes remained the major mononuclear cell population with a very large excess of CD8+ T cells. All patients progressed after the first induction cycle with the exception of the only patient treated after autologous BMT who reached a very good partial remission with disappearance of the local tumor and bone metastases. Although very preliminary, these data clearly show that the efficacy of IL-2 largely depends on the patient's immunological status with the optimal effect being observed when IL-2 is given in the first few months following an autograft.

Interleukin-2 with and without LAK cells in metastatic renal cell carcinoma: the Lyon first-year experience in 20 patients.

Thirty-one patients with metastatic renal cell carcinoma were seen at the Centre Léon Bérard from October 1987 to October 1988. According to our protocol, 11 were excluded leaving 20 in the study. The median age was 55 years (range 36 to 79 years). The median number of metastases was 9 (range 2 to 29) and the median number of metastatic sites was 3 (range 1 to 4). Seventeen patients received a continuous infusion of recombinant interleukin-2 (rIL-2) of 3 x 10(6) U/m2/day, on days 1 to 5, with lymphapheresis on days 7 to 10 and IL-2 + LAK on days 11 to 15. Three patients received IL-2 alone. The clinical toxicity of IL-2 was as expected (100% fever, 88% erythema, 88% vomiting, 87% weight gain, 76% oliguria, 76% diarrhoea, 70% pruritus, 70% weakness, 41% severe hypotension, 41% acute renal failure, 33% disorientation, 23% respiratory distress, 12% ventilation and 5% coma) with no toxic deaths. Other toxicity was mild (median platelet nadir was 93,000 and median nadir of Hb 8.1 g/dl) except for the creatinine level which was found to be between 200 and 400 mumol/l in 45% of the courses and over 400 mumol/l in 24% of the courses. Eight capillary leak syndromes were observed. Among the three patients receiving IL-2 alone, one PD, one SD and one early toxicity were recorded. Among 15 evaluable patients receiving IL-2 + LAK, three had PR (20%) and two mixed response (PR and progression before 2 months); two had stable disease and eight had progression. No clinical or biological factor was able to predict response. However, the five objective responses were observed among the eight patients with a capillary leak syndrome. Lymphocyte peaks or platelet nadir were not related to response in this group of patients. The median number of harvested mononuclear cells was 9.8 x 10(10) and the median number of mononucleated cells reinjected was 5.9 x 10(10).

Dihydropyrimidine dehydrogenase activity in cancer patients.

Dihydropyrimidine dehydrogenase (DPD) is the major catabolic enzyme of pyrimidines and fluoropyrimidines. The clinical course of 2 patients with suspected DPD deficiency is described. Both patients had significantly delayed clearance of fluorouracil (5-FU), elevated plasma uracil concentrations, and subsequent lethal toxicity. The prevalence of DPD deficiency in the general population is unknown, but given the large number of cancer patients treated with 5-FU, it may be of great clinical significance. Lymphocytes have been previously shown to be a useful marker of systemic DPD activity. Because DPD activity has not been previously reported in a large population of cancer patients using 5-FU as the substrate, we determined DPD activity in lymphocytes from 66 patients with cancer. DPD activity was determined by a sensitive high performance liquid chromatography method. The mean DPD activity (S.D.) in 66 patients with head and neck cancer was 0.189 (0.071) nomol/min/mg protein with wide interpatient variability (range 0.058-0.357). DPD activity was not correlated to age (r = -0.164, P = 0.188). The mean DPD activity in men [0.192 (0.074)] was not significantly different from that in women [0.172 (0.057); t-test P = 0.418]. Likewise, there was no statistical difference in DPD activity in patients who had not received prior chemotherapy [0.195 (0.066)] to patients receiving one or more cycles of chemotherapy [0.186 (0.074); t-test P = 0.638].

Repeated courses of high dose melphalan and unpurged autologous bone marrow transplantation in children with acute non-lymphoblastic leukemia in first complete remission.

Eleven children between the ages of 1 and 16 years with acute non-lymphoblastic leukemia (ANLL) in first remission were included in a study of double unpurged autologous bone marrow transplantation (ABMT). Prior to each ABMT patients received massive chemotherapy with melphalan at a dosage of 140 mg/m2. The first ABMT was done within a median of 4 months after the achievement of complete remission. As soon as the children had adequate hematologic recovery, a second marrow collection was done, followed by a second course of melphalan and a second ABMT. The duration of aplasia was significantly longer after the second ABMT than after the first, but the non-hematologic toxicity was relatively mild in each case and no patient died from the procedure. Four patients relapsed and seven are alive in unmaintained complete remission with a median duration of leukemia-free survival of 29 months (range 15-56 months) after the first ABMT. These data demonstrate the feasibility of repeating ABMT after melphalan in children with ANLL. The eventual impact of such therapy needs to be demonstrated in prospective randomized studies.

Anti LFA1 monoclonal antibody for the prevention of graft rejection after T cell-depleted HLA-matched bone marrow transplantation for leukemia in adults.

A mouse IgG monoclonal antibody (MoAb) directed against the human LFA1 molecule (25.3 MoAb) was used in nine adult leukemic patients to prevent graft rejection after T cell-depleted HLA matched bone marrow transplantation. Based on the results of a previous study in children 0.1 mg/kg of 25.3 was given on days -3, -1, +1, +3, +5 in addition to a standard conditioning regimen with cyclophosphamide (120 mg/kg) and fractionated total body irradiation. The marrow transplant was T cell-depleted using T101 Fab immunotoxin ricin A chain. Seven patients received post-graft immunosuppression with methotrexate and cyclosporine A; two patients received no immunosuppression post-graft. A mean T cell depletion of 98.3% (80-100%) was achieved. Tolerance to the infusions of 25.3 MoAb was excellent. No patient developed any form of graft-versus-host disease. However two patients failed to engraft and three patients had delayed graft failures. These results show that this regimen of anti LFA1 MoAb, which was extremely good at permitting engraftment of HLA mismatched T cell-depleted transplant in children with constitutional diseases, is not able to prevent graft failure and rejection of T cell-depleted HLA matched transplants in adults with leukemia. Further efforts are needed to overcome graft failures in this clinical situation.

Allogeneic or autologous bone marrow transplantation for acute lymphoblastic leukemia in first complete remission.

Forty-seven patients with high risk acute lymphoblastic leukemia (ALL) received an allogeneic (allo) or autologous (auto) bone marrow transplant (BMT). Patients in both groups were comparable in terms of age, initial presentation of ALL and induction chemotherapy. Allo patients were transplanted earlier (median 3 months after CR) than auto patients (median 6.5 months after CR). Auto patients received more consolidation chemotherapy before BMT. All patients received total body irradiation 2.2 Gy/day x 5 days after cyclophosphamide 60 mg/kg x 2 (18 allo and five auto) or melphalan 140 mg/m2 (seven allo and 17 auto). Prevention of graft-versus-host disease (GVHD) was by conventional immunosuppression in 17 patients and T cell depletion in eight. Seven patients (28%) developed moderate to severe acute GVHD. Auto marrow was treated in vitro in each case. Seven patients died in CR from BMT complications (five allo and two auto). The probability of relapse was 9% for patients receiving allo BMT and 52% for patients receiving auto BMT (p less than 0.01). The disease-free survival was 71% for allo BMT and 40% for auto BMT (p = NS). Early BMT is an effective form of consolidation for high risk patients with ALL in first CR. An allogeneic anti-leukemia effect was demonstrated in this study.

Donor bone marrow treatment with T101 Fab fragment-ricin A-chain immunotoxin prevents graft-versus-host disease.

Thirty-eight patients with haematological malignancies were treated with bone marrow transplantation using histocompatible immunotoxin T cell-depleted marrow siblings. All patients received conventional postgraft immunosuppression (methotrexate and/or cyclosporin A). Donor bone marrow was treated ex vivo with T101 Fab fragment coupled to ricin A-chain (T101 Fab-RTA) at a concentration of 10(-8) M of A-chain in association with NH4Cl (2 x 10(-2) M) in pH adjusted (7.8) incubation medium. A median cytoreduction of 99.5% (91-99.5) was obtained. The median of follow-up was 300 days. Only three patients developed grade II acute graft-versus-host disease (GVHD) (actuarial rate of acute GVHD: 9.1%). No chronic GVHD occurred. All patients but one engrafted. Six out of the 37 patients developed a documented bone marrow rejection (actuarial rate of graft failure: 18%). Ten patients relapsed (actuarial rate of relapse: 36.9%). These findings demonstrate that treatment of donor marrow with T101 Fab-RTA in association with NH4Cl at critical pH value can achieve a high level of mature T cell depletion and greatly reduce the incidence of bone marrow rejection and relapse after T cell-depleted allogeneic bone marrow transplantation.

Role of splenectomy in incidence and severity of acute graft-versus-host disease: a multicenter study of 157 patients.

Allogeneic bone marrow transplantation is a therapeutic option for many hematological malignancies. Graft-versus-host disease (GVHD) remains one of the major complications and has a high mortality rate. The pathophysiological mechanisms involved are poorly understood and GVHD prevention regimens still give disappointing results. This study concerned 157 patients with diverse diagnoses from Bordeaux, Grenoble and Marseille who had undergone an HLA-matched transplantation without T cell depletion. Thirty-one patients (20%) had been splenectomized before transplantation. The role of splenectomy in the incidence and severity of acute GVHD was investigated using a univariate and multivariate analysis of 11 risk factors including splenectomy. Univariate analysis found three significant risk factors linked with GVHD incidence: splenectomy, age of recipient and GVHD prevention by monotherapy versus a combination of methotrexate plus cyclosporin. Multivariate analysis retained only the effects of age and GVHD prevention on GVHD incidence and showed that splenectomy was the most important factor in GVHD severity. One explanation for the role of splenectomy could be the spleen's possible function as a filter of activated T lymphocytes from the transplant. We therefore concluded that it would be preferable to abstain from splenectomizing patients before transplantation although splenectomy is still advisable in certain malignancies after transplantation.

Intensive chemotherapy with high doses of BCNU, etoposide, cytosine arabinoside, and melphalan (BEAM) followed by autologous bone marrow transplantation: toxicity and antitumor activity in 26 patients with poor-risk malignancies.

Twenty-six patients (median age 33 years) with poor-risk malignancies were treated with high-dose combination chemotherapy associating BCNU-etoposide-cytosine arabinoside and melphalan (BEAM) followed by autologous bone marrow transplantation (ABMT). Twenty-one patients had malignant lymphomas, three, acute lymphoblastic leukemia (ALL), and two, malignant thymomas. Eleven patients (group 1) were not in complete remission (CR) at the time of BEAM, and fifteen patients (group 2) were in CR. Hematological recovery occurred in all patients. The duration of aplasia and the non-hematological toxicities were similar in both groups. Ten of the eleven patients (group 1) evaluable for response achieved CR and one achieved partial remission (PR). Five patients relapsed, and five are in continuous CR with a short follow-up (median 8 months). Among the fifteen patients in CR at the time of BEAM (group 2), four patients relapsed and ten patients are in unmaintained continuous CR with a median follow-up of 15 months (one patient died in CR). The disease-free survival is 53%, with 29% for patients receiving BEAM while in relapse (group 1) and 65% for patients receiving BEAM while in CR (group 2). These data indicate that BEAM followed by ABMT can produce a high antitumor response with an acceptable toxicity in patients with poor-risk malignancies.

Inhibition of dihydropyrimidine dehydrogenase by alpha-interferon: experimental data on human tumor cell lines.

Interferons (IFNs) are very promising fluorouracil (FU) biochemical modulators. The pharmacological origin sustaining the FU-IFN synergistic interaction is not clearly understood. It was recently shown that alpha-IFN was associated with a dose-dependent decrease in FU clearance in treated patients. Dihydropyrimidine dehydrogenase (DPD) is the key regulating enzyme for FU catabolism. The effects on DPD exerted by both the IFN dose and the duration of exposure were evaluated in a panel of five human cancer cell lines. All cell lines investigated exhibited quantifiable DPD activity with inter-cell-line variability (0.118-0.318 nmol min-1 mg protein-1). A prolonged exposure to IFN (up to 5 days) was necessary to obtain a significant inhibition of DPD activity. A concentration-dependent significant decrease in DPD activity, reaching 50% of the initial activity determined for the highest IFN concentration (10(5) IU/ml), was demonstrated in all cell lines tested (5-day IFN exposure). For three cell lines, IFN potentiated the FU-induced growth inhibition in a concentration-dependent manner. Considering all cell lines and all IFN concentrations, it appears that globally, the greater the inhibition of DPD activity, the greater the FU potentiation (Spearman rank correlation on all cell lines, P = 0.011).

Recombinant interleukin-2 (rIL-2) after autologous bone marrow transplantation (BMT): a pilot study in 19 patients.

In vivo use of rIL-2 autologous BMT may be the means of reproducing a kind of "adoptive immunotherapy" from grafted cells after allogeneic BMT. This approach may enhance the spontaneous generation of cytotoxic T-cells and NK cells which are presumably involved in this immunotherapy. Potential risks of such an approach would be to increase the usual toxicity of rIL-2 and to jeopardize the hemopoietic reconstitution. To determine the feasibility of this approach we have treated 19 poor prognosis patients with a succession of autologous BMT followed 78 +/- 12 days later by a continuous infusion of rIL-2. Eighteen million international units (IU) per m2 per day of Proleukine (CETUS, Amsterdam, The Netherlands) were administrated over 6 or 12 days. No patient died of the procedure. Clinical toxicity related to rIL-2 was not increased. Hemopoietic toxicity, significant both for platelets and granulocytes, was transient. Immune stimulation was dramatic for lymphocytes and subpopulations (CD3+ and NK cells) and for cytolytic functions (NK and LAK activity). This trial establishes the feasibility of administration of high doses of rIL-2, 2 months after autologous BMT. In this setting a 6 day period of continuous infusion of 18 million per m2 per day of Proleukine appears to be a regularly tolerable dosage conducting to a major immune activation and invites further studies to determine the clinical impact of such an approach.

Granulocytic sarcoma with meningeal leukemia but no bone marrow involvement at presentation. A report of two cases with characteristic cerebrospinal fluid cytology.

Two cases occurred of granulocytic sarcoma with cerebrospinal fluid involvement but no associated leukemia on presentation. Both cases were difficult to identify by histology and were initially misdiagnosed as malignant lymphoma. The characteristic cerebrospinal fluid cytologic picture allowed the diagnosis. These cases underscore the value of cytologic examination of tumor imprints and the use of myeloid markers in panels for immunophenotyping lymphomas.

[Intraperitoneal high dose chemotherapy as consolidation treatment for advanced ovarian carcinoma: a pilot study]. / Traitement de clôture des adénocarcinomes ovariens de stade avancé: étude pilote de chimiothérapie haute dose par voie intrapéritonéale.

Consolidation treatment of advanced ovarian carcinoma, especially the place of intraperitoneal chemotherapy, remains a controversial subject. From January 1988 to July 1995, 39 patients, median age 54 years, received intraperitoneal chemotherapy as consolidation treatment after second-look surgery. At the time of intraperitoneal chemotherapy, 30 patients had no residual disease. Intraperitoneal drug administration used a Tenckoff catheter or a lumbar needle. Treatment combined 5 fluorouracil 1 g/m2 and cisplatin 200 mg/m2, associated with a systemic sodium thiosulfate rescue as nephroprotector. A pharmacological analysis was done for 9 patients: the exposure of peritoneal cavity to cisplatin exceeded that of the plasma by 11 fold. Hematologic and nephrologic toxicity were acceptable. The median follow-up is 43 months. The disease free survival is 36,6 months, but 48,5 months if no residual disease at the time of intraperitoneal chemotherapy. Consolidation treatment by intense intraperitoneal chemotherapy is a feasible approach and might be beneficial in chemosensitive patients devoid of macroscopic remnants, but must be compared with others approaches.

[Results of a randomized study comparing combination of navelbine-cisplatin to combination of vindesine-cisplatin and to navelbine alone in 612 patients with inoperable non-small cell lung cancer]. / Résultats d'une étude randomisée comparant l'association Navelbine-cisplatinum à l'association vindésine-cisplatinum et à la Navelbine seule chez 612 malades porteurs d'un carcinome bronchique non à petites cellules inopérable.

The combination of vindesine and cisplatin is considered a reference regimen in advanced NSCLC which has yielded a significant improvement in the duration of survival. A phase II study of a new semi-synthetic vinca alkaloid, Navelbine, reported an unusually high 29% response rate in stage III-IV NSCLC and a phase I-II study established the feasibility of the combination of Navelbine and cisplatin. We, therefore, designed a prospective randomized trial to compare Navelbine and cisplatin (NVB-P) to vindesine and cisplatin (VDS-P) and to evaluate whether the best of these regimens affords a survival benefit compared to Navelbine alone (NVB), an outpatient regimen. Forty-five centers included 612 patients in this study: 206 in NVB-P, 200 in VDS-P and 206 in NVB. Navelbine was given at a dose of 30 mg/m2 weekly, cisplatin at 120 mg/m2 on day 1, day 29 and then every 6 weeks and vindesine at 3 mg/m2 weekly for 6 weeks and then every other week. Treatment was continued until progression or toxicity. Patients' characteristics were similar in the three groups with 59% of patients presenting with metastatic disease. An objective response rate was observed in 30% of patients in NVB-P versus 19% in VDS-P (P = .02) and 14% in NVB (P < .001). The median duration of survival was 40 weeks in NVB-P compared to 32 weeks in VDS-P and 31 weeks in NVB. The comparison of survival between the three groups demonstrated an advantage for NVB-P compared to VDS-P (P = .04) and NVB (P = .02). Neutropenia was significantly higher in the NVB-P group (P < .001) and neurotoxicity more frequent with VDS-P (P < .004). Since our results have demonstrated that NVB-P yields a longer survival duration and a higher response rate than VDS-P or NVB alone, with acceptable toxicity, this combination should be considered a reference regimen in advanced NSCLC.

[Application of the gel test using and anti-IgA antiglobulin for the immunologic diagnosis of autoimmune hemolytic anemia with a negative direct Coombs test]. / Application du gel test utilisant une antiglobuline anti-IgA au diagnostic immunologique d'anémie hémolytique auto-immune à test de Coombs direct négatif.

Autoimmune hemolytic anemias (AIHA) are characterized by hyperhemolysis associated with the presence of the immunoglobulins IgG, IgM or IgA on the red cell membrane. These immunoglobulins react as auto-antibodies against the red cell auto-antigens of the patient. The diagnosis is supported by clinical and biological signs of hemolysis, and by the identification of the auto-antibodies using the direct antiglobulin test (DAT). Here we report 14 cases of patients who showed the clinical and biological profile of AIHA, but who gave a negative DAT. We therefore tried to determine the presence of IgA on the red cell membrane with a method more sensitive than the DAT: the gel test using anti-IgA. With such a gel test, we demonstrated that there were IgA auto-antibodies on the red cell membrane in the 14 cases, therefore confirming the diagnosis of AIHA. We discuss the interest of performing a gel test with anti-IgA in each case where AIHA is suspected, but in which a negative DAT has been observed.

Theoretical foundations of a prepared sibling class.

Family-centered maternity care is a frequently used phrase, yet children, an integral part of the family, are not always involved in formal preparation for a new infant. Should children be included in the preparation for a new arrival? A formal assessment to answer this question led to the planning and implementation of a Sibling Preparation Class. This article discusses objectives with implementation methods and correlates their direct application to class content. Nursing implications and suggestions for further research are included.

["Standards, Options and Recommendations 2001" for radiotherapy in patients with non-metastatic infiltrating breast cancer. Update. National Federation of Cancer Campaign Centers (FNCLCC)]. / Standards, Options et Recommandations 2001 pour la radiothérapie des patientes atteintes d'un cancer du sein infiltrant non métastatique, mise à jour. Fédération nationale des centres de lutte contre le cancer (FNCLCC).

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of french cancer centers (FNCLCC), the 20 french cancer centers, and specialists from french public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines for non metastatic breast cancer patients according to the definitions of the Standards, Options and Recommendations project. METHODS: Data were identified by searching Medline, web sites, and using the personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to 148 independent reviewers. RESULTS: This article presents the chapter radiotherapy resulting from the 2001 update of the version first published in 1996. The modified 2001 version of the standards, options and recommendations takes into account new information published. The main recommendations are: (1) Breast irradiation after conservative surgery significantly decrease the risk of local recurrence (level of evidence A) and the decrease in the risk of local recidive after chest wall irradiation is greater as the number of risk factors for local recurrence increases (level of evidence A). (2) After conservative surgery, a whole breast irradiation should be performed at a minimum dose of 50 Gy in 25 fractions (standard, level of evidence A). (3) A boost in the tumour bed should be performed in women under 50 years, even if the surgical margins are free (standard, level of evidence B). (4) Internal mammary chain irradiation is indicated for internal or central tumours in the absence of axillary lymph node involvement (expert agreement) and in the presence of lymph node involvement (standard, level of evidence B1). (5) Sub- and supra-claviculr lymph node irradiation is indicated in patients with axillary node involvement (standard, level of evidence B1).