[ICU performance: results of a French study involving 80,000 ICU stays]. / Performance en réanimation: résultats du PHRC Sfar-SRLF.

OBJECTIVE: The Standard Mortality Ratio (SMR), comparing the observed in-hospital mortality to the predicted, may measure the intensive care units (ICU) performance. STUDY DESIGN: Multicentric retrospective national study. METHODS: A probability model using a severity score such SAPS II calculated the predicted mortality rate. A national French study has been undertaken to compare the SMR of ICUs and looked for explanation. RESULTS: One hundred six units, 34 were medical (32%), 18 surgical (17%) and 57 medical/surgical (51%) participated to the study. Forty-six ICUs (43%) were located in teaching hospitals. The SMR of the 87,099 stays was 0.84 (0.82-0.85). The SMR of ICUs varied from 0.41 to 1.55. Ten units had a SMR>0.85, which suggested a low performance. They had more stays for cardiovascular failures, as compared with others. The best units (SMR<0.82) had more stays for drug overdose. The SMR increased with the number of organ failures, from 0.47 with zero failure to 1.11 with 4 or more organ failures. The stays with cardiovascular failure, either unique or associated, had a higher SMR. The 7935 stays with a drug overdose had a SMR of 0.12 (0.10-0.14), which suggested a bad calibration of the model in theses cases. CONCLUSION: The case mix must be taken in account when comparing the ICUs performance by the mean of SMR, particularly when the units admitted a lot of drug overdoses.

Comparative genomic hybridization analysis of Enterococcus faecalis: identification of genes absent from food strains.

Enterococcus faecalis, a member of the natural microbiota of animal and human intestinal tracts, is also present as a natural contaminant in a variety of fermented foods. Over the last decade, E. faecalis has emerged as a major cause of nosocomial infections. We investigated the genetic diversity in 30 clinical and food isolates, including strains V583 and MMH594, in order to determine whether clinical and food isolates could be distinguished. Data were obtained using comparative genomic hybridization and specific PCR with a total of 202 probes of E. faecalis, selected using the available V583 genome sequence and part of the MMH594 pathogenicity island. The cognate genes encoded mainly exported proteins. Hybridization data were analyzed by a two-component mixture model that estimates the probability of any given gene to be either present or absent in the strains. A total of 78 genes were found to be variable, as they were absent in at least one isolate. Most of the variable genes were clustered in regions that, in the published V583 sequence, related to prophages or mobile genetic elements. The variable genes were distributed in three main groups: (i) genes equally distributed between clinical and dairy food isolates, (ii) genes absent from dairy food-related isolates, and (iii) genes present in MMH594 and V583 strains only. Further analysis of the distribution of the last gene group in 70 other isolates confirmed that six of the probed genes were always absent in dairy food-related isolates, whereas they were detected in clinical and/or commensal isolates. Two of them corresponded to prophages that were not detected in the cognate isolates, thus possibly extending the number of genes absent from dairy food isolates. Genes specifically detected in clinical isolates may prove valuable for the development of new risk assessment markers for food safety studies and for identification of new factors that may contribute to host colonization or infection.

Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte.

PURPOSE: To analyze the long-term outcome of patients included in the Lymphome Non Hodgkinien study 98-5 (LNH98-5) comparing cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) to rituximab plus CHOP (R-CHOP) in elderly patients with diffuse large B-cell lymphoma. PATIENTS AND METHODS: LNH98-5 was a randomized study that included 399 previously untreated patients, age 60 to 80 years, with diffuse large B-cell lymphoma. Patients received eight cycles of classical CHOP (cyclophosphamide 750 mg/m(2), doxorubicin 50 mg/m(2), vincristine 1.4 mg/m(2), and prednisone 40 mg/m(2) for 5 days) every 3 weeks. In R-CHOP, rituximab 375 mg/m(2) was administered the same day as CHOP. Survivals were analyzed using the intent-to-treat principle. RESULTS: Median follow-up is 5 years at present. Event-free survival, progression-free survival, disease-free survival, and overall survival remain statistically significant in favor of the combination of R-CHOP (P = .00002, P < .00001, P < .00031, and P < .0073, respectively, in the log-rank test). Patients with low-risk or high-risk lymphoma according to the age-adjusted International Prognostic Index have longer survivals if treated with the combination. No long-term toxicity appeared to be associated with the R-CHOP combination. CONCLUSION: Using the combination of R-CHOP leads to significant improvement of the outcome of elderly patients with diffuse large B-cell lymphoma, with significant survival benefit maintained during a 5-year follow-up. This combination should become the standard for treating these patients.

Beneficial effect of highly active antiretroviral therapy on the prognosis of AIDS-related systemic non-Hodgkin lymphomas.

The influence of HAART on the survival of patients with AIDS-related lymphoma (ARL) was evaluated. A retrospective analysis of 73 HIV-1-infected patients with proven ARL diagnosed between 1992 and 2000 was conducted. Patients received uniformly the same chemotherapy regimen according to CD4 cell counts at NHL diagnosis:, patients with CD4 cells below or above 100 cells x 10(6)/liter received CHOP or ACVBP regimens, respectively. Event-free survival (EFS) and survival were estimated by the Kaplan-Meir method and a Cox model was used to evaluate the effect of different variables on survival. At diagnosis of ARL, the median age was 37 years and 22 patients (30%) had prior AIDS-defining events. Median CD4 cell count was 99 x 10(6)/liter. The median follow-up was 60 months. Ann Arbor stage 3-4 was noted in 60 patients (82%) and bone marrow or meningeal involvement was present in 13 (17%) and 12 (16%) patients, respectively. Two groups were identified: group 1 (n = 38) included patients who had never received HAART and group 2 (n = 35) included those who received HAART either before the diagnosis or following ARL. There was no statistical significant differences in lymphoma extensive stage, presence of B symptoms, meningeal involvement, CD4 cell count at diagnosis, prior AIDS events, or chemotherapy regimens between the two groups. Median survival (MS) of the whole cohort of patients was 8 months. Estimated EFS was significantly higher (30 months) in group 2 compared to group 1 (6.1 months) (p = 0.03). In the multivariate Cox model HAART has an independent significant effect on EFS (p = 0.0085). No influence on outcome was found for other variables except for prior AIDS and bone marrow involvement. HAART has significantly improved the survival and EFS in patients with ARL, independently of chemotherapy regimen.

[Completeness of ICU activity reports sent to French healthcare authorities]. / Exhaustivité des résumés d'unité médicale adressés aux départements d'information médicale.

INTRODUCTION: Hospital units report on their inpatient care activity by writing yearly activity reports, which are used by their Medical Information Department (MID) to develop standardized summaries for communication to healthcare authorities. The data are categorized by uniform patient groups and used to describe inpatient care activity and to guide resource allocation. The objective of this study was to evaluate the completeness of activity reports from intensive care units (ICUs) in France. METHODS: Activity reports sent in 1998 and 1999 by French ICUs participating in the study were collected using dedicated abstracting software supplied to the relevant MIDs. Completeness of data in the activity reports was evaluated, with special attention to the SAPSII score, Omega rating of ICU procedures according to the Classification of Medical Procedures, and primary and secondary diagnoses. RESULTS: The 106 ICUs that volunteered for the study reported data on 107,652-hospital stays. Mean age and SAPSII were 55 +/- 21 years and 35 +/- 21 years, respectively. Mean ICU and hospital lengths of stay were 6.2 +/- 12.4 and 16.1 +/- 21.6 days, respectively. Mean ICU and hospital mortality rates were 15% and 19%. The SAPSII and Omega procedures were reported for 81% and 80% of stays, respectively. The SAPSII and Omega procedures were calculated or coded in 94% (100/106) and 96% (102/106) of ICUs, respectively. Mean number of Omega procedures was 4.3+/-3.9. However, only 5% (5/106) of ICUs entered the SAPSII for every stay, and 21% (22/106) of ICUs failed to enter the SAPSII for over 20% of stays. Similarly, 53% (56/106) of ICUs rated no more than five Omega procedures on average per stay. The primary diagnosis was reported for all stays, and the mean number of secondary diagnoses was 3.5 +/- 3.8. In 80% (86/106) of ICUs, no more than five secondary diagnoses were coded on average per stay. CONCLUSION: The analysis of this national database shows that data communicated to the MIDs and therefore to the healthcare authorities, are incomplete regarding SAPSII, ICU procedures, treatment intensity, and diagnoses. This may lead to the underestimation of ICU activity and resource needs, particularly if the SAPSII and selected procedures identified as markers for high-intensity critical care are used in the future.

Does the presentation of audiometric test data have a positive effect on the perceptions of workplace noise and noise exposure avoidance?

Research and 'common knowledge' has for many years accepted that education and feedback supplied to individuals during and immediately after workplace health assessments provides valuable information to workers about their health. Further, if more relevant and detailed information could be supplied then awareness and preventative action may increase proportionately. This research carried out with a rural Australian population has shown that preventative action did not increase in proportion to a corresponding increase in the amount and variety of information provided in connection with hearing health status. Two research groups underwent hearing tests, both with pure tone audiometry (PTA) while the second group also underwent otoacoustic emission (OAE) testing. Test results were presented to the subjects at the conclusion of their test session. An analysis of questionnaire responses at six week and twelve months follow up showed that more information did not result in increased preventative action. Barriers seem to exist such that individuals feel that they are not able to effectively act to reduce overall noise exposure. While self-efficacy initially increased, it declined to close to its initial value over the longer period. Other measures such as perceived susceptibility to hearing loss and the benefits of exposure reduction significantly increased and remained at the same increased level after twelve months. So, while overall awareness of noise and the risks of exposure were increased after both types of hearing test there was no increased hearing health benefit due to additional testing and hearing information.

Surgical resection plus chemotherapy versus chemotherapy alone: comparison of two strategies to treat diffuse large B-cell gastric lymphoma.

BACKGROUND: The usefulness of chemotherapy to treat gastric diffuse large B-cell lymphomas (DLBCL) is well known. Whether or not chemotherapy should be performed as the only treatment or after surgical resection is debated. The aim of this study was to compare two strategies: surgical resection plus chemotherapy versus chemotherapy alone. PATIENTS AND METHODS: Between January 1988 and December 1996, 58 patients included in the trials promoted by the Groupe d'Etude des Lymphomes de l'Adulte (GELA) (LNH-87 and LNH-93) received chemotherapy and 48 included in the protocol of the Groupe d'Etude des Lymphomes Digestifs (GELD) underwent surgical resection followed by chemotherapy. They all presented with localized DLBCL (stage IE and IIE according to the Ann Arbor classification). From the GELA group, seven patients received additional radiotherapy. Gastrectomy was total in 27 of the 48 patients in the GELD group. In both groups chemotherapy included anthracyclin and alkylating agents. Chemotherapy was more intensive in the GELA group than in the GELD group. RESULTS: In the GELA and the GELD groups, distribution according to sex ratio, age (>60 or < or = 60 years), ECOG performance status (> or = 2 or <2) and staging (IE or IIE) was similar. Univariate analysis comparing prognostic factors in both groups showed significant differences: serum lactate dehydrogenase level above normal (28.6% versus 2.4%, P = 0.001), tumor size >10 cm (28.6% versus 12.5%, P = 0.04), patients with International Prognostic Index (IPI) >1 (21.4% versus 11.1%, P = 0.168) and 5-year survival (79% versus 90%, P = 0.03). Multivariate analysis of prognostic factors with a Cox model showed that IPI was the only independent prognostic factor (odds ratio 3, P = 0.03). Consequently, patients with IPI 0-1 were selected for comparison between the GELA group (44 patients) and the GELD group (40 patients). There was no significant difference between the two groups. Median follow-up was 59 months (range 3-128). Estimates of 5-year survival rates and event-free survival rates were 90.5% versus 91.1% (P = 0.303) and 85.9% versus 91.6% (P = 0.187), respectively. In the GELA group, seven of 44 patients died: five from a lymphoma-unrelated cause and two from tumor progression. In the GELD group, four of 40 patients died: two of unrelated causes and two from tumor progression. CONCLUSIONS: This study shows that in localized gastric DLBCL with IPI 0-1, a similar 5-year survival rate (>90%) is to be expected with either surgery plus chemotherapy or chemotherapy alone.

Adult lymphoblastic lymphoma: a retrospective analysis of 92 patients under 61 years included in the LNH87/93 trials.

Since 1987, the GELA has initiated multicenter prospective trials for aggressive non-Hodgkin's lymphomas (NHL). Lymphoblastic lymphomas (LBL) were included in those studies until 1997, and 92 LBL patients under 61 years were identified after histological review. The protocols prescribed high-dose anthracycline regimens, four cycles given every 15 days as induction and lasted for

[Medical characteristics of patients in long-term care facilities and predictions on the weight of their management]. / Caractéristiques médicales des patients en unités de soins de longue durée et prédictions de la lourdeur de la prise en charge.

The objective of this study was to highlight the heterogeneous nature of the medical profiles of patients living in long term care units (LCU) and to present the morbidity factors associated with-the weight and burden of ensuring long term medical care and treatment. Typology analysis, performed on a group of 600 LCU patients, highlights two types of patients: one who is characterised by having few or no serious diseases, and the other (representing nearly one-third of the sample population) corresponding to patients with serious poly-pathologies and requiring a high level of medical attention and nursing care. Factors associated with a higher level of care are diseases such as those related to cardiac or respiratory deficiencies. This predictive model for the burden of care could be used to measure the suitability between the state of the patients and the their optimum structures for care.

Model-based methodology for analyzing incomplete quality-of-life data and integrating them into the Q-TWiST framework.

BACKGROUND: The standard Q-TWiST approach defines a series of health states and weights each state's duration according to its quality of life (QOL) to calculate quality-adjusted lifetimes. However, a fixed weight may not adequately reflect time variations in QOL. METHODS: To account for measurements derived from irregular visits and informative missing data, the authors estimated the mean QOL profile using a mixed-effect growth curve model for the response, combined with a logistic regression model for the drop-out process. RESULTS: Using data from a clinical study of lymphoma patients, the authors demonstrated better readaptation to normal life for patients younger than 30. Sensitivity analyses and computer simulations demonstrated that modeling the drop-out probability as a function of the QOL measurements is necessary if conditioning by health state is not possible. CONCLUSION: Our model-based approach is useful to analyze studies with incomplete QOL data, especially when approximate QOL assessment by health state is not possible.

p53 gene mutations are associated with poor survival in low and low-intermediate risk diffuse large B-cell lymphomas.

BACKGROUND: p53 alterations have been associated with a poor prognosis in aggressive B-cell lymphoma. We investigated the clinical relevance of p53 status in diffuse large B-cell lymphoma (DLBCL), focusing on patients who belong to lower risk groups of the international prognostic index and were uniformly treated. We aimed to determine whether this biological marker could identify among such patients those with a pejorative outcome who could benefit from a distinct therapeutic approach. PATIENTS AND METHODS: We studied 69 patients presenting with no, one (low-risk, n = 40) or two (low-intermediate risk, n = 29) risk factors treated with an anthracyclin-containing induction regimen. p53 exons 5-8 mutations were screened for using denaturing gradient gel electrophoresis and confirmed by direct sequencing. Immunohistochemical detection of p53 protein and of its downstream target p21 were also evaluated in 60 of 69 cases. RESULTS: p53 mutations were detected in 16 of 69 (23%) lymphoma samples. The presence of a p53 gene mutation affected survival (P = 0.01), with a 6-year survival rate estimated to be 44% in mutated patients, compared with 79% in non-mutated ones. Using a stepwise Cox model, p53 mutation constituted the only parameter affecting survival (relative risk = 2.7, P = 0.03). A p53+/p21- immunohistochemical pattern (n = 15), suggestive of a disrupted p53 function, strongly correlated with p53 gene status and was associated with a lower 6-year survival rate when compared with a p53(-) or p53+/p21+ phenotype (47% versus 74%, P = 0.05). CONCLUSIONS: p53 alterations constitute a pejorative biological indicator able to discriminate among clinically defined lower risk patients with DLBCL.

[Quality of medical database to valorize the DRG model by ISA cost indicators]. / Qualité du recueil PMSI pour la valorisation par points ISA du modèle GHM.

BACKGROUND: The use of the French version of the DRG model is focused on cost allocation, based on the case-mix system and the use a weight called ISA (Synthetic Index of Activity) for each DRG. However, this administrative database is becoming more and more used by both researchers and health policy makers for health planning and benchmarking. In France, data abstraction and coding of medical records is done by physicians. The objective of this study was to determine the accuracy of a database of the discharge summaries used for DRGs and to compare consequences of inappropriate coding on budget estimation and risk adjustment. METHODS: Samples of discharge summaries from six cardiology units were recoded by trained physicians in data abstracting and coding. Comparison between initial and recoded diagnoses (errors on main diagnosis or on comorbidities) used by the DRG system algorithm, and the original and final case-mix were performed. The before and after abstracted data were stratified and compared by principal diagnosis (myocardial infarction or congestive heart failure) and discharge status (dead or alive). MAIN RESULTS: Comorbidities were underreported by physicians of cardiology units compared to reabstracted data (mean number of secondary diagnoses per summary: 2.1 vs. 3.6, p<0.001), especially those which had a minimal impact on the DRG classification. In spite of a 15% rate of wrong DRGs, there was no significant difference in the total amount of ISA after data reviewing. Underreporting of comorbidities is more important for medical records of dead patients at discharge but, without significant effect on rate of change in DRG and amount of ISA. CONCLUSION: Discharge summaries used in the French DRGs system consistently underestimate the presence of comorbid conditions, which has direct implications for policy-makers comparing performance between hospital units. Both clinical practitioners and policy makers should be aware of this bias when assessing patient's quality of care or performing health planning through discharge summaries.

Human immunodeficiency virus-related lymphoma: relation between clinical features and histologic subtypes.

PURPOSE: Non-Hodgkin's lymphoma occurs frequently in patients with human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS). We determined the association between the clinical and histologic features of HIV-related lymphoma. SUBJECTS AND METHODS: We reviewed the medical records of 291 patients with noncerebral HIV-related lymphoma who had been treated in multicenter trials coordinated by the Groupe d'Etude des Lymphomes de l'Adulte between 1988 and 1997. This study was performed mainly before the availability of combination antiretroviral therapy. RESULTS: The main histologic subtypes were centroblastic lymphoma in 131 patients (45%), immunoblastic lymphoma in 39 patients (13%), and Burkitt's lymphoma (including the classical form and the variant with plasmacytic differentiation) in 115 patients (40%). Burkitt's lymphoma was the most aggressive form, whereas immunoblastic lymphoma occurred in severely immunodeficient patients. Two-year survival after enrollment was 15% in immunoblastic lymphoma, 32% in Burkitt's lymphoma, and 31% in centroblastic lymphoma (P = 0.006), but multivariate analysis did not confirm the independent prognostic value of histologic subtype. Instead, five independent pretreatment factors increased the risk of mortality: age 40 years or older [relative risk (RR) = 1.5; 95% confidence interval (CI), 1.1 to 2.1; P = 0.005], elevated serum lactate dehydrogenase level (RR = 1.5; 95% CI, 1.1 to 2.1; P = 0.02), having a diagnosis of AIDS before lymphoma (RR = 1.8; 95% CI, 1.2 to 2.6; P = 0.006), CD4(+) cell count less than 100 x 10(6)/L (RR = 1.8; 95% CI, 1.3 to 2.6; P = 0.0004), and impaired performance status (RR = 2.4; 95% CI, 1.7 to 3.4; P <0.0001). CONCLUSION: Several pretreatment characteristics of HIV-related lymphoma were linked to the histologic form, but HIV disease parameters other than those of lymphoma were the main determinants of outcome, so the histologic features of the lymphoma were not associated with prognosis.

Advanced Hodgkin disease with large mediastinal involvement can be treated with eight cycles of chemotherapy alone after a major response to six cycles of chemotherapy: a study of 82 patients from the Groupes d'Etudes des Lymphomes de l'Adulte H89 trial.

BACKGROUND: The prognostic impact of large mediastinal involvement (mediastinum/thorax [M/T] ratio > 0.33) in advanced Hodgkin disease (HD) and the optimal treatment with chemotherapy or combined treatment remains controversial. METHODS: Among 533 assessable patients with Ann Arbor Stage IIIB/IV HD included in the H89 trial, 82 had large mediastinal mass defined on chest X-ray. All patients received induction with six cycles of chemotherapy (mechlorethamine, vincristine, procarbazine, prednisone-doxorubicin, bleomycin, vinblastine or doxorubicin, vinblastine, bleomycin, procarbazine, prednisone); then complete and good partial responders were randomized between two consolidation treatments: 2 cycles of the same chemotherapy or (sub)total lymph node irradiation. RESULTS: Among 82 patients with an M/T ratio greater than 0.33, 48 were very large (ratio > 0.45). A large mediastinal mass was associated with supradiaphragmatic disease, younger age, histologic nodular sclerosis, and different sex ratio compared with other H89 trial patients. Biologic parameters and prognostic factors were similar for both groups. Although the major response rate to induction chemotherapy (after 6 cycles) was lower for patients with large mediastinal mass (78% vs. 86%), the 5-year overall survival rate (80% vs. 79%) and event free survival rate (59% vs. 61%) were similar (P = 0.64 and 0.3, respectively). The outcome was the same for patients (74%) with a large mediastinal mass randomized to 1 of the 2 consolidation arms. Analysis of progression showed that 68% (21 of 31) of failures occurred early during treatment and involved the mediastinum in 86% of the cases. CONCLUSIONS: For patients with large mediastinal mass and advanced HD who achieved a major response of at least 75% after 6 cycles of chemotherapy, a consolidation radiation therapy can be replaced by 2 additional cycles of chemotherapy.

A UMLS-based knowledge acquisition tool for rule-based clinical decision support system development.

Decision support systems in the medical field have to be easily modified by medical experts themselves. The authors have designed a knowledge acquisition tool to facilitate the creation and maintenance of a knowledge base by the domain expert and its sharing and reuse by other institutions. The Unified Medical Language System (UMLS) contains the domain entities and constitutes the relations repository from which the expert builds, through a specific browser, the explicit domain ontology. The expert is then guided in creating the knowledge base according to the pre-established domain ontology and condition-action rule templates that are well adapted to several clinical decision-making processes. Corresponding medical logic modules are eventually generated. The application of this knowledge acquisition tool to the construction of a decision support system in blood transfusion demonstrates the value of such a pragmatic methodology for the design of rule-based clinical systems that rely on the highly progressive knowledge embedded in hospital information systems.

Mediastinal lymphoma: quantitative changes in gadolinium enhancement at MR imaging after treatment.

PURPOSE: To compare changes in gadolinium enhancement at magnetic resonance (MR) imaging with outcome in mediastinal lymphoma after treatment. MATERIALS AND METHODS: Thirty-one patients with bulky mediastinal lymphoma (17 with Hodgkin disease, 14 with non-Hodgkin lymphoma) underwent serial MR imaging before and up to 50 months after treatment, with routine follow-up (including computed tomography). Signal intensity ratios between masses and muscle were calculated on T1-weighted, T2-weighted, and contrast material-enhanced T1-weighted spin-echo MR images. The percentage enhancement and signal intensity ratios of mediastinal masses on T2-weighted MR images were calculated at diagnosis and during and after treatment. RESULTS: Twenty-one patients with persistent complete remission had a mean percentage enhancement of residual masses (4%; range, -26% to 40%) that was significantly lower than that of initial masses (78%; range, 41%-124%). Although the mean signal intensity ratio of residual masses on T2-weighted images was significantly lower than that of initial masses, an increase in this ratio was observed in four patients after treatment. In seven patients with relapse, the percentage enhancement value of the residual mass was as high as that of the initial mass. CONCLUSION: Gadolinium enhancement of lymphomatous masses of the mediastinum decreased markedly after treatment in patients in continuous complete remission but not in patients with relapse.

Noninvasive versus conventional mechanical ventilation. An epidemiologic survey.

A prospective survey was performed over a period of 3 wk among 42 intensive care units to assess the incidence of use and effectiveness of noninvasive mechanical ventilation (NIV) in clinical practice. All patients requiring ventilatory support for acute respiratory failure (ARF), either with endotracheal intubation (ETI) or NIV, were included. Ventilatory support was required in 689 patients, 581 with ETI and 108 (16%) with NIV (35% of patients not intubated on admission). Reasons for mechanical ventilation were coma (30%), cardiogenic pulmonary edema (7%), and hypoxemic (48%) and hypercapnic ARF (15%). NIV was never used for patients in coma (who were excluded from further analysis), but was used in 14% of patients with hypoxemic ARF, in 27% of those with pulmonary edema, and in 50% of those with hypercapnic ARF. NIV was followed by ETI in 40% of cases. The incidence of both nosocomial pneumonia (10% versus 19%, p = 0.03), and mortality (22% versus 41%, p < 0.001) was lower in NIV patients than in those with ETI. After adjusting for differences at baseline, Simplified Acute Physiology Score (SAPS) II (odds ratio [OR] = 1.05 per point; confidence interval [CI]: 1.04 to 1.06), McCabe/Jackson score (OR = 2.18; CI: 1.57 to 3.03), and hypoxemic ARF (OR = 2.30; CI: 1.33 to 4.01) were identified as risk factors explaining mortality; success of NIV was associated with a lower risk of pneumonia (OR = 0.06; CI: 0.01 to 0.45) and of death (OR = 0.16; CI: 0.05 to 0.54). In NIV patients, SAPS II and a poor clinical tolerance predicted secondary ETI. Failure of NIV was associated with a longer length of stay. In conclusion, NIV can be successful in selected patients, and is associated with a lower risk of pneumonia and death than is ETI.

Outcome is not improved by the use of alternating chemotherapy in elderly patients with aggressive lymphoma.

INTRODUCTION: A prospective randomised study involving 810 elderly patients was conducted in an attempt to compare alternating chemotherapy with conventional first-line chemotherapy in aggressive non-Hodgkin's lymphoma in order to improve prognosis with an acceptable toxicity for elderly patients. PATIENTS AND METHODS: Patients included were 55-69 years old and had at least one adverse prognostic factor. Patients were treated either with ACVBP followed by consolidation (n = 396) or with an alternating regimen (n = 414). This regimen was an association of active drugs in NHL relapsing patients, alternating VIMMM with ACVBP for induction and alternation of VIM and ACVM in consolidation. Eight hundred and sixty-six patients were randomised. After histological review, 810 patients met the inclusion criteria: 396 in arm A, 414 in arm B. RESULTS: The complete response rate after induction was superior for conventional first-line therapy (58.5% vs 48%, P = 0.003) but at the end of treatment, the CR rate was not statistically different (52% vs 48%, P = 0.19). Conventional chemotherapy had a better five-year event-free survival than alternating regimen (33% (95% CI: 30-36%) vs 28% (95% CI: 26-30%), P = 0.0289) but overall survival was not statistically different (40% (CI 95% 38-42%) vs 36% (CI 95% 34-38%), P = 0.068). In this elderly high risk population, the toxicity was very high: 19% in arm A and 26% in arm B died during treatment. CONCLUSION: Alternating regimen did not improve outcome, was less efficient and more toxic.

Assessing the Cox model assumption as a statistical tool for classifying lymphomas.

INTRODUCTION: The Cox model is widely used in medical research for comparing survival. Lymphomas might exhibit important differences in long-term cure rate despite a similar survival. METHODS: Using log-rank test, we compared event-free survival (EFS), and the survival of 64 patients with mantle cell lymphoma (MCL), 525 patients with follicular lymphoma, and 1136 patients with diffuse centroblastic lymphoma (CB). RESULTS: Although EFS and survival of MCL were significantly shorter than those of follicular lymphoma, checking the validity of the proportional hazards assumption shows that the distribution of rates of events and deaths over time did not differ in MCL and follicular lymphoma. In contrast, the ratios of hazards (events and deaths rates) did not remain constant over time in MCL and CB, because of a decrease in late events and deaths rates in the latter histological type. CONCLUSION: Checking the validity of the Cox model hypothesis might be a useful tool for assessing long-term cure rate in seldom lymphoma subtypes. Despite a short overall survival, MCL should not be considered to be an aggressive lymphoma, in which available chemotherapy may cure a subset of patients.

Tandem autotransplant as first-line consolidative treatment in poor-risk aggressive lymphoma: a pilot study of 36 patients.

PURPOSE: In the previous LNH87-2 study, consolidative high-dose therapy followed by stem cell transplantation (HDT) improved disease-free survival, as well as survival for patients (pts) presenting with two or three factors of the age-adjusted international prognostic index (Aa-IPI) in first complete remission (CR). In order to improve further the outcome of such patients, we conducted a pilot study of consolidative tandem autotranplant. PATIENTS AND METHODS: Thirty-six patients (pts) under 60 years of age with two or three factors of the Aa-IPI were enrolled. Their main characteristics were: diffuse large B-cell lymphoma (83%), Aa-IPI three factors (50%), and marrow involved (36)%. The procedure consisted of 1) induction with four cycles of ACVBP (doxorubicin, cyclophosphamide, vindesine, bleomycin, prednisone) 2) in responding pts, peripheral blood stem cell (PBSC) collection after the fourth cycle of ACVBP (11 pts) or after an additional mobilization regimen (Cyclophosphamide-VP16) (17 pts) 3) a first HDT (mitoxantrone, cyclophosphamide, VP16 and carmustine) followed by PBSC infusion 4) a second HDT (busulfan, carboplatin and melphalan) followed by PBSC infusion. Among the 29 patients responding to induction, 28 received the first HDTand 24 the second. RESULTS: The rates of three-year-event free survival and survival are 47% (95% confidence interval (95% CI: 31%-63%) and 50% (95% CI: 37%-69%), respectively. Eighteen patients remained free of evolutive disease and 18 patients have died, 15 from disease progression and three from treatment-related toxicity after tandem transplant (two veno-occlusive disease and one cerebral toxoplasmosis). CONCLUSION: We conclude that tandem transplant did not improve the results of the LNH87-2 study in which patients received a single consolidative HDT.