scholarly journals No Efficacy of the Combination of Lopinavir/Ritonavir Plus Hydroxychloroquine Versus Standard of Care in Patients Hospitalized With COVID-19: A Non-Randomized Comparison

2021 ◽  
Vol 12 ◽  
Author(s):  
Roberta Gagliardini ◽  
Alessandro Cozzi-Lepri ◽  
Andrea Mariano ◽  
Fabrizio Taglietti ◽  
Alessandra Vergori ◽  
...  
Keyword(s):  
Cox Regression ◽  
Specific Treatment ◽  
Standard Of Care ◽  
Arterial Oxygen ◽  
Cumulative Probability ◽  
Invasive Ventilation ◽  
Positive Serology ◽  
Inverse Probability Weights ◽  
Viral Shedding ◽  
Single Use

Objectives: No specific treatment has been approved for COVID-19. Lopinavir/ritonavir (LPV/r) and hydroxychloroquine (HCQ) have been used with poor results, and a trial showed advantages of combined antiviral therapy vs. single antivirals. The aim of the study was to assess the effectiveness of the combination of antivirals (LPV/r and HCQ) or their single use in COVID-19 hospitalized patients vs. standard of care (SoC).Methods: Patients ≥18 years with SARS-CoV-2 infection, defined as positive RT-PCR from nasal/oropharyngeal (NP/OP) swab or positive serology, admitted at L. Spallanzani Institute (Italy) were included.Primary endpoint: time to invasive ventilation/death. Secondary endpoint: time to two consecutive negative SARS-CoV-2 PCRs in NP/OP swabs. In order to control for measured confounders, a marginal Cox regression model with inverse probability weights was used.Results: A total of 590 patients were included in the analysis: 36.3% female, 64 years (IQR 51–76), and 91% with pneumonia. Cumulative probability of invasive ventilation/death at 14 days was 21.2% (95% CI 17.6, 24.7), without difference between SOC, LPV/r, hydroxychloroquine, HCQ + LPV/r, and SoC. The risk of invasive ventilation/death in the groups appeared to vary by baseline ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2). Overall cumulative probability of confirmed negative nasopharyngeal swabs at 14 days was 44.4% (95% CI 38.9, 49.9), without difference between groups.Conclusion: In this retrospective analysis, we found no difference in the rate of invasive ventilation/death or viral shedding by different strategies, as in randomized trials performed to date. Moreover, even the combination HCQ + LPV/r did not show advantages vs. SoC.

scholarly journals Attenuation of COVID-19-induced cytokine storm in a young male patient with severe respiratory and neurological symptoms

2021 ◽  
Author(s):  
Christian Muschitz ◽  
Anita Trummert ◽  
Theresa Berent ◽  
Norbert Laimer ◽  
Lukas Knoblich ◽  
...  
Keyword(s):  
Decision Making ◽  
Male Patient ◽  
Young Male ◽  
Standard Of Care ◽  
Multiple Organ ◽  
Cytokine Storm ◽  
Invasive Ventilation ◽  
Organ Systems ◽  
The Central Nervous System

SummarySevere acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), the etiological agent of coronavirus disease 2019 (COVID-19), produces protean manifestations and causes indiscriminate havoc in multiple organ systems. This rapid and vast production of proinflammatory cytokines contributes to a condition termed cytokine storm. A 35-year-old, otherwise healthy, employed, male patient was tested positive for COVID-19. He was admitted to the hospital on disease day 10 due to retarded verbal reactions and progressive delirium. On account of these conditions and the need for noninvasive/invasive ventilation, a combination treatment with baricitinib and remdesivir in conjunction with standard of care was initiated. The cytokine storm was rapidly blocked, leading to a vast pulmonary recovery with retarded recovery of the central nervous system. We conclude that the rapid blockade of the COVID-19-induced cytokine storm should be considered of avail as a principle of careful decision-making for effective recovery.

scholarly journals A novel predictor of clinical progression in patients on active surveillance for prostate cancer

2019 ◽  
Vol 13 (8) ◽  
Author(s):  
Guan Hee Tan ◽  
Antonio Finelli ◽  
Ardalan Ahmad ◽  
Marian Wettstein ◽  
Alexandre Zlotta ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Cox Regression ◽  
Area Under The Curve ◽  
Progression Free Survival ◽  
Roc Curves ◽  
Standard Of Care ◽  
Low Risk ◽  
Clinical Progression

Introduction: Active surveillance (AS) is standard of care in low-risk prostate cancer (PC). This study describes a novel total cancer location (TCLo) density metric and aims to determine its performance in predicting clinical progression (CP) and grade progression (GP).     Methods: This was a retrospective study of patients on AS after confirmatory biopsy (CBx). We excluded patients with Gleason ≥7 at CBx and <2 years follow-up. TCLo was the number of locations with positive cores at diagnosis (DBx) and CBx. TCLo density was TCLo / prostate volume (PV). CP was progression to any active treatment while GP occurred if Gleason ≥7 was identified on repeat biopsy or surgical pathology. Independent predictors of time to CP or GP were estimated with Cox regression. Kaplan-Meier analysis compared progression-free survival curves between TCLo density groups. Test characteristics of TCLo were explored with receiver operating characteristic (ROC) curves.     Results: We included 181 patients who had CBx between 2012-2015, and met inclusion criteria. The mean age of patients was 62.58 years (SD=7.13) and median follow-up was 60.9 months (IQR=23.4). A high TCLo density score (>0.05) was independently associated with time to CP (HR 4.70, 95% CI: 2.62-8.42, p<0.001), and GP (HR 3.85, 95% CI: 1.91-7.73, p<0.001). ROC curves showed TCLo density has greater area under the curve than number of positive cores at CBx in predicting progression.     Conclusion: TCLo density is able to stratify patients on AS for risk of CP and GP. With further validation, it could be added to the decision-making algorithm in AS for low-risk localized PC.

scholarly journals Clinical Management of Hypertension, Inflammation and Thrombosis in Hospitalized COVID-19 Patients: Impact on Survival and Concerns

2021 ◽  
Vol 10 (5) ◽  
pp. 1073
Author(s):  
Patricia Martínez-Botía ◽  
Ángel Bernardo ◽  
Andrea Acebes-Huerta ◽  
Alberto Caro ◽  
Blanca Leoz ◽  
...  
Keyword(s):  
Arterial Hypertension ◽  
Clinical Management ◽  
Cox Regression ◽  
Angiotensin Receptor Blockers ◽  
Treatment Options ◽  
Clinical Manifestations ◽  
Specific Treatment ◽  
Hospitalized Patients ◽  
Thrombosis Prophylaxis ◽  
The Impact

The most severe clinical manifestations of the Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), are due to an unbalanced immune response and a pro-thrombotic hemostatic disturbance, with arterial hypertension or diabetes as acknowledged risk factors. While waiting for a specific treatment, the clinical management of hospitalized patients is still a matter of debate, and the effectiveness of treatments to manage clinical manifestations and comorbidities has been questioned. In this study, we aim to assess the impact of the clinical management of arterial hypertension, inflammation and thrombosis on the survival of COVID-19 patients. The Spanish cohorts included in this observational retrospective study are from HM Hospitales (2035 patients) and from Hospital Universitario Central de Asturias (72 patients). Kaplan Meier survival curves, Cox regression and propensity score matching analyses were employed, considering demographic variables, comorbidities and treatment arms (when opportune) as covariates. The management of arterial hypertension with angiotensin-converting enzyme 2 (ACE2) inhibitors or angiotensin receptor blockers is not detrimental, as was initially reported, and neither was the use of non-steroidal anti-inflammatory drugs (NSAIDs). On the contrary, our analysis shows that the use on itself of corticosteroids is not beneficial. Importantly, the management of COVID-19 patients with low molecular weight heparin (LMWH) as an anticoagulant significantly improves the survival of hospitalized patients. These results delineate the current treatment options under debate, supporting the effectiveness of thrombosis prophylaxis on COVID-19 patients as a first-line treatment without the need for compromising the treatment of comorbidities, while suggesting cautiousness when administering corticosteroids.

scholarly journals Assessment of Outcome Predictors after First Attack of Optic Neuritis

2011 ◽  
Vol 38 (6) ◽  
pp. 887-895 ◽  
Author(s):  
Mansoureh Mamarabadi ◽  
Hadie Razjouyan ◽  
Fatemeh Mohammadi ◽  
Mehdi Moghaddasi
Keyword(s):  
Risk Factors ◽  
Optic Neuritis ◽  
Corticosteroid Therapy ◽  
Cox Regression ◽  
Female Gender ◽  
Cumulative Probability ◽  
High Dose ◽  
Risk Of Progression ◽  
Dose Corticosteroid ◽  
Iranian Patients

Background:Optic Neuritis (ON) is one of the most common clinically isolated syndromes which develops into clinically diagnosed Multiple Sclerosis (CDMS) over time.Objective:To assess the conversion rate of Iranian patients presenting with idiopathic ON to CDMS as well as monitoring potential demographic and clinical risk factors.Methods:Atotal of 219 patients' medical records of idiopathic ON from March 2001 to May 2009 were reviewed. Demographic findings, ophthalmologic characteristics on admission and discharge, diagnostic approaches, type and dosage of therapy were retrospectively reviewed. A structured telephone interview was then conducted to identify patients who had subsequently been diagnosed with MS. Survival analysis was used to evaluate the cumulative probability of MS conversion and contributory risk factors.Results:From the 219 ON patients, 109 [age 11-51, female: 81%] were followed up. Among the male gender the mean age of patients developing MS was significantly lower (P=0.01). In cox regression model, female sex (p=0.07), bilateral ON (p=0.003), MRI abnormalities (p <0.001) and high dose (5g) corticosteroid therapy (p<0.001) were identified as risk factors for the development of MS. The two and five year cumulative probability of developing MS were 27% and 45%, respectively.Conclusions:Idiopathic ON in Iranian patients carries higher risk of progression to MS compared to other Asian countries. MRI lesions are the strongest independent risk factor of developing CDMS. Bilateral ON, female gender and high dose corticosteroid therapy are also important factors in predicting CDMS development.

scholarly journals Evaluation of independent predictors of in-hospital mortality in patients with severe trauma

2019 ◽  
Vol 147 (7-8) ◽  
pp. 455-460
Author(s):  
Marija Milenkovic ◽  
Zaneta Terzioski ◽  
Adi Hadzibegovic ◽  
Jovana Stanisavljevic ◽  
Ksenija Petrovic ◽  
...  
Keyword(s):  
Hospital Mortality ◽  
Cox Regression ◽  
Arterial Oxygen Saturation ◽  
Area Under The Curve ◽  
Case Fatality ◽  
Scoring Systems ◽  
Severe Trauma ◽  
Arterial Oxygen ◽  
Emergency Center ◽  
Cox Regression Analysis

Introduction/Objective. The aim of this study was to determine independent predictors and the best trauma scoring system (REMS, RTS, GSC, SOFA, APPACHE II) of in-hospital mortality in patients with severe trauma at the Department of Emergency, Emergency Center, Clinical Center of Serbia, Belgrade. Methods. Longitudinal study included 208 consecutive patients with severe trauma. In order to determine independent survival contributors, univariate and multivariate Cox regression analyses were performed. The power of above-mentioned scoring systems (measured at admission to the Emergency center) to predict mortality was compared using the area under the curve (AUC). Results. There were 208 patients (159 male, 49 female), with the average age of 47.3 ? 20.7 years. Majority of patients were initially intubated (86.1%) on admission to the emergency department, and 59.6% patients were sedated before intubation. After finishing of diagnostic procedures, 17 patients were additionally intubated, and, at that time, 94.2% patients were on mechanic ventilation. The majority of patients was traumatized in a car crash (33.2%), followed by falls from height (26.4%) and as pedestrians (22.6%). Patients had an average of 24.7 ? 21.2 days spent in intensive care unit. The overall case-fatality ratio was 17/208 (8.2%). In Cox regression analysis only elevated heart rate (HR = 1.03, p = 0.012) and decreased arterial oxygen saturation (SpO2) (HR = 0.91, p = 0.033) singled out as independent contributors to in-hospital mortality of patients with severe trauma. REMS (AUC 0.72 ? 0.64) and SOFA (AUC 0.716 ? 0.067) scores were found fair and similar predictor of in-hospital mortality, while APACHE II (AUC 0.614 ? 0.062) and RTS (0.396 ? 0.068) were poor predictors. Conclusion. Results of this study showed an important role of REMS, which appears to provide balance between the predictive ability and the practical application, and components of REMS in prediction of outcome in patients with severe trauma and that HR and SpO2 are independent predictors of in-hospital mortality.

Fecundity among women with polycystic ovary syndrome (PCOS)—a population-based study

2019 ◽  
Vol 34 (10) ◽  
pp. 2052-2060 ◽  
Author(s):  
S Persson ◽  
E Elenis ◽  
S Turkmen ◽  
M S Kramer ◽  
E-L Yong ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Cox Regression ◽  
Polycystic Ovary ◽  
Nordic Country ◽  
Reproductive Potential ◽  
Population Based ◽  
Fertility Treatment ◽  
Cumulative Probability ◽  
Ovary Syndrome ◽  
Population Based Study

Abstract STUDY QUESTION Does the long-term fecundity of women with polycystic ovary syndrome (PCOS) differ from those without PCOS? SUMMARY ANSWER Cumulative probability of childbirth is similar between women with and without PCOS. WHAT IS KNOWN ALREADY PCOS is the main cause of anovulatory infertility in women after menarche. Previous studies indirectly suggest that fecundity in women with PCOS over the longer term may not be lower than in women without PCOS. STUDY DESIGN, SIZE, DURATION This is a population-based study using four linked Swedish national registries. A total of 45 395 women with PCOS and 217 049 non-PCOS women were included. Follow-up began at the age of 18 years and continued for a maximum of 26 years, from 1989 to the end of 2015. Childbirth was the main outcome, as identified from the Medical Birth Register. PARTICIPANTS/MATERIALS, SETTING, METHODS All women born between 1971 and 1997 who were identified with a PCOS diagnosis in the Swedish Patient Registry between 1 January 2001 and 31 December 2016 were included in the study population. Five controls per women with PCOS were randomly drawn from the Total Population Registry. The control women were born in the same year and living in the same municipality as the patient. The fecundity ratio (FR) was calculated by clustered Cox regression using a robust variance, adjusted for maternal birth period, country of birth and level of education. MAIN RESULTS AND THE ROLE OF CHANCE The cumulative probability of childbirth was 80.2% (95% CI, 79.5–80.9%) in women with PCOS and 78.2% (95% CI, 77.9–78.5%) in those without PCOS. Adjusted FR was 0.81 (95% CI, 0.80–0.82) for first childbirth and 0.58 (95% CI, 0.57–0.60) for first childbirth following a spontaneous pregnancy. The FR for second childbirth was 0.79 (95% CI, 0.77–0.80). Women with PCOS had more than one child less frequently than the comparison group. Within the PCOS group, early age at diagnosis, later birth year, Nordic country of origin and low educational level positively influenced the FR. LIMITATIONS, REASONS FOR CAUTION Results are not adjusted for BMI, and time from intention to conceive to first childbirth could not be captured. Data on pregnancies, miscarriages or abortions and fertility treatment are unknown for women who did not give birth during the study period. Women with PCOS who did not seek medical assistance might have been incorrectly classified as not having the disease. Such misclassification would lead to an underestimation of the true association between PCOS and outcomes. WIDER IMPLICATIONS OF THE FINDINGS While cumulative probability of childbirth is similar between groups, women with PCOS need longer time to achieve their first childbirth. Women with PCOS have a lower FR and give birth to fewer children per woman than women without PCOS. Early diagnosis of and information about PCOS may improve affected women’s reproductive potential. STUDY FUNDING/COMPETING INTEREST(S) This study was funded by the Swedish Society of Medicine. Inger Sundström Poromaa has, over the past 3 years, received compensation as a consultant and lecturer for Bayer Schering Pharma, MSD, Gedeon Richter, Peptonics and Lundbeck A/S. The other authors declare no competing interests.

086 The rapid efficacy of natalizumab vs fingolimod in patients with active relapsing-remitting multiple sclerosis (RRMS): results from reveal, a randomised, head-to-head study

2018 ◽  
Vol 89 (6) ◽  
pp. A35.1-A35
Author(s):  
Helmut Butzkueven ◽  
Douglas Jeffery ◽  
Douglas L Arnold ◽  
Massimo Filippi ◽  
Jeroen JG Geurts ◽  
...  
Keyword(s):  
Negative Binomial ◽  
Cox Regression ◽  
Negative Binomial Regression ◽  
Patient Characteristics ◽  
Estimating Equation ◽  
Study Patient ◽  
Cumulative Probability ◽  
Open Label ◽  
Randomised Study ◽  
Kaplan Meier

IntroductionREVEAL was designed as a 1 year, multicentre, randomised, rater- and sponsor-blinded, prospective study comparing natalizumab and fingolimod in patients with active RRMS. Although the study closed early (for non-safety/non-efficacy reasons), data permitted comparison of effects occurring shortly after treatment initiation. This analysis compares onset of efficacy with natalizumab and fingolimod in REVEAL.MethodsPatients were randomised to open-label intravenous natalizumab 300 mg every 4 weeks (n=54) or oral fingolimod 0.5 mg once daily (n=54). Magnetic resonance imaging was scheduled every 4 weeks for the first 24 weeks and at weeks 36 and 52. Analyses included Kaplan-Meier and Cox regression, negative binomial regression (annualised relapse rate [ARR] and number of T1 gadolinium-enhancing [Gd+] lesions) and a negative binomial generalised estimating equation (cumulative Gd +lesions over time).ResultsAs expected for a randomised study, patient characteristics and follow-up time (median 39 weeks) were generally similar between groups. Natalizumab patients were less likely than fingolimod patients to develop new Gd +lesions (for ≥1 lesion, cumulative probability 40.68% vs 57.99%; hazard ratio [HR]=1.678 [95% CI: 0.865 to 3.255]; p=0.1258; for ≥2 lesions, cumulative probability 11.54% vs 48.48%; HR=4.053 [95% CI: 1.474 to 11.144]; p=0.007). Natalizumab patients consistently had 63%–72% fewer Gd +lesions than fingolimod patients, with between-group differences apparent within 4 weeks and reaching significance by 12 weeks (p=0.030). ARR was 83% lower with natalizumab than with fingolimod (0.05 vs 0.29; p=0.023), and cumulative probability of relapse was 1.85% with natalizumab vs 22.28% with fingolimod (HR=12.184 [95% CI: 1.552 to 95.634]; p=0.017). Adverse events were consistent with known safety profiles.ConclusionThese results suggest that natalizumab reduces disease activity more rapidly and to a greater extent than fingolimod in patients with active RRMS. Given the early study closure, available data did not permit primary endpoint evaluation, and interpretation of these results requires caution.Study SupportBiogen.

Impact of thiopurines on the natural history and surgical outcome of ulcerative colitis: a cohort study

Gut ◽  
2018 ◽  
Vol 68 (4) ◽  
pp. 623-632 ◽  
Author(s):  
Carl Eriksson ◽  
Sara Rundquist ◽  
Yang Cao ◽  
Scott Montgomery ◽  
Jonas Halfvarson
Keyword(s):  
Ulcerative Colitis ◽  
Natural History ◽  
Hospital Admission ◽  
Cox Regression ◽  
University Hospital ◽  
Cumulative Probability ◽  
Disease Extent ◽  
Novel Approach ◽  
Beneficial Impact

ObjectiveThiopurines are used as maintenance therapy in ulcerative colitis (UC), but whether these drugs influence the natural history of the disease is unknown. We aimed to assess the effect of thiopurines in terms of colectomy, hospital admission, progression in disease extent and anti-tumour necrosis factor (TNF) therapy within 10 years from initiation.DesignPatients diagnosed with UC within the Örebro University Hospital catchment area, during 1963–2010, who initiated thiopurines (n=253) were included. To overcome the risk of confounding by indication, we compared patients who stopped treatment within 12 months because of an adverse reaction (n=76) with patients who continued therapy or discontinued due to other reasons (n=177) and assessed long-term outcomes using Cox regression with adjustment for potential confounding factors.ResultsThe cumulative probability of colectomy within 10 years was 19.5% in tolerant patients compared with 29.0% in intolerant (adjusted HR 0.49; 95% CI 0.21 to 0.73). The probability of hospital admission was 34.0% in tolerant versus 56.2% in intolerant patients (adjusted HR 0.36; 95% CI 0.23 to 0.56). The risk for progression in disease extent was 20.4% in tolerant patients compared with 48.8% in intolerant (adjusted HR 0.47; 95% CI 0.21 to 1.06). Within 10 years, 16.1% of tolerant and 27.5% of intolerant patients received anti-TNF therapy (adjusted HR 0.49; 95% CI 0.26 to 0.92).ConclusionBased on the novel approach of comparing patients tolerant and intolerant to thiopurines, we reveal that thiopurines have a profound beneficial impact of the natural history and long-term colectomy rates of UC.

scholarly journals Renal Remission Status and Longterm Renal Survival in Patients with Lupus Nephritis: A Retrospective Cohort Analysis

2018 ◽  
Vol 45 (5) ◽  
pp. 671-677 ◽  
Author(s):  
Julie E. Davidson ◽  
Qinggong Fu ◽  
Beulah Ji ◽  
Sapna Rao ◽  
David Roth ◽  
...  
Keyword(s):  
Lupus Nephritis ◽  
Cox Regression ◽  
Cohort Analysis ◽  
Standard Of Care ◽  
Renal Survival ◽  
Endstage Renal Disease ◽  
American College Of Rheumatology ◽  
Remission Status ◽  
Kaplan Meier ◽  
Remission Criteria

Objective.This observational study was a retrospective analysis of prospectively collected Hopkins Lupus Cohort data to compare longterm renal survival in patients with lupus nephritis (LN) who achieved complete (CR), partial (PR), or no remission following standard-of-care LN induction therapy.Methods.Eligible patients with biopsy-proven LN (revised American College of Rheumatology or Systemic Lupus Collaborating Clinics criteria) were identified and categorized into ordinal (CR, PR, or no remission) or binary (response or no response) renal remission categories at 24 months post-diagnosis [modified Aspreva Lupus Management Study (mALMS) and modified Belimumab International Lupus Nephritis Study (mBLISS-LN) criteria]. The primary endpoint was longterm renal survival [without endstage renal disease (ESRD) or death].Results.In total, 176 patients met the inclusion criteria. At Month 24 postbiopsy, more patients met mALMS remission criteria (CR = 59.1%, PR = 30.1%) than mBLISS-LN criteria (CR = 40.9%, PR = 16.5%). During subsequent followup, 18 patients developed ESRD or died. Kaplan–Meier plots suggested patients with no remission at Month 24 were more likely than those with PR or CR to develop the outcome using either mALMS (p = 0.0038) and mBLISS-LN (p = 0.0097) criteria for remission. Based on Cox regression models adjusted for key confounders, those in CR according to the mBLISS-LN (HR 0.254, 95% CI 0.082–0.787; p = 0.0176) and mALMS criteria (HR 0.228, 95% CI 0.063–0.828; p = 0.0246) were significantly less likely to experience ESRD/mortality than those not in remission.Conclusion.Renal remission status at 24 months following LN diagnosis is a significant predictor of longterm renal survival, and a clinically relevant endpoint.

Non-Hodgkin's lymphomas of childhood: an analysis of the histology, staging, and response to treatment of 338 cases at a single institution.

1989 ◽  
Vol 7 (2) ◽  
pp. 186-193 ◽  
Author(s):  
S B Murphy ◽  
D L Fairclough ◽  
R E Hutchison ◽  
C W Berard
Keyword(s):  
Cox Regression ◽  
Specific Treatment ◽  
Stage Iv ◽  
Stage I ◽  
Stage Ii ◽  
Stage Iii ◽  
Response To Treatment ◽  
Clinical Staging ◽  
Prognostic Indicators ◽  
Hodgkin's Lymphomas

Between 1962 and 1986, a total of 338 consecutive newly diagnosed children and adolescents with non-Hodgkin's lymphomas (NHLs) were evaluated and treated at St Jude Children's Research Hospital (SJCRH). Median follow-up is 6.6 years (range, 1.8 to 23 years). The patients ranged in age from 7 months to 21 years (median, 10 years), and 71% were males. All cases were staged (I to IV) by a clinical staging system. Eighteen percent were stage I, 21% stage II, 43% stage III, and 18% stage IV. Cases frankly leukemic at diagnosis (ie, greater than 25% marrow blasts) were excluded from the analysis. Pathologic material from all cases was reviewed and classified according to the Working Formulation. The histologic distribution of cases was as follows: 38.8% diffuse small non-cleaved cell (undifferentiated, Burkitt's and non-Burkitt's); 26.3% diffuse large-cell, mainly immunoblastic; 28.1% lymphoblastic; and 6.8% other. Treatment policy evolved over time to a stage- and histology-specific strategy for treatment assignment, and overall results significantly improved by era from 37% (+/- 5%) 2-year event-free survival (EFS) for patients treated before 1975 to 77% (+/- 4%) since 1978. By univariate and multivariate Cox regression analyses, the era of treatment (hence, the protocol-specific treatment itself), the stage, and the log of the initial serum lactic dehydrogenase (LDH) emerged as the most powerful prognostic indicators, while histology per se was not significantly related to outcome. For the 154 patients treated since 1978, the 2-year EFS by stage was 97% (+/- 3%) for stage I, 86% (+/- 6%) for stage II, 73% (+/- 6%) for stage III, and 47% (+/- 11%) for stage IV (P less than .0001). Compared with our previous experience, we conclude that the cure rate of childhood NHL has doubled in the last decade with modern management.

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