Analysis Of Relapse Rates Research Articles

Analysis of relapse rates and risk factors of tapering or stopping pharmacologic therapies in axial spondyloarthritis patients with sustained remission.

The objectives of this study are to evaluate whether tapering or stopping strategies of pharmacologic therapies are efficacious for maintaining remission in patients with axial spondyloarthritis (axSPA) and to analyze the risk factors of disease relapse. Patients diagnosed as axSPA with ankylosing spondylitis disease activity score based on C reactive protein (ASDAS-CRP) ≤2.0 for at least 3 months were randomized into three groups: continuing non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs) (group 1), tapering NSAIDs and DMARDs by 50% (group 2), or discontinuing NSAIDs and DMARDs (group3) after 6 months of tapering. The primary endpoint of observation was disease relapse or sustained remission till 12 months. One hundred and eight patients were analyzed in this study. All patients fulfilled ASDAS remission criteria at baseline. Other than NSAIDs therapy, 63.0% of the patients received sulfasalazine, 33.3% biological DMARDs, and 19.4% other DMARDs. Overall, 87 patients (80.6%) remained in remission for 12 months, whereas 21 patients (19.4%) relapsed at the end of the study. There were significant differences of relapse rates among three different study groups (group 1, 5.4%; group 2, 13.2%; group 3, 42.7%; p<0.001), while no significant difference was found between group 1 and group 2 (p=0.430). Multivariate logistic regression identified high ASDAS-CRP at baseline (p=0.001) and drug discontinuation (p<0.001) as predictors for relapse. This randomized controlled study demonstrated that tapering NSAIDs and DMARDs by 50% in patients with axSPA in sustained remission is a feasible treatment strategy. Besides, disease relapse may be related with ASDAS-CRP before treatment tapering.

Durable efficacy of cladribine tablets in patients with multiple sclerosis: analysis of relapse rates and relapse-free patients in the CLARITY and CLARITY Extension studies (P6.353)

Durable efficacy of cladribine tablets in patients with multiple sclerosis: analysis of relapse rates and relapse-free patients in the CLARITY and CLARITY Extension studies (P6.353)

An Analysis of Relapse Rates and Predictors of Relapse in 2 Randomized, Placebo-Controlled Trials of Desvenlafaxine for Major Depressive Disorder.

To evaluate relapse rates and predictors of relapse in 2 randomized, placebo-controlled trials of desvenlafaxine for major depressive disorder (MDD). Study 1: week 8 responders to open-label desvenlafaxine 50 mg/d entered a 12-week open-label stability phase. Patients with a continuing, stable response at week 20 were randomly assigned to 6-month, double-blind treatment (desvenlafaxine 50 mg/d or placebo). Study 1 was conducted between June 2009 and March 2011 at 87 sites worldwide. Study 2: week 12 responders to open-label desvenlafaxine 200 or 400 mg/d were randomly assigned to 6-month, double-blind treatment (desvenlafaxine 200 mg/d, 400 mg/d, or placebo). Study 2 was conducted between June 2003 and August 2005 at 49 sites in Europe, the United States, and Taiwan. Relapse was assessed separately by study with log-rank test using protocol definitions of relapse and with 17-item Hamilton Depression Rating Scale (HDRS-17) score ≥ 16 at any time during the double-blind phase. Kaplan-Meier estimates evaluated time to relapse, censoring data at months 1, 2, and 3 and overall; treatments were compared using hazard ratios. Cox proportional hazards models assessed relapse predictors. Overall relapse rates for all definitions were significantly lower for desvenlafaxine versus placebo for both studies (all P ≤ .002). In study 1, rates were significantly lower for desvenlafaxine versus placebo at month 2 (P = .016) and month 3 (P = .007) using the protocol definition. In study 2, relapse rates were significantly lower for desvenlafaxine versus placebo at months 1, 2, and 3 for both definitions (P < .0001-.002). Hazard ratios were similar at months 1, 2, and 3 and overall for both studies (0.382-0.639). Desvenlafaxine 50 to 400 mg/d effectively prevented relapse at 6 months. Desvenlafaxine significantly prevented relapse early (month 1) versus placebo only in study 2. ClinicalTrials.gov identifiers:NCT00887224 and NCT00075257.

Biology and prognosis of 1,685 recently diagnosed HER2-positive breast carcinomas

10501 Background: Understanding biology, prognosis and drug-sensitivity of HER2-positive breast cancer might help optimization of treatment of patients affected by this type of cancer. Most available studies are retrospective and suffer from the low frequency of this tumor subset. Methods: We conducted a large national retrospective/prospective study involving 1685 patients (cases) with HER2-positive (2+, 3+ score) primary breast carcinomas diagnosed in Italy in 2000/2001; for each case, in each participating center, a control was identified as the first consecutive patient with HER2-negative cancer (0, 1+ score). Results: In addition to the already known association with some pathologic parameters such as grade, hormone receptors, and ductal histotype, the four HER2 categories also displayed specific features, for example, a significantly higher frequency of p53-positivity among HER2–2+ tumors than in the other three categories, and a significantly lower frequency of lymphoid infiltration and desmoplasia, accompanied by a higher frequency of vascular invasion, in HER2–1+ as compared to HER2–0 tumors. Neither tumor size nor nodal involvement were associated with HER2 status. With a median follow-up of 4 yrs, the HER2-positive group showed a 20% relapse rate versus 14% in the HER2-negative group (p &lt; 0.001). Analysis of relapse rates in the four HER2 categories indicated that only 3+ tumors show a significantly poorer prognosis, in both node-positive and node-negative subgroups; however, when patients who underwent invasive surgery are considered, the HER2–2+ patients also showed a significantly increased relapse rate as compared to negative cases, consistent with a stimulation of tumor cells by growth factors released at the time of surgery. Analysis of relapse rates according to type of therapy confirms the unresponsiveness to tamoxifen but sensitivity to chemotherapy, in particular taxanes, of HER2-positive tumors. Indeed, HER2-positive tumors were found to have a significantly better prognosis than HER2-negative when treated with taxanes. Conclusions: The present analysis conducted in a very large series of HER2-positive cases suggests innovative findings that can help optimization of treatment strategy for patients with HER2-positive breast cancer. No significant financial relationships to disclose.

Efficacy of venlafaxine and placebo during long-term treatment of depression: a pooled analysis of relapse rates

The objective of this analysis was to determine the efficacy of venlafaxine in comparison with that of placebo during long-term treatment. A pooled analysis of relapse rates in outpatients with major depression continuing long-term treatment (up to 12 months) after responding to short-term treatment (6 weeks) was performed combining the data from four randomized, double-blind, placebo-controlled clinical trials. Relapses were defined as two consecutive Clinical Global Impression (CGI) severity scores greater than 3 (mildly ill), as a CGI severity score greater than 3 at withdrawal regardless of the reason for withdrawal, or as withdrawal due to lack of efficacy. Data from 304 patients (185 venlafaxine, 119 placebo) well balanced for baseline characteristics were included in the pooled analysis. Percentages of patients completing the long-term phase were 38% venlafaxine and 26% placebo (p = 0.034). Cumulative relapse rates by 6 months of long-term treatment were 11% venlafaxine and 23% placebo (p = 0.019). Cumulative relapse curves for the venlafaxine and placebo groups over the 1-year long-term treatment differed significantly (p = 0.022). The results from this analysis indicate that long-term treatment with venlafaxine in patients with major depressive disorder is effective in maintaining the initial response compared with placebo and suggest that venlafaxine will be effective in the prevention of relapse.

Autologous Bone Marrow Transplantation in Hematological Malignancies

Autologous bone marrow transplantation (ABMT) has developed considerably in the past 15 years and is now a routine procedure for the consolidation of acute leukemias, non-Hodgkin's lymphomas and Hodgkin's disease. In addition, ABMT has been tested in multiple myeloma (MM) and even considered in highly selected cases of chronic myelocytic leukemia (CML). Interest has resulted from the discovery of new purging procedures such as long-term cultures with or without serum-free media containing various lymphokines, the evaluation of cryoinjury on malignant cells, the increased detection of minimal residual disease using PCR, and the acceleration of hemopoietic recovery post-ABMT through the use of peripheral blood stem cells and/or lymphokines. Results presented include data from the international (ABMTR) and European (EBMT) registries, and our own unit in Paris. With respect to acute leukemias, (a) the EBMT listed 1,688 patients. The overall results were as follows: for patients autografted in complete remission (CR) 1, the leukemia-free survival and relapse rate at 7 years were 48 +/- 2% and 41 +/- 3% for AML and 44 +/- 5% and 45 +/- 5% in acute lymphoblastic leukemia (ALL), respectively. In CR2, the figures were 34 +/- 4% and 54 +/- 5% for AML and 32 +/- 3% and 62 +/- 4% for ALL, respectively. Patients not relapsing at 1 year post-ABMT had a probability of being cured at 7 years of 86 and 71% if autografted in CR1 and CR2 for AML and 81 and 59% for ALL, respectively. Multivariate analysis of relapse rates in several subpopulations confirmed the efficacy of marrow purging in AML CR1: in patients transplanted prior to January 1988 (minimum follow-up of 2 years), the relapse rate with purged marrow was 35 +/- 5% vs. 47 +/- 3% (p less than 0.005). (b) In Paris, St-Antoine, using TBI and marrow purged with mafosfamide at levels individually adjusted (Blood 1986;67:1367), the probability of remission and DFS were 84 and 62% in AML CR1 63 and 59% in ALL CR1, respectively. There was a statistically significant relationship between the relapse rate and the residual amount of CFUGM progenitors in the marrow after purging. The cutoff point was 0.3%, with a relapse rate of 54% in those receiving marrow containing the higher residual CFUGM fractions and only 29% in those receiving less. With respect to non-Hodgkin's lymphomas, the EBMT listed 698 patients. In intermediate or high grade lymphomas, the DFS at 6 years was 30% and 18% in sensitive and resistant relapses, respectively.(ABSTRACT TRUNCATED AT 400 WORDS)

Surgical treatment of carcinoma of the breast: IV. Prognosis according to extent of involvement of the axillary lymph nodes.

This is a retrospective study of 462 patients who had masectomy and axillary dissection for carcinoma of the breast during 1971-1980. Actuarial analysis of relapse rates up to 5 years showed that the extent of involvement of axillary lymph nodes was the most important prognostic factor. Among patients without any axillary metastasis, those with tumor smaller than 2 cm, colloid, or other less common carcinomas had significantly better prognosis than those with other lesions. Patients younger than 45 years old had higher relapse rate. Among patients with four or more positive axillary nodes, those with tumors smaller than 9 cm or those with nine or fewer positive nodes also had lower relapse rate than those with larger tumors or more positive nodes. Adjuvant systemic chemotherapy has improved the prognosis of patients with four or more positive nodes. Our findings are discussed and compared to those reported in the literature.

Application of life table method to naturalistic designs—A comparison of efficacy of tricyclic antidepressants and benzodiazepines in ambulatory depressives

Anyclinician who follows patients under naturalistic clinic conditions accumulates a wealth of observations about their responses to various treatments. Without random assignment to treatment or other features of the controlled experimental design, information on treatment efficacy obtained from these naturally occurring situations is limited. However, through the use of appropriate statistical techniques such as life table method, considerably more information may be extracted. Although there is no substitute for experimental control, the exploitation of naturalistic data can be of value. Information on large samples collected at a relatively low cost can be utilized, and hypotheses based on ongoing clinical practice may be generated and subsequently tested in controlled randomized trials. The life table method, also called the actuarial method, is uniquely suited to the analysis of longitudinal data and, when applied appropriately, is a sophisticated way of using naturalistically collected data to their maximal extent. 1 This article will discuss the utility of life table method for analysis of longitudinal data collected under naturalistic designs and will illustrate its usefulness in approximating quasiexperimental conditions. Its application will be illustrated in an analysis of relapse rates and of recovery rates in depressed outpatients who are receiving either tricyclic antidepressants or minor tranquilizers.