scholarly journals Further research on the clinical relevance of the ulcerative colitis colonoscopic index of severity for predicting 5-year relapse

2021 ◽  
Author(s):  
Natsuki Ishida ◽  
Shunya Onoue ◽  
Takahiro Miyazu ◽  
Satoshi Tamura ◽  
Shinya Tani ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Colonic Mucosa ◽  
Rank Test ◽  
Clinical Relapse ◽  
Characteristic Analysis ◽  
Log Rank Test ◽  
Index Of Severity ◽  
Time To Relapse ◽  
Free Rate

Abstract Purpose The ulcerative colitis colonoscopic index of severity (UCCIS) evaluates the state of the entire colonic mucosa in ulcerative colitis. However, no cut-off values of scores for predicting clinical relapse in patients with ulcerative colitis have been established. This study aimed to determine the cut-off values for predicting clinical relapse in patients with ulcerative colitis. Methods The endoscopic scores (sum of Mayo endoscopic subscores (S-MES) and UCCIS) of 157 patients with ulcerative colitis experiencing clinical remission and their subsequent clinical course were retrospectively reviewed. The optimal cut-off values for predicting relapse and relapse-free rates were analyzed by receiver operating characteristic analysis. Results Forty patients with ulcerative colitis experienced relapse within 24 months. The median UCCIS for these patients at the time of study enrollment was significantly higher than that for patients with clinical remission (P < 0.001). The cut-off value of the UCCIS for predicting relapse was 9.8. The relapse-free rate was significantly lower in patients with UCCIS ≥ 9.8 than in those with UCCIS < 9.8 (log-rank test P < 0.001). For patients who experienced relapse within 5 years, the optimal cut-off values for the UCCIS and S-MES were 10.2 and 1, respectively (P = 0.004). Conclusions The data from this study indicate that the USSIC is a more relevant score than the S-MES for predicting the time to relapse in patients with ulcerative colitis in remission.

scholarly journals P453 Comparison of therapeutic effects between groups of thiopurine alone and combination of thiopurine with 5-ASA after remission introduced by oral tacrolimus for patients with severe ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S405-S406
Author(s):  
T Sato ◽  
K Kojima ◽  
R Koshiba ◽  
K Fujimoto ◽  
M Kawai ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Rank Test ◽  
Therapeutic Effects ◽  
Aminosalicylic Acid ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Time To Relapse

Abstract Background Although thiopurine is recommended to be used for maintenance after remission, the reliable data of maintenance introduced by tacrolimus is limited for patients with ulcerative colitis (UC). 5-aminosalicylic acid (5-ASA) is reported to induce 6-thioguanine nucleotides (6-TGN) levels higher in patients with inflammatory bowel diseases. However, the data of 5-ASA are few reported among East Asians. Methods A retrospective cohort study was conducted evaluating the 70 patients with severe UC who were primary responders to oral tacrolimus from April 2015 to March 2018. Twenty-seven patients were administered maintenance treatment with thiopurine. We evaluated the efficacy of thiopurines with and without 5-ASA in these patients, using ΔMCV, lowest WBC, highest 6TGN between groups of thiopurine alone and thiopurine+ 5-ASA. Kaplan–Meier analysis was used to assess time to relapse between groups of thiopurine and thiopurine+5-ASA. Results The median follow-up period was 430 days (interquartile range 207–952 days). The statistical significances were not found in patients background between groups of thiopurine and thiopurine+5-ASA. ΔMCV were significantly greater (p &lt; 0.01), lowest WBC were significantly lower (p = 0.02) in the thiopurines+5-ASA group than in thiopurines alone group. The highest 6-TGN levels tended to be higher in thiopurine+5-ASA group than in thiopurine alone group (p = 0.09). The rate of relapse was significantly higher in the thiopurine alone group than in thiopurines+5-ASA group (p = 0.03). Kaplan–Meier curves confirmed that thiopurine+5-ASA group appeared to protect against relapse (log-rank test, p &lt; 0.01). Conclusion Thiopurine+5-ASA induced significantly lower relapse than thiopurine alone after remission introduced by tacrolimus in the patients with severe UC, along with significantly greater the ΔMCV and lower the lowest WBC.

scholarly journals P310 The efficacy of linked colour imaging, a novel endoscopic enhancement system, for diagnosing mucosal redness in ulcerative colitis patients in clinical remission

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S309-S309
Author(s):  
T Takagi ◽  
K Uchiyama ◽  
M Kajiwara ◽  
Y Azuma ◽  
S Takayama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Colonic Mucosa ◽  
Mucosal Healing ◽  
Time Interval ◽  
Histological Activity ◽  
Index Of Severity ◽  
Long Term Prognosis ◽  
Linked Color Imaging ◽  
Relapse Rates

Abstract Background Endoscopic mucosal healing is considered as an important therapeutic goal in ulcerative colitis (UC) patients, and several endoscopic evaluations for colonic mucosa such as Mayo endoscopic subscore (MES) and Colitis Endoscopic Index of Severity (UCEIS) are used in clinical practice. Though the strict mucosal healing is defined as MES 0, the relapse of UC has been shown in the patients diagnosed as MES 0. In the present study, we aimed to investigate the efficacy of Linked Color Imaging (LCI), a novel endoscopic enhancement system, to predict long-term prognosis in UC patients diagnosed with MES 0. Methods Twenty-six patients with UC in clinical remission and diagnosed with MES 0 were enrolled. Endoscopic colonic images were assessed by LCI and UCEIS, using a LASEREO endoscopic system (FUJIFILM Co., Tokyo, Japan). Endoscopic LCI images were classified into three subgroups by LCI classification as previously reported. Briefly, LCI patterns were classified as A, no redness; B, redness with visible vessels; and C, redness without visible vessels. Forty months was defined as the time interval between endoscopic diagnosis and relapse of UC. Histological activity was scored according to the Geboes’ score (GS) and the active mucosa was defined by GS&gt;2B.1. Results LCI classification can further subdivide the colonic mucosa diagnosed as MES 0. The patients with LCI-A showed no relapse and the non-relapse rates compared with the patients with LCI-B showed significantly higher (p = 0.033), while the relapse rates of the patients with UCEIS 0 showed no difference compared with UCEIS 1 (p = 0.148). There was no statistical difference in the composition of LCI-A and relapse rate between active and inactive mucosa diagnosed by GS score. Conclusion Endoscopic LCI classification can further subdivide samples diagnosed MES 0. LCI can be a novel and surpassing approach to evaluate mucosal healing and predict the outcome in UC patients.

Endoscopic and Histological Assessment, Correlation, and Relapse in Clinically Quiescent Ulcerative Colitis (MARQUEE)

2020 ◽  
Author(s):  
Mark T Osterman ◽  
Frank I Scott ◽  
Franz F Fogt ◽  
Erin D Gilroy ◽  
Susan Parrott ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Clinical Remission ◽  
Clinical Relapse ◽  
High Prevalence ◽  
Histological Indices ◽  
Index Of Severity ◽  
Multicenter Prospective Study ◽  
Multicenter Prospective Cohort Study ◽  
Research Alliance

Abstract Objective It is difficult to predict relapse in quiescent ulcerative colitis (UC), but newer endoscopic and histological indices could improve this. This study aimed to determine in UC patients in clinical remission (1) the prevalence of active endoscopic and histological disease; (2) the correlation between endoscopic and histological scores; and (3) the predictive power of these scores for clinical relapse. Design This multicenter prospective cohort study conducted by the Crohn’s and Colitis Foundation Clinical Research Alliance included 100 adults with UC in clinical remission undergoing surveillance colonoscopy for dysplasia. Endoscopic activity was assessed using the Mayo endoscopic score (MES), ulcerative colitis endoscopic index of severity (UCEIS), and ulcerative colitis colonoscopic index of severity (UCCIS). Histology was assessed with the Riley index subcomponents, total Riley score, and basal plasmacytosis. Results Only 5% of patients had an MES of 0, whereas 38% had a score of 2 to 3; using the UCEIS, the majority of patients had at least mild activity, and 15% had more severe activity. Many patients also had evidence of histological disease activity. The correlations among endoscopic indices, histological subcomponents, and total score were low; the highest correlations occurred with the subcomponent architectural irregularity (ρ = 0.43–0.44), total Riley score (ρ = 0.35–0.37), and basal plasmacytosis (ρ = 0.35–0.36). Nineteen patients relapsed clinically over 1 year, with the subcomponent architectural irregularity being the most predictive factor (P = 0.0076). Conclusions This multicenter prospective study found a high prevalence of both endoscopic and histological disease activity in clinically quiescent UC. The correlations between endoscopy and histology were low, and the power to predict clinical relapse was moderate.

scholarly journals P807 UCEIS is associated with PRO2, partial Mayo and SCCAI remission in UC: preliminary results from a prospective study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S631-S631
Author(s):  
P A Golovics ◽  
L Gonczi ◽  
J Reinglass ◽  
C Verdon ◽  
W Afif ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Roc Analysis ◽  
Clinical Decision Making ◽  
Activity Index ◽  
Operating Characteristics ◽  
Faecal Calprotectin ◽  
Patient Reported ◽  
Index Of Severity ◽  
Active Disease

Abstract Background Optimal management of patients with ulcerative colitis (UC) requires the accurate assessment of disease activity. Endoscopic evaluation is considered the gold standard approach, but it is invasive. We aimed to determine the operating characteristics of the Ulcerative Colitis Endoscopic Index of Severity (UCEIS), to quantify the cut off most closely correlated with clinical remission or activity and determine agreement with the Mayo endoscopic subscore (MES), Baron score, clinical scores and biomarkers. Methods 136 patients were included prospectively (age: 48 (IQR38-61) years, duration 12 (4–19)years, 63 females, 53.7% extensive disease, 40.4% on biologicals) at the time of the colonoscopy. Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Mayo endoscopic subscore (MES), Baron scores were calculated, as well as the2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI). CRP and faecal calprotectin (FCAL) was available in 58.1 and 33.8% of patients. 20.7% had clinical flare, treatment was escalated in 17.8% of patients. ROC analysis and K-statistics were performed and Spearman’s correlation was calculated. Results UCEIS was strongly associated to PRO2 SF (AUC:0.866), RBS (AUC:0.921), PRO2 combined remission (AUC:0.905), partial MAYO (AUC:0.956) and SCCAI (AUC:0.907) remission in a ROC analysis. A UCEIS of ≤3 was identified as the best cut-off to identify RBS subscore of 0, or total PRO2 remission (RBS 0 and SF ≤1), partial MAYO (≤2) and SCCAI (≤2.5) remission, while a UCEIS≥4 identified active disease frequently needing change in medical therapy. A moderate agreement was found between UCEIS and MES (K=0.451) or Baron (K=0.499) scores. Correlation between FCAL and UCEIS (coeff:0.743, p &lt; 0.0001) was strong, while modest only with CRP (coeff:0.333, p = 0.01). Conclusion A UCEIS was strongly associated with clinical remission defined as PRO2, SF, RBS, partial Mayo or SCCAI with best agreement with RBS and partial Mayo remission. A UCEIS of ≤3 was identified as a cut-off for quiescent disease, while a UCEIS≥4 identified active disease, which can support clinical decision-making based on endoscopic findings. Agreement between UCEIS and FCAL was strong, while agreement with UCEIS and MES/Baron scores was moderate.

scholarly journals P696 The usefulness to treatment enhancement for the patients of ulcerative colitis with clinical remission diagnosed as Mayo endoscopic subscore 1

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S564-S564
Author(s):  
M Kubota Kajiwara ◽  
K Uchiyama ◽  
Y Azuma ◽  
R Yasuda ◽  
S Takayama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Treatment Group ◽  
Clinical Remission ◽  
Clinical Symptoms ◽  
Mucosal Healing ◽  
Endoscopic Examination ◽  
Clinical Relapse ◽  
Oral Medicine ◽  
Clinical Background ◽  
Observation Period

Abstract Background In many clinical trials of ulcerative colitis (UC), Mayo endoscopic subscore (MES) has been used to diagnose mucosal healing to evaluate the effectiveness of various treatment. Although both MES 0 and MES 1 were defined as the endoscopic mucosal healing, several studies reported that the risk of clinical relapse was significantly higher in the patients diagnosed as MES 1 compared with MES 0. However, it has not been established the beneficial effect to escalate the treatment for the patients diagnosed as MES 1 to avoid clinical relapse. In the present study, we retrospectively investigated the effectiveness about the escalation of treatment for UC patients with clinical remission diagnosed as MES 1. Methods A total of 68 patients with UC diagnosed as clinical remission (4 and under of Lichtiger CAI score) between April 2014 to October 2019 were enrolled in this study. All patients were endoscopically diagnosed as MES 1 and observation period was 12 months from the time of endoscopy. Relapse of UC was defined as the need for more aggressive treatment for UC due to aggravation of clinical symptoms or endoscopic findings. The relapse ratio was compared between the patients who continued the same treatment and the patients who had enhanced treatment. Enhanced treatment was defined as additional oral medicine or local preparations including enemas, suppositories, and foams within 3 months from endoscopic examination. Results In 68 patients, 12 patients were received enhanced treatment and 56 patients were continued the same treatments. There were no significant differences in clinical background between the two groups such as mean age (enhanced treatment group vs. same treatment group: 47.9 years vs. 42.9 years), disease type, disease duration (110.3 months vs. 94.8 months), and disease activity (Lichtiger CAI score: 2.5 vs. 2.8). The group of the enhanced treatment included 8 patients with oral 5-aminosalicylates escalation and 4 patients with additional local preparations. The relapse ratio was higher in patients with same treatment group (0%) compared with enhanced treatment group (14.3%). Conclusion Our results indicate that the enhancement of the treatment for UC patients with clinical remission diagnosed as MES 1 is effective to avoid relapse.

scholarly journals P335 Treatment strategies after mucosal healing (MH) in ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S323-S323
Author(s):  
A Sitibondo ◽  
A Viola ◽  
G Costantino ◽  
A Centritto ◽  
A Belvedere ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Demographic Data ◽  
Age At Onset ◽  
Treatment Strategies ◽  
Smoking Behaviour ◽  
Mucosal Healing ◽  
Rank Test ◽  
Clinical Relapse ◽  
Therapeutic Goals ◽  
Mean Time

Abstract Background MH and deep remission are the major therapeutic goals in the treatment of ulcerative colitis (UC), but the best therapeutic strategy after reaching MH in terms of maintenance or de-escalation is still poorly defined. This retrospective study aimed to evaluate the maintenance of remission in patients who maintained therapy vs. patients de-escalating treatment. Methods Data of patients with UC who reached mucosal healing were retrospectively investigated. Demographic data/gender, age), disease-related data (extension, duration, age at onset), together with data on smoking behaviour and on therapy after reaching MH were collected. MH was defined as an endoscopic Mayo score of 0. The primary endpoint was clinical relapse regardless of therapeutic regimen. The outcome of patients maintained on therapy was compared with patients who de-escalated therapy and to patients with mild disease maintained on mesalazine. Results One hundred thirty-five patients with MH were followed for a mean time of 94 months (SD 57.2) and divided into 3 groups: group 1 (de-escalation; 45 patients), in which MH was reached with IMM or biologics and therapy was continued with only mesalazine, group 2 (no de-escalation; 40 patients) in which MH was reached with IMM or biologics, group 3 (only treatment with 5-ASA; 50 patients). In the 3 groups, disease relapse occurred in 62%, 30% and 38% respectively in a mean time of 22, 25 and 36 months. Patients who de-escalated therapy were more likely to relapse than patients who maintained initial treatment (p = 0.003, log-rank test)(Figure 1). A subgroup analysis showed as only for MH reached with anti-TNFs de-escalation strategy was related to an increasing risk of relapse (p = 0.003). No risk factors for relapse were identified on multivariate analysis. Conclusion Maintaining treatment after MH is reached represents the best strategy to maintain remission. Patients on anti-TNFs were more likely to relapse after de-escalation. An evaluation on pharmacoeconomics seems to be advised in order to identify a more sustainable strategy.

P2609H2FPEF score as a prognostic value in HFpEF patients

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Sueta ◽  
T Nishihara ◽  
E Yamamoto ◽  
K Tsujita
Keyword(s):  
Confidence Interval ◽  
Cardiovascular Events ◽  
Left Ventricular ◽  
Hazard Ratio ◽  
Left Ventricular Ejection ◽  
Rank Test ◽  
Characteristic Analysis ◽  
Simple Method ◽  
Log Rank Test ◽  
Cerebrovascular Events

Abstract Background The H2FPEF score is recognized as a simple method to diagnose heart failure (HF) with preserved left ventricular ejection fraction (HFpEF). Purpose We investigated the value of the H2FPEF score in predicting subsequent cardiovascular events in HFpEF patients. Methods This study was a retrospective, single-center, observational study. We calculated the H2FPEF scores for 404 consecutive HFpEF patients. Subjects were subdivided into low- (0–3), intermediate- (4–6), and high-score (7–9) groups and followed for 50-months. The primary and secondary endpoints were composite cardiovascular/ cerebrovascular events (cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, hospitalization for HF decompensation and non-fatal stroke) occurrence and HF-related events (hospitalization for HF decompensation) occurrence at 50-months, respectively. Results Kaplan–Meier analyses demonstrated a significantly higher incidence of cardiovascular/cerebrovascular events in proportion to a higher H2FPEF score (log-rank test, P=0.005). The HF-related event rate was higher in proportion to the H2FPEF score (log-rank test, P<0.001). Multivariate Cox hazard analyses identified the H2FPEF score (per 1 point) as an independent predictor of cardiovascular and HF-related events (Table, hazard ratio, 1.179; 95% confidence interval, 1.066–1.305; P=0.001 and hazard ratio, 1.288; 95% confidence interval, 1.134–1.463; P=0.001, respectively). Receiver operating characteristic analysis showed that the H2FPEF significantly predicted cardiovascular events (Figure A, AUC 0.626, 95% CI 0.557–0.693; P<0.001) and HF-related events (Figure B, AUC 0.680, 95% CI 0.600–0.759; P<0.001). The cutoff H2FPEF score was 5.5 for the identification of cardiovascular and HF-related events. Conclusion The H2FPEF score is a potentially useful marker for the prediction of cardiovascular and HF-related events in HFpEF patients.

scholarly journals H2FPEF Score as a Prognostic Value in HFpEF Patients

2019 ◽  
Vol 32 (11) ◽  
pp. 1082-1090 ◽  
Author(s):  
Daisuke Sueta ◽  
Eiichiro Yamamoto ◽  
Taiki Nishihara ◽  
Takanori Tokitsu ◽  
Koichiro Fujisue ◽  
...  
Keyword(s):  
Cardiovascular Events ◽  
Area Under The Curve ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Rank Test ◽  
Characteristic Analysis ◽  
Simple Method ◽  
Ventricular Ejection Fraction ◽  
Log Rank Test ◽  
Cerebrovascular Events

Abstract Background The H2FPEF score is recognized as a simple method to diagnose heart failure (HF) with preserved left ventricular ejection fraction (HFpEF). We investigated the value of the H2FPEF score in predicting subsequent cardiovascular events in HFpEF patients. Methods This study was a retrospective, single-center, observational study. We calculated the H2FPEF scores for 404 consecutive HFpEF patients. Subjects were subdivided into low- (0–3), intermediate- (4–6), and high-score (7–9) groups and followed for 50 months. The primary and secondary endpoints were composite cardiovascular/cerebrovascular events (cardiovascular death, nonfatal myocardial infarction, unstable angina pectoris, hospitalization for HF decompensation, and nonfatal stroke) occurrence and HF-related events (hospitalization for HF decompensation) occurrence at 50 months, respectively. Results Kaplan–Meier analyses demonstrated a significantly higher incidence of cardiovascular/cerebrovascular events among those with a higher H2FPEF score (log-rank test, P = 0.005). The HF-related event rate was higher in proportion to the H2FPEF score (log-rank test, P < 0.001). Multivariate Cox hazard analyses identified the H2FPEF score (per 1 point) as an independent predictor of cardiovascular and HF-related events (hazard ratio [HR], 1.179; 95% confidence interval [CI], 1.066–1.305; P = 0.001 and HR, 1.288; 95% CI, 1.134–1.463; P = 0.001, respectively). Receiver operating characteristic analysis showed that the H2FPEF significantly predicted cardiovascular events (area under the curve [AUC], 0.626; 95% CI, 0.557–0.693; P < 0.001) and HF-related events (AUC, 0.680; 95% CI, 0.600–0.759; P < 0.001). The cutoff H2FPEF score was 5.5 for the identification of cardiovascular and HF-related events. Conclusion The H2FPEF score might be a potentially useful marker for the prediction of cardiovascular and HF-related events in HFpEF patients. Clinical Trails Registration Trail Number UMIN000029600.

scholarly journals P248 Endoscopic evaluation of colonic mucosa in ulcerative colitis patients in clinical remission

2013 ◽  
Vol 7 ◽  
pp. S109 ◽  
Author(s):  
O. Shchukina ◽  
E. Kondrashina ◽  
O. Orlov ◽  
A. Vladimirova ◽  
A. Botina ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Colonic Mucosa ◽  
Endoscopic Evaluation

MRD Kinetics Can Predict the Time to Relapse after Autologous Stem Cell Transplantation (SCT) in Chronic Lymphocytic Leukemia (CLL).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 714-714
Author(s):  
Matthias Ritgen ◽  
Sebastian Boettcher ◽  
Stephan Stilgenbauer ◽  
Hartmut Dohner ◽  
Monika Brueggeman ◽  
...  
Keyword(s):  
Clinical Remission ◽  
Control Group ◽  
Clinical Relapse ◽  
Observation Group ◽  
Myeloablative Conditioning ◽  
Standard Curve ◽  
Log Linear ◽  
Time To Relapse ◽  
Observation Period ◽  
Median Slope

Abstract Introduction: Ongoing studies suggest, that myeloablative conditioning chemotherapie with autologous SCT is not a curative treatment option in high risk CLL patients. For this reason a method to predict progression free survival (pfs) in individual patients (pts) is desirable. Minimal residual disease (MRD) short after auto SCT in pts with CLL are known to be homogeneous low with increasing MRD level at later time points. Early MRD increase is associated with clinical risk factors and high risk for clinical relapse. Methods: To estimate time to progression in individual patients we studied MRD kinetics between 12 and 36 months after SCT (observation period) by quantitative ASO-primer IgH PCR and/or MRD flow in 37 poor risk CLL pts (5 % with mutated IgH, advanced Binet stage, high lymphocyte count). We postulated LOG-linear growth kinetics from 12 months after SCT until clinical relapse, which allowed calculation of time to predicted hematologic relapse (pHR) after auto SCT. All patients were in clinical remission before myeloablative conditioning regimen of TBI and high-dose cyclophosphamide following autologous SCT. 16/37 pts. with relapsed disease served as a control group whereas 21 pts in continuing clinical remission defined an observation group. LOG-MRD kinetics were described by a linear standard curve defined by 2 or more samples of patients in clinical remission more than 6 months (mos) apart. Significant MRD change was defined by a change of more than 0.5 orders of magnitude within the observation time. By this standard curve time to pHR, defined as a CLL level of 0.5 (i.e. 50% of all blood cells are CLL cells), was estimated. Results: 28 of all 37 pts. showed increasing, 4 stable and 5 decreasing MRD level during the observation period. In the control group of 16 pts. with clinical relapse, MRD level of one pt. remained stable until 36 mos after SCT, whereas 15 pts. showed significant MRD increase with a median slope of 0.093 (0.04 to 0.25) LOG-MRD level and a median time to pHR of 51 (27 – 92) mos compared to an observed median pfs of 39 (28 – 64) mos after SCT (ns). Median difference between pfs and time to pHR was 3.5 (5.4 – 60) mos. Only in 5 of 15 pts this difference exceeded 12 mos of whom all relapsed earlier than the estimated time point. In the observation group of 21 pts 9 (4 and 5 respectively) pts showed stable MRD level or significant MRD decrease. 12/21 pts showed significant MRD increase with a median slope of 0.08 (0.03 – 0.17) and a median time to pHR of 57 (28 – 160) mos. Only in 2/12 pts the clinical relapse preceded the pHR (0.4 and 7.4 mos) within the median clinical follow up period of 45 (25 – 69) mos. Conclusions: LOG-linear MRD models can characterize CLL increase from 12 momths after SCT: Increasing MRD kinetics predict the time to clinical relapse with acceptable accuracy in the majority of CLL pts, although this simple model tends to overestimate the time to relapse. Further improvement of the model, e.g. by calculating absolute CLL numbers and/or by more sophisticated statistical methods might minimize this error. Nevertheless, this overestimation might also be caused by biological reasons, e.g. clonal evolution or subclone selection.

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