Effectiveness of Clofarabine in Elderly AML Patients with Adverse Cytogenetics Unfit for Intensive Chemotherapy.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 1985-1985 ◽  
Author(s):  
Alan K. Burnett ◽  
M. Baccarani ◽  
Peter Johnson ◽  
John Yin ◽  
Andrew Saunders ◽  
...  

Abstract Outcomes for elderly patients with AML are almost uniformly poor, and it has been shown (Wheatley et al., Blood2005, 106(11) 199a) that patients with adverse cytogenetics have a particularly poor prognosis. Additionally, a large proportion of such patients are considered not to be fit for intensive chemotherapy (Juliusson et al, Leukemia, 2006 (20): 42–7), and given best supportive care, or low-dose Ara-C. The NCRI AML14 trial observed no remissions in 18 patients with adverse cytogenetics treated with Ara-C, and no remissions in 20 patients treated with hydroxyurea. We present here a combined analysis of the BIOV-121 Study, and the UWCM-0001 study. Both studies were for untreated patients over 65 years of age who were not considered fit for chemotherapy. The treatment comprised clofarabine 30mg/m2 on days 1–5 repeated after 28–42 days for up to 3 courses. The primary endpoints were overall response (CR, CRi or PR) and safety. Patients: A total of 95 patients were recruited, of whom 95 received clofarabine 30mg/m2. Twenty-six patients (27%) had adverse cytogenetics. Results: 10/26 patients (38%) achieved either CR or CRi. With a median follow-up of 10 months (range 2–17 months), 1 year survival is 20%, with 19/26 patients having died. At most recent follow-up, 4/10 patients achieving CR or CRi are still alive in remission. Discussion: The remission rate of 38% seen with clofarabine compares favourably, not only with traditional non-intensive approaches (which have failed to induce any remissions in similar sized cohorts), but also to the 42% remission rate seen in patients treated with intensive daunorubicin/Ara-C based chemotherapy in the NCRI AML14 trial. One year survival rates are also encouraging, at 20% compared to 0%, 5% and 23% for patients treated with Ara-C, supportive care, and intensive chemotherapy respectively. Exploratory comparisons of survival between the 30mg clofarabine patients and the three treatment regimens give highly significant survival advantages compared to Ara-C and HU (p=0.0001, p=0.004 respectively) and no significant difference between clofarabine and DA (p=1.0), although confidence intervals in this case are wide. Conclusions: Clofarabine has the ability to induce remissions in patients with adverse cytogenetics, unlike Ara-C and supportive care, and survival in this group is improved. Remission rates and survival are similar to those seen for patients treated with intensive chemotherapy. Clofarabine is clearly worthy of further investigation, and may provide an important treatment option for high risk patients with AML.

2006 ◽  
Vol 21 (4) ◽  
pp. 195-198 ◽  
Author(s):  
D Bergqvist ◽  
G Agnelli ◽  
A T Cohen ◽  
P E Nilsson ◽  
A Le Moigne-Amrani ◽  
...  

Objective: ENOXACAN II was a randomized, double-blind trial that showed prolonged (four-week) thromboprophylaxis with enoxaparin to be more effective than and as safe as standard (one-week) thromboprophylaxis in patients undergoing surgery with a curative intent for abdominopelvic cancer. This follow-up study compared long-term, all-cause mortality in both groups. Methods: Survival rates were calculated on the randomized, treated population ( n = 501). The primary efficacy endpoint was survival at one year. An exploratory analysis including survival data up to 44 months was performed. Because some patients were deemed to have undergone palliative as opposed to curative surgery, and there was a significant difference between the treatment groups in the percentage of patients undergoing palliative surgery, the survival analyses were adjusted for the type of surgery performed. Results: When adjusted for type of surgery, there was a trend towards reduced mortality among patients undergoing palliative surgery in the prolonged prophylaxis group (hazard ratio [HR] = 0.598, P = 0.3565) that became more pronounced beyond the pre-specified one year follow-up period (HR = 0.469, P = 0.078). This trend may reflect a beneficial effect of prolonged prophylaxis on survival in the palliative surgery group (one-year survival 65.4 versus 50% for standard prophylaxis). In patients undergoing curative surgery, one-year survival rates were equal in the standard and prolonged prophylaxis groups (93.8 and 93.2%, respectively). Conclusion: Prolonged thromboprophylaxis with enoxaparin may affect long-term survival in palliative surgery for cancer, but further investigation is warranted.


2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 234-236
Author(s):  
P Willems ◽  
J Hercun ◽  
C Vincent ◽  
F Alvarez

Abstract Background The natural history of primary sclerosing cholangitis (PSC) in children seems to differ from PSC in adults. However, studies on this matter have been limited by short follow-up periods and inconsistent classification of patients with autoimmune cholangitis (AIC) (or overlap syndrome). Consequently, it remains unclear if long-term outcomes are affected by the clinical phenotype. Aims The aims of this is study are to describe the long-term evolution of PSC and AIC in a pediatric cohort with extension of follow-up into adulthood and to evaluate the influence of phenotype on clinical outcomes. Methods This is a retrospective study of patients with AIC or PSC followed at CHU-Sainte-Justine, a pediatric referral center in Montreal. All charts between January 1998 and December 2019 were reviewed. Patients were classified as either AIC (duct disease on cholangiography with histological features of autoimmune hepatitis) or PSC (large or small duct disease on cholangiography and/or histology). Extension of follow-up after the age of 18 was done for patients followed at the Centre hospitalier de l’Université de Montréal. Clinical features at diagnosis, response to treatment at one year and liver-related outcomes were compared. Results 40 patients (27 PSC and 13 AIC) were followed for a median time of 71 months (range 2 to 347), with 52.5% followed into adulthood. 70% (28/40) had associated inflammatory bowel disease (IBD) (78% PSC vs 54% AIC; p=0.15). A similar proportion of patients had biopsy-proven significant fibrosis at diagnosis (45% PSC vs 67% AIC; p=0.23). Baseline liver tests were similar in both groups. At diagnosis, all patients were treated with ursodeoxycholic acid. Significantly more patients with AIC (77% AIC vs 30 % PSC; p=0.005) were initially treated with immunosuppressive drugs, without a significant difference in the use of Anti-TNF agents (0% AIC vs 15% PSC; p= 0.12). At one year, 55% (15/27) of patients in the PSC group had normal liver tests versus only 15% (2/13) in the AIC group (p=0.02). During follow-up, more liver-related events (cholangitis, liver transplant and cirrhosis) were reported in the AIC group (HR=3.7 (95% CI: 1.4–10), p=0.01). Abnormal liver tests at one year were a strong predictor of liver-related events during follow-up (HR=8.9(95% CI: 1.2–67.4), p=0.03), while having IBD was not (HR=0.48 (95% CI: 0.15–1.5), p=0.22). 5 patients required liver transplantation with no difference between both groups (8% CAI vs 15% CSP; p=0.53). Conclusions Pediatric patients with AIC and PSC show, at onset, similar stage of liver disease with comparable clinical and biochemical characteristics. However, patients with AIC receive more often immunosuppressive therapy and treatment response is less frequent. AIC is associated with more liver-related events and abnormal liver tests at one year are predictor of bad outcomes. Funding Agencies None


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Guoqiang Ma ◽  
Chaoan Wu ◽  
Miaoting Shao

AbstractSeveral authors have suggested that implants can be placed simultaneously with onlay bone grafts without affecting outcomes. Therefore, the purpose of this study was to answer the following clinical questions: (1) What are the outcomes of implants placed simultaneously with autogenous onlay bone grafts? And (2) is there a difference in outcomes between simultaneous vs delayed placement of implants with autogenous onlay bone grafts? Databases of PubMed, Embase, and Google Scholar were searched up to 15 November 2020. Data on implant survival was extracted from all the included studies (single arm and comparative) to calculate point estimates with 95% confidence intervals (CI) and pooled using the DerSimonian–Laird meta-analysis model. We also compared implant survival rates between the simultaneous and delayed placement of implants with data from comparative studies. Nineteen studies were included. Five of them compared simultaneous and delayed placement of implants. Dividing the studies based on follow-up duration, the pooled survival of implant placed simultaneously with onlay grafts after <2.5 years of follow-up was 93.1% (95% CI 82.6 to 97.4%) and after 2.5–5 years was 86% (95% CI 78.6 to 91.1%). Implant survival was found to be 85.8% (95% CI 79.6 to 90.3%) with iliac crest grafts and 95.7% (95% CI 83.9 to 93.0%) with intra-oral grafts. Our results indicated no statistically significant difference in implant survival between simultaneous and delayed placement (OR 0.43, 95% 0.07, 2.49, I2=59.04%). Data on implant success and bone loss were limited. Data indicates that implants placed simultaneously with autogenous onlay grafts have a survival rate of 93.1% and 86% after a follow-up of <2.5 years and 2.5–5years respectively. A limited number of studies indicate no significant difference in implant survival between the simultaneous and delayed placement of implants with onlay bone grafts. There is a need for randomized controlled trials comparing simultaneous and delayed implant placement to provide robust evidence.


Author(s):  
Florin Eggmann ◽  
Thomas J. W. Gasser ◽  
Hanjo Hecker ◽  
Mauro Amato ◽  
Roland Weiger ◽  
...  

Abstract Objectives This study aimed to retrospectively evaluate clinical and radiographic outcomes of partial pulpotomy performed in permanent teeth with carious pulp exposure. Materials and methods Records of patients undergoing treatment at an undergraduate dental clinic between 2010 and 2019 were screened for partial pulpotomies in teeth with a presumptive diagnosis of normal pulp or reversible pulpitis. The follow-up had to be ≥ 1 year. Patient data were retrieved and analyzed using Mantel-Cox chi square tests and Kaplan–Meier statistics. The level of significance was set at α = 0.05. Results Partial pulpotomy was performed in 111 cases, of which 64 (58%) fulfilled the eligibility criteria. At the time of partial pulpotomy, the mean age was 37.3 (± 13.5) years (age range 18–85). The mean observation period was 3.1 (± 2.0) years. Two early failures (3.1%) and five late failures (7.7%) were recorded. The overall success rate of maintaining pulp vitality was 89.1%, with 98.4% tooth survival. The cumulative pulp survival rates of partial pulpotomy in patients aged < 30 years, between 30 and 40 years, and > 40 years were 100%, 75.5%, and 90.5%, respectively, with no significant difference between the age groups (p = 0.225). At follow-up, narrowing of the pulp canal space and tooth discoloration were observed in 10.9% and 3.1% of cases, respectively. Conclusions Across age groups, partial pulpotomy achieved favorable short and medium-term outcomes in teeth with carious pulp exposure. Clinical relevance Adequate case selection provided, partial pulpotomy is a viable operative approach to treat permanent teeth with deep carious lesions irrespective of patients’ age.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Walid El Moghazy ◽  
Samy Kashkoush ◽  
Glenda Meeberg ◽  
Norman Kneteman

Background. We aimed to assess incidentally discovered hepatocellular carcinoma (iHCC) over time and to compare outcome to preoperatively diagnosed hepatocellular carcinoma (pdHCC) and nontumor liver transplants.Methods.We studied adults transplanted with a follow-up of at least one year. Patients were divided into 3 groups according to diagnosis of hepatocellular carcinoma.Results.Between 1990 and 2010, 887 adults were transplanted. Among them, 121 patients (13.6%) had pdHCC and 32 patients (3.6%) had iHCC; frequency of iHCC decreased markedly over years, in parallel with significant increase in pdHCC. Between 1990 and 1995, 120 patients had liver transplants, 4 (3.3%) of them had iHCC, and only 3 (2.5%) had pdHCC, while in the last 5 years, 263 patients were transplanted, 7 (0.03%) of them had iHCC, and 66 (25.1%) had pdHCC (P<0.001). There was no significant difference between groups regarding patient survival; 5-year survival was 74%, 75.5%, and 77.3% in iHCC, pdHCC, and non-HCC groups, respectively (P=0.702). Patients with iHCC had no recurrences after transplant, while pdHCC patients experienced 17 recurrences (15.3%) (P=0.016).Conclusions.iHCC has significantly decreased despite steady increase in number of transplants for hepatocellular carcinoma. Patients with iHCC had excellent outcomes with no tumor recurrence and survival comparable to pdHCC.


2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0002
Author(s):  
Alastair Faulkner ◽  
Alistair Mayne ◽  
Fraser Harrold

Category: Midfoot/Forefoot Introduction/Purpose: Morton’s neuroma is a common condition affecting the foot and is associated with chronic pain and disability. Conservative management including a combination of orthotic input; injection or physiotherapy, and surgical excision are current treatment options. There is a paucity of literature regarding patient related outcome measures (PROMs) data in patients managed conservatively. We sought to compare conservative with surgical management of Morton’s neuroma using PROMs data in patients with follow-up to one year. Methods: Prospective data collection commenced from April 2016. Patients included had to have a confirmed Morton’s neuroma on ultrasound scan. Patient demographics including age, sex and BMI were collected. The primary outcome measures were the Manchester Foot Score for pain (MOX-FQ), EQ time trade off (TTO) and EQ visual analogue scale (VAS) taken pre-operatively; at 26-weeks and at 52-weeks post-operatively. Results: 194 patients were included overall: 79 patients were conservatively managed and 115 surgically managed. 19 patients were converted from conservative to surgical management. MOX-FQ pain scores: pre-op conservative 52.15, surgical 61.56 (p=0.009), 6-months conservative 25.1, surgical 25.39 (p=0.810), 12 months conservative 18.54, surgical 20.52 (p=0.482) EQ-TTO scores: pre-op conservative 0.47, surgical 0.51 (p=0.814), 6-months conservative 0.41, surgical 0.49 (p=0.261), 12 months conservative 0.26, surgical 0.37 (p=0.047) EQ-VAS scores: pre-op conservative 63.84, surgical 71.03 (p=0.172), 6-months conservative 46.10, surgical 52.51 (p=0.337), 12 months conservative 30.77, surgical 37.58 (p=0.227) Satisfaction at 12 months: conservative 17 (21.5%), surgical 32 (27.8%) p=0.327 Conclusion: This is one of the first studies investigating long-term PROMs specifically in conservative management for Morton’s neuroma patients. There was no significant difference in pain score and EQ-VAS between all conservative treatments and surgical management at 12 months There was no significant difference in satisfaction at 12 months between conservative and surgical groups.


2017 ◽  
Vol 16 (4) ◽  
pp. 318-322
Author(s):  
Marcelo Simoni Simões ◽  
Ernani Vianna de Abreu ◽  
Samuel Bamberg Pydd

ABSTRACT Objectives: To observe the degree of correction and postoperative evolution of the spinopelvic parameters in patients with sagittal imbalance submitted to 3-column osteotomies. Methods: Retrospective analysis of 20 cases of 3-column osteotomies in patients with evident sagittal imbalance and minimum follow-up of one year, computing evolution of radiological data as a function of time, complications and reinterventions, and classification into subgroups by preoperative spinopelvic measures and complications. The variation of measures, quantitative and categorical variables, and differences between groups were evaluated using the Wilcoxon, Spearman, Fischer’s exact test, Kruskal-Wallis and Mann-Whitney tests. Results: There was improvement of all the sagittal parameters, ideal correction in 55% of the cases and maintained until the end of the follow-up in 40% of the cases. No correlation was found between obtaining optimal correction and data or preoperative measurements. Clinical and infectious complications did not affect the maintenance of the correction. The most common mechanical complications were pseudoarthrosis-related rod fracture at osteotomy (30%) and failures at the lower fixation level (15%). There was no significant difference in the maintenance of the correction between the groups with and without mechanical complications treated. In the untreated mechanical complications there was a significantly higher radiological worsening (p<0.05) in the maintenance parameters of the curve correction (loss of 27.5 ± 14.39o vs. 3.69 ± 3.68o) and increased pelvic tilt (PT) (increase of 12.25 ± 7.27o vs. 1.13 ± 1.93o). Conclusion: The perfect correction was obtained in 55% of cases and the significant loss of correction occurred only in cases of untreated mechanical complications.


JMS SKIMS ◽  
2014 ◽  
Vol 17 (2) ◽  
pp. 55-58
Author(s):  
Shams Ul Bari ◽  
Ajaz Ahmad Malik ◽  
Khurshid Alam Wani ◽  
Ajaz A Rather

Background: Chemical sphincterotomy is a novel way for treating patients of chronic anal fissure which avoids the risk of fecal incontinence associated with traditional surgical methods. Aims and objectives: The aim of this study was to compare the results of topical Diltiazem with topical Glyceril trinitrate in the management of chronic anal fissure. Methods: 71 patients in the age group of 15 - 61 years with chronic anal fissure were included in this prospective, randomized, double-blind trial over a period of two years with further follow up for one year. The patients were randomly allocated to either Diltiazem gel 2% (37 patients) or Glyceril trinitrate ointment 0.2% (34 patients) and were asked to use the treatment twice daily for 8 weeks. Each patient was reviewed every two weeks. Symptoms, healing, side effects and recurrence were compared using SPSS version 10 employing X2 test. A p-value below 0.05 was considered statistically significant. Results: Patients who received topical diltiazem (DTZ) showed statistically significant difference than those who were prescribed topical glyceril trinitrate in terms of symptoms, wound healing, side effects ( headaches) and recurrence (p=0.03 and 0.003 respectively). Healing occurred in 34 of 37 (92%) patients treated with Diltiazem after 6 weeks and 27 of 34 (80%) patients treated with Glyceril trinitrate after 8 weeks, which shows a significant difference in favour of Diltiazem (P < 0.001). The rest of the patients did not heal and underwent sphincterotomy (SILS). Headache occurred in all of the patients treated with Glyceril trinitrate but none of the patients treated with Diltiazem. Conclusion: Diltiazem gel was found to be better than Glyceril trinitrate ointment due to significantly higher healing rate and fewer side-effects. JMS 2014;17(2):55-58


2013 ◽  
Vol 5 (1) ◽  
pp. e2013050 ◽  
Author(s):  
Elihu Estey

Although “less intense” therapies are finding more use in AML, the principal problem in AML remains lack of efficacy rather than toxicity. Hence less intense therapies are of little use if they are not more effective as well as less toxic than standard therapies.. Assignment of patients to less intense therapies should be based on other factors in addition to age. Azacitidine and decitabine, the most commonly used less intense therapies in AML very probably produce better OS than best “supportive care” or “low-dose” ara-C. However improvement is relatively small when compared to expected life expectancy in the absence of disease. Accordingly, while azacitidine or decitabine should be considered the standards against which newer therapies are compared, continued investigation of potentially more effective therapies needs to continue. Better means for evaluating the large number of these therapies (and their combinations) are also needed.   


2018 ◽  
Vol 2018 ◽  
pp. 1-5 ◽  
Author(s):  
Stuardo Valenzuela ◽  
José M. Olivares ◽  
Nicolás Weiss ◽  
Dafna Benadof

The placement of immediate implants in the posterior sector is a widespread procedure where the success and survival rates are similar to those of traditional protocols. It has several anatomical challenges, such as the presence of interradicular bone septa that hinder a correct three-dimensional positioning of the implant and may compromise primary stability and/or cause damage of neighboring structures. The aim of this article is to present the treatment and the one-year clinical follow-up of a patient who received immediate implant placement using an interradicular bone-drilling technique before the molar extraction.


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