Less Treatment Related Mortality with Variable Intensity Conditioning Than Non-Myeloablative Conditioning in Unrelated and Related Adult Allogeneic Transplant Recipients.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 5051-5051
Author(s):  
Carolyn L. Bigelow ◽  
Stephanie Elkins ◽  
Cheryl L. Hardy ◽  
Joe Clark Files
Keyword(s):  
Acute Gvhd ◽  
Transplant Recipients ◽  
Allogeneic Transplant ◽  
Myeloablative Conditioning ◽  
Variable Intensity ◽  
Group 2 ◽  
One Year ◽  
Treatment Related Mortality ◽  
Related Mortality ◽  
Group 1

Abstract For the past four years our adult allogeneic transplant program has employed two alternative approaches to standard recipient conditioning, the use of non-myeloablative “mini” conditioning and variable intensity conditioning. We now report a retrospective comparison of relapse, day +100 and one year survival, engraftment and grades I-II and III-IV acute GVHD in unrelated as well as related recipients in these two preparative regimen groups. Patients with a variety of malignancies were not randomized to receive either non-myeloablative (Group 1) or variable intensity (Group 2) conditioning. Twenty patients with a median age of 49 (range 27–64, Group 1) and 17 patients also with a median age of 49 (range 24–58, Group 2) received either marrow or peripheral blood stem cells, usually with a 6/6 match grade; one recipient in Group 2 received a cord blood transplant (4/6 match). Group 1 regimen consisted of fludarabine 30 mg/m2 x 3d and TBI 200 cGY. Group 2 regimen consisted of Campath 20 mg/d either 5 or 3 days, fludarabine x 5d and melphalan 140 mg/m2 x 1d. GVHD prophylaxis was the same in both groups (standard dose cyclosporine or tacrolimus and MMF.) All patients received an adequate CD34+ cell dose and none of the products was manipulated. Relapse rate was 37% in Group 1 and 53% in Group 2. Day+100 survival and one year survival were 55% and 20%, respectively, in Group 1 vs 69% and 33% in Group 2. Only one patient in Group 2 had acute GVHD, grades I-II; none had grades III-IV. However, in Group 1, 6 patients had grades I-II and 8 had grades III-IV (40%). Graft failure occurred in five patients in Group 1, while no patients in Group 2 experienced it. We conclude, first, that in our program the application of variable intensity conditioning has been quite successful in unrelated transplant recipients, as well as in related. Second, significant treatment related mortality in the form of graft failure and acute GVHD occurred less frequently in recipients who received this conditioning than in those receiving non-myeloablative conditioning. This regimen requires some further modification to enhance its tumoricidal properties; however, its treatment-related toxicity is minimal and allows us to offer this therapy to patients with co-morbid conditions and older age.

Reduced Intensity Conditioning Regimens with Alemtuzumab Result in Low Treatment-Related Mortality and Low Relapse Rate in Unrelated and Related Allotransplantation Recipients.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5253-5253
Author(s):  
Carolyn L. Bigelow ◽  
Stephanie Elkins ◽  
Vincent Herrin ◽  
Cheryl L. Hardy ◽  
Joe Clark Files
Keyword(s):  
Overall Survival ◽  
Cord Blood ◽  
Relapse Rate ◽  
Acute Gvhd ◽  
Reduced Intensity Conditioning ◽  
Group 2 ◽  
Reduced Intensity ◽  
Treatment Related Mortality ◽  
Related Mortality ◽  
Group 1

Abstract From September, 2003, to July, 2006, 29 adult patients with hematological malignancies received reduced intensity conditioning (RIC) instead of standard conditioning for allogeneic transplant. The RIC regimens used in our program employ an ablative dose of melphalan and patients become cytopenic and transfusion-dependent. Patients were transplanted for a variety of malignancies including multiple myeloma, AML, CML, NHL, MDS, one renal cell carcinoma and one CLL. Eleven (38%) were in CR at time of transplant while 18 (62%) had relapsed or refractory disease. With a median follow-up of 8 mon (range 1–27 mon) we have completed a retrospective analysis of treatment-related mortality, d+100 and overall survival, engraftment, grades I-II and III-IV acute GVHD, and relapse rate. Two RIC regimens were used consecutively, consisting of either: fludarabine 30 mg/m2 × 5 d and melphalan 140 mg/m2 × 1 d in both groups, and Alemtuzumab 20 mg/d × 3d (Group 1) and × 2d (Group 2). Group 1 was 10 patients and Group 2 was 19. Median age was 53, range 24–66. Median age of Group 1 was 47 (range 24–59) and of Group 2 was 54 (range 34–66). Seventeen patients received MUD products (4 in Group 1 and 13 in Group 2) and twelve received MRD products. Cell source was bone marrow (8 patients), PBSC (18 patients) cord blood (2 patients) and combined products in 2 transplants (2 patients). All patients received an adequate C34+ cell dose or TNC dose (cord blood) and none of the products was manipulated. HLA matches were 6/6 antigen matches or better in Group 1 except for a 4/6 allele matched cord blood. All products were 6/6 or better in Group 2 except for two who were 8/10 allele matches, one 5/6 antigen match and a 4/6 serological match (cord). GVH prophylaxis was tacrolimus tapering after d+100 and MMF tapering after d+30. All patients except one achieved a WBC graft, and the ANC >500/dl occurred at a median of 12 d (range 10–48 d). The graft failure was a CML in Group 2 who received the 8/10 marrow product followed by a cord blood transplant that also failed. Eight (28%) of the cohort developed acute GVHD grades I-II (one from Group 1, 7 from Group 2) and two developed grades III-IV (one from each group). Five (17%) went on to develop chronic GVHD (one from Group 1, 4 from Group 2). Relapse or disease progression occurred in only 38% (4 in Group 1 and 7 in Group 2). Seven from the cohort were treated with one or more DLI to accelerate conversion to full chimerism and two from each group developed acute GVHD following the treatment. Incidence of treatment-related mortality by d+100 was low at 21%, with two patients in Group 1 and 4 in Group 2. Overall survival was 41%, 3 in Group 1 and 9 in Group 2. Most surprising was the overall survival of MUD patients, 41%, all from Group 2, which is higher than that reported by NMDP for unrelated transplants. In summary, we plan to continue accruing patients to both Alemtuzumab dosing regimens in order to compare the incidence of GVHD and relapse rate in each treatment arm. We conclude that a RIC regimen utilizing Alemtuzumab allows for a relatively low treatment-related mortality (21%), a low relapse rate (38%) and a superior survival (41%), especially in MUD transplants.

Addition of More Immunosuppressive Drugs As Graft-Versus-Host Disease (GVHD) Prophylaxis Does Not Improve Gvhd Outcomes in Reduced Intensity Allogeneic Hematopoietic Cell Transplantation from Unrelated Donors

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5786-5786
Author(s):  
Mauricette Michallet ◽  
Mohamad Sobh ◽  
Fiorenza Barraco ◽  
Xavier Thomas ◽  
Marie Balsat ◽  
...  
Keyword(s):  
Acute Gvhd ◽  
Chronic Gvhd ◽  
Immunosuppressive Drugs ◽  
Advisory Committees ◽  
Gvhd Prophylaxis ◽  
Unrelated Donors ◽  
Group 3 ◽  
Group 2 ◽  
Related Mortality ◽  
Group 1

Abstract Background: Reduced-intensity conditioning (RIC) regimens have led to a dramatic reduction of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The concept of RIC is to deliver adequate immunosuppression with manageable graft-versus-host disease (GVHD) and the eventual development of a potent graft-versus-leukemia effect. Nevertheless, GVHD prophylaxis remains a challenging task after allo-HSCT. While the combination of cyclosporine A (CsA) and a short course of methotrexate (Mtx) after transplantation is considered as the gold standard for GVHD prophylaxis after conventional myeloablative allo-HSCT from HLA-identical siblings, there is no consensus on the optimal preventive GVHD prophylaxis after RIC allo-HSCT. On the other hand, recent and ongoing studies are evaluating a promising GVHD prophylaxis strategy using post-transplantation cyclophosphamide (PTCy). The aim of this study is to evaluate the impact of different GVHD prophylaxis used after RIC allo-HSCT in patients receiving peripheral blood stem cells (PBSC) from unrelated donors for hematological malignancies. Patients and methods: We evaluated 127 consecutive patients with hematological malignancies who received RIC allo-HSCT and were followed in our center between January 2008 and January 2016; 74 (58%) were males, median age was 58 years (range: 18-70), 52 (41%) had acute myeloid leukemia, 36 (28%) myelodysplastic syndrome, 12 (10%) myeloproliferative syndrome, 9 (7%) Non-Hodgkin lymphoma, 9 (7%) chronic lymphocytic leukemia, 6 (5%) multiple myeloma and 3 (2%) chronic myeloid leukemia. At transplantation, 65 (51%) patients were in complete response (CR) or chronic phase (CP). RIC regimen consisted on fludarabine, intermediate doses of IV busulfan and anti-thymocyte golbulins (ATG) (Thymoblobulin) in 56 (44%) patients and a sequential FLAMSA regimen in 71 (56%) patients and who also received similar doses of ATG (Thymoglobulin). PBSC donors were 10/10 HLA matched in 81 (64%) patients and 9/10 HLA mismatched in 46 (36%) patients. Patients were divided according to GVHD prophylaxis into 3 groups: group 1 consisted on CsA alone with 23 (18%) patients, group 2 include patients who received either CsA + mycophenolate mofetil (MMF), n= 64 (50%) or CsA + Mtx, n= 20 (16%) or CsA + cyclophosphamide n= 5 (4%), and group 3 included patients receiving CsA + MMF + tacrolimus n= 15 (12%) patients. Results: After transplantation, all patients in group 1 engrafted after a median of 17 (3-25) days, 81/89 (91%) engrafted in group 2 after a median of 17 (5-58) days and 14/15 (94%) engrafted in group 3 after a median of 16 (9-24) days. We did not observe any significant impact of the type of GVHD prophylaxis on the 100-day incidence of grade II to IV acute GVHD, which occurred in 6/15 (40%), 34/81 (42%) and 7/14 (50%) for the groups 1, 2 and 3 respectively (p=0.18). Grade III-IV acute GVHD occurred in 3 (20%), 24 (29%) and 5 (33%) in the three groups respectively (p=0.11). Similarly, cumulative incidence of 1 year chronic GVHD was not different between groups 1, 2 and 3 reaching 46%, 43% and 46% respectively (p=0.6) among them 3/15 (20%), 18 (22%) and 3/14 (21%) patients had an extensive form. After a median follow-up of 22 months for surviving patients, although there was no significant difference between the three groups in terms of non-relapse mortality, we observed more infection-related mortality with 45% and 83% in groups 2 and 3 respectively compared to 47% in group 1. The cumulative incidence of relapse at 2 years was 22%, 31 and 26% for the three groups respectively (p=0.23). Overall survival rates at two years were 43%, 31% and 44 % for groups 1, 2 and 3 respectively (p=0.42). The multivariate analysis taking into account the type of disease, donor HLA matching, disease status at transplantation, type of RIC and the type of prophylaxis, showed that the incidence of acute GVHD was influenced only by the use of FLAMSA regimen from mismatched donors, HR= 2.2 [1.3-3.1], p=0.05 which had also the same impact on the occurrence of chronic GVHD. Conclusion: Despite its limitations and the need for prospective randomized studies, the results of our study suggest that in the RIC allo-HSCT from unrelated donors, the different GVHD prophylaxis associations lead to similar GVHD outcomes. Patients with more immunosuppressive drugs had a higher incidence of infection-related mortality and in which PTCy could be a better option. Disclosures Nicolini: BMS: Consultancy, Honoraria; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Ariad: Honoraria, Membership on an entity's Board of Directors or advisory committees.

scholarly journals Intracoronary Injection of Autologous CD34+ Cells Improves One-Year Left Ventricular Systolic Function in Patients with Diffuse Coronary Artery Disease and Preserved Cardiac Performance—A Randomized, Open-Label, Controlled Phase II Clinical Trial

2020 ◽  
Vol 9 (4) ◽  
pp. 1043 ◽  
Author(s):  
Pei-Hsun Sung ◽  
Yi-Chen Li ◽  
Mel S. Lee ◽  
Hao-Yi Hsiao ◽  
Ming-Chun Ma ◽  
...  
Keyword(s):  
Systolic Function ◽  
Coronary Intervention ◽  
Left Ventricular ◽  
Diffuse Coronary Artery Disease ◽  
Cd34 Cells ◽  
Group 2 ◽  
Artery Disease ◽  
One Year ◽  
Lv Systolic Function ◽  
Group 1

This phase II randomized controlled trial tested whether intracoronary autologous CD34+ cell therapy could further improve left ventricular (LV) systolic function in patients with diffuse coronary artery disease (CAD) with relatively preserved LV ejection fraction (defined as LVEF >40%) unsuitable for coronary intervention. Between December 2013 and November 2017, 60 consecutive patients were randomly allocated into group 1 (CD34+ cells, 3.0 × 107/vessel/n = 30) and group 2 (optimal medical therapy; n = 30). All patients were followed for one year, and preclinical and clinical parameters were compared between two groups. Three-dimensional echocardiography demonstrated no significant difference in LVEF between groups 1 and 2 (54.9% vs. 51.0%, respectively, p = 0.295) at 12 months. However, compared with baseline, 12-month LVEF was significantly increased in group 1 (p < 0.001) but not in group 2 (p = 0.297). From baseline, there were gradual increases in LVEF in group 1 compared to those in group 2 at 1-month, 3-months, 6-months and 12 months (+1.6%, +2.2%, +2.9% and +4.6% in the group 1 vs. −1.6%, −1.5%, −1.4% and −0.9% in the group 2; all p < 0.05). Additionally, one-year angiogenesis (2.8 ± 0.9 vs. 1.3 ± 1.1), angina (0.4 ± 0.8 vs. 1.8 ± 0.9) and HF (0.7 ± 0.8 vs. 1.8 ± 0.6) scores were significantly improved in group 1 compared to those in group 2 (all p < 0.001). In conclusion, autologous CD34+ cell therapy gradually and effectively improved LV systolic function in patients with diffuse CAD and preserved LVEF who were non-candidates for coronary intervention (Trial registration: ISRCTN26002902 on the website of ISRCTN registry).

scholarly journals Effect of anterior capsular polishing on the incidence of YAG capsulotomy

2016 ◽  
Vol 11 (3) ◽  
Author(s):  
Muhammad A Ahad ◽  
Mohammad Rashad Qamar ◽  
Sameh K Hindi ◽  
Martin N Kid
Keyword(s):  
Outcome Measure ◽  
Early Postoperative Period ◽  
Controlled Study ◽  
Control Group ◽  
Anterior Capsule ◽  
Main Outcome Measure ◽  
Group I ◽  
Group 2 ◽  
One Year ◽  
Group 1

Purpose: To study the effect of anterior capsule polishing during phacoemulsification on the incidence of post operative YAG laser capsulotomy. Method: A retrospective controlled study of 159 patients who underwent uncomplicated phacoemulsification with anterior capsular polishing between October 1998 and March 2000. 169 age matched patients who underwent phacoemulsification but without anterior capsule polishing served as controls. Main outcome measure: Incidence of visually significant YAG capsulotomy, which improved the Snellen acuity for more than 1 line or at least 1 line with subjective improvements in symptoms. Results: 2.51 % of patients with anterior capsular polishing (Group 1) had YAG capsulotomy compared to 7.1% of patients in control group at one year. However, after two years, 11.3% of patients in Group I had YAG capsulotomy compared to 12.4% in Group 2. Conclusion: Anterior capsular polishing during cataract surgery may delay the opacification of posterior capsule during the early postoperative period. But does not decrease the incidence of YAG capsulotomy after two years.

scholarly journals Pulsed Radiofrequency for Chronic Inguinal Neuralgia

2015 ◽  
Vol 2;18 (2;3) ◽  
pp. E147-E155
Author(s):  
Yasser M. Amr
Keyword(s):  
Pain Relief ◽  
Nerve Root ◽  
Small Sample ◽  
Pulsed Radiofrequency ◽  
Group 2 ◽  
One Year ◽  
The One ◽  
Inguinal Neuralgia ◽  
Group 1

Background: Chronic inguinal neuralgia has been reported after inguinal herniorrhaphy, caesarean section, appendectomy, and trauma to the lower quadrant of the abdomen or inguinal region. Objectives: This study was designed to evaluate the efficacy of pulsed radiofrequency in management of chronic inguinal neuralgia. Study Design: Randomized, double-blind controlled trial. Setting: Hospital outpatient setting. Methods: Twenty-one patients were allocated into 2 groups. Group 1 received 2 cycles of pulsed radiofrequency (PRF) for each nerve root. In Group 2, after stimulation, we spent the same time to mimic PRF. Both groups received bupivacaine 0.25% + 4 mg dexamethasone in 2 mL for each nerve root. Visual Analogue Scale (VAS) was assessed. Duration of the first block effective pain relief was reported. Repeated PRF blockade was allowed for any patient who reported a VAS > 30 mm in both groups during the one year follow-up period. The number and duration of blocks were reported and adverse effects were also reported. Results: Significantly longer duration of pain relief was noticed in Group 1 (P = 0.005) after the first block, while the durations of pain relief of the second block were comparable (P = 0.59). In Group 1 the second PRF produced pain relief from the twenty-fourth week until the tenth month while in Group 2, pain relief was reported from the sixteenth week until the eighth month after the use of PRF. All patients in Group 2 received 3 blocks (the first was a sham PRF) during the one year follow-up period. Meanwhile, 2 PRF blocks were sufficient to achieve pain relief for patients in Group 1 except 4 patients who needed a third PRF block. No adverse events were reported. Limitations: Small sample size. Conclusion: For intractable chronic inguinal pain, PRF for the dorsal root ganglion represents a promising treatment modality. Key words: Radiofrequency, chronic, inguinal neuralgia

scholarly journals The difference in outcome of patients with open inguinal hernia repair by using delayed absorbable sutures instead of non-absorbable sutures for mesh fixation

2020 ◽  
Vol 8 (1) ◽  
pp. 24
Author(s):  
Ali G. Mohammed Redha ◽  
Adil A. Jaber ◽  
Aqeel M. Nasser
Keyword(s):  
Hernia Repair ◽  
Mesh Fixation ◽  
Good Alternative ◽  
P Value ◽  
Absorbable Sutures ◽  
Significant Difference ◽  
The Difference ◽  
Group 2 ◽  
One Year ◽  
Group 1

Background: Different methods are found for mesh fixation in inguinal hernioplasty both open and laparoscopic. In open technique, sutures have been the method of choice for their reduced costs and surgeons’ habits. Whether absorbable instead of non-absorbable sutures can be used still a matter of debate in view of hernia recurrence and post-operative complications.Methods: This is a prospective done on 158 male patients with uncomplicated unilateral inguinal hernias. Two groups of 69 patients were evaluated after periods up to 1 year after open hernioplasty by using delayed absorbable sutures in one group (group 1) and non-absorbable sutures in the other group (group 2) for fixation of mesh.Results: In spite of a noticeable reduction in complication in the group 1 in term of number and percentage when compared with group 2 mainly chronic pain, there is no significant difference (p value>0.05). However, these results are associated with zero recurrence in both groups during a period of one year follow up.Conclusions: Delayed absorbable sutures are good alternative of non-absorbable sutures in open mesh hernia repair associated with less complications and almost no increase in chance of recurrence.  

scholarly journals Drug-eluting balloon treatment in femoropopliteal in-stent restenosis of different lengths

2020 ◽  
Vol 28 (3) ◽  
pp. 460-466
Author(s):  
Berkan Özpak
Keyword(s):  
Stent Restenosis ◽  
Significant Difference ◽  
Stent Length ◽  
Drug Eluting ◽  
Group 3 ◽  
Group 2 ◽  
Drug Eluting Balloon ◽  
One Year ◽  
In Stent Restenosis ◽  
Group 1

Background: In this study, we present one-year results of drug-eluting balloon treatment of femoropopliteal in-stent restenosis. Methods: A total of 62 patients (48 males, 14 females; mean age 64.2±9.1 years; range, 54 to 81 years) who underwent drug-eluting balloon stenting for femoropopliteal in-stent restenosis between August 2013 and October 2017 were included in the study. The patients were classified into three groups based on the narrowing length of stenosis in the stents. Group/Class 1 (n=17): narrowing <1/2 of the stent length; Group/Class 2 (n=22): narrowing >1/2 of the stent length, not totally occluded; and Group/Class 3 (n=23): totally occluded. In-stent restenosis was treated with drug-eluting balloon treatment. Results: There was a significant difference among all classes in terms of in-stent restenosis. The length of stenosis was a predictor for in-stent restenosis. The mean stent length was 107.7±24.6 mm in Group 1, 164.6±17.9 mm in Group 2, and 180±19.3 mm in Group 3. For non-occluded in-stent restenosis, restenosis rate at one year after balloon angioplasty was 47.1% in Group 1, 86.4% in Group 2, and 95.7% in Group 3. Femoropopliteal bypass was performed in five patients in whom treatment failed. None of the patients required amputation. Conclusion: The length of in-stent restenosis in the femoropopliteal arterial stents is an important predictor for recurrent stenosis, when re-flow is achieved with drug-eluting balloons.

scholarly journals Short versus standard PFN outcome analysis in unstable intertrochantric fracture

2018 ◽  
Vol 4 (5) ◽  
pp. 747
Author(s):  
Pravin Kumar Jangde ◽  
Anant Kumar Singh
Keyword(s):  
Hip Fractures ◽  
Trochanteric Fracture ◽  
The Elderly ◽  
Outcome Analysis ◽  
Femoral Canal ◽  
Femoral Nail ◽  
Group 2 ◽  
One Year ◽  
Group B ◽  
Group 1

<p class="abstract"><strong>Background:</strong> Hip fractures in the elderly are frequent. Intertrochanteric hip fractures account for approximately half of all hip fractures in the elderly; of these, from 50% to 60% are classified as unstable. In our study we tried to compare outcome of unstable trochantric fracture in terms length of PFN (180 vs 240 mm).</p><p class="abstract"><strong>Methods:</strong> 80 patients of unstable trochanteric fracture were randomly allotted to 2 groups who were treated with closed reduction and internal fixation with proximal femoral nail of size 180 mm(group A) and 240mm (group B). Patients in both the group were compared right from the fracture configuration till the one year post-operative period.<strong></strong></p><p class="abstract"><strong>Results:</strong> In the study of 80 patients there were 18 males (45%) and 22 females (55%) in group 1, and 23 male (57%) and 17 female (42.5%) in group 2. Group 1 patient had a better range of movements than group 2. Femoral canal impingement was present in 6 (15%) of patients of group 1 and 28(70%) patients of group 2 showed femoral canal impingement.</p><p class="abstract"><strong>Conclusions:</strong> There are very few studies which compare the length of PFN to the outcome. The standard PFN group presented with complications like femoral nail impingement and hence more thighs pain and less range of movements even after one year of follow up. We conclude that for Indian group of population who have a relatively short femora gives a better result with a shorter length implant.</p>

Sign in / Sign up

Export Citation Format

Share Document