Low-Dose Prednisone Decreases the Severity but Not the Frequency of Lenalidomide Associated Tumor Flare Feaction (TFR) in Chronic Lymphocytic Leukemia (CLL) Patients.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4987-4987
Author(s):  
Laurie Musial ◽  
Kena C. Miller ◽  
Amy Tonelli ◽  
Rami Manochakian ◽  
Swaminathan Padmanabhan ◽  
...  
Keyword(s):  
Low Dose ◽  
Oral Prednisone ◽  
Single Agent ◽  
Lymphocytic Leukemia ◽  
Common Side Effect ◽  
Low Grade ◽  
Group A ◽  
Considerable Morbidity ◽  
Group B ◽  
Dose Prednisone

Abstract Introduction: Lenalidomide (L) is clinically active in pts with CLL. TFR is a common side effect of L, unique to CLL pts and is characterized by tender enlargement of lymph nodes (LN), spleen and/or liver with low-grade fever, rash and/or increase in white blood cell count. Onset is usually with 24 hours of first dose and it is rarely seen after the 1st cycle. The underlying etiology of TFR remains undetermined though clinical presentation is suggestive of an immune activation phenomenon. Diagnosis, management and effective prophylaxis of TFR is crucial for the pt care as it is associated with considerable morbidity and mimics disease progression. We investigated the effectiveness of low-dose prednisone prophylaxis in CLL pts treated with L. Method & Results: Forty five pts (36 male, 9 female), median age 64 years (range 42–75) with rel/ref CLL were enrolled on a phase II clinical trial. Single agent L (max. dose 25mg/day) was given to all pts enrolled. No prophylaxis was given to the first 29 pts (group A). Subsequently 16 pts (group B) were treated with prednisone 20mg PO QD × 5 days followed by 10mg PO QD × 5 days, starting day 1 of treatment. Median age was 64 years (range 42–75) with 36M and 9F. Stage III/IV disease was noted in 64% (n=18) of the pts. Twenty four (83%) pts in group A and 13 (81%) in group B developed TFR with > grade II TFR was seen in 31% and 6%, respectively. Among pts with TFR, 4 achieved complete remission (CR) and had grade > 2 reaction vs. 19 pts with a < partial remission who had a median of grade 1 (range 1–2) TFR. Conclusion: Although the sample size investigated is small, we observed that use of oral prednisone prophylaxis decreased the severity but not the overall incidence of TFR. We therefore recommend that low-dose prednisone be considered for lenalidomide associated TFR in patients with CLL.

Combined Antithrombotic Therapy but Not Single-Agent Therapy with Low-Dose Aspirin Deteriorated Platelet Activation in Patients with Antiphospholipid Syndrome (APS).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4002-4002 ◽  
Author(s):  
Masahide Yamazaki ◽  
Yasuko Kadohira ◽  
Eriko Morishita ◽  
Hidesaku Asakura ◽  
Shinji Nakao
Keyword(s):  
Platelet Activation ◽  
Antiphospholipid Syndrome ◽  
Plasma Levels ◽  
Antithrombotic Therapy ◽  
Low Dose ◽  
Single Agent ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Group A ◽  
Group B

Abstract Antiphospholipid syndrome (APS) is one of autoimmune disorders characterized with recurrent thromboses. It is considered that plasma levels of D-dimer and prothrombin fragment 1+2 (F1+2) could reflect hypercoagulable state in APS patients and those monitoring may be useful for a predictor of venous thromboses. In contrast, the estimation of platelet activation is difficult. Recently, plasma levels of platelet-derived microparticle (PDMP), which released from activated platelets, could be measured using ELISA supplied from JIMRO Co. JAPN (“JIMRO test PDMP”). We previously presented that plasma levels of PDMP were significantly elevated in APS-patients with arterial thromboses and that could reflect platelet activated condition in vivo. To evaluate the preventory effect of thromboses and the inhibitory effects for platelet activation by several kinds of antithrombotic agents in APS, 30 APS patients with cerebral infarctions were randomly treated with low-dose aspirin alone (Group A, n=10), aspirin plus warfarin (Group B, n=10), or aspirin plus cirostazole (Group C, n=10). Their plasma PDMP levels were measured using “JIMRO test PDMP” (JIMRO Co., JAPAN) before and after antithromboitic treatment on a regular schedule, and MRI brain scans were also underwent in every six months. Plasma PDMP levels in group B and group C significantly decreased by combined antithrombotic therapy (18.0 ± 7.1 to 13.0 ± 8.2 U/mL, 17.8 ± 6.7 to 12.4 ± 7.8 U/mL, p < 0.03 and < 0.01, respectively) but not in Group A (18.2 ± 8.1 to 17.9 ± 9.1, NS). Brain MRI revealed worsening of lacuna infarctions in only one patient in Group A. No serious adverse effects were shown in any patients. These findings suggest that single use of aspirin could be enough for prevention of arterial thrombosis in APS patients and that plasma PDMP levels may be useful for an indicator of antiplatelet therapy.

CONVENTIONAL VERSUS THREE-DIMENSIONAL CONFORMAL EXTERNAL RADIOTHERAPY IN CANCER CERVIX: A COMPARATIVE STUDY FOR COMPLIANCE, RESPONSE AND TOXICITY

2016 ◽  
Vol 1 (2) ◽  
Author(s):  
Richa Gupta ◽  
Piyush Kumar ◽  
D. P. Singh ◽  
Arvind Kumar Chauhan ◽  
Kamal Sahni
Keyword(s):  
Clinical Response ◽  
Three Dimensional ◽  
Common Side Effect ◽  
P Value ◽  
High Dose ◽  
Cancer Cervix ◽  
Conventional Radiotherapy ◽  
Radiation Fields ◽  
Group A ◽  
Group B

INTRODUCTION: Cervical cancer is the second most frequent cancer among Indian women. Radiotherapy is the cornerstone of treatment in all its stages. Three-dimensional conformal radiotherapy (3DCRT) combines multiple radiation fields to deliver precise dose of radiation to the affected area. Tailoring each of the radiation fields to focus on the tumor delivers a high dose of radiation to the tumor and avoids nearby healthy tissue. The present study is done to compare conventional radiotherapy versus 3DCRT in cancer cervix for compliance, clinical response and toxicity. MATERIAL AND METHODS: Fifty patients were enrolled and randomised into two radiotherapy plans with radical intent - Group A treated by conventional radiotherapy and group B treated by 3DCRT. Concurrent cisplatin was delivered on weekly (35mg/m2) or tri-weekly (75mg/m2) basis during external beam Radiotherapy and was followed by High Dose Radiotherapy Brachytherapy. Clinical response and complication assessment were evaluated.Collected data was analyzed using standard statistical methods and softwares to calculate level of significance using “p” value by chi square test. RESULTS: In this study mean age of the patients was 48 years (26-67 years). The anemia was the most common side effect seen in both groups (96% vs 88%, p=0.29). Neutropenia was more in group B (36% vs 44%, p= 0.56). Lower GI toxicity was seen only in patients in group A (20% vs 0%, p=0.018). In follow up there were no significant early rectal and bladder reactions in both groups and 2 patients in each group had late rectal reactions of grade I and II (p= 0.312). No significant skin, bladder and small intestinal toxicity were seen in both groups. CONCLUSION: Conventional radiotherapy gives equally efficacious response though accompanied by toxicities which were acceptable.

Efficacy and safety of nivolumab and trabectedin in pretreated patients with advanced soft tissue sarcomas (STS): Preliminary results of a phase II trial of the German Interdisciplinary Sarcoma Group (GISG-15, NitraSarc) for the non-L sarcoma cohort.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11545-11545
Author(s):  
Daniel Pink ◽  
Dimosthenis Andreou ◽  
Anne Flörcken ◽  
Alexander Golf ◽  
Stephan Richter ◽  
...  
Keyword(s):  
Phase Ii ◽  
Single Agent ◽  
Primary Efficacy ◽  
Primary Efficacy Endpoint ◽  
Efficacy And Safety ◽  
Disease Stabilization ◽  
Group A ◽  
Pretreated Patients ◽  
Grade 3 ◽  
Group B

11545 Background: Single-agent PD-1 inhibitors have modest activity in the treatment of most STS. Potential strategies to increase efficacy include combination therapies targeting the tumor microenvironment. Considering that apart from direct growth inhibition and death of malignant cells, trabectedin (Tr) also induces macrophage depletion and/or different immunologic effects, suggesting a possible synergistic effect of combined Tr plus anti-PD-1 treatment. We therefore aimed to evaluate the efficacy and safety of combined Tr and nivolumab (Ni) as a second-line treatment in STS. Methods: The prospective, explorative, two group, non-randomized phase II NiTraSarc trial enrolled pretreated patients (pt) with advanced STS (Group A: lipo- or leiomyosarcomas, Group B: non-L-sarcomas). Pt were initially treated with 3 cycles of Tr 1.5 mg/m2, followed by the combination of Tr 1.5 mg/m2 + Ni 240 mg (“late combination cohort” (LCC)) for up to 16 cycles. After positive results of a preplanned interim analysis, pt received the combination therapy starting with cycle 2 (“early combination cohort” (ECC)). 92 pt were recruited to the trial (55 in Group A, 37 in Group B). Primary efficacy endpoint is progression-free survival rate after 6 months (PFSR6) according to RECIST v.1.1. This is a first analysis of the primary efficacy endpoint in Group B based on a modified intention-to-treat (mITT) population of evaluable 36 pt: 23 and 13 pt from the LCC and ECC, respectively. Results: The most common Group B subtypes comprised undifferentiated pleomorphic/not otherwise specified sarcoma (UPS/NOS, 13pt) and fibromyxoid sarcoma (FMS, 6pt). After a median follow-up of 5 months (m) PFSR6 was 13.9% for all pt, 8.7% in LCC and 23.1% in ECC. Median duration of disease stabilization (DoDS) was 4m in all pt, the LCC and the ECC. Two pt had a partial response (PR), 10 had disease stabilization (SD), while 13 pt progressed, and 11 had missing data. By subtype: PR- UPS/NOS=2 (DoDS 12.7m/12.5m). SD: UPS/NOS=3, epithelioid=2, synovial=2, FMS=1, fibrosarcoma=1, other=1. All 36 pt experienced at least one adverse event (AE) reaching a total of 579 AEs, 141 (24.4%) of which were considered to be grade ≥3 treatment-related AEs. The main grade ≥3 AEs were: leukopenia (47.2% of pt), neutropenia (41.7% of pt), thrombocytopenia (33.3% of pt), increased ALT (30.6% of pt), and anemia (27.8% of pt). Conclusions: Tr+Ni was well tolerated and showed activity in at least some patients with non-L-sarcomas (mostly UPS/NOS) especially in the ECC. Analyses of the collected data, including PD-L1 expression profile, with the goal to establish whether Tr+Ni should be further pursued in these patients, are ongoing. ClinicalTrials.gov Identifier: NCT03590210; EudraCT: 2017-001083-38. Clinical trial information: NCT03590210.

Immunity to Diphtheria, Pertussis, Tetanus, and Poliomyelitis in Children with Acute Lymphocytic Leukemia After Cessation of Chemotherapy

PEDIATRICS ◽  
1981 ◽  
Vol 67 (2) ◽  
pp. 222-229 ◽  
Author(s):  
A. van der Does-van den Berg ◽  
J. Hermans ◽  
J. Nagel ◽  
G. van Steenis
Keyword(s):  
Acute Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
First Year ◽  
Healthy Children ◽  
Healthy Control ◽  
Antibody Titers ◽  
Group A ◽  
One Year ◽  
Group B ◽  
Antibody Levels

Antibody titers to diphtheria, pertussis, tetanus, and poliomyelitis (types I to III) were measured in previously vaccinated children with acute lymphocytic leukemia in remission after cessation of therapy. The response to revaccination one year after therapy was stopped was also studied. The patients' antibody titers were compared with those of healthy children, matched for age and sex. Two groups of patients were studied: one group (group A, N = 30) was given two drugs (6-mercaptopurine, methotrexate); the other group (group B, N= 19) was given three drugs (6-mercaptopurine, methotrexate, and cyclophosphamide) for maintenance treatment. In general, the patients' antibody titers were lower than those of healthy children, but in most patients they were still at levels considered to be protective. No significant differences in antibody levels between the two patient groups were found. A spontaneous rise in antibody titers in the first year after termination of therapy was not observed. After revaccination the rise in antibody titers was correlated with preexisting antibody titers in the same way in patients as in healthy children, and the antibody titers in patients and in healthy control subjects were on roughly the same level.

Bruton tyrosine kinase inhibitors (BTKi) therapies in chronic lymphocytic leukemia (CLL): Review of multiple trials data for incidence of lymphocytosis and designation of partial response with lymphocytosis (PRL).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19502-e19502
Author(s):  
Jayant Narang ◽  
Christiana Caplan ◽  
Katarina Ludajic ◽  
Sambit Ray ◽  
Surabhi Bajpai ◽  
...  
Keyword(s):  
Partial Response ◽  
Kinase Inhibitors ◽  
Absolute Lymphocyte Count ◽  
Lymphocytic Leukemia ◽  
Additional Parameter ◽  
True Incidence ◽  
Overall Response ◽  
Group A ◽  
Definition Of ◽  
Group B

e19502 Background: In trials with BTKi, lymphocytosis alone may not be a sign of progression but rather treatment related redistribution of lymphocytes from tissues into the peripheral blood (Cheson et al 2012). This observation was later incorporated in iwCLL 2018 criteria. However, no clear details were provided on how to assess lymphocytosis along with other parameters to derive an overall timepoint response (OTR) in a clinical trial setting. While PRL is a response category used to assess lymphocytosis in many clinical trials, it has not been defined in iwCLL 2018. Furthermore, iwCLL 2018 defines Absolute Lymphocyte Count (ALC) progression (PD) as an increase of ALC ≥ 50% compared to baseline whereas conventionally progression is defined in comparison to nadir, which may lead to under reporting of ALC PD. Methods: Data from multiple (8) phase II/III CLL trials with BTKi (frontline and relapsed/refractory setting), were retrospectively analyzed. Subjects with a post baseline (post-BL) timepoint (TP) were analyzed for the incidence of ALC PD and an OTR designation of PRL, PD and other non-PD assessments (Stable Disease (SD), Non-PD and Unknown (UNK)). Results: We identified 1976 subjects with a total of 17134 post BL TPs. There were 1182 TPs (6%) with ALC PD. Out of these TPs with ALC PD, 497 TPs had OTR of PRL (42% TPs with ALC PD), 365 TPs (31%) were assessed as non-PD and 320 (27%) TPs were assessed as PD. 104 TPs (33%) of subjects with OTR of PD had at least one additional parameter driving PD. Thus, ALC PD is a common occurrence with BTKi and in line with the Cheson 2012 guidance, ALC PD alone should not be considered as overall progression. We propose that initial ALC PD with BTKi should not be considered a sign of progression but rather a treatment effect and should be assessed as PRL. However, PRL should only be assessed if Partial Response (PR) is achieved in at least 2 other involved iwCLL group A parameters (nodes, liver or spleen) and 1 group B parameter (hemoglobin or platelets). An initial decrease/normalization of the ALC compared to baseline with a subsequent progression compared to nadir, may be considered true progression in a setting of continued BTKi. If only one other group A parameter is involved and is PR with associated ALC PD, SD may be a more appropriate overall response than PRL. Conclusions: ALC PD and PRL are common in BTKi, but there is a need for standardization of the definition of ALC PD and its role in determination of OTR of PRL. We propose that ALC PD should be assessed by comparing ALC with nadir and not baseline. If PRL is assigned only when PR is met by other criteria along with ALC PD, PRL could be a part of determining Overall response rate (ORR) in protocols. Future prospective studies are needed to estimate the true incidence of ALC PD and its impact on ORR with BTKi as well as other agents which induce lymphocytosis.

scholarly journals Low Dose Bupivacaine plus Fentanyl in Subarachnoid Block for Caesarean Section

2016 ◽  
Vol 4 (1) ◽  
pp. 24-30
Author(s):  
Nasir Uddin Ahmed ◽  
Masuda Islam Khan ◽  
Aynul Islam Khan ◽  
AKM Akhtaruzzaman
Keyword(s):  
Blood Pressure ◽  
Caesarean Section ◽  
Systolic Blood Pressure ◽  
Postoperative Analgesia ◽  
Low Dose ◽  
Hyperbaric Bupivacaine ◽  
Haemodynamic Stability ◽  
Group A ◽  
Group B ◽  
Mean Time

Background: Spinal anaesthesia induced hypotension, a common problem during caesarean section, is associated with maternal nausea and vomiting and the risk of neonatal acidosis. Low dose local anaesthetic combined with opioids spinal anaesthesia better preserves maternal haemodynamic stability, resulting in equally efficacious anaesthesia.Objectives: To investigate whether this synergistic action could be used to provide effective anaesthesia while preventing hypotension during caesarean operation.Materials and method: This prospective study included 60 pregnant mothers scheduled for caesarean operation who were then divided into two groups (thirty in each). Group-A received a spinal injection of 12.5 mg of standardized 0.5% hyperbaric bupivacaine and group-B received 8 mg of 0.5% hyperbaric bupivacaine with 20 ?gm fentanyl. Hypotension was defined as the systolic blood pressure drops below 90 mm of Hg or a decrease of systolic blood pressure 25% from pre anaesthesia level and hypotension was treated with a bolus of 5 to 10 mg of intravenous ephedrine. The quality of anaesthesia and postoperative analgesia were evaluated.Results: The mean time required to reach peak sensory level was earlier in group-B than group-A and was statistically significant (p<0.05). The decrease in systolic blood pressure in group-A was significantly more than group-B (p<0.05) and vasopressor requirement was also significantly more in group-A compared to group-B (p<0.05). Mean time of two segment regression of sensory analgesia and complete sensory recovery was significantly early in group-B (p<0.05). Duration of motor recovery in group-B was significantly earlier (p<0.05). The duration of effective analgesia was significantly more in group-B (p<0.05).Conclusion: Low dose Bupivacaine with fentanyl provided excellent intraoperative sensory and motor blockade, haemodynamic stability, and effective postoperative analgesia for caesarean delivery.Delta Med Col J. Jan 2016 4(1): 24-30

Phase II study of gemcitabine and oxaliplatin in patients with recurrent ovarian cancer: an Australian and New Zealand Gynaecological Oncology Group study

2007 ◽  
Vol 17 (2) ◽  
pp. 359-366 ◽  
Author(s):  
P. Harnett ◽  
M. Buck ◽  
P. Beale ◽  
A. Goldrick ◽  
S. Allan ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Single Agent ◽  
Recurrent Ovarian Cancer ◽  
Ca 125 ◽  
Platinum Sensitive ◽  
Best Response ◽  
Platinum Based Chemotherapy ◽  
Group A ◽  
Intent To Treat ◽  
Group B

Gemcitabine and oxaliplatin have shown single-agent activity in relapsed ovarian cancer. This combination was used to determine response rates, time-to-event efficacy measures, and toxicity in patients with recurrent ovarian cancer. Patients with prior platinum-based chemotherapy who had measurable lesions and/or elevated CA-125 levels were identified as group A (platinum-refractory/platinum-resistant patients) and group B (platinum-sensitive patients). All patients received gemcitabine 1000 mg/m2 on days 1 and 8 and oxaliplatin 130 mg/m2 on day 8 every 21 days for up to eight cycles. Seventy-five patients (21 in group A and 54 in group B), with a median age of 58 years (range, 37–78), were enrolled. A median of six cycles (range, 1–8) was administered. By intent-to-treat analysis, 15 patients with measurable disease achieved partial response for an overall best response rate of 20.0% (9.5% in group A and 24.1% in group B). CA-125 response was observed in 48.4% patients (30.0% in group A and 57.1% in group B). Median time to progressive disease was 7.1 months (95% CI, 5.6–9.0 months) with 5.0 months in group A and 8.3 months in group B. Median overall survival was 17.8 months (95% CI, 12.9–21.3 months) with 9.2 months for group A and 20.0 months for group B. Major grade 3/4 toxicities were neutropenia (61.3%), leukopenia (24.0%), nausea (16.0%), and vomiting (22.7%). We conclude that the combination of oxaliplatin and gemcitabine is active in patients with recurrent ovarian cancer, but the regimen is unsatisfactory for further study due to modest response and relatively high toxicity.

scholarly journals Temsirolimus Has Activity in Non–Mantle Cell Non-Hodgkin's Lymphoma Subtypes: The University of Chicago Phase II Consortium

2010 ◽  
Vol 28 (31) ◽  
pp. 4740-4746 ◽  
Author(s):  
Sonali M. Smith ◽  
Koen van Besien ◽  
Theodore Karrison ◽  
Janet Dancey ◽  
Peter McLaughlin ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Single Agent ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Mantle Cell ◽  
Group A ◽  
Group B ◽  
Indolent Lymphomas

PurposeDespite high initial remission rates, most lymphomas relapse and require further therapy. The mammalian target of rapamycin (mTOR) pathway is a validated target in mantle cell lymphoma, but has not been extensively evaluated in other lymphomas.Patients and MethodsWe performed a phase II trial of single-agent temsirolimus 25-mg weekly in patients with relapsed aggressive and indolent lymphomas. The primary objective was overall and complete response rate. Patients were stratified by histology: group A (diffuse large B-cell lymphoma, transformed follicular lymphoma), group B (follicular lymphoma), and group C (chronic lymphocytic leukemia/small lymphocytic lymphoma, and other indolent lymphomas).ResultsEighty-nine patients were treated, with outcome strongly dependent on histology. Group A had an overall and complete response rate of 28.1% and 12.5%, respectively, and median progression-free survival (PFS) of 2.6 months and median overall survival (OS) of 7.2 months. Group B had overall and complete response rates of 53.8% and 25.6%, respectively, and median PFS of 12.7 months; median OS has not yet been reached. Group C had a partial response rate of 11% with no complete responders. Toxicity was mainly mild and/or reversible myelosuppression and mucositis; however, four patients developed pneumonitis.ConclusionsSingle-agent temsirolimus has significant activity in both diffuse large B-cell lymphoma and follicular lymphoma, although the durability of responses and PFS are longer for patients with follicular lymphoma. This is the first report of substantial activity of temsirolimus in lymphomas other than mantle cell lymphoma, and supports further evaluation of mTOR as a target in these diseases.

Comparative Study of Low Dose Conjugate Equine Estrogen 0.3 mg vs Standard Dose Conjugate Equine Estrogen 0.625 mg as Hormone Replacement Therapy

2013 ◽  
Vol 1 (2) ◽  
pp. 45-49
Author(s):  
Meeta Gupta ◽  
Poonam Yadav ◽  
Sarvesh Kumar
Keyword(s):  
Hormone Replacement Therapy ◽  
Comparative Study ◽  
Replacement Therapy ◽  
Low Dose ◽  
Standard Dose ◽  
Hormone Replacement ◽  
Mineral Density ◽  
Conjugate Equine Estrogen ◽  
Group A ◽  
Group B

ABSTRACT Introduction Since menopause was related to variety of genitourinary, vasomotor, psychological and musculoskeletal changes, conjugated equine estrogen (CEE) was introduced for all menopause-related symptoms in various doses. Materials and methods It is a comparative study in which 100 postmenopausal women were selected (natural or surgical menopause) with one or more menopausal symptoms. All patients were randomly divided in two groups. Group A received 0.3 mg CEE and group B received 0.625 mg CEE, and both groups were compared with each other in various aspects. Results Both the groups were comparable to each other with respect to mean age, residence, type of menopause, total duration of menopause. Both the groups show comparable improvement in vasomotor, genitourinary and psychological symptoms and p > 0.05 which is not significant. On evaluation of bone mineral density (BMD), the group B showed significant improvement than group A (p < 0.001). Effect on endometrium was not significant. Conclusion Because of the complications of estrogen ± progestin, it should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risk for individual women. How to cite this article Yadav P, Singh R, Kaur H, Gupta M, Kumar S. Comparative Study of Low Dose Conjugate Equine Estrogen 0.3 mg vs Standard Dose Conjugate Equine Estrogen 0.625 mg as Hormone Replacement Therapy. J South Asian Feder Menopause Soc 2013;1(2):45-49.

Allogeneic Transplant in Patients with Poor Prognosis B-Chronic Lymphocytic Leukemia (B-CLL): Comparative Study between Myeloablative(M) and Non-Myeloablative(NM) Conditioning Regimen.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2306-2306 ◽  
Author(s):  
M.D. Caballero ◽  
J.A. García-Marco ◽  
R. Martino ◽  
J. Esteve ◽  
M.V. Mateos ◽  
...  
Keyword(s):  
At Risk ◽  
Poor Prognosis ◽  
Chronic Gvhd ◽  
Conditioning Regimen ◽  
Lymphocytic Leukemia ◽  
Allogeneic Transplant ◽  
Peripheral Blood Stem Cells ◽  
Group A ◽  
Group B ◽  
Patients With Poor Prognosis

Abstract Sustained complete remissions (CR) have been reached with allogeneic transplant in patients with poor prognosis B-CLL; however, mortality rates are high (20–50%); in order to reduced TRM, NM conditioning are widely used in haematological malignancies; however it is not clear if the use of NM regimens can maintain the efficacy reducing the toxicity. IN this report we performed a retrospective comparison between 30 patients (group A) who have received myeloablative conditioning consisted of TBI plus Cy in 23 pts (74%), TBI, Cy plus VP-16 in 6 pts (19%) and BuCy in 1 patient and 31 patients (Group B) who have received a NM transplant. Conditioning regimens in Group B included: Fludarabine plus Melphalan, 20 pts (64%), Fludarabine, Busulphan and ATG, 5 pts (16%), Fludarabine, TBI and ATG, 4 pts (13%) and Fludarabine plus TBI, 1 patient. All patients received peripheral blood stem cells from a HLA related identical donor. T-cell depletion was performed in 14 patients of the group A. Median age at transplant was significantly higher in the group B patients (53 versus 45, respectively) (p&lt;0,005); no differences were observed in terms of status at transplant and n° of previous chemotherapy lines as well in the risk of graft versus host disease (GVHD) and transplant related mortality (TRM) (See Table, below). With a median follow-up of 71 and 36 months for groups A and B respectively,Overall Survival and Event Free Survival are similar for both groups (53% versus 64% and 60% versus 68%, respectively). Although patients in the NM transplant group were older toxicity was similar in both groups; moreover a similar efficacy has been observed suggesting the clear role of graft versus tumour effect in B-CLL probably more important that the type ofconditining. Table 1 GROUP A Myeloablative Group B Non-myeloablative p Number of previuous chemotherapy lines 2 (1-6) 2 (1-8) NS Acute GVHD 15/30 (48%) 20/31 (64%) NS Grade II-IV 11/30 (35%) 12 /31(38%) NS Chronic GVHD 12/26pts at risk (46%) 18/27 pts at risk (66%) NS Extense 8 pts (30%) 9 pts (33%) NS TRM 7/30 (23%) 7/31 (22%) NS

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