scholarly journals Ibrutinib Plus Fludarabine, Cyclophosphamide, and Rituximab As the Treatment for Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia: A Single-Center Real World Study

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 29-30
Author(s):  
Huayuan Zhu ◽  
Hui Shen ◽  
Yilian Yang ◽  
Chong-Yang Ding ◽  
Yeqin Sha ◽  
...  
Keyword(s):  
High Risk ◽  
Chronic Lymphocytic Leukemia ◽  
Interim Analysis ◽  
Response Rate ◽  
Risk Group ◽  
Complete Response ◽  
High Risk Group ◽  
Lymphocytic Leukemia ◽  
Occurrence Rate ◽  
Hematological Toxicity

Purpose: To evaluate the safety and efficacy of ibrutinib plus fludarabine, cyclophosphamide, and rituximab (iFCR) as the treatment for chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) patients, we conducted time-limited, minimal residual disease (MRD)-driven real world study in The First Affiliated Hospital of Nanjing Medical University Methods: We enrolled patients aged 18 to 65 years old with CLL/SLL who required treatment. Oral Ibrutinib was given continuously (420 mg/day) from day 0, and patients were administered intravenously rituximab (375mg/m2 in day 0 of cycle 1; 500mg/m2 in day 0 of cycle 2-3), fludarabine (25mg/m2, days 1-3) and cyclophosphamide (250mg/m2, days 1-3), every 28-day cycles. All the patients received 3 cycles of iFCR in the first stage. Interim analysis was done according to the 2018 iwCLL criteria and MRD was detected by flow cytometry. Patients who achieved complete response (CR) or partial response (PR) with low MRD level (L-MRD, 10-4-10-2) or undetectable MRD (uMRD) level (<10-4) in peripheral blood (PB) were given 3 times of rituximab or the 4th cycle of iFCR, and then turned to ibrutinib maintenance. Patients who achieved PR with high MRD level (>10-2) in PB or bone marrow (BM), or with diameter of residual lymph node larger than 3cm were administered another 3 cycles of iFCR (6 in all) and followed by ibrutinib maintenance. The primary endpoint was the proportion of patients who achieved uMRD in the PB after 3 cycles of iFCR. The secondary endpoint was overall response rate (ORR), complete response rate (CR) and the number of adverse events (AE). Results: Between May 2019 and June 2020, 29 CLL/SLL patients were enrolled in this cohort with 27 CLL and 2 SLL. 26 of patients were the previously untreated and 3 of patients were relapse or treated before. The median age of patients was 53 years old. Unmutated IGHV was detected in 14 (50.0%) of 29 patients, 4 patients had del(17p) and/or TP53 mutation (13.8%), 7 patients had del(11q) (24.1%), 7 had NOTCH1 mutation (24.1%) and 7 had MYD88 mutation (24.1%). 8 patients (30.8%) were classified as low-risk group according to CLL-IPI, with 9 in intermediate-risk group (34.6%), 5 in high-risk group (19.2%) and 4 in very-high risk group (15.4%). At data cutoff (1st July, 2020), the median follow-up and treatment time was seven months (1-13 months) with 23 patients had completed at least two cycles of iFCR. At interim analysis, the ORR was 100% with 8 patients achieved CR (34.8%), 3 achieved CRi (13.0%) and 12 achieved PR (52.2%). 57.1% (12/21) achieved uMRD in both PB and BM, among which 6 of them (28.6%) achieved CR/CRi and 6 achieved PR (28.6%). All four patients with TP53 abnormalities achieved PR and two of them (50.0%) achieved uMRD in both PB and BM. One of 6 patients with del(11q) achieved CR (16.7%) and five achieved PR (83.3%), with 2 achieved uMRD in both PB and BM (33.3%). Among 13 assessable patients with unmutated IGHV, four of them achieved CR (30.8%) and nine achieved PR (69.2%), with 5 achieved uMRD in both PB and BM (38.5%). 18 patients had turned to ibrutinib maintenance with 12 of them finished 4th cycle of iFCR or 3 additional cycles of rituximab and could be assessed further. 10 of the patients achieved CR/CRi (83.3%) and 2 achieved PR (16.7%), with 8 achieved uMRD in both PB and BM (66.7%). The most common hematological toxicity events were neutropenia and thrombocytopenia and the non-hematological toxicity events were nausea and vomiting. The occurrence rate of grade 3 to 4 neutropenia and agranulocytic fever were 51.9% (15/29) and 17.2% (5/29) respectively. The most common ibrutinib-related AE were purpura, rash and diarrhea. The occurrence rate of AE induced discontinued ibrutinib more than 7 days, discontinued ibrutinib fewer than 7 days and ibrutinib decrement were 20.7%(6/29), 17.2%(5/29) and 20.7%(6/29) respectively. Conclusion: MRD-driven Ibrutinib plus FCR could achieve high response rate with uMRD in yonger fit patients with CLL/SLL, with manageable toxicity. Ibrutinib plus FCR could be one of the most promising choice as a time-limited regimen in the new drug era. Disclosures No relevant conflicts of interest to declare.

scholarly journals BTK Inhibitor Ibrutinib/Zanubrutinib Plus Bendamustine and Rituximab As the Initial Treatment for Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia：a Single Arm Real-World Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4697-4697
Author(s):  
Huayuan Zhu ◽  
Wei Wu ◽  
Yeqin Sha ◽  
Ze Jin ◽  
Yilian Yang ◽  
...  
Keyword(s):  
Initial Treatment ◽  
Response Rate ◽  
Residual Disease ◽  
Risk Group ◽  
High Risk Group ◽  
Lymphocytic Leukemia ◽  
Occurrence Rate ◽  
Hematological Toxicity ◽  
Btk Inhibitor ◽  
Minimal Residual

Abstract Introduction To evaluate the safety and efficacy of BTK inhibitor ibrutinib or zanubrutinib plus bendamustine and rituximab (iBR or zBR) as the initial treatment for chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) patients, we conducted this single-arm retrospective observational study. Methods We enrolled patients over 18 years old with CLL/SLL who required treatment. iBR or zBR were administrated as following, ibrutinib 420 mg daily or zanubrutinib 160 mg twice daily from day 0, rituximab 375 mg/m 2 on day 0 of cycle 1 and 500 mg/m 2 on day 0 of cycle 2-6, bendamustine (70 mg/m 2, days 1-2), 28 days per cycle, ibrutinib or zanubrutinib was maintained at least 2 years and planned to discontinue in patients with undetectable minimal residual disease (uMRD) in both peripheral blood (PB) and bone marrow (BM). Response assessment was conducted after 3 cycles and 2 months after 6 cycles (EOT) according to 2018 iwCLL criteria in patients with CLL and 2014 Lugano criteria in patients with SLL. Minimal residual disease (MRD) in PB was detected after each cycle and MRD in BM was detected after 3 and 6 cycles by flow cytometry. uMRD was defined as less than 1 CLL cell per 10 4 leukocytes by flow cytometry. R esults At data cut-off (15 th June 2021), 10 treatment-naïve patients in the First Affiliated Hospital of Nanjing Medical University were enrolled, with 9 CLL and 1 SLL. All patients had completed planned six cycles of iBR(n=8) or zBR(n=2). The median age was 56 years old. Unmutated IGHV was detected in 30.0% (3/10) patients, one patient (1/8, 12.5%) had both del(17p) and TP53 mutation. Among 9 patients with CLL, 3 (33.3%) was classified as low-risk group according to CLL-IPI, 4(44.4%) in intermediate-risk, 1(11.1%) in high-risk group and 1(11.1%) in very-high risk group (Table 1). After 3 cycles, the overall response rate (ORR) was 100%, and complete remission (CR) rate was 20.0%, one patient achieved CRi (CR with incomplete bone marrow recovery). 50% (5/10) and 37.5% (3/8) patients achieved uMRD in PB and BM respectively. The ORR was 100% (10/10) and CR rate was 60.0%, 3 patients achieved CRi (30.0%) at EOT. 60.0% (6/10) and 50.0% (5/10) patients achieved uMRD in PB and BM respectively (Table 2, Figure 1). The most common hematological toxicity events were neutropenia and thrombocytopenia, and the non-hematological toxicity events were malaise, pruritus, nausea, vomiting and hematuria. The occurrence rate of grade 3 to 4 neutropenia and agranulocytic fever were 40.0% (4/10) and 10.0% (1/10) respectively. The most common ibrutinib-related AE were purpura, rash, diarrhea and hematuria. The occurrence rate of AE induced discontinued ibrutinib or zanubrutinib were 30.0% (3/10). Conclusion Here, we first reported the efficacy and tolerance of BTK inhibitor plus BR as initial treatment in a small cohort of CLL/SLL patients. BTK inhibitor plus BR could achieved high response rate and high proportion of undetectable MRD，with manageable toxicity. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

Efficacy and Safety Of Bendamustine In Combination With Rituximab For Elderly Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia. A Retrospective Multicenter Study

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5309-5309 ◽  
Author(s):  
Luca Laurenti ◽  
Barbara Vannata ◽  
Idanna Innocenti ◽  
Francesco Autore ◽  
Francesco Ghio ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Elderly Patients ◽  
Response Rate ◽  
Complete Response ◽  
Lymphocytic Leukemia ◽  
Hematological Toxicity ◽  
Efficacy And Safety ◽  
Front Line ◽  
Good Safety Profile ◽  
Standard Risk

Abstract Chronic Lymphocytic Leukemia (B-CLL) is the most prevalent adult leukemia in western countries, with a median age of onset of 65 years. Front-line therapy for B-CLL young patients is chemo-immunotherapy with Fludarabine-Cyclophosphamide and Rituximab (FCR). However, many B-CLL patients are elderly and with comorbidities. FCR regimen can result in a significant myelosuppression and a high rate of early and late infections, suggesting that it may be too toxic and therefore unsuitable for this large subpopulation of patients. Data from the CLL 5 phase III trial of the German CLL study group (GCLLSG) comparing Fludarabine vs Chlorambucil (Chl) in patients older than 65 years showed no differences in overall survival and progression free survival (PFS) between Fludarabine and Chl. Recently, Bendamustine as single agent showed superiority in comparison to Chl in terms of overall response rate (ORR) and PFS, with a good safety profile. Later, the addition of Rituximab (RTX) to Bendamustine (Benda-R) was shown to be efficacious and safe in the same treatment-naïve setting. Insufficient data are available in patients older than 70 years regarding the efficacy and safety, nevertheless increased incidence of extra-hematological toxicity was noted in this subgroup. Here we report our multicentre retrospective study focusing on responses and toxicities rate in elderly patients with B-CLL. We report data on 24 elderly patients with previously untreated B-CLL observed in 7 Italian Centers from November 2000 to June 2012. All patients were treated with a median of 6 cycles of Bendamustine (range, 3-6) at the median dose of 90 mg/m2 (range, 70-90 mg/m2) for 2 consecutive days every 28 days plus RTX (375 mg/m2 for the first course and 500 mg/m2 for subsequent cycles every 28 days). The median number of RTX cycles was 6 (range, 3-6). The mean dose of RTX was 4500 mg (range, 1500-6200 mg). The primary end points were the ORR (complete response CR and partial response PR) and hematological-extrahematological toxicities rate. Twenty male and four female with a median age of 72 years (range, 65-87 years) were included in the study. Only one patient was unfit with a CIRS score of 7. All patients had ECOG less than 2. Two B-CLL patients had A/I progressive stage according Binet and Rai, 10 patients had B/II and 12 patients had C/III or C/IV. The median lymphocytes count at diagnosis was 37.040/mmc (range, 2.200-140.000). FISH analysis was performed in 19/25 patients: 12 patients were classified as standard risk (normal karyotype, del13q14 or +12) and 7 patients as high risk (del11q and del17p). The analysis of the IgVH, available in 12 patients, showed 7 patients with somatic mutation and 5 patients with germ-line sequences. Only one patient was admitted to the hospital and one received reduced bendamustine dose for neutropenia. Fifteen patients received bendamustine at the dosage of 90 mg/m2 while 9 were treated with 70 mg/m2. The ORR rate was 87.5%: ten patients (41.7%) obtained a complete response and eleven patients (45.8%) obtained a partial response. Among biological features the presence of standard risk FISH karyotype showed a statistical significance in terms of better response to therapy (p= 0.013) and progression (p=0.034). Hematological toxicity was recorded in 7 patients (29%) (neutropenia grade III/IV), 5 of them required G-CSF. Extra-hematological toxicity grade I-III was noticed in 8 patients (3 skin reactions, 3 infusion related reactions, 2 nausea and vomiting). At the present only four patients showed a progressive disease with a PFS of 92% at 12 months. Only one unresponsive patient died from Richter disease 6 months after the end of therapy. When we stratified patients in two groups according to the age, we found that patients younger than 75 years (15 patients) showed a better response (p=0.004) and a delayed time to progression (p=0.027) in comparison to patients more than 75 years. Retrospective data from this group of elderly B-CLL patients indicate Benda-R front-line provide a high response rate and a good safety profile. Also in a subgroup of very elderly patients (age > 75 years) the association of bendamustine 90 mg/m2 and rituximab at standard dose is recommended because of a low rate of dose delay/reduction and acceptable hematological/extrahematological toxicities. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Cyclophosphamide, fludarabine, alemtuzumab, and rituximab as salvage therapy for heavily pretreated patients with chronic lymphocytic leukemia

Blood ◽  
2011 ◽  
Vol 118 (8) ◽  
pp. 2085-2093 ◽  
Author(s):  
Xavier C. Badoux ◽  
Michael J. Keating ◽  
Xuemei Wang ◽  
Susan M. O'Brien ◽  
Alessandra Ferrajoli ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Chronic Lymphocytic Leukemia ◽  
Salvage Therapy ◽  
Progression Free Survival ◽  
Complete Response ◽  
High Risk Group ◽  
Lymphocytic Leukemia ◽  
High Rate ◽  
Free Survival

Abstract Patients with relapsed chronic lymphocytic leukemia (CLL) and high-risk features, such as fludarabine refractoriness, complex karyotype, or abnormalities of chromosome 17p, experience poor outcomes after standard fludaradine-based regimens. Alemtuzumab is a chimeric CD52 monoclonal antibody with activity in CLL patients with fludarabine-refractory disease and 17p deletion. We report the outcome for 80 relapsed or refractory patients with CLL enrolled in a phase 2 study of cyclophosphamide, fludarabine, alemtuzumab, and rituximab (CFAR). All patients were assessed for response and progression according to the 1996 CLL-working group criteria. For the intention-to-treat analysis, the overall response rate was 65%, including 29% complete response. The estimated progression-free survival was 10.6 months and median overall survival was 16.7 months. Although we noted higher complete response in high-risk patients after CFAR compared with a similar population who had received fludarabine, cyclophosphamide, and rituximab as salvage therapy, there was no significant improvement in progression-free survival and overall survival appeared worse. CFAR was associated with a high rate of infectious complications with 37 patients (46%) experiencing a serious infection during therapy and 28% of evaluable patients experiencing late serious infections. Although CFAR produced good response rates in this highly pretreated high-risk group of patients, there was no benefit in survival outcomes.

scholarly journals Bone marrow transplantation for leukemia following a new busulfan and cyclophosphamide regimen

Blood ◽  
1987 ◽  
Vol 70 (5) ◽  
pp. 1382-1388 ◽  
Author(s):  
PJ Tutschka ◽  
EA Copelan ◽  
JP Klein
Keyword(s):  
High Risk ◽  
Acute Leukemia ◽  
Marrow Transplantation ◽  
Risk Group ◽  
Chronic Phase ◽  
Length Of Hospital Stay ◽  
High Risk Group ◽  
Lymphocytic Leukemia ◽  
Myelogenous Leukemia ◽  
Standard Risk

Abstract Busulfan 16 mg/kg and cyclophosphamide 120 mg/kg were used as conditioning prior to allogeneic marrow transplantation in 50 adult patients with acute nonlymphocytic leukemia (ANLL), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML). A standard risk group of 20 patients included those with acute leukemia in remission and CML in chronic phase. A high-risk group of 30 patients included individuals with refractory acute leukemia, acute leukemia in relapse, acute leukemia following preleukemia, and CML in accelerated and blastic phase. Complete remission and sustained complete engraftment were achieved in all evaluable patients. The duration of aplasia was remarkably short (median of 8 days), resulting in a low infection rate during the period of neutropenia, a reduced need for blood product support, and a short length of hospital stay. Three-year actuarial relapse-free survival in both standard-risk (88.9% +/- 10.5%) and high- risk (50.5% +/- 9.6%) groups compares favorably with that reported with total body irradiation (TBI) containing regimens.

Treatment of refractory chronic lymphocytic leukemia with fludarabine phosphate via the group C protocol mechanism of the National Cancer Institute: five-year follow-up report.

1997 ◽  
Vol 15 (2) ◽  
pp. 458-465 ◽  
Author(s):  
J M Sorensen ◽  
D A Vena ◽  
A Fallavollita ◽  
H G Chun ◽  
B D Cheson
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
National Cancer Institute ◽  
Response Rate ◽  
Performance Status ◽  
Treatment Protocol ◽  
Complete Response ◽  
Lymphocytic Leukemia ◽  
Motor Dysfunction ◽  
Hematologic Toxicity ◽  
Contributing Factors

PURPOSE To provide fludarabine to physicians for the management of patients with advanced refractory chronic lymphocytic leukemia (CLL) and to determine the response rate and duration, toxicity, and survival with this agent. PATIENTS AND METHODS This phase II protocol was open to all eligible patients whose local physicians obtained written permission from the National Cancer Institute (NCI) to register patients onto this protocol. Of 791 national and international enrolled patients, 724 with a median age of 65 years received fludarabine, of which 703 were assessable for response. RESULTS Thirty-two percent of assessable patients responded (95% confidence interval [CI], 29% to 36%), with 21 patients (3%) obtaining a complete response and 205 (29%) a partial response. The median duration of response was 13.1 months and the median survival time from registration was 12.6 months. Age, performance status (PS), and Rai stage correlated with survival (P < .01). Grade 4 hematologic toxicity was reported in 43% and was associated with infection in 22%. Neurotoxicity (primarily grade 1 motor dysfunction) was reported in 14% patients and correlated with age. CONCLUSION This study describes the toxicity and activity of fludarabine in refractory CLL in a setting that more closely resembles clinical practice than most published trials. The low response rate may be related to advanced stage (89% Rai high-risk), disease-related symptoms (63% had B symptoms), and/or degree of prior treatment. Other contributing factors inherent in a group C treatment protocol included lack of central pathology review, variable supportive care, and a tendency to use this mechanism at a later stage in the disease.

Influence of Chromosomal Aberrations on Response to First Line Therapy in B-Cell Chronic Lymphocytic Leukemia: Interim Analysis of PALG-CLL3 Randomized Study Comparing Cladribine Plus Cyclophosphamide vs Fludarabine Plus Cyclophosphamide.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2046-2046
Author(s):  
Tadeusz Robak ◽  
Jerzy Z. Blonski ◽  
Ewa Wawrzyniak ◽  
Aleksandra Palacz ◽  
Joanna Gora-Tybor ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
B Cell ◽  
Chromosomal Aberrations ◽  
Interim Analysis ◽  
Chromosomal Abnormalities ◽  
Complete Response ◽  
Lymphocytic Leukemia ◽  
Lower Probability ◽  
Trisomy 12 ◽  
Cell Chronic Lymphocytic Leukemia

Abstract Impact of cytogenetic abnormalities on treatment with different purine nucleoside analogs in patients (pts) with B-cell chronic lymphocytic leukemia (B-CLL) is largely unknown. One of objectives of PALG-CLL3 trial, comparing cladribine plus cyclophosphamide (CC) with fludarabine plus cyclophosphamide (FC) in previously untreated progressive B-CLL, was to verify the response to treatment in subsets of pts characterized by common cytogenetic abberrations. Chromosomal abnormalities were assessed using fluorescence in situ hybridization (FISH) on interphase nuclei of lymphocytes on whole blood smears prior to the start of the study treatment. Pts were screened for trisomy 12, deletions (del) 11q, del 13q and del 17p using DNA probes: CEP12, LSI: ATM, D13S319 and p53 (Vysis), respectively. For the purpose of the present interim analysis complete cytogenetic results were available in 133 pts out of 423 pts included to the study. In this group the chromosomal aberrations were detected in 102 pts (77%) including single abnormalities observed in 69 pts (52%) and two or more aberrations in 33 pts (25%). Thirty-one pts (23%) exhibited a normal interphase FISH pattern. The most frequent single abnormality was del 13q found in 38 pts (29%), while del 17p, trisomy 12 and del 11q were identified in 14 pts (11%), 11 pts (8%), and 6 pts, (5%), respectively. The most frequently observed associations of chromosomal aberrations were: del 13q with del 11q (11 pts, 8%) and del 13q with del 17p (10 pts, 8%). Four pts (3%) revealed three chromosomal abnormalities including association of trisomy 12/del 11q/del 13q in two pts, trisomy 12/del 11q/del 17p in one pt and del 11q/del 13q/del 17p in one pt. Overall, treatment was completed and response assessed in 113 out of 133 pts with known FISH pattern. In this group of pts del 17p was the only chromosomal abnormality that correlated significantly with treatment outcome. Pts with del 17p (21, 19%) had lower probability to achieve a complete response (CR) (0.044). Interestingly, in independent analyses of both treatment arms, the negative impact of 17p was seen in pts treated with FC (p=0.002), but not in pts treated with CC (p=0.6). Moreover, comparing response rates between treatment arms we found that CC was superior to FC in terms of complete response in pts with del 17p (57% CR in CC v 14% CR in FC arm, p=0.04). In conclusion, chromosomal abnormalities can be detected in majority B-CLL pts requiring treatment. Our preliminary results suggest that CC combination may have some advantage in terms of CR achievement in B-CLL pts harboring del 17p.

Chronic Lymphocytic Leukemia: Evaluation of Cytogenetic Markers as Prognostic Factors

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4860-4860
Author(s):  
Jose Carda ◽  
Patricia Sousa ◽  
Patricia Olim ◽  
Emília Magalhães ◽  
Luis Rito ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Retrospective Study ◽  
High Risk ◽  
Chronic Lymphocytic Leukemia ◽  
Progressive Disease ◽  
Risk Group ◽  
Staging System ◽  
Lymphocytic Leukemia ◽  
Intermediate Risk

Abstract Abstract 4860 Backgroud: Chronic lymphocytic leukemia (CLL) is one of the most frequent chronic lymphoproliferative disorders in Europe. It is characterized by persistent monoclonal lymphocitosis with localized or generalized lymphadenopathy. Despite the initial clinical presentation, it has a heterogeneous natural history, with the majority of patients living 10–12 years, but with some patients dying rapidly, within 2–3 years of diagnosis. Beside clinical prognostic factors, novel cytogenetic markers are recognized to be useful in predicting disease free and overall survival in CLL. AIMS: In a retrospective study throughout 10 years (1999-2009), we analyzed the clinical and biological presentation and compared the evolution and survival of patients with B-CLL using different cytogenetic markers. METHODS: We identified 112 cases (63 males and 49 females) of B-CLL with cytogenetic study by fluorescence in situ hybridization (FISH). RESULTS: Amongst 112 patients, the male to female (M/F) ratio was 1.3:1 and the median age was 70 (43-96) years. At diagnosis, the median lymphocyte count was 15.5 G/L (5.4-173). Fifty five patients (49%) had lymphadenopathies and seventeen (15%) had splenomegaly and/or hepatomegaly at presentation. By the revised Rai staging system seventy (63%) patients were included in low risk group, thirty (27%) in intermediate risk group and twelve (10%) in high risk group. The expression of ZAP-70 and CD38 by flow citometry was performed in 75 patients and revealed 13 (17%) patients CD38+ and 12 (16%) ZAP70+. The study of chromosomal aberrations with FISH showed thirty six patients (32%) with no abnormality, thirty six (32%) with isolated 13q deletion, fifteen (14%) with 12 trisomy, twelve (11%) with 11q deletion and thirteen (11%) with 17p deletion. Forty (36%) patients showed progressive disease in a median time of sixteen months (0-120), thirteen with 13qdel, seven with 17pdel and five with 12 trisomy. After treatment two patients showed progressive disease, six maintain a stable disease and thirty two obtain a remission, nine in complete remission. The Overall Survival (OS) at ten years was 70%. By the revised Rai staging system the OS at ten years was 80% for low risk, 70% for intermediate risk and all the high risk patients died during follow up. The OS at five years for the del13q-, 12 trisomy, del11q- and del17p- was 90%, 88%, 58% and 60%, respectively. SUMMARY: Chronic lymphocytic leukemia is currently considered a chronic disorder with a favourable outcome, but with a variable evolution to progressive disease. This retrospective study allowed the characterization of patient with CLL in our department and the acknowledgement that our results are quite similar to the published data. Disclosures: No relevant conflicts of interest to declare.

Long-Term Follow-Up of Patients With Chronic Lymphocytic Leukemia (CLL) Receiving Fludarabine Regimens as Initial Therapy

Blood ◽  
1998 ◽  
Vol 92 (4) ◽  
pp. 1165-1171 ◽  
Author(s):  
M.J. Keating ◽  
S. O’Brien ◽  
S. Lerner ◽  
C. Koller ◽  
M. Beran ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Median Survival ◽  
Response Rate ◽  
Single Agent ◽  
Complete Response ◽  
Initial Therapy ◽  
Lymphocytic Leukemia ◽  
Poor Correlation ◽  
American Society ◽  
Febrile Episodes

One hundred seventy-four patients with progressive or advanced chronic lymphocytic leukemia (CLL) have received initial therapy with fludarabine as a single agent or fludarabine combined with prednisone. The overall response rate was 78% and the median survival was 63 months. No difference in response rate or survival was noted in the 71 patients receiving fludarabine as a single agent compared with the 103 patients who received prednisone in addition. The median time to progression of responders was 31 months and the overall median survival was 74 months. Patients over the age of 70 years had shorter survivals. Patients with advanced stage disease (Rai III and IV) had a somewhat shorter survival than earlier stage patients. More than half the patients who relapsed after fludarabine therapy responded to salvage treatment, usually with fludarabine-based regimens. Second remissions were more common in patients who had achieved a complete remission on their initial treatment. The CD4 and CD8 T-lymphocyte subpopulations decreased to levels in the range of 150 to 200/μL after the first 3 courses of treatment. Although recovery towards normal levels was slow, the incidence of infections was low in patients in remission (1 episode of infection for every 3.33 patient years at risk) and decreased with time off treatment. There was no association of infections or febrile episodes with the use of corticosteroids or the CD4 count at the end of treatment and a poor correlation with the increase in CD4 counts during remission. Infectious episodes were less common in patients who had a complete response compared with partial responders. Richter’s transformation occurred in 9 patients and Hodgkin’s disease occurred in 4 patients. Five other patients died from other second malignancies. Fludarabine appears to be an effective initial induction therapy with a reasonable safety profile for patients with CLL. © 1998 by The American Society of Hematology.

scholarly journals Retrospective analysis of pediatric hepatoblastoma with tumor rupture: experience from a single center

2021 ◽  
Author(s):  
Yu-Tong Zhang ◽  
Yu-fei Zhao ◽  
Dian-fei Yang ◽  
Jian Chang
Keyword(s):  
High Risk ◽  
Poor Prognosis ◽  
Risk Group ◽  
Interleukin 2 ◽  
Complete Response ◽  
High Risk Group ◽  
Free Fluid ◽  
Tumor Rupture ◽  
High Risk Factor ◽  
Peritoneal Perfusion

Abstract Background Hepatoblastoma (HB) tumor rupture is currently considered as a high-risk factor in some risk-stratification systems. This study aimed to investigate the value of HB tumor rupture in predicting the poor prognosis of child patients. Methods The clinical data from children with high-risk HB or HB tumor rupture at our institution from October 2008 to October 2017 were retrospectively reviewed and analyzed. Results Altogether 34 children with high-risk HB or HB tumor rupture were retrospected, including 25 in the high-risk group and 9 in tumor rupture group. The 3-year overall survival (OS) rate in tumor rupture group was significantly higher than that in high-risk group (100% vs 60%, p=0.035). In tumor rupture group, 7 (77.8%) out of 9 patients had the hemoglobin level ≤ 8 g/L and 3 (33.3%) had that ≤ 6 g/L at the time of diagnosis. Peritoneal perfusion with normal saline and interleukin-2 was implemented for each patient until the free fluid was under normal level. At the end of the treatment, 7 (77.8%) of 9 patients achieved complete response (CR). No patient died at the last follow-up. Conclusions Tumor rupture is not predictive of poor prognosis with the risk of peritoneal dissemination/relapse.

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