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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 14 ( 2023-05-10), p. 2607-2616
    Abstract: Rituximab/chemotherapy is a cornerstone of treatment for Waldenström's macroglobulinemia (WM). In addition, bortezomib has shown significant activity in WM. This study evaluated the efficacy and safety of dexamethasone, rituximab, and cyclophosphamide (DRC) as first-line treatment in WM. METHODS In this European study, treatment-naïve patients were randomly assigned to DRC or bortezomib-DRC B-DRC for six cycles. The primary end point was progression-free survival. Secondary end points included response rates, overall survival, and safety. RESULTS Two hundred four patients were registered. After a median follow-up of 27.5 months, the estimated 24-month progression-free survival was 80.6% (95% CI, 69.5 to 88.0) for B-DRC and 72.8% (95% CI, 61.3 to 81.3) for DRC ( P = .32). At the end of treatment, B-DRC and DRC induced major responses in 80.6% versus 69.9% and a complete response/very good partial response in 17.2% versus 9.6% of patients, respectively. The median time to first response was shorter for B-DRC with 3.0 (95% CI, 2.8 to 3.2) versus 5.5 (95% CI, 2.9 to 5.8) months for DRC. This resulted in higher major response rates (57.0% v 32.5%; P 〈 .01) after three cycles of B-DRC compared with DRC. At best response, the complete response/very good partial response increased to 32.6% for B-DRC. Both treatments were well tolerated: grade ≥ 3 adverse events occurred in 49.2% of all patients (B-DRC, 49.5%; DRC, 49.0%). Peripheral sensory neuropathy grade 3 occurred in two patients treated with B-DRC and in none with DRC. CONCLUSION This large randomized study illustrates that B-DRC is highly effective and well tolerated in WM. The data demonstrate that fixed duration immunochemotherapy remains an important pillar in the clinical management of WM.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Leukemia & Lymphoma, Informa UK Limited, Vol. 54, No. 2 ( 2013-02), p. 417-420
    Type of Medium: Online Resource
    ISSN: 1042-8194 , 1029-2403
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2013
    detail.hit.zdb_id: 2030637-4
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  • 3
    Online Resource
    Online Resource
    American Medical Association (AMA) ; 2005
    In:  Archives of Dermatology Vol. 141, No. 3 ( 2005-03-01)
    In: Archives of Dermatology, American Medical Association (AMA), Vol. 141, No. 3 ( 2005-03-01)
    Type of Medium: Online Resource
    ISSN: 0003-987X
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    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2005
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  • 4
    In: The Lancet Haematology, Elsevier BV, Vol. 7, No. 2 ( 2020-02), p. e112-e121
    Type of Medium: Online Resource
    ISSN: 2352-3026
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
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  • 5
    In: Leukemia, Springer Science and Business Media LLC, Vol. 35, No. 6 ( 2021-06), p. 1597-1609
    Type of Medium: Online Resource
    ISSN: 0887-6924 , 1476-5551
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    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2008023-2
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  • 6
    In: Blood, American Society of Hematology, Vol. 138, No. Supplement 1 ( 2021-11-05), p. 3570-3570
    Abstract: Background Richter syndrome (RS) refers to the onset of aggressive lymphoma, mostly diffuse large B cell lymphoma (DLBCL), in patients with chronic lymphocytic leukemia (CLL). The outcome of RS patients is usually very poor with both low response rates to chemoimmunotherapy and short survival. While BCR and BCL2 inhibitors have transformed the management of CLL patients, these drugs do not prevent the onset of RS. Modulating anti-tumor immunity has recently been suggested as a promising approach in RS (Ding, 2017). Blinatumomab is a bi-specific T-cell engaging antibody construct that transiently links CD3-positive T cells to CD19-positive B-cells, inducing T-cell activation and subsequent lysis of tumor cells. It has been approved for the treatment of patients with relapsed or refractory B-ALL and has also been evaluated in the setting of persisting minimal residual disease. Recently, blinatumomab (stepwise dosing 9-28-112 μg/d) has been evaluated in patients with relapsed or refractory DLBCL and demonstrated promising results (ORR 43%) with acceptable safety (Viardot, 2016). We hypothesized that blinatumomab would improve response in RS patients failing to achieve CR after initial debulking with R-CHOP. Methods We report here the first results of a phase 2 multicenter study investigating the efficacy and safety of blinatumomab after R-CHOP debulking therapy for patients with untreated RS of DLBCL histology (NCT03931642). The patients with persisting (PR, SD) or progressive disease (PD) after 2 cycles of R-CHOP were eligible to receive an 8-week course of blinatumomab induction. Blinatumomab was administered at a stepwise dose of 9 μg/d in the first week, 28 μg/d in the second week, and 112 μg/d thereafter. The primary endpoint was CR rate according to the revised Lugano criteria after the 8-week induction course of blinatumomab. An additional 4-week consolidation cycle was optional. Allo-HSCT was further allowed for eligible patients. Results A total of 34 patients out of 41 has already been enrolled in the trial to date. Median age was 66 years (range, 38-82) and sex ratio M/F was 23/12. CLL features at baseline were as follows: 57% had 17p deletion and 67% TP53 mutations. Sixty-five percent had complex karyotype and 79% unmutated IGHV status. Median number of prior therapeutic lines for CLL was 2 (range, 0-7): 19 (54%) patients previously received chemo-immunotherapy, 23 (66%) patients were exposed to ibrutinib and 11 (31%) to venetoclax. As of the data cut-off of June 1st, 2021, the blinatumomab induction course has been completed for 18 patients. Ten patients did not receive blinatumomab for the following reasons: 7 patients achieved CR after R-CHOP, 2 patients died because of febrile neutropenia after R-CHOP and 1 patient presented severe pneumonia after R-CHOP. Three patients are still on R-CHOP and 3 others on blinatumomab to date. Regarding toxicity during blinatumomab, data are available for the 18 patients having completed the blinatumomab induction to date. All patients had at least one grade 1 adverse event (AE), 10 had grade ≥3 AE. The most common AE ( & gt; 1 case), regardless of relationship to blinatumomab, were fever (4 patients), CRS (2 patients), sepsis (2 patients), vein thrombosis (2 patients), anemia (4 patients), neutropenia (3 patients), lymphopenia (5 patients), thrombocytopenia (3 patients) and hyperglycemia (5 patients). In terms of neurologic events, 5 (28%) experienced neurotoxicity (all recovered) including grade 3 encephalopathy, grade 4 confusion, grade 3 anxiety, grade 1 myoclonus, grade 2 ataxia, grade 1 sleep disorder and grade 1 ICANS (each in 1 pt). Blinatumomab was temporarly stopped in 3 patients and permanently in 2. In terms of efficacy, after R-CHOP debulking therapy (n=31 evaluable patients), 7 patients achieved CR, 6 patients were in PR, 7 patients were stable and 11 patients were progressive. At evaluation after the blinatumomab induction (n=18 evaluable patients), 4 (22.2%) patients achieved CR, 4 (22.2%) patients PR, 2 (11.1%) patients were stable and the remaining 8 (44.5%) were progressive. Considering the whole strategy (including R-CHOP debulking) (n=28), 15 (54%) patients achieved overall response including 11 (39%) CR. Conclusions Our preliminary data suggest that blinatumomab suggests encouraging anti-tumor activity and acceptable toxicity in patients with RS. Disclosures Ysebaert: Abbvie, AstraZeneca, Janssen, Roche: Other: Advisory Board, Research Funding. Ferrant: AstraZeneca: Honoraria; Janssen: Other: Travel, Accommodations, Expenses; AbbVie: Honoraria, Other: Travel, Accommodations, Expenses. de Guibert: Janssen: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Gilead: Consultancy, Honoraria. Laribi: Astellas Phama, Inc.: Other: Personal Fees; AstraZeneca: Other: Personal Fees; Novartis: Other: Personal Fees, Research Funding; Le Mans Hospital: Research Funding; IQONE: Other: Personal Fees; Jansen: Research Funding; BeiGene: Other: Personal Fees; Takeda: Other: Personal Fees, Research Funding; AbbVie: Other: Personal Fees, Research Funding. Feugier: Abbvie: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Amgen: Honoraria; Astrazeneca: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. OffLabel Disclosure: blinatumomab is approved for acute lymphoblastic leukemia. The aim of this phase 2 study is to evaluated it in patients with Richter's syndrome.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2021
    detail.hit.zdb_id: 1468538-3
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  • 7
    In: Blood, American Society of Hematology, Vol. 136, No. Supplement 1 ( 2020-11-5), p. 26-26
    Abstract: Background: Rituximab/chemotherapy is still one of the cornerstones of treatment for patients with Waldenström's macroglobulinemia (WM) despite the emergence of BTK inhibitors. Beside Rituximab-Bendamustine the combination Dexamethasone, Rituximab and Cyclophospamide (DRC) is the most widely recommended immunochemotherapy in national and international guidelines based on its low myelotoxicity and anti-lymphoma activity in WM. In addition, the proteasome inhibitor Bortezomib (B) has shown significant activity in WM as single agent or combined with Rituximab and/or Dexamethasone. This study aimed at evaluating the efficacy and toxicity of Bortezomib-DRC (B-DRC) as first line treatment in WM. Methods: In this prospective randomized multicenter European phase II study, patients with the diagnosis of WM confirmed by reference pathology and in need of treatment were randomized 1:1 to DRC (Dexamethasone 20 mg orally d1, Rituximab 375 mg/m2 IV d1 cycle 1 and 1400 mg SC d1 cycle 2-6, Cyclophosphamide 100 mg/m2 x 2 orally d1-5) or to B-DRC (DRC plus Bortezomib SC 1,6mg/m2 day 1, 8, 15) for 6 cycles (28d interval). Primary endpoint was progression free survival (PFS). Secondary endpoints included response rates, overall survival (OS), and toxicity. Results: Of 204 registered patients, 2 patients were excluded due to incorrect randomization. Median follow-up was 27.5 months at the time of the data cut. Median age was 68 years (range 34-89) in both arms. According to the ISSWM prognostic score 14 % of patients were at low, 73 % at intermediate and 13 % at high risk in both treatment arms. Median baseline hemoglobin for B-DRC and DRC was 10.0 and 9.8 g/dl and median baseline IgM 31.7 and 31.9 g/dl, respectively. Mutational status was available for 72 patients: in the B-DCR vs DRC treatment arm 26 and 16 patients were MYD88 mutated (MYD88MT) and CXCR4 wildtype (CXCR4WT), 8 and 12 patients were MYD88MT/CXCR4MT and 5 and 5 patients MYD88WT/CXCR4WT, respectively. Median PFS has not been reached in the B-DRC arm (95% CI: 33.5; --) compared to 50.1 months in the DRC arm (95% CI: 31.1; --) with an estimated PFS at 24 months of 80.6 % (95% CI: 69.5; 88.0) and 72.8 % (95% CI: 61.3; 81.3), respectively (p=0.32). Median OS has not been reached in either treatment arm with 5 deaths and 6 deaths in the B-DRC and DRC arm, respectively. At the end of treatment B-DRC induced major responses (at least PR) in 79.1 % of patients (vs 68.9% for DRC) and a CR/VGPR in 18.7 % of patients (vs 11.1 % for DRC) with an overall response of 91.2 compared to 86.7 % for DRC. Compared to baseline IgM decreased by 79 % and 73 % and Hb increased by 28 % and 32 % in the B-DRC and DRC arm, respectively. Responses and PFS were independent of the mutational status in both treatment arms. B-DRC and DRC were well tolerated: grade ≥3 AEs occurred in 48% of all patients (B-DRC 48%, DRC 47%). Most common grade ≥3 AEs included neutropenia (25%), anemia (6%), and thrombocytopenia (5%). Overall, 16 pts (8%) developed infections (1% grade ≥3). Serious AEs occurred in 40 pts (20%) (DRC: 26 (26%), B-DRC: 14 (14%)). Peripheral sensory neuropathy occurred in 18 patients treated with B-DRC (2 patients with grade 3, 16 patients grade 1-2) and in 3 patients treated with DRC (all grade 1 and 2). Conclusions: This is the first and largest prospective randomized trial to evaluate bortezomib in combination with standard immunochemotherapy, demonstrating that B-DRC is a well-tolerated regimen which induces a high rate of major responses including deep remissions after 6 months of treatment with a 2-year PFS of 81%, independently of the mutational status of MYD88 and CXCR4. At this time point of analysis, adding Bortezomib to DRC did not induce significant differences in PFS compared to DRC alone. Future trials will have to compare chemotherapy-free approaches such as continuous treatment with BTK inhibitors with fixed duration treatments exemplified by B-DRC to understand which of the two treatment approaches offers the highest long - term sustained clinical benefit to WM patients. Disclosures Buske: Roche, Janssen, Bayer, MSD: Research Funding; Morphosys: Membership on an entity's Board of Directors or advisory committees; Roche, Janssen, AbbVie, Pfizer, Celltrion: Honoraria, Speakers Bureau. Dimopoulos:Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Research Funding, Speakers Bureau; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Speakers Bureau. Kastritis:Genesis Pharma: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding. Tomowiak:Roche: Research Funding; Gilead: Research Funding; Janssen: Honoraria; AbbVie: Honoraria; Beigene: Honoraria; Takeda: Honoraria. Hajek:Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Abbvie: Consultancy, Honoraria; PharmaMar: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Research Funding; Oncopeptides: Consultancy. Viardot:Roche: Honoraria, Other: advisory board; Kite/Gilead: Honoraria, Other: advisory board; Novartis: Honoraria, Other: advisory board; Amgen: Honoraria, Other: advisory board. Aurran:Janssen: Honoraria. Lepretre:Gilead: Honoraria; Astra Zeneca: Honoraria; AbbVie: Honoraria; Janssen: Honoraria. Leblond:AbbVie: Honoraria; Gilead: Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Astra Zeneca: Membership on an entity's Board of Directors or advisory committees; Lilly: Honoraria; Janssen: Honoraria; Roche: Honoraria; Astra Zeneca: Honoraria; Amgen: Honoraria; Gilead: Honoraria; Beigene: Honoraria; Beigene: Membership on an entity's Board of Directors or advisory committees. de Guibert:Gilead Sciences: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. Garcia-Sanz:Amgen: Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria; Gilead: Honoraria, Research Funding; Incyte: Research Funding; Janssen: Honoraria, Research Funding; Novartis: Honoraria; Pharmacyclics: Honoraria; Takeda: Consultancy, Research Funding. Gomes da Silva:roche: Consultancy; abbvie: Consultancy; BMS: Consultancy; MSD: Consultancy; Janssen: Consultancy; Gilead: Consultancy. Morel:Janssen: Honoraria. OffLabel Disclosure: Bortezomib in combination with DRC in Waldenström's Macroglobulinemia
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2020
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 8
    In: Blood, American Society of Hematology, Vol. 132, No. Supplement 1 ( 2018-11-29), p. 5549-5549
    Abstract: Introduction.The BCL-2 inhibitor venetoclax has demonstrated high efficiency in relapsed/refractory (R/R) CLL patients with an overall response rate (ORR) of 79%, regardless of the TP53gene status. Venetoclax has then been EMEA-approved for CLL patients with TP53disruption who are unsuitable for or have failed a BCR inhibitor (BCRi) and those without TP53 inactivation who have failed both immunochemotherapy and a BCRi. Whether this agent provides a well-balanced safety/efficacy profile and a prolonged survival in real-world practice remains to be investigated. Methods. An early access program (ATU) of venetoclax was available in France between July 22thand December 4th, 2016 for R/R CLL patients as per EMEA label. We retrospectively analyzed the outcome of patients included in this program who had received at least one day of venetoclax. Data quality was ensured using on-site data verification and computerized discrepancy errors. Results. Data concerning both clinical features andoutcome were available for 72 of the 93 patients for whom venetoclax was requested in this program. Among them, only 63 patients received at least one day of venetoclax for progressive CLL or Richter syndrome (RS) and were included in the present analysis. Median age was 69 years (range, 25-89) and sex ratioM/F was 47/16. A total of 56 patients received venetoclax for CLL and 7 for RS. Patients had previously received a median of 4 prior therapeutic lines (range, 0-7) including FCR in 43 (68%) of them, BTK inhibitor (BTKi) in 46 (73%) and PI3Kδ inhibitor (PI3Kδi) in 21 (33%); 5 had prior autologous stem cell transplantation (SCT) and 4 allogeneic SCT. At time of treatment with venetoclax, 32 (76%) patients carried TP53disruption (data available for 42 patients) and 19 (61%) had complex karyotype (CK) defined as ≥ 3 abnormalities (data available for 31 patients). IGHV mutational status was available for 26 patients. Treatment was administered as per label recommandations with a 5-week ramp up phase until the target dosage of 400 mg per day. Median follow-up was 17 months. Median time on therapy was 11.9 months (range, 0.1-24.6). Among adverse events of interest, tumor lysis syndrome (TLS) was observed in 19% of case, most of them being biological TLS and 3% were clinical TLS, and 15 (24%) patients developed infections requiring hospitalization. Autoimmune cytopenia was seen in 9.5% of patients. Four (7%) patients developed RS while on venetoclax for progressive CLL. To date, a total of 30% of patients remains on therapy. Three patients proceeded to allo-SCT after venetoclax therapy. Among the 7 patients who received venetoclax for RS, 2 had an objective response that lasted 7 and 14 months. However, median overall survival (OS) was only 1.1 months (95% CI, 0.7-1.5). Regarding the CLL cohort, ORR was 73%. It did not significantly differ according to the TP53status (90% with TP53disruption vs 69%, P= 0.189). Conversely, CK was associated with a lower ORR (92% vs 56%, P= 0.024). No impact of the type of prior BCRi (BTKi vs PI3Kδ inhibitor) was noted. 2-year progression-free survival (PFS) was 62% without significant impact of the TP53status (59% in case of TP53disruption vs 68% if wt-TP53,P= 0.587). Patients with CK had 2-year PFS of 44% compared to 78% for those without CK (P= 0.182). 2-year overall survival (OS) was 65% for the whole cohort and significantly better for responding patients than for non responders (76% vs 31%, P 〈 0.001). TP53disruption was associated with 2-year OS of 65% vs 90% (P= 0.176). Patients with CK had 53% of 2-year OS vs 62% for the remaining cohort (P= 0.236). There was no difference for the type of prior therapies (BTKi, PI3Kδ inhibitor or prior SCT) or IGHV mutational status. Patients who stopped venetoclax therapy had a very poor outcome with a median OS of 5 months. Conclusions.Our real-life study shows response rates and survival data that are in line with those observed in pioneer venetoclax clinical trials. CK should be evaluated as a predictive factor for response to venetoclax. Disclosures Herbaux: Janssen: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Gilead Sciences, Inc.: Consultancy, Honoraria. Laribi:Roche: Other: Grant; Teva: Other: Grant; Hospira: Other: Grant; Sandoz: Other: Grant; Gilead: Other: Personal fees; Novartis: Other: Grant and personal fees; Takeda: Other: Grant and personal fees; Amgen: Other: Personal fees. Feugier:Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Guieze:abbvie: Honoraria; janssen: Honoraria; gilead: Honoraria.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2018
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  • 9
    In: Blood, American Society of Hematology, Vol. 106, No. 11 ( 2005-11-16), p. 4759-4759
    Abstract: Background: Administration of the monoclonal anti-CD20 antibody Rituximab has been associated with infusional toxicity, leading to strict guidelines of use, i.e., infusion times from 4 to 6 hours. Even with pretreatment acetaminophen and diphenydramine, grade 3/4 adverse events including bronchospasm and hypotension occur in ~10% of patients with the first, and in 〈 2% with subsequent infusions. Presence of circulating malignant CD20 bearing cells represents a risk factor for developing grade 3/4 reactions. The pathophysiogy of this infusional toxicity is thought to be a “cytokine release syndrome” occuring within the 2 first hours of infusion. In few cases, it can be related to an anaphylactic reaction, occurring in the first minutes of infusion. Based on these observations and because infusional toxicity may be lower by the concomitant use of steroids, we established new guidelines of rituximab administration based on the number of circulating CD20+ cells, cycle number of the infusion, and allowing a total one-hour infusion time. Methods: A 1 mg/kg dose of steroids + diphenydramine + acetaminophen were given 20 minutes before each rituximab infusion. Rituximab dose was 375 mg/m2 diluted in 500 ml bottle. In the absence of circulating CD20+ cells, patients received their first course of rituximab according to the standard recommendations (from 50 mg/h and increasing by levels of 50mg/h every 30 min) until the fifth level. Then the remaining dose was administered at 500ml/h, with a total infusion time of ~3 h. The subsequent infusions were given at 100 mg/h for 15 minutes then at 500 ml/h, i.e. in one hour. In case of circulating malignant CD20+ cells, the first rituximab administration was administrated over 2 days: 50mg/m2 in 4h on day 1, and 325mg/m2 on day 2 according to the instructions described above. The subsequent infusions were administered according the one-hour protocol. Results: 69 patients have been treated in our outpatient unit, according to this protocol, for a total of 115 courses including 21 first cycles. Patients characteristics are as follows: median age 61 (range 26–85); 50% male; histology: 27 DLCBL including (IPI ≤1: 17 patients, IPI ≥2: 10 patients), 22 follicular, 2 mantle cell, 3 marginal zone, 2 lymphoplasmocytic, 1 Castelman disease, 11 CLL and 1 idiopathic thrombopenic purpura; treatment: R-CHOP in 51 patients, R-fludarabine/cytoxan in 15, R-chlorambucil in 1 and Rituximab alone in 2. Among the 21 first courses treatment was R-CHOP in 13, R- fludarabine/cytoxan in 3 and Rituximab in 5. No grade 3/4 toxicity was noted neither during the first nor the subsequent cycles. During the first infusion 2 patients developed grade 2, and 3 developed grade 1 reactions. One CLL patient had a grade 1 reaction after the second cycle. Conclusions: Taking into account the presence of circulating malignant CD20+ cells, a 3h first and one-hour subsequent infusion protocol is safe and well tolerated, independently of diagnosis and chemotherapy regimen. This protocol allows a sparing of 2 to 4 hours treatment time, very convenient for patients and in outpatient unit management.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
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  • 10
    Online Resource
    Online Resource
    American Society of Hematology ; 2016
    In:  Blood Vol. 127, No. 19 ( 2016-05-12), p. 2356-2358
    In: Blood, American Society of Hematology, Vol. 127, No. 19 ( 2016-05-12), p. 2356-2358
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
    detail.hit.zdb_id: 1468538-3
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