Rituximab in the Treatment of Adults with Chronic Idiopathic Thrombocytopenic Purpura (ITP) and Autoimmune Hemolytic Anemia (AIHA).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3930-3930 ◽  
Author(s):  
Ghassan Zalzaleh ◽  
Ahmad Jajeh ◽  
Diemante Tamoseviciene
Keyword(s):  
Partial Response ◽  
Hemolytic Anemia ◽  
Complete Response ◽  
Pure Red Cell Aplasia ◽  
Lymphocytic Leukemia ◽  
Overall Response ◽  
Medical Centers ◽  
History Of ◽  
Refractory Itp

Abstract Corticosteroids have been the first line of treatment of ITP since 1950, however some patients do not respond to this treatment (refractory) and some will relapse after its discontinuation. For such patients second line treatments were introduced. Some patients will continue to be refractory to this treatment and need other therapy modality. Rituximab is a chimeric monoclonal antibody directed against the CD20 antigen exposing B Lymphocytes, causing its depletion. This could alter the production of auto-antibodies in some Auto-Immune diseases and thus could be used in their treatment. Few medical centers had reported using Rituximab in the treatment of refractory (ITP) and (AIHA), yet its definite role could not be determined, and here we share our experience. Patients with documented diagnosis of ITP or AIHA who were refractory to at least two lines of therapy including steroids were offered to receive Rituximab (375mg/m2 weekly for 4 weeks). 15 patients were enrolled, 10 with ITP, 4 with AIHA, 1 with Coombs negative Hemolytic anemia, and 1 with pure red cell aplasia. One had both ITP and AIHA. 10 were females and 5 males. 5 were >60 years old and 10 were < 60 years old. 2 out of the 10 patients with ITP had also Chronic Lymphocytic Leukemia (CLL). Duration of follow up ranged from 2 months to 17 months (average 7 mos). Of the 10 patients with refractory ITP treated with Rituximab overall response was 60%. 4 were NR (no response), 2 were MR (minimal response: Platelets increased to <50000), 2 were PR (Partial response: Platelets increased to <100000) and 2 were complete response (Platelets became normal). 3 patients of 6 with Hemolytic anemia or PRC aplasia had NR, 1 had MR (Hct <30), and 2 had partial response (Hct 30–35). No complete response was observed in this group. In 3 patients with hemolytic anemia and CLL 1 had MR, 1 had PR and 1 had NR. 2 patients with hemolytic anemia who had NR died as a complication of their disease (one with septic shock and one with severe autoimmune flare up). Only one patient with refractory ITP had mild allergic side effects and did not complete 4 doses. No Rituximab related mortality was observed. CONCLUSION: Rituximab therapy had a variable but valuable effect in the treatment of patients with chronic refractory ITP and refractory/ relapsed AIHA. Overall response in our group reached 60%. No clinical or laboratory parameters were found to predict response, although there was a suggestion that males, younger age, and no history of splenectomy have a better chance of response. As we lack an effective alternative treatment in chronic refractory ITP and AIHA, Rituximab use could be a valid option in view of its mild toxicity. Further follow up of our patients and input from other institutions in this regard are needed.

A Retrospective Study of the Combination of Rituximab, Cyclophosphamide and Dexamethasone for the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia

2019 ◽  
Vol 143 (3) ◽  
pp. 244-249 ◽  
Author(s):  
Caroline I. Piatek ◽  
Hillel Bocian ◽  
Sandra Algaze ◽  
Ilene C. Weitz ◽  
Casey O'Connell ◽  
...  
Keyword(s):  
Hemolytic Anemia ◽  
Autoimmune Hemolytic Anemia ◽  
Immune Modulation ◽  
Complete Response ◽  
Primary Objective ◽  
Additional Treatment ◽  
Lymphocytic Leukemia ◽  
Immunocompromised Patients ◽  
Treatment Changes

The combination of rituximab, cyclophosphamide, and dexamethasone (RCD) is highly effective in the treatment of warm autoimmune hemolytic anemia (WAIHA) associated with chronic lymphocytic leukemia (CLL). We treated a cohort of patients with relapsed/refractory WAIHA, without CLL, with RCD. The primary objective was to evaluate the overall response (OR) of RCD therapy. Complete response (CR) was defined as a hemoglobin (Hgb) ≥12 g/dL. Partial response (PR) was defined as Hgb 10–11.9 g/dL or ≥2 g/dL increase in Hgb. Sustained response was defined as Hgb ≥10 g/dL with no treatment changes. A total of 16 patients with relapsed/refractory WAIHA received RCD (7 primary WAIHA, 9 secondary WAIHA) for a median of 4 cycles (range: 2–6). The median pretreatment Hgb was 10.0 g/dL (range: 4.3–12.2). The median best Hgb achieved was 12.5 g/dL (range: 10.6–15.1) with a median of 2 cycles until best Hgb response. The OR was 94% (11 CR, 4 PR). Two immunocompromised patients were admitted for infections during RCD treatment. There were no deaths during the treatment or follow-up period. Following a response to RCD, 4 patients received noncorticosteroid immune modulation therapy and 4 patients continued on corticosteroid therapy. Seven patients received no additional treatment.

Comparison of Proposed NIH Response Criteria with Clinician-Reported Changes in Organ-Specific and Overall Response

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1978-1978
Author(s):  
Jeanne Palmer ◽  
Stephanie J. Lee ◽  
Xiaoyu Chai ◽  
Barry Storer ◽  
Joseph Pidala ◽  
...  
Keyword(s):  
Partial Response ◽  
Disease Activity ◽  
Stable Disease ◽  
Progressive Disease ◽  
Complete Response ◽  
Response Criteria ◽  
Kappa Statistics ◽  
Overall Response ◽  
Organ Specific

Abstract Abstract 1978 In 2005, a NIH consensus conference was held to better define methods for research in chronic GVHD (cGVHD). Provisional definitions of response categories for individual organs and overall cGVHD disease activity were proposed: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). These response criteria were designed to improve consistency in documentation of disease activity across different centers, to allow less biased response assessments by comparison of enrollment and follow-up measures, rather than relying on clinician perceptions of change in the setting of clinical trials. In this study, we compared the proposed response criteria with clinician-reported changes in organ specific and overall responses. Good agreement would suggest that the proposed response criteria mirror clinician judgments of whether patients are responding to treatment or not. Methods: Patients ≥ 2 years of age diagnosed with cGVHD requiring systemic treatment ≤ 3 years after transplantation were eligible and assessed every 3–6 months. At each visit, clinicians reported the following: organ specific measures (used to calculate the NIH organ response for skin, mouth, eye and overall), perception of change in organ and overall involvement (completely gone = CR; very much or moderately improved = PR; a little better, stable, or a little worse = SD; or moderately or very much worse = PD), and overall aggregate response (CR, PR, SD, PD). Kappa statistics were used to compare agreement between these measures, with 0.21–0.4 considered fair agreement. Results: As of September 2010, 290 patients who had at least one follow-up visit 3 or 6 months beyond enrollment were included, with median age of 51 years (2–79). Based on NIH overall response criteria, 24 (8%) had CR, 83 (29%) had PR, 25 (9%) had SD, and 158 (54%) had PD for an overall CR+PR of 37%. In contrast, clinicians reported that 31 (11%) had CR, 171 (59%) had PR, 30 (10%) had SD and 56 (19%) had PD for an overall CR+PR of 70%. For organ specific comparisons, agreement rates between NIH proposed response measures and clinician reported changes in skin, mouth and eye were fair. For overall response, agreement rates between the calculated NIH response and clinician-reported overall change and clinician-reported response status were also fair. (Table) Conclusions: For both organ-specific and overall comparisons, the proposed NIH response criteria do not agree well with responses determined by clinicians. These data suggest that conclusions from prior literature reporting high overall CR+PR rates based on clinician judgment would not be supported if the current NIH response criteria had been used to measure response. Additional studies are needed to validate candidate response criteria through correlation with a robust, objective and informative gold standard.Table.Calculated NIH and clinician reported response rates in specific organs and overallOrganResponse measureNNICRPRSDPDKappa with NIH responseSkinCalculated NIH skin response28635%22%7%15%21%Clinician reported skin change28629%17%17%32%5%0.39*/0.43**MouthCalculated NIH mouth response28720%15%7%45%13%Clinician reported mouth change28720%15%29%33%4%0.28*/0.35**EyeCalculated NIH eye response16840%10%4%26%19%Clinician reported eye change16844%2%10%39%5%0.29*/0.26**OverallCalculated NIH overall response288—8%29%9%54%Clinician reported overall change285—7%41%45%8%0.24**Clinician reported response status288—11%59%10%19%0.20**NI, not involved; CR, complete response/completely resolved; PR, partial response/moderately better, very much better; SD, stable disease/a little better/stable/a little worse; PD, progressive disease/moderately worse, very much worse*simple kappa, including all patients**weighted kappa, limited to patients with involvement by both measures at enrollment Disclosures: No relevant conflicts of interest to declare.

Bendamustine Combined With Rituximab in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia: A Multicenter Phase II Trial of the German Chronic Lymphocytic Leukemia Study Group

2011 ◽  
Vol 29 (26) ◽  
pp. 3559-3566 ◽  
Author(s):  
Kirsten Fischer ◽  
Paula Cramer ◽  
Raymonde Busch ◽  
Stephan Stilgenbauer ◽  
Jasmin Bahlo ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Partial Response ◽  
Phase Ii ◽  
Overall Response Rate ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Complete Response ◽  
Lymphocytic Leukemia ◽  
Refractory Disease ◽  
Overall Response

Purpose The objective of this trial was to evaluate safety and efficacy of bendamustine combined with rituximab (BR) in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL). Patients and Methods Seventy-eight patients, including 22 patients with fludarabine-refractory disease (28.2%) and 14 patients (17.9%) with deletion of 17p, received BR chemoimmunotherapy. Bendamustine was administered at a dose of 70 mg/m2 on days 1 and 2 combined with rituximab 375 mg/m2 on day 0 of the first course and 500 mg/m2 on day 1 during subsequent courses for up to six courses. Results On the basis of intent-to-treat analysis, the overall response rate was 59.0% (95% CI, 47.3% to 70.0%). Complete response, partial response, and nodular partial response were achieved in 9.0%, 47.4%, and 2.6% of patients, respectively. Overall response rate was 45.5% in fludarabine-refractory patients and 60.5% in fludarabine-sensitive patients. Among genetic subgroups, 92.3% of patients with del(11q), 100% with trisomy 12, 7.1% with del(17p), and 58.7% with unmutated IGHV status responded to treatment. After a median follow-up time of 24 months, the median event-free survival was 14.7 months. Severe infections occurred in 12.8% of patients. Grade 3 or 4 neutropenia, thrombocytopenia, and anemia were documented in 23.1%, 28.2%, and 16.6% of patients, respectively. Conclusion Chemoimmunotherapy with BR is effective and safe in patients with relapsed CLL and has notable activity in fludarabine-refractory disease. Major but tolerable toxicities were myelosuppression and infections. These promising results encouraged us to initiate a further phase II trial evaluating the BR regimen in patients with previously untreated CLL.

Prior Biliary Tree Instrumentation Does Not Preclude Hepatic Arterial Therapy for Malignancy

2010 ◽  
Vol 76 (6) ◽  
pp. 618-621 ◽  
Author(s):  
Jason T. Bowling ◽  
Nathan P. Reuter ◽  
Robert C.G. Martin ◽  
Kelly M. Mcmasters ◽  
Cliff Tatum ◽  
...  
Keyword(s):  
Partial Response ◽  
Biliary Tree ◽  
Complete Response ◽  
Infectious Complications ◽  
Toxicity Profile ◽  
Increased Risk ◽  
History Of ◽  
Tree Manipulation ◽  
Hepatic Malignancies

Hepatic arterial therapy (HAT) has become an accepted alternative for patients with unresectable hepatic malignancies. HAT has an acceptable toxicity profile, yet its safety for use in patients who have undergone significant biliary manipulation is undocumented. A retrospective review identified 18 consecutive patients with unresectable hepatic malignancies who had undergone significant prior biliary tree manipulation. All patients received peri-HAT antibiotics. Clinicopathologic, treatment-related, and outcomes data were collected and analyzed. Eighteen patients who had HAT were analyzed; 72 per cent were men, the median age was 61 years, and 61 per cent had greater than 25 per cent hepatic parenchymal replacement by tumor. Seventy-eight per cent of patients had an indwelling biliary stent and 22 per cent had undergone a hepaticojejunostomy Twenty-two per cent of patients developed a complication, none of which were infectious, and there were no peri-HAT deaths. The majority of patients had evidence of either a partial response (55%) or stable disease (22%) upon follow-up. One patient had a complete response to HAT. The median survival was 27 months. Hepatic arterial therapy seems to be safe for patients with unresectable hepatic malignancies and a history of significant biliary instrumentation. There is no increased risk of infectious complications in this population after HAT

scholarly journals Lenalidomide as initial therapy of elderly patients with chronic lymphocytic leukemia

Blood ◽  
2011 ◽  
Vol 118 (13) ◽  
pp. 3489-3498 ◽  
Author(s):  
Xavier C. Badoux ◽  
Michael J. Keating ◽  
Sijin Wen ◽  
Bang-Ning Lee ◽  
Mariela Sivina ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Partial Response ◽  
Elderly Patients ◽  
Progression Free Survival ◽  
Complete Response ◽  
Initial Therapy ◽  
Lymphocytic Leukemia ◽  
Common Grade ◽  
Grade 3

Abstract The best initial therapy for elderly patients with chronic lymphocytic leukemia (CLL) has not yet been defined. We investigated the activity of lenalidomide as initial therapy for elderly patients with CLL. Sixty patients with CLL 65 years of age and older received treatment with lenalidomide orally 5 mg daily for 56 days, then titrated up to 25 mg/d as tolerated. Treatment was continued until disease progression. At a median follow-up of 29 months, 53 patients (88%) are alive and 32 patients (53%) remain on therapy. Estimated 2-year progression-free survival is 60%. The overall response rate to lenalidomide therapy is 65%, including 10% complete response, 5% complete response with residual cytopenia, 7% nodular partial response, and 43% partial response. Neutropenia is the most common grade 3 or 4 treatment-related toxicity observed in 34% of treatment cycles. Major infections or neutropenic fever occurred in 13% of patients. Compared with baseline levels, we noted an increase in serum immunoglobulin levels across all classes, and a reduction in CCL3 and CCL4 plasma levels was noted in responding patients. Lenalidomide therapy was well tolerated and induced durable remissions in this population of elderly, symptomatic patients with CLL. This study was registered at www.clinicaltrials.gov as #NCT00535873.

Clinical Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 29-29 ◽  
Author(s):  
Saad Usmani ◽  
Brendan Weiss ◽  
Nizar J Bahlis ◽  
Andrew Belch ◽  
Sagar Lonial ◽  
...  
Keyword(s):  
Partial Response ◽  
Board Of Directors ◽  
Research Funding ◽  
Complete Response ◽  
Clinical Activity ◽  
Open Label ◽  
Advisory Committees ◽  
Combined Analysis ◽  
Overall Response

Abstract Introduction : Daratumumab (DARA) is a novel human CD-38-targeting monoclonal antibody in clinical development for multiple myeloma (MM). In two clinical studies (NCT00574288 [GEN501] and NCT01985126 [Sirius]), DARA monotherapy showed remarkable clinical activity and was well tolerated in heavily treated patients (pts) with relapsed and refractory (RR) MM (Lokhorst HM. J Clin Oncol 2014;32 Suppl:abstr 8513. Lonial S. J Clin Oncol 2015;33 Suppl: abstr LBA8512). A combined analysis of efficacy of 16 mg/kg DARA in these two studies is presented. Methods : GEN501, a first-in-human open-label, two-part (Part 1 dose escalation; Part 2 dose expansion) study, enrolled pts with MM that had relapsed after or were refractory to ≥2 prior therapies. Sirius, an open-label, two-part study, enrolled pts with MM with ≥3 prior therapies, including a PI or IMiD, or were refractory to both a PI and an IMiD. Eligibility criteria included pts with absolute neutrophil count ≥1000/mm3, hemoglobin ≥7.5 g/dL, platelet count ≥75×109/L (GEN501) or ≥50×109/L (Sirius), and alanine aminotransferase ≤3.5 (GEN501) or ≤2.5 (Sirius) times the upper limit of normal. In GEN501 Part 2, the first 16 mg/kg DARA infusion was followed by a 3 week rest period, and then qw for 7 weeks, q2w for 14 weeks, and q4w thereafter. In Sirius, 16 mg/kg DARA was infused qw for 8 weeks, q2w for 16 weeks, and q4w thereafter. The combined analysis comprised pts treated with 16 mg/kg DARA in Sirius and Part 2 of GEN501. In both studies overall response rates (ORR) were assessed according to IMWG response criteria. Results: The combined analysis included 148 pts (42 and 106 pts from GEN501 and Sirius, respectively). The median (range) age was 64 (31-84) years. Median time since initial diagnosis was 5.8 and 4.8 years in GEN501 and Sirius, respectively, and 62% and 82% of pts had received >3 prior therapies, respectively. In GEN501, 76% of pts were refractory to their last therapy and 64% were refractory to both a PI and IMiD; a greater proportion of pts in Sirius were refractory to their last therapy (97%) and double refractory to a PI and IMiD (95%). The ORR was 36% in GEN501 and 29% in Sirius; the ORR for the combined analysis was 31%. Best overall response is shown in Table. Responses deepened over time and the combined rate of very good partial response (VGPR) or better was 11% with 2 pts with complete responses (CR) and 3 with stringent CRs (sCR) across the two studies. In the combined analysis, median duration of response was 7.6 months and 46% of responders remained progression free at 1-year after a median follow-up of 9.3 months. Median overall survival (OS) had not been reached at median follow-up times of 10.2 months (GEN501) and 9.3 months (Sirius). The estimated 1-year OS rate (95% CI) was 77% (58-88), 65% (51-76), and 69% (58-77) for GEN501, Sirius, and the combined analysis, respectively. Forty-four of 46 responders were still alive at the time of the primary analysis. At a subsequent data cutoff for the combined analysis, after a median follow-up of 14.8 months, the estimated median OS was 19.9 months (95% CI, 15.1 - not estimable). ORR was similar across prespecified subgroups which included age, ISS stage, number of prior therapies, and refractory status. Conclusions : Single-agent DARA (16 mg/kg) demonstrated remarkable clinical activity (31% ORR) in a combined analysis of two studies in heavily pretreated MM pts. The quality of the observed responses (11% VGPR or better, 2 CRs, and 3 sCRs) was noteworthy in this highly refractory population. DARA shows promising activity in pts who have exhausted other approved myeloma treatment options. Table. Best Overall Response. 16 mg/kg MMY2002 n (%) GEN501 Part 2 n (%) Total n (%) Combined analysis set 106 42 148 Best response Stringent Complete Response (sCR) 3 (2.8) 0 3 (2.0) Complete response (CR) 0 2 (4.8) 2 (1.4) Very good partial response (VGPR) 10 (9.4) 2 (4.8) 12 (8.1) Partial response (PR) 18 (17.0) 11 (26.2) 29 (19.6) Minimal response (MR) 5 (4.7) 4 (9.5) 9 (6.1) Stable disease (SD) 46 (43.3) 22 (52.4) 68 (45.9) Progressive disease (PD) 18 (17.0) 0 18 (12.2) Not evaluable (NE) 6 (5.7) 1 (2.4) 7 (4.7) Overall response (sCR+CR+VGPR+PR) 31 (29.2) 15 (35.7) 46 (31.1) Disclosures Usmani: Celgene Corporation: Consultancy, Honoraria; Janssen: Research Funding; Onyx: Consultancy, Honoraria, Research Funding. Weiss:Janssen and Millennium: Consultancy; Janssen and Onclave: Research Funding. Bahlis:Johnson & Johnson: Research Funding; Amgen: Consultancy; Johnson & Johnson: Consultancy; Johnson & Johnson: Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau. Lonial:Celgene: Consultancy, Research Funding; Janssen: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Millennium: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Onyx: Consultancy, Research Funding. Lokhorst:Genmab: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Amgen: Honoraria. Voorhees:Janssen, Celgene, GlaxoSmithKline,Onyx Pharmaceuticals and Oncopeptides: Consultancy, Research Funding; Array BioPharma, Celgene, GlaxoSmithKline, and Oncopeptides: Consultancy; Millennium/Takeda and Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees. Richardson:Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Millennium Takeda: Membership on an entity's Board of Directors or advisory committees; Johnson & Johnson: Membership on an entity's Board of Directors or advisory committees. Axel:Janssen: Employment. Feng:Janssen: Employment. Uhlar:Janssen: Employment. Wang:Janssen: Employment. Khan:Janssen: Employment. Ahmadi:Janssen: Employment. Nahi:Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Risk Profile, Efficacy and Safety of Rituximab in Patients with Relapsed or Refractory Idiopathic Thrombocytopenic Purpura in a Minority Cohort with Long Term Follow up

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4546-4546
Author(s):  
Shylendra B Sreenivasappa ◽  
R. Catchatourian ◽  
Barbara Yim
Keyword(s):  
Platelet Count ◽  
Partial Response ◽  
Median Time ◽  
Response Rate ◽  
Complete Response ◽  
Thrombocytopenic Purpura ◽  
Significant Difference ◽  
Time To Relapse ◽  
Refractory Itp

Abstract Background: Idiopathic Thrombocytopenic Purpura (ITP) is a common hematological disorder. We sort to characterize the risk profiles and efficacy of rituximab in relapsed or refractory ITP in a largely minority cohort. Methods: 23 patients (pts) with relapsed or refractory ITP treated with Rituximab were identified and studied as a retrospective cohort. Demographics, presentation, dosage schedule, tolerability and response were analyzed. Continuous data were analyzed via Student’s T test, categorical data via Fisher’s exact test and time to progression data was analyzed via Kaplan Meier life table analysis and log rank test. Results: Of the 23 patients, 20 female (87%), 3 male (13%). median age at diagnosis was 45 yr (range 20–66).9 pt were African American (39%), 9 Hispanics (39%), 4 Asian (17.4%), 1 Caucasian(4.3%), 9 (39.6%) had more than one co morbidities, 17 (73.8%) had received 3 or more treatment regimens. All pt received steroids, 18 (78.3%) received IVIg, 13 (56.6%) Anti D immunoglobulin, 5 (21.7%) Vincristine, 3 (13%) Azathioprine, 2(8.7%) Cyclophosamide, 6 (26.1%) underwent a Splenectomy before Rituximab therapy. The median time from diagnosis to rituximab therapy was 15 months (range 1 to 269). Median platelet count before rituximab therapy was 11 (range 3 to 200). Rituximab was administered at the dose of 375mg/m2 IV once a week for 4 weeks. The response rate was 47.8%. Response was defined as Complete response, platelet count of &gt; 100 × 109/L, Partial response &gt;50 × 109/L. 9 pt (39%) achieved complete response, 2 pt (8.7%) achieved partial response. 12 pt (52.2%) did not respond. Median time to response was 13.5 days (range 1–30). There was no statistically significant difference in the response when compared by gender (p=0.64), race (p= 0.398), prior splenectomy (p=0.64), prior anti D immunoglobulin (p=1.0), prior Vincristine (p=1.0), prior cyclophosamide (p=.45), prior azathioprine (p=1.0). Four pt (17.4%) had a serious adverse reaction to rituximab. One pt had diffuse hives after infusion, three pt developed diffuse pancytopenia, two pts had gram negative sepsis and died. The median follow up after rituximab therapy was 18 months (range 1–60). The median time to relapse was 7 months (range of 1 to 59). There was no statistically significant difference in time to relapse among gender (p=0.19), race (p= 0.45), Prior splenectomy (p=0.86), prior Anti D immunoglobulin (p=0.32), prior vincristine (p=0.75). Conclusion: In this primarily minority based cohort the response rate to Rituximab (48% vs. 62%) and duration of response (7 months vs. 10.5 months) was lower than other published data but the rate of serious adverse events (17% vs. 7%) was higher. Rituximab must be used cautiously in this sub group of patients. There is need for a randomized controlled clinical trail to assess the efficacy of Rituximab in this population and further studies are warranted in minority populations.

scholarly journals Sialendoscopy With Intraductal Steroid Irrigation in Patients With Sialadenitis Without Sialoliths

2019 ◽  
Vol 98 (5) ◽  
pp. 291-294 ◽  
Author(s):  
Saudamini J. Lele ◽  
Mickie Hamiter ◽  
Torrey Louise Fourrier ◽  
Cherie-Ann Nathan
Keyword(s):  
Treatment Option ◽  
Case Series ◽  
Complete Response ◽  
Definitive Treatment ◽  
Invasive Technique ◽  
Effective Treatment Option ◽  
Patient Reported ◽  
History Of ◽  
The Mean

Sialendoscopy has emerged as a safe, effective and minimally invasive technique for management of obstructive and inflammatory salivary gland disease. The aim of our study was to analyze outcomes of sialendoscopy and steroid irrigation in patients with sialadenitis without sialoliths. We performed a retrospective analysis of patients who underwent interventional sialendoscopy with steroid irrigation from 2013 to 2016, for the treatment of sialadenitis without sialolithiasis. Twenty-two patients underwent interventional sialendoscopy with ductal dilation and steroid irrigation for the treatment of sialadenitis without any evidence of sialolithiasis. Conservative measures had failed in all. Eleven patients had symptoms arising from the parotid gland, 4 patients had symptoms arising from the submandibular gland, while 6 patients had symptoms in both parotid and submandibular glands. One patient complained of only xerostomia without glandular symptoms. The mean age of the study group which included 1 male and 21 females was 44.6 years (range: 3-86 years). Four patients had autoimmune disease, while 7 patients had a history of radioactive iodine therapy. No identifiable cause for sialadenitis was found in the remaining 11 patients. The mean follow-up period was 378.9 days (range: 16-1143 days). All patients underwent sialendoscopy with ductal dilation and steroid irrigation. Twelve patients showed a complete response and 9 patients had a partial response, while 1 patient reported no response. Only 3 patients required repeat sialendoscopy. The combination of sialendoscopy with ductal dilation and steroid irrigation is a safe and effective treatment option for patients with sialadenitis without sialoliths refractory to conservative measures. Prospective studies with a larger case series are needed to establish its role as a definitive treatment option.

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 Trends in the risk of second primary malignancies among survivors of chronic lymphocytic leukemia

2019 ◽  
Vol 9 (10) ◽  
Author(s):  
Vivek Kumar ◽  
Sikander Ailawadhi ◽  
Leyla Bojanini ◽  
Aditya Mehta ◽  
Suman Biswas ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Hematological Malignancies ◽  
Lymphocytic Leukemia ◽  
Second Primary ◽  
Standardized Incidence Ratio ◽  
Improved Outcomes ◽  
History Of ◽  
Second Primary Malignancies

Abstract With improving survivorship in chronic lymphocytic leukemia (CLL), the risk of second primary malignancies (SPMs) has not been systematically addressed. Differences in risk for SPMs among CLL survivors from the Surveillance, Epidemiology, and End Results (SEER) database (1973–2015) were compared to risk of individual malignancies expected in the general population. In ~270,000 person-year follow-up, 6487 new SPMs were diagnosed with a standardized incidence ratio (SIR) of 1.2 (95% CI:1.17–1.23). The higher risk was for both solid (SIR 1.15; 95% CI:1.12–1.18) and hematological malignancies (SIR 1.61; 95% CI:1.5–1.73). The highest risk for SPMs was noted between 2 and 5 months after CLL diagnosis (SIR 1.57; 95% CI:1.41–1.74) and for CLL patients between 50- and 79-years-old. There was a significant increase in SPMs in years 2003–2015 (SIR 1.36; 95% CI:1.3–1.42) as compared to 1973–1982 (SIR 1.19; 95% CI:1.12–1.26). The risk of SPMs was higher in CLL patients who had received prior chemotherapy (SIR 1.38 95% CI:1.31–1.44) as compared to those untreated/treatment status unknown (SIR 1.16, 95% CI:1.13–1.19, p < 0.001). In a multivariate analysis, the hazard of developing SPMs was higher among men, post-chemotherapy, recent years of diagnosis, advanced age, and non-Whites. Active survivorship plans and long-term surveillance for SPMs is crucial for improved outcomes of patients with a history of CLL.

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