Cyclophosphamide, Vincristine, Myocet and Prednisone ± Rituximab (COMP±R) Regimen Is Safe and Effective as First Line or Salvage Therapy in Elderly Non Hodgkin Lymphoma (NHL): Preliminary Data of Single Centre Experience.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3747-3747
Author(s):  
Elsa Pennese ◽  
Claudio Cristofalo ◽  
Michelina Dargenio ◽  
Maria Rosaria De Paolis ◽  
Pasquale Forese ◽  
...  

Abstract Abstract 3747 Poster Board III-683 Background despite the prognosis of aggressive non-Hodgkin Lymphoma has considerably improved over the past decades, the treatment of elderly patients with NHL is still a difficult challenge for the clinician. A retrospective EORTC study conducted in patients with aggressive NHL and age above 70 years showed that about half of patients received an aggressive treatment and that only 15% of investigators employed full-dose regimens from the first cycle. We here present the preliminary data of CHOP-like regimen delivered as first-line or salvage therapy to elderly or young patients with NHL and not eligible for more aggressive therapy. Patients and methods from July 2006 to January 2009, 27 pts (M/F:11/16) with a median age of 71 years (range: 53-84) were included in the study. Twenty-four pts (88%) were more than 65 yo, 18 (66%) had high-grade and 9 (34%) an indolent lymphoma. Stage III-IV disease according to Ann Arbor staging occurred in 18 pts (66%) whereas aaIPI, evaluated only for pts with aggressive NHL, was 3 2 in 9 pts (18%). ENS involvement ≥ 1 was present in 11 (41%) and BM involvement in 13 pts (48%). Most of pts (60%) had ECOG PS ≥ 1. Twenty out of 27 pts (74%) received COMP±R as first-line treatment and 7 (26%) as salvage therapy; all but one of pre-treated pts had received more than 1 line of chemotherapy (range 2-4). Twenty-five (92%) pts had co-morbidity with more than 1 disease in 44% of cases. Median LVEF was 59% (range: 35-80%). COMP±R regimen consisted of cyclophosphamide 750 mg/m2 IV d1, vincristine 1.4 mg/m2 IV d1 (capped at 2mg), liposome-encapsulated doxorubicin (MyocetÒ) at the dose of 50 mg/m2 IV d1 and Prednisone 100 mg/die PO d 1-5 with or without Rituximab at dose of 375 mg/m2 d8 at first course and at d1 of subsequent courses according to B or T-cell lymphoma phenotype respectively. To pts with early stage disease were planned 4 courses of COMP±R±IF-RT while those with advanced stage of disease received six courses of chemotherapy delivered every 3 weeks. Median number of cycles delivered was 5.6 (range: 4-8). All patients completed the planned treatment and most of them (92%) received G-CSF at dose of 300 mg/die as primary (67%) or secondary (25%) prophylaxis. ESA support was need in 8 pts (30%). Results complete response (CR) was achieved in 21 (78%) and partial response (PR) in 3 (11%) of pts with an ORR of 89%; three pts had stable (n=2) or progressive disease (n=1). The regimen was safe and well tolerated with dose reduction occurring in 9 pts (34%). None of pts developed cardiac toxicity. The mainly adverse events recorded was neutropenia occurring in 15% of pts and febrile neutropenia in 6 pts (23%). Extra-haematological toxicity was mild (WHO grade 1-2) and recorded in 18% of pts. There was no treatment-related fatal toxicity. With a median follow-up of 15 months (range 6-33) the OS and EFS was 93% and 89% respectively. Conclusion COMP±R regimen shows to be safe and effective in a group of elderly patients both as first line or salvage therapy. However more patients and longer follow-up is required to assess definitively the role of this regimen in elderly patients with untreated aggressive NHL. A prospective phase II trial is ongoing at our Institution. Disclosures: No relevant conflicts of interest to declare.

MedPharmRes ◽  
2019 ◽  
Vol 3 (3) ◽  
pp. 1-6
Author(s):  
Truc Phan ◽  
Tram Huynh ◽  
Tuan Q. Tran ◽  
Dung Co ◽  
Khoi M. Tran

Introduction: Little information is available on the outcomes of R-CHOP (rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone) and R-CVP (rituximab with cyclophosphamide, vincristine and prednisone) in treatment of the elderly patients with non-Hodgkin lymphoma (NHL), especially in Vietnam. Material and methods: All patients were newly diagnosed with CD20-positive non-Hodgkin lymphoma (NHL) at Blood Transfusion and Hematology Hospital, Ho Chi Minh city (BTH) between 01/2013 and 01/2018 who were age 60 years or older at diagnosis. A retrospective analysis of these patients was perfomed. Results: Twenty-one Vietnamese patients (6 males and 15 females) were identified and the median age was 68.9 (range 60-80). Most of patients have comorbidities and intermediate-risk. The most common sign was lymphadenopathy (over 95%). The proportion of diffuse large B cell lymphoma (DLBCL) was highest (71%). The percentage of patients reaching complete response (CR) after six cycle of chemotherapy was 76.2%. The median follow-up was 26 months, event-free survival (EFS) was 60% and overall survival (OS) was 75%. Adverse effects of rituximab were unremarkable, treatment-related mortality accounted for less than 10%. There was no difference in drug toxicity between two regimens. Conclusions: R-CHOP, R-CVP yielded a good result and acceptable toxicity in treatment of elderly patients with non-Hodgkin lymphoma. In patients with known cardiac history, omission of anthracyclines is reasonable and R-CVP provides a competitive complete response rate.


2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 7542-7542 ◽  
Author(s):  
Jonathan W. Friedberg ◽  
Andres Forero-Torres ◽  
Beata Holkova ◽  
Jerome H. Goldschmidt ◽  
Ralph V. Boccia ◽  
...  

2017 ◽  
Vol 24 (4) ◽  
pp. 262
Author(s):  
P. Laneuville ◽  
J.F. Larouche ◽  
A. Tosikyan ◽  
A. Christofides

The 2017 annual meeting of the American Society of Clinical Oncology took place in Chicago, Illinois, 2–6 June. At the meeting, results from key studies in the first-line treatment of indolent non-Hodgkin lymphoma (inhl) were presented. Of those studies, two were selected for oral presentations: 9-year follow-up data from the stil nhl1 trial, which compared the efficacy and safety of bendamustine plus rituximab (br) with those of rituximab plus cyclophosphamide–vincristine–prednisone–doxorubicin (r-chop); and 5-year follow-up data from the bright study, which compared br with r-chop and r-cvp (rituximab plus cyclophosphamide–vincristine–prednisone) combined. Our meeting report describes the foregoing studies and includes interviews with key investigators, plus commentaries from three Quebec hematologists on the potential effects for Canadian practice.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19528-e19528
Author(s):  
Debra E. Irwin ◽  
Stephen Thompson ◽  
Rinat Ribalov ◽  
Azhar Choudhry

e19528 Background: Patients with Indolent non-Hodgkin lymphoma (iNHL) have shown positive outcomes with ibrutinib monotherapy (IM) as well as bendamustine/rituximab combination (BR) therapy, but no studies have reported on patient outcomes using real-world data. The current analysis evaluated serious infections and cardiovascular complications in iNHL patients treated with first-line IM or BR therapy using US real-world data. Methods: Administrative claims from the MarketScan® Research Databases were used to identify adult patients enrolled in commercial or Medicare supplemental insurance plans based on a first prescription fill of IM or BR therapy (the index date) from 2/1/14 to 9/1/19. Patients included in the study were diagnosed with iNHL, were treatment naïve, and were continuously enrolled for ≥12 months both prior to and following the index date. Serious infections and cardiovascular complications requiring hospitalization (diagnosis code in any position) and associated inpatient costs were evaluated during a fixed 12-month follow-up period. Statistical differences in outcome distributions and costs (reported per patient per month [PPPM]) between the groups were tested. Results: Of 1,948 iNHL patients, 147 had IM and 1,058 had BR as index therapy with ≥12 months of follow-up data. Patients receiving IM were older, more often male, and more likely to have had a lower respiratory tract infection (LRTI) or atrial fibrillation (AF) during baseline compared to BR patients, otherwise the groups had similar baseline characteristics. Hospitalization for serious infections was similar for IM and BR patients during the follow-up period (17.0% vs. 14.4%; p = 0.397); among hospitalized patients, the IM and BR groups incurred similar PPPM inpatient costs ($2,839 vs. $3,954; p = 0.188). Specifically, 7.5% of IM patients had a bacterial infection hospitalization and incurred $2,561 PPPM vs 7.6% of BR patients who incurred $3,975 PPPM (both p > 0.05); 8.8% of IM patients had a LRTI hospitalization and incurred $3,629 PPPM vs 6.1% of BR patients who incurred $4,980 PPPM (both p > 0.05). Hospitalization for cardiovascular complications was similar during follow-up for IM and BR patients (15.6% vs. 12.2%; p = 0.237); among hospitalized patients, the IM and BR groups incurred similar PPPM costs ($3,777 vs. $3,862; p = 0.948). Specifically, 7.5% of IM patients had a hospitalization for AF and incurred $4,481 PPPM vs 3.6% of BR patients who incurred $4,860 PPPM (p = 0.025 and p = 0.875, respectively). Conclusions: In a real-world setting, serious infections and cardiovascular complications requiring hospitalization, including associated costs, were similar among iNHL patients treated with first-line IM or BR over 12 months, although IM patients were more likely to have an AF-related complication.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 777-777 ◽  
Author(s):  
Umberto Vitolo ◽  
Marco Ladetto ◽  
Carola Boccomini ◽  
Andrea Evangelista ◽  
Enrica Gamba ◽  
...  

Abstract Abstract 777 Introduction. Fludarabine containing regimens are effective in FL; the role of Rituximab (R) maintenance has been established recently. Aim of the study was to investigate efficacy and safety of R-maintenance vs. observation in elderly FL patients who respond to a brief chemo-immunotherapy with four courses of R-FND + four doses of Rituximab as consolidation. Methods. From January 2004 to December 2007, elderly patients (age 60–75) with untreated advanced stage FL who required treatment, were enrolled by 33 FIL centers. Treatment plan was: four courses of R-FND (standard doses of Rituximab, Fludarabine, Mitoxantrone, Dexamethasone) every 28 days followed by four weekly Rituximab infusions as consolidation; responding (Complete Response, CR + CRu + Partial Response, PR) patients were randomized between a short Rituximab maintenance with a single dose every two months for a total of four doses (Arm A) or observation (Arm B). Qualitative and quantitative PCR monitoring for IgH/Bcl-2 rearrangement on bone marrow (BM) was performed at diagnosis, after R-FND and R consolidation and during maintenance/observation. Results. 242 patients were enrolled at diagnosis in the study and 234 were eligible for treatment: median age was 66 yrs; advanced stage II 14%, stage III 21% and stage IV 65%; BM involvement and B symptoms were documented in 55% and 18% respectively. According to FLIPI risk patients were: Low 11%, Intermediate 34%, High 55%. According to Comprehensive Geriatric Assessment (CGA), concomitant illness were: one in 38% and greater than or equal to two in 23% of patients. Qualitative PCR analysis for IgH/Bcl-2, performed in 223 patients at diagnosis, was positive in 49%. Two hundred and two (86%) patients completed the induction treatment and were randomized between maintenance or observation; 32 were not because of stable/progressive disease (15), adverse events (nine) or other causes (eight). At the end of chemoimmunoterapy and consolidation overall response rate was 86% with 68% CR and 18% PR. After four courses of chemo-immunotherapy, 90 patients were in PR of whom 37 (41%) were converted to CR with the addition of Rituximab consolidation. As regard to Bcl2 analysis, PCR negativity was detected in 61% after R-FND and increased to 73% after R consolidation. With a median follow-up of 33 months, two-years Overall Survival and Progression Free Survival (PFS) were 93% (95% CI 92%–97%) and 77% (95% CI 71%–93%), respectively. Two-years PFS according to maintenance/observation phase was: 80% vs 68% (p.225), Figure 1. Two-years PFS rates according to FLIPI score were 87% for low/intermediate risk and 70% for high risk (p < 0.0001). A total of 1119 courses were delivered; the most frequent CTC grade 3–4 toxicity was neutropenia in 25% of the courses, with only 13 events of serious infections. Two toxic deaths during treatment (0.8%) occurred: 1 HBV reactivation and 1 Steven Johnson syndrome. In the maintenance/observation phase the following severe (WHO grade 3–4) toxicities were recorded: 15 patients experienced neutropenia, 8 cardiac events, 4 infections; no other relevant toxicities were recorded. Second malignancy were recorded in 11 patients. Conclusions. a short term chemo-immunotherapy R-FND + Rituximab consolidation is able to achieve high CR rate and a good two-years PFS in elderly FL patients. Good results were also observed in higk-risk FLIPI score. Two-years PFS of 80% in patients randomized to R maintenance was promising although there was no statistical difference compared to observation. This finding may be attributed to the relatively short follow-up or to the choice of a short course of Rituximab maintenance (only four doses) or both.Figure 1Figure 1. Disclosures: Vitolo: Jannsen-Cilag: Speakers Bureau; Celgene: Speakers Bureau; Roche Italy: Speakers Bureau. Off Label Use: The study includes use of Rituximab as maintenance in responding patients after first line chemoimmunotherapy. Gamba:Roche Italia: Employment. Supekar:Roche Italia: Employment.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3719-3719 ◽  
Author(s):  
Andrew D McQuillan ◽  
William BG Macdonald ◽  
Michael F Leahy ◽  
J Harvey Turner

Abstract Abstract 3719 Introduction: Radio-immunotherapy (RIT) with 131I-rituximab has demonstrated efficacy in relapsed and refractory non-Hodgkin lymphoma (NHL). 131I-tositumomab has been shown to be an effective first-line agent in follicular NHL with durable response. We aimed to evaluate the efficacy and safety of first-line 131I-rituximab RIT and the duration of response in previously untreated patients with follicular NHL, given that this radiolabeled chimeric antibody treatment can be repeated upon relapse. Methods: Fifty consecutive patients with newly diagnosed, symptomatic, advanced follicular NHL received a prescribed therapy activity of 131I-rituximab predicated upon a fixed, whole-body radiation dose of 0.75 Gy. All patients were treated as outpatients. All patients received a standard four-week course of rituximab at a dose of 375 mg/m2 in conjunction with the radionuclide therapy, and subsequent rituximab maintenance at 3-monthly intervals for one year. Response was determined by 18F-FDG PET/CT scans at baseline, and at 3 and 12 months post-treatment. Results: Overall response rate (ORR) at 3 months was 98%, with complete response (CR) seen in 38 patients (76%) and partial response (PR) in 11 patients (22%). Four patients (36%) assessed as having PR at 3 months converted to CR in the year following treatment, so that 84% of patients were in CR at one year. During median follow-up of 33 months (range 12–61 months) only one patient (2.6%) among those who had achieved CR has relapsed, while progressive disease has been seen in seven patients (64%) of those with PR at first post-treatment assessment. Only three of the seven patients with PD have so far required further treatment; one with local radiotherapy and two who have received combination chemotherapy. Median progression-free survival (PFS) has not yet been reached. Toxicity was limited to hematological Grade 4 neutropenia in 5 patients (10%) and thrombocytopenia in 5 patients (10%). One patient received a single platelet transfusion. There were no episodes of bleeding or infection. Three patients have died; one from transformed, aggressive NHL (the only non-responder) and the other two from non-hematological malignancies not apparent at study entry. Conclusion: First-line 131I-rituximab RIT of advanced follicular NHL is effective and safe. Early response rates are similar to those observed with combination chemotherapy and rituximab regimens. Durable CR is present in 82% of patients over a median follow-up of 33 months and median PFS has not yet been reached. Of those with documented PR at 3 months, approximately one-third subsequently converted to CR, while the remaining two-thirds developed PD. Disclosures: Off Label Use: radiolabelled rituximab.


2007 ◽  
Vol 139 (1) ◽  
pp. 90-93 ◽  
Author(s):  
Alberto Fabbri ◽  
Mariapia Lenoci ◽  
Alessandro Gozzetti ◽  
Ida Chitarrelli ◽  
Francesca Olcese ◽  
...  

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2845-2845
Author(s):  
Xin Li ◽  
Qian Cheng ◽  
Rui Liu ◽  
Liqing Kang ◽  
Nan Xu ◽  
...  

Abstract Background: CD20 antibody-based chemotherapy has been verified as a valid strategy and prolonged the overall survival (OS) of CD20(+) B-cell Non-Hodgkin Lymphoma (B-NHL) patients. However, over 40% of these patients finally would be relapsed or refractory(R/R) to CD20 antibody rituximab. Treatment of these R/R B-NHL patients has not been standardized yet. Furthermore, it is still a question that whether CD20-specific CAR T-cells could provide an alternative therapy in rituximab-relapsed/refractory B-NHL patients. Methods: Here, we conducted a prospective single-center study on patients with relapsed/refractory to CD20 antibody(No.ChiCTR2000036350). The aim of this study aims was to evaluate the efficacy and in vivo persistence of CART-20 cells in subjects with rituximab R/R CD20(+) B-NHL patients. Between October 2017 to December 2020, 15 patients with R/R B-NHL patients (including 14 DLBCL patents and 1 MCL patient) received anti-CD20 specific CAR T cell therapy. The efficacy of CAR T-cells therapy was evaluated at different assessment points by CT scan or 18FDG-PET. CAR-T expansion in blood was monitored regularly by real-time quantitative PCR (qPCR). Results: In this study, the clinical characteristic of these enrolled patients was a median age at 48 years (range 30 to 66), male n=7(47%). 10 (67%) patients were relapsed and 5 patients (33%) were refractory to rituximab-based chemotherapy.(Table 1) All of these patients were at advanced stage III/IV and 7 (47%) of them were diagnosed with bulky disease. The median time from latest rituximab utilization is 70 days (rang 31-471 days) before CAR T-20 cells infusion. The median number of lines of previous treatments was 4 (2-8). 14 patients (93%) received CAR T-20 with a dose of 1*10^7/kg, the median follow-up time for patients was 219 days (32 to 1231). CRS (100%) was observed in all 15 infusion patients: 11 patients grade I-II and 4 patients' grade ≥III. ICANS was recorded only in 1 patient (grade I). At 30 days after the infusion, the clinical response of all 15 infusion patients could be assessed: 4 (27%) CR, 11 (73%) PR, and ORR 100%.(Figure 1) 5 patients who were in PR at 30 days converted to CR, with a median time of 116 (6-858), and continued follow-up without relapse; 6 patients (40%) had relapse, with a median relapse time of 136 days (48- 1050), this might be related to the short time of rituximab before the CAR-T infusion.Although the cases are limited, we can still draw a preliminary conclusion that the use of rituximab within three months may not affect the efficacy of CD20-CAR-T, but may lead to early recurrence. Furthermore, the persistence time of CART-20 cells were comparably longer than that CART-19 cell infusions. Conclusions: In conclusion,these findings suggest that the use of CAR T-20 can be served as a salvage therapy in Rituximab-refractory CD20(+) B-cell Non-Hodgkin Lymphoma and raises the possibility of using CAR T-20 in an early disease stage. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2918-2918
Author(s):  
Talha Badar ◽  
Narendranath Epperla ◽  
Aniko Szabo ◽  
Steven Borson ◽  
John Vaughn ◽  
...  

Abstract Background Classical Hodgkin Lymphoma (cHL) is a highly curable disease; however, 10% of patients (pts) with limited stage and 20%-30% with advanced stage disease still fail first line-treatment. Autologous hemopoietic cell transplantation (auto-HCT) is the standard of care in pts who fail to achieve remission with first-line therapy, or who relapse after induction chemotherapy. However, approximately 50% of cHL pts will ultimately relapse post auto-HCT. These pts historically have had poor outcomes, with median survival in the 1.5 year range. In recent years, highly active new therapies such as brentuximab vedotin (BV), checkpoints inhibitors (i.e. nivolumab and pembrolizumab), and increased accessibility to allogeneic HCT (including utilization of haploidentical donors) have become more widely available. We hypothesized that, in recent years, survival has improved in cHL patients who relapse after auto-HCT since the introduction of these novel therapies into more widespread clinical practice. Methods We conducted a multi-center retrospective study from 3 academic institutions in the U.S. (Medical College of Wisconsin, Ohio State University, and Washington University in St. Louis) to evaluate survival of cHL pts after the failure of an auto-HCT. We reviewed 341 pts who received auto-HCT from 2006-2015. Among them, 126 (37%) pts relapsed post auto-HCT and were evaluated in more detail. For the purpose of analysis, pts were divided into 2 cohorts based on timing of auto-HCT; 2006-2010 (Cohort 1, n=57) and 2011-2015 (Cohort 2, n=69) to compare outcomes. Results The median age at auto-HCT, time from diagnosis to transplant, time from transplant to relapse were similar in Cohort 1 & 2 (see Table 1). The proportion of pts who achieved complete remission (CR) at the time of auto-HCT were 22.8% in Cohort 1 and 40.6% in Cohort 2. Whereas, 68.4% of pts in Cohort 1 and 52.2% of pts in Cohort 2 had partial remission (PR) at the time of auto-HCT. The median number of lines of therapy after relapse from auto-HCT were 2 each in Cohort 1 (range, 0-13) and Cohort 2 (range, 0-7), respectively (p= 0.74). Twenty-five (45%) pts in Cohort 1 and 49 (73%) pts in Cohort 2 received BV as a salvage therapy post auto-HCT (p= 0.002). Similarly, 3 (5.5%) pts in Cohort 1 versus (vs.) 21 (32%) pts in Cohort 2 received check point inhibitors as salvage therapy post auto-HCT relapse (p= <0.001). Fourteen (25%) pts in Cohort 1 and 26 (38%) pts in Cohort 2, received allogeneic HCT after relapse from auto-HCT (p= 0.10). At 5 years follow up after relapse from auto-HCT, 36.5% of pts were alive in Cohort 1 and 58.3% of pts in Cohort 2 (p= 0.03) (Fig. 1A). The proportion of pts alive at 5 years follow up from time of auto-HCT (using left truncation analysis) was 34% and not reached (NR) in Cohort 1 and Cohort 2, respectively (p= 0.02) (Fig.1B). We performed multivariate analysis for overall survival (OS) from time of auto-HCT relapse; Cohort 1 vs. 2 (HR; 0.35, 95% CI 0.18-0.65, p= 0.0009), disease status at auto-HCT (CR vs. progressive disease [PD]) (HR; 2.51, 95% CI 0.85-7.34, p= 0.01), age at auto-HCT (HR; 1.04, 95% CI 1.01-1.06, p= 0.0005) and time to relapse from auto-HCT (HR; 0.61, 95% CI 0.48-0.76, p= <0.0001), retained independent prognostic significance for OS. Conclusion Our analysis supports that survival of cHL pts post auto-HCT failure has significantly improved in recent years (2011-2015), most likely due to incorporation of novel therapies including BV, checkpoint inhibitors, and more widespread use of allogeneic HCT. Disclosures Shah: Miltenyi: Other: Travel funding, Research Funding; Juno Pharmaceuticals: Honoraria; Exelexis: Equity Ownership; Oncosec: Equity Ownership; Geron: Equity Ownership; Lentigen Technology: Research Funding. Hamadani:Celgene Corporation: Consultancy; Janssen: Consultancy; MedImmune: Consultancy, Research Funding; ADC Therapeutics: Research Funding; Takeda: Research Funding; Cellerant: Consultancy; Ostuka: Research Funding; Sanofi Genzyme: Research Funding, Speakers Bureau; Merck: Research Funding.


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