Faculty of 1000 evaluation for 90Yttrium-Ibritumomab Tiuxetan Consolidation of First Remission in Advanced-Stage Follicular Non-Hodgkin Lymphoma: Updated Results After a Median Follow-Up of 7.3 Years From the International, Randomized, Phase III First-Line Indolent Trial.

2013 ◽  
Author(s):  
Nicolas Mounier
Keyword(s):  
Hodgkin Lymphoma ◽  
Phase Iii ◽  
Advanced Stage ◽  
First Line ◽  
Ibritumomab Tiuxetan ◽  
Non Hodgkin Lymphoma ◽  
First Remission

90Yttrium-Ibritumomab Tiuxetan Consolidation of First Remission in Advanced-Stage Follicular Non-Hodgkin Lymphoma: Updated Results After a Median Follow-Up of 7.3 Years From the International, Randomized, Phase III First-Line Indolent Trial

2013 ◽  
Vol 31 (16) ◽  
pp. 1977-1983 ◽  
Author(s):  
Franck Morschhauser ◽  
John Radford ◽  
Achiel Van Hoof ◽  
Barbara Botto ◽  
Ama Z.S. Rohatiner ◽  
...  
Keyword(s):  
Survival Rates ◽  
Progression Free Survival ◽  
Complete Response ◽  
Phase Iii ◽  
Induction Treatment ◽  
Advanced Stage ◽  
First Line ◽  
Ibritumomab Tiuxetan ◽  
First Remission

PurposeUpdated results are presented after a median follow-up of 7.3 years from the phase III First-Line Indolent Trial of yttrium-90 (90Y) –ibritumomab tiuxetan in advanced-stage follicular lymphoma (FL) in first remission.Patients and MethodsPatients with CD20+stage III or IV FL with complete response (CR), unconfirmed CR (CRu), or partial response (PR) after first-line induction treatment were randomly assigned to90Y-ibritumomab consolidation therapy (rituximab 250 mg/m2days −7 and 0, then90Y-ibritumomab 14.8 MBq/kg day 0; maximum 1,184 MBq) or no further treatment (control). Primary end point was progression-free survival (PFS) from date of random assignment.ResultsFor 409 patients available for analysis (90Y-ibritumomab, n = 207; control, n = 202), estimated 8-year overall PFS was 41% with90Y-ibritumomab versus 22% for control (hazard ratio [HR], 0.47; P < .001). For patients in CR/CRu after induction, 8-year PFS with90Y-ibritumomab was 48% versus 32% for control (HR, 0.61; P = .008), and for PR patients, it was 33% versus 10% (HR, 0.38; P < .001). For90Y-ibritumomab consolidation, median PFS was 4.1 years (v 1.1 years for control; P < .001). Median time to next treatment (TTNT) was 8.1 years for90Y-ibritumomab versus 3.0 years for control (P < .001) with approximately 80% response rates to second-line therapy in either arm, including autologous stem-cell transplantation. No unexpected toxicities emerged during long-term follow-up. Estimated between-group 8-year overall survival rates were similar. Annualized incidence rate of myelodysplastic syndrome/acute myeloblastic leukemia was 0.50% versus 0.07% in90Y-ibritumomab and control groups, respectively (P = .042).Conclusion90Y-ibritumomab consolidation after achieving PR or CR/CRu to induction confers 3-year benefit in median PFS with durable 19% PFS advantage at 8 years and improves TTNT by 5.1 years for patients with advanced FL.

90Yttrium-Ibritumomab-Tiuxetan As First-Line Therapy Or As Consolidation Treatment In Advanced Stage Follicular Non-Hodgkin Lymphoma: Long-Term Results After a Median Follow-Up Of 61 Months

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5123-5123
Author(s):  
Katharina Troppan ◽  
Angelika Valentin ◽  
Werner Linkesch, MD
Keyword(s):  
Advanced Stage ◽  
First Line ◽  
Ibritumomab Tiuxetan ◽  
Consolidation Treatment ◽  
Non Hodgkin Lymphoma ◽  
First Line Therapy ◽  
Significant Difference ◽  
Long Term Follow Up

Abstract Purpose Radioimmunotherapy combines biologic and radiolytic mechanisms to target and destroy tumor cells. 90Y-Ibritumomab-Tiuxetan (90YIT) is a murine anti-CD20 monoclonal antibody engaged for radioimmunotherapeutic targeting of CD20+ lymphoma cells. We report on our long-term follow-up data of 90YIT as first-line or consolidation treatment in advanced stage follicular Non-Hodgkin lymphoma (FL). Patients & Methods Between March 2004 and October 2010, forty-seven patients with CD20+ FL grade 1 to 3a in stages II, III, or IV were treated with a single dose of 90Yttrium-Ibritumomab-Tiuxetan (90YIT) at our institution. The median age was 61 years (range 41-83; male 55%) and 77% (n=36) of patients were in an advanced stage of the disease (stage III/IV). 90YIT was administered on an outpatient basis on day 8 after pretreatment with Rituximab (250mg/m²) on day 1. A mean of 1122 MBq (range 680-240) 90YIT was administered. Fourteen patients received 90YIT as first-line therapy, twenty-seven patients were treated with 90YIT after a median of 2 pretreatment courses (range 1-5) as consolidation therapy in remission (15 patients in CR, 12 patients in PR), and six patients showed progressive disease (PD) at time of 90YIT treatment. Median follow-up was 61 months (range 0-111). Results After a median follow-up of 61 months (range 0-111 months), 32 patients are still alive, including 21 patients in CR since 90YIT treatment. There was no significant difference concerning PFS and OS between first-line treatment and consolidation treatment, but we found a significant difference, comparing these two groups versus PD (PFS 51 months vs. 48 months vs. 8 months, p<0.023; OS 59 months vs. 71 months vs. 10 months, p<0.002) (figure 1 & 2). Survival rates were 85% (first-line), 67% (consolidation) and 33% (PD), respectively. Patients who maintained a CR after 90YIT treatment, showed significantly longer OS compared to patients with relapse after 90YIT (71 months vs. 52 months, p<0.001). No significant difference in PFS and OS was seen, concerning sex, age, or clinical stage. No unexpected toxicities emerged during long-term follow-up. Conclusion 90YIT as first-line, as well as consolidation therapy after achieving at least PR, provides a cost-efficient, long progression-free and overall survival in advanced stage FL. No benefit is shown in patients with PD, where we don't recommend 90YIT treatment. Disclosures: No relevant conflicts of interest to declare.

Phase III Trial of Consolidation Therapy With Yttrium-90–Ibritumomab Tiuxetan Compared With No Additional Therapy After First Remission in Advanced Follicular Lymphoma

2008 ◽  
Vol 26 (32) ◽  
pp. 5156-5164 ◽  
Author(s):  
Franck Morschhauser ◽  
John Radford ◽  
Achiel Van Hoof ◽  
Umberto Vitolo ◽  
Pierre Soubeyran ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Phase Iii ◽  
Induction Treatment ◽  
Advanced Stage ◽  
First Line ◽  
Ibritumomab Tiuxetan ◽  
Phase Iii Trial ◽  
Conversion Rates ◽  
First Remission ◽  
Yttrium 90

PurposeWe conducted an international, randomized, phase III trial to evaluate the efficacy and safety of consolidation with yttrium-90 (90Y)–ibritumomab tiuxetan in patients with advanced-stage follicular lymphoma in first remission.Patients and MethodsPatients with CD20+stage III or IV follicular lymphoma, who achieved a complete response (CR)/unconfirmed CR (CRu) or partial response (PR) after first-line induction treatment, were randomly assigned to receive90Y-ibritumomab tiuxetan (rituximab 250 mg/m2on day −7 and day 0 followed on day 0 by90Y-ibritumomab tiuxetan 14.8 MBq/kg; maximum of 1,184 MBq) or no further treatment (control). The primary end point was progression-free survival (PFS), which was calculated from the time of random assignment.ResultsA total of 414 patients (consolidation, n = 208; control, n = 206) were enrolled at 77 centers.90Y-ibritumomab tiuxetan consolidation significantly prolonged median PFS (after a median observation time of 3.5 years) in all patients (36.5 v 13.3 months in control arm; hazard ratio [HR] = 0.465; P < .0001) and regardless of whether patients achieved PR (29.3 v 6.2 months in control arm; HR = 0.304; P < .0001) or CR/CRu (53.9 v 29.5 months in control arm; HR = 0.613; P = .0154) after induction treatment. Median PFS with consolidation was prolonged in all Follicular Lymphoma International Prognostic Index risk subgroups. After90Y-ibritumomab tiuxetan consolidation, 77% of patients in PR after induction converted to CR/CRu, resulting in a final CR rate of 87%. The most common toxicity with90Y-ibritumomab tiuxetan was hematologic, and grade 3 or 4 infections occurred in 8% of patients.ConclusionConsolidation of first remission with90Y-ibritumomab tiuxetan in advanced-stage follicular lymphoma is highly effective with no unexpected toxicities, prolonging PFS by 2 years and resulting in high PR-to-CR conversion rates regardless of type of first-line induction treatment.

RIT with 90Y Ibritumomab Tiuxetan in Patients with Non-Hodgkin Lymphoma Over 65 Years.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2742-2742
Author(s):  
Marcio M Andrade ◽  
Anel Montes ◽  
Ilda Murillo ◽  
Jose M Grasa ◽  
Teresa Baringo ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Median Time ◽  
Response Rate ◽  
Haematological Toxicity ◽  
Red Blood Cell Transfusion ◽  
First Line ◽  
Ibritumomab Tiuxetan ◽  
Non Hodgkin Lymphoma ◽  
First Line Therapy ◽  
Line Therapy

Abstract Abstract 2742 Introduction: 90Y Ibritumomab tiuxetan (90Y-IT) has become an efficient alternative to therapy in non-Hodgkin Lymphoma, mainly in elderly patients. The aim of this study is to analyse our updated information of patients treated with 90YIbritumomab/tiuxetan in a prospective study according clinical practice setting and to analyse treatment outcome. Subjects and Methods: 39 non Hodgkin lymphoma patients were included in a clinical protocol conducted by a multidisciplinary team and treated in the same centre. According the inclusion criteria: patients over 65 years old diagnosed as CD20+ NHL with neutrophils ≥ 1,5 × 109/L, platelets ≥ 100 × 109/L, bone marrow lymphocytes CD20+ ≤ 25%. All patients received 0,3 or 0,4 mCi /kg IV (88%) of 90YIbritumomab/tiuxetan and response evaluation was performed 12 weeks after. Period of study: September 2005/July 2012. The 90Y-IT was administered as consolidation of first line therapy (Rituximab alone, R-COP, R-CHOP21) or in relapsed/refractory status. Endpoints: Objective response rate (ORR), time to relapse (PFS) overall survival (OS) and safety. Other clinical prognostic factors were observed to assess their possible influence upon treatment value. Results: Until May 2012, 39 patients had received treatment with 90YIbritumomab/tiuxetan and completed the evaluation protocol and were considered to analysis; M/F 18/21 mean age 72.8 years (65–87); ECOG 0–1 92.3%. According OMS classification: NHL-follicular 27 (69.2%), mantle cell Lymphoma 7 (17.9%), DLBCL 4 (10.3%) and 1MALT (2.6%). Score distribution: low risk 19 (48.7%), intermediate 12 (30.8.2%) and advanced 8 (20.5%). Previous therapy schedules ≤2 (66.7%), >2 (33.3%). The median follow-up time: 42.0 months (95% CI: 4.0; 62.0), mean PFS: 38.1 months (95% CI: 30.8; 45.4) median NR. 13 patients received 90Y-IT as consolidation of first line therapy (33.3%) and 26 relapsed/refractory (66.6%). ORR was 84.6 % CR: 29 (74.3%); PR 4 (10.2%) and 6 failures (15.4%) in relapsed/refractory disease. Mean estimated OS since 90Y-IT: 54.4 months (95% CI: 49.4; 59.3) and mean estimated OS since diagnosis 159 months. Median PFS was NR. The mean PFS for patients in consolidation therapy was 54.2 months (95% CI: 47.4; 61.1). Safety: thrombocytopenia being the most frequent, G3–4 (35.9%), median time to developed haematological toxicity: fourth week, and neutropenia G3–4 (41.0%), the median time to recover normal values was 4.2 and 2.6 weeks respectively. In 5 (12.9%) of patients red blood cell transfusion was required, and 10 platelet transfusions (25.6%). The most frequent non haematological toxicity was asthenia. One patient developed a severe mucositis. Four patients have concomitant associated tumours (colon, breast, lung and prostate) and two patients over 77 years developed a rectum carcinoma after 18 months of 90Y-IT and another prostate and renal tumour after 8 years. Comments: In our experience 90Y Ibritumomab tiuxetan is a safety and effective therapy in patients with NHL over 65 years. According to obtained PFS results, it seems like the use of this kind of therapy as used in early part of therapy offers good and maintained response rate with lower toxicity in this fragile population. The OS in this population was not inferior to observed in younger NHL patients. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Phase III Randomized Intergroup Trial of CHOP Plus Rituximab Compared With CHOP Chemotherapy Plus 131Iodine-Tositumomab for Previously Untreated Follicular Non-Hodgkin Lymphoma: SWOG S0016

2013 ◽  
Vol 31 (3) ◽  
pp. 314-320 ◽  
Author(s):  
Oliver W. Press ◽  
Joseph M. Unger ◽  
Lisa M. Rimsza ◽  
Jonathan W. Friedberg ◽  
Michael LeBlanc ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Phase Iii ◽  
Advanced Stage ◽  
Chop Chemotherapy ◽  
Non Hodgkin Lymphoma ◽  
Potential Benefits ◽  
Group B ◽  
Follicular Lymphomas ◽  
Leukemia Group

Purpose Advanced follicular lymphomas (FL) are considered incurable with conventional chemotherapy and there is no consensus on the best treatment approach. Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B compared the safety and efficacy of two immunochemotherapy regimens for FL in a phase III randomized intergroup protocol (SWOG S0016) that enrolled 554 patients with previously untreated, advanced-stage FL between March 1, 2001, and September 15, 2008. Patients and Methods Patients were eligible for the study if they had advanced-stage (bulky stage II, III, or IV) evaluable FL of any grade (1, 2, or 3) and had not received previous therapy. In one arm of the study, patients received six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy at 3-week intervals with six doses of rituximab (CHOP-R). In another arm of the study, patients received six cycles of CHOP followed by consolidation with tositumomab/iodine I-131 tositumomab radioimmunotherapy (RIT). Results After a median follow-up period of 4.9 years, the 2-year estimate of progression-free survival (PFS) was 76% on the CHOP-R arm and 80% on the CHOP-RIT arm (P = .11). The 2-year estimate of overall survival (OS) was 97% on the CHOP-R arm and 93% on the CHOP-RIT arm (P = .08). Conclusion There was no evidence of a significant improvement in PFS comparing CHOP-RIT with CHOP-R. However, PFS and OS were outstanding on both arms of the study. Future studies are needed to determine the potential benefits of combining CHOP-R induction chemotherapy with RIT consolidation and/or extended rituximab maintenance therapy.

scholarly journals RIT with Y90-Ibritumomab Tiuxetan in Follicular Non-Hodgkin Lymphoma: Evaluation of Recent Outcomes in a Single Institution

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Marcio Miguel Andrade Campos ◽  
Anel E. Montes Limón ◽  
Jose María Grasa ◽  
Paola Lievano ◽  
Teresa Baringo ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Early Stage ◽  
Therapy Outcomes ◽  
Clinical Database ◽  
Ibritumomab Tiuxetan ◽  
Score Distribution ◽  
Non Hodgkin Lymphoma ◽  
Relapsed Disease ◽  
Previous Disease

Background. Based on historical data we reviewed our hospital clinical database to analyse our updated information and therapy outcomes of follicular non-Hodgkin lymphoma (F-NHL) patients treated with90Y-Ibritumomab tiuxetan.Patients and Methods. Between 2005 and 2011, 56 F-NHL patients were included in a clinical protocol conducted by a multidisciplinary team and treated in the same centre. All patients received 0.3 or 0.4 mCi/kg IV (88%) of90Y-IT; response evaluation was performed 12 weeks after.Results. M/F 44.6%/55.4%, mean age 61.45 years (30–85); ECOG 0-1 96.9%. According to FLIPI score, distribution were good: 58.5%, intermediate: 29.2%, and poor: 12.3%. Previous therapies: >2: 40% (26). ORR was 94.6% (53/56). CR: 85.7%; CR according to previous disease: relapsed disease: 90% (27/30), refractory disease: 42.85% (3/7), consolidation with CR: 92.85% (13/14), and consolidation with PR: 100% (5/5). Global PR and NR were 8.9% (5) and 5.3% (3), respectively. Mean OS 63.86 months with a mean follow-up time of 57 months (2–73). Mean TTP: 52.65 months (95% CI: 43.83–61.48). Median OS and TTP were not achieved. No hospital submissions or deaths were registered.Conclusions. This study confirms the safety and high efficacy of90Y-IT in F-NHL patients, RIT in early stage of disease could improve outcomes.

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 ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Hodgkin Lymphoma ◽  
Preliminary Data ◽  
Salvage Therapy ◽  
First Line ◽  
Who Grade ◽  
Early Stage Disease ◽  
Non Hodgkin Lymphoma ◽  
Co Morbidity

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.

scholarly journals ASCO 2017 meeting summary: updates to practice-changing studies in untreated non-Hodgkin lymphoma

2017 ◽  
Vol 24 (4) ◽  
pp. 262
Author(s):  
P. Laneuville ◽  
J.F. Larouche ◽  
A. Tosikyan ◽  
A. Christofides
Keyword(s):  
Hodgkin Lymphoma ◽  
Meeting Report ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Non Hodgkin Lymphoma ◽  
American Society ◽  
Oral Presentations ◽  
First Line Treatment

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.

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