Fractionated <sup>90</sup>Y-Ibritumomab Tiuxetan Radioimmunotherapy As an Initial Therapy of Follicular Lymphoma: An International Phase II Study in Patients Requiring Treatment According to GELF/BNLI Criteria

Illidge, Tim; Mayes, Sam; Pettengell, Ruth; Bates, Andrew; Bayne, Mike; Radford, John; Ryder, W. David J.; Gouill, Steven Le; Jardin, Fabrice; Tipping, Jill; Zivanovic, Maureen A.; Kraeber‐Bodéré, Françoise; Bardiès, Manuel; Bodet-Milin, Caroline; Malek, E; Huglo, D.; Morschhauser, Franck

doi:10.1200/jco.2013.50.3110

Cited by 58 publications

(35 citation statements)

References 26 publications

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“…21 Illidge et al assessed two injections of Zevalin (11.1 MBq/kg) given 8-12 weeks apart in 74 patients with FL grade I-IIIa with at least one criteria of high tumor burden or B symptoms; 55 patients received the two planned Zevalin infusions, whereas 17 received only one infusion. 22 At a median follow-up of 1.52 years (range, 0.13-3.69 years), the PFS was 67% and 20 patients had progressed. The ORR was 97.1% with 64% of CR/ CRu.…”

Section: High Efficacy Of Rit In Nhblmentioning

confidence: 98%

Radioimmunoconjugates for the Treatment of Cancer

Kraeber-Bodéré

Bodet-Milin

Rousseau

et al. 2014

Seminars in Oncology

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Section: High Efficacy Of Rit In Nhblmentioning

confidence: 98%

Radioimmunoconjugates for the Treatment of Cancer

Kraeber-Bodéré

Bodet-Milin

Rousseau

et al. 2014

Seminars in Oncology

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“…Various studies have excluded patients with 20-25 % bone marrow involvement at the time of treatment [56][57][58]. Pretreatment with rituximab has been explored in patients who have greater than 20 % bone marrow involvement and has been demonstrated to be safe [59]. Importantly, the rates of myelodysplasia (MDS) and acute myeloid leukemia (AML) are low when RIT is used as initial therapy [56][57][58][59][60].…”

Section: Monoclonal Antibodiesmentioning

confidence: 99%

“…Pretreatment with rituximab has been explored in patients who have greater than 20 % bone marrow involvement and has been demonstrated to be safe [59]. Importantly, the rates of myelodysplasia (MDS) and acute myeloid leukemia (AML) are low when RIT is used as initial therapy [56][57][58][59][60]. & I 131 tositumomab demonstrated an ORR of 95 % and CR rate of 75 % in a population of patients with advanced stage, low tumor burden FL [56].…”

Section: Monoclonal Antibodiesmentioning

confidence: 99%

“…Dosimetry has been used to calculate the dose for Y 90 ibritumomab tiuxetan; however, a single dose of 15 MBq/kg has been given as well [57,58]. A dose of 11.1 MBq per kilogram has also been used 8 weeks apart for fractionation of Y 90 ibritumomab tiuxetan in patients who met GELF criteria for treatment [59]. The dosing of I 131 rituximab was determined by dosimetry as well in the study examining it as first-line treatment.…”

Section: Monoclonal Antibodiesmentioning

confidence: 99%

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Follicular Lymphoma: First-Line Treatment Without Chemotherapy for Follicular Lymphoma

Reagan

Friedberg

2015

Curr. Treat. Options in Oncol.

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Opinion statement: The optimal initial treatment of follicular lymphoma (FL) is not known, and initial management of patients varies considerably between providers and institutions. The assertion that patients with low tumor burden can be observed for a period of time is being challenged owing to the safety and tolerability of novel therapeutics and the movement of the field away from traditional chemotherapy agents. Single agent rituximab has become increasingly popular as initial management of patients with low tumor burden disease, and there is evidence that prolonged treatment with rituximab can improve progression-free survival (PFS) when compared to induction with rituximab or observation. Radioimmunotherapy (RIT) has similarly shown efficacy in low tumor burden disease. Novel agents such as lenalidomide, idelalisib, and ibrutinib are being studied in the first-line setting. Importantly, none of these strategies have demonstrated an improved overall survival in a randomized study versus observation. It is the opinion of the authors that endpoints such as PFS alone, while important, should not drive changes in management with limited resources. Composite endpoints including quality of life are more informative on the true impact of treatments on patients with follicular lymphoma. Providers should encourage all patients to be treated in the context of an appropriate clinical trial when possible. If a patient is not a clinical trial candidate, we typically treat patients with advanced stage and high tumor burden with chemoimmunotherapy. The decision to give maintenance rituximab is individualized to the patient, as there is no overall survival benefit. In patients with early stage disease, we favor consideration of radiation therapy if the patient is a candidate. Our initial recommendation to patients with advanced stage, low tumor burden disease, is close observation or "watch and wait." We have observed that most patients become comfortable over time with an observation approach. If a patient is not comfortable with this recommendation, we will use single agent rituximab. If the patient responds to therapy, we do not recommend maintenance rituximab in low tumor burden disease but rather prefer a retreatment strategy or an extended schedule of four additional doses of rituximab.

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“…The results of 2 clinical comparative studies are rather convincing and, importantly, involved a substantial number of patients. With 90 Y-ibritumomab tiuxetan, an increase of 32% of cumulative activity in fractionation with regard to a single dose brought about no significant change of hematologic toxicity but a real gain of progression-free survival from 26 to 40.2 mo (10,11). With the 177 Lu-labeled anti-prostate-specific membrane antigen huJ591, developed to treat metastatic prostate cancer, an increase of 14% of cumulative activity in fractionation with regard to a single dose brought about a slight decrease in hematologic toxicity and an improved clinical efficacy, with an improvement of 50% prostatespecific antigen decline rates from 12.5% to 29.2% and overall survival from 21.8 to 45.3 mo (12,13).…”

mentioning

confidence: 99%

Radioimmunotherapy: From Current Clinical Success to Future Industrial Breakthrough?

2015

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Radi oimmunotherapy is a targeted molecular therapy that bears on radiobiologic and immunologic processes, without crossresistance with other anticancer cytotoxic drugs. Since the first reports in the literature at the beginning of the 1980s, radioimmunotherapy techniques have significantly progressed because of advancements in recombinant humanized or human monoclonal antibodies, the synthesis of more stable chelates for radiolabeling, and pretargeting techniques that increase the therapeutic index. Several pivotal clinical studies demonstrated the efficacy of radioimmunotherapy in non-Hodgkin B-cell lymphoma (NHL), and 2 radioimmunotherapy-products targeting the CD20 antigen have been approved: 131 I-tositumomab (Bexxar; GlaxoSmithKline) and 90 Yibritumomab tiuxetan (Zevalin; Spectrum Pharmaceuticals). The marketing of 131 I-tositumomab is now discontinued. 90 Y-ibritumumab can be integrated in clinical practice using nonablative activities for the treatment of relapsed or refractory follicular lymphoma See page 444 patients or as consolidation after induction chemotherapy in frontline treatment in follicular lymphoma patients (1,2). Numerous publications have also reported promising efficacy of anti-CD20 radioimmunotherapy in other more aggressive NHL subtypes (3,4) and of anti-CD22 radioimmunotherapy delivered as fractionated injections in different NHL subtypes (5). However, despite the safety and proven high clinical efficacy of radioimmunotherapy in NHL patients resistant to both chemotherapy and rituximab (probably the most effective treatment as a monotherapy in NHL), this outpatient treatment has not been widely adopted by the medical community. This is due to a combination of factors, including concerns about secondary myelodysplasia/acute leukemia risk, the lack of large randomized studies, the availability of many novel competing targeted agents such as ibrutinib or idelalisib, and the inability of oncohematologists to administer the therapy in their own departments (6,7).Because solid tumors are more resistant to radiation and less accessible to large molecules such as antibodies, demonstrations of clinical efficacy of radioimmunoconjugates remain limited, and no large randomized study has been published. However, some radioimmunotherapy approaches have shown promising results in specific clinical settings, especially for small-volume tumors disseminated to bone marrow or at an early minimal residual disease stage. For example, adjuvant radioimmunotherapy using the anticarcinoembryonic antigen 131 I-labetuzumab delivered after salvage resection of liver colorectal metastases showed improved median overall survival and 5-y survival rates in a phase II study, compared with historic and contemporaneous controls not receiving radioimmunotherapy (8). However, these results need to be confirmed in multicenter randomized phase III trials.In most cases, radioimmunotherapy is currently considered as a single-injection therapy agent, which is not realistic for the treatment of metastatic cancers. Fractionati...

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Fractionated ⁹⁰Y-Ibritumomab Tiuxetan Radioimmunotherapy As an Initial Therapy of Follicular Lymphoma: An International Phase II Study in Patients Requiring Treatment According to GELF/BNLI Criteria

Abstract: Fractionated RIT using (90)Y-IT is an effective initial treatment for advanced-stage FL in patients with higher tumor burden requiring treatment.

Cited by 58 publications

References 26 publications

Radioimmunoconjugates for the Treatment of Cancer

Radioimmunoconjugates for the Treatment of Cancer

Follicular Lymphoma: First-Line Treatment Without Chemotherapy for Follicular Lymphoma

Radioimmunotherapy: From Current Clinical Success to Future Industrial Breakthrough?

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Fractionated 90Y-Ibritumomab Tiuxetan Radioimmunotherapy As an Initial Therapy of Follicular Lymphoma: An International Phase II Study in Patients Requiring Treatment According to GELF/BNLI Criteria

Abstract: Fractionated RIT using (90)Y-IT is an effective initial treatment for advanced-stage FL in patients with higher tumor burden requiring treatment.

Cited by 58 publications

References 26 publications

Radioimmunoconjugates for the Treatment of Cancer

Radioimmunoconjugates for the Treatment of Cancer

Follicular Lymphoma: First-Line Treatment Without Chemotherapy for Follicular Lymphoma

Radioimmunotherapy: From Current Clinical Success to Future Industrial Breakthrough?

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Product

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Fractionated ⁹⁰Y-Ibritumomab Tiuxetan Radioimmunotherapy As an Initial Therapy of Follicular Lymphoma: An International Phase II Study in Patients Requiring Treatment According to GELF/BNLI Criteria