Effects of ibritumomab injection: A Synthesis of Findings from 19 Studies

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Original Abstract of the Article

Major Research Findings

Ibritumomab tiuxetan is a radiolabeled monoclonal antibody that targets B-cell non-Hodgkin lymphoma tumor cells. It is used in radioimmunotherapy (RIT) to deliver radiation to the tumor cells. The studies show that ibritumomab tiuxetan is effective in treating non-Hodgkin lymphoma. 14 investigated the optimization of the labeling of HD-Zevalin with special regard to simplicity, speed, safety and radiation protection. 9 aimed to carry out two different dose estimation approaches in patients with NHL treated with a myeloablative amount of (90)Y-labelled ibritumomab tiuxetan. 10 assessed the radiation exposure associated with (90)Y-ibritumomab tiuxetan when used as consolidation therapy in adults with low or minimal tumor burden after first-line therapy of advanced FL. 18 determined the relative biologic effects (RBE) of alpha-particle radiation from 227Th-rituximab and of beta-radiation from 90Y-tiuexetan-ibritumomab compared with external beam X-radiation in the Raji lymphoma xenograft model. 12 evaluated the efficacy and side effects of radioimmunotherapies with Zevalin(®) (RIT-Z) in Japanese patients with low-grade B-cell NHL.

Benefits and Risks

Benefits Summary

Ibritumomab tiuxetan is an effective treatment for non-Hodgkin lymphoma. 14 investigated the optimization of the labeling of HD-Zevalin with special regard to simplicity, speed, safety and radiation protection. 9 aimed to carry out two different dose estimation approaches in patients with NHL treated with a myeloablative amount of (90)Y-labelled ibritumomab tiuxetan. 10 assessed the radiation exposure associated with (90)Y-ibritumomab tiuxetan when used as consolidation therapy in adults with low or minimal tumor burden after first-line therapy of advanced FL. 18 determined the relative biologic effects (RBE) of alpha-particle radiation from 227Th-rituximab and of beta-radiation from 90Y-tiuexetan-ibritumomab compared with external beam X-radiation in the Raji lymphoma xenograft model. 12 evaluated the efficacy and side effects of radioimmunotherapies with Zevalin(®) (RIT-Z) in Japanese patients with low-grade B-cell NHL.

Risks Summary

Ibritumomab tiuxetan injection carries a risk of radiation exposure, particularly to the fingers. 14 investigated the optimization of the labeling of HD-Zevalin with special regard to simplicity, speed, safety and radiation protection. 17 measured the radiation doses received by radiation team members performing (90)Y-ibritumomab tiuxetan administration. Ibritumomab tiuxetan injection can also cause side effects such as myelosuppression, infections, and gastrointestinal symptoms. 9 found that radioinduced myelodepression was overcome by stem cell autografting. 10 assessed the radiation exposure associated with (90)Y-ibritumomab tiuxetan when used as consolidation therapy in adults with low or minimal tumor burden after first-line therapy of advanced FL. 8 presented a case study of a man with B-cell non-Hodgkin lymphoma showing the progression of the extravasation and steps taken to treat and eventually heal the extravasation site.

Comparison between Studies

Commonalities

The studies show that ibritumomab tiuxetan is effective in treating non-Hodgkin lymphoma and it is associated with radiation exposure, particularly to the fingers. Many of the studies focused on optimizing the treatment to minimize radiation exposure to both patients and healthcare workers.

Differences

The studies vary in their focus, patient populations, and methods. 14 investigated the optimization of the labeling of HD-Zevalin with special regard to simplicity, speed, safety and radiation protection. 9 aimed to carry out two different dose estimation approaches in patients with NHL treated with a myeloablative amount of (90)Y-labelled ibritumomab tiuxetan. 10 assessed the radiation exposure associated with (90)Y-ibritumomab tiuxetan when used as consolidation therapy in adults with low or minimal tumor burden after first-line therapy of advanced FL. 18 determined the relative biologic effects (RBE) of alpha-particle radiation from 227Th-rituximab and of beta-radiation from 90Y-tiuexetan-ibritumomab compared with external beam X-radiation in the Raji lymphoma xenograft model. 12 evaluated the efficacy and side effects of radioimmunotherapies with Zevalin(®) (RIT-Z) in Japanese patients with low-grade B-cell NHL. 17 measured the radiation doses received by radiation team members performing (90)Y-ibritumomab tiuxetan administration.

Consistency and Discrepancies of Results

The studies consistently show that ibritumomab tiuxetan is effective in treating non-Hodgkin lymphoma. The studies also consistently suggest that ibritumomab tiuxetan injection carries a risk of radiation exposure to both patients and healthcare workers. 14 investigated the optimization of the labeling of HD-Zevalin with special regard to simplicity, speed, safety and radiation protection. 17 measured the radiation doses received by radiation team members performing (90)Y-ibritumomab tiuxetan administration and found that the doses received by the index and thumb of the right hand and the index finger of the left hand of the radiation oncologist were significantly reduced by using the injection box method. However, the studies differ in the specific details of the radiation exposure and the effectiveness of mitigation strategies. 9 found that radioinduced myelodepression was overcome by stem cell autografting. 10 assessed the radiation exposure associated with (90)Y-ibritumomab tiuxetan when used as consolidation therapy in adults with low or minimal tumor burden after first-line therapy of advanced FL.

Real-World Implications

Ibritumomab tiuxetan is an important treatment option for non-Hodgkin lymphoma. However, it is crucial to be aware of the potential risks of radiation exposure. 14 investigated the optimization of the labeling of HD-Zevalin with special regard to simplicity, speed, safety and radiation protection. Healthcare providers should use appropriate safety measures to minimize radiation exposure to both themselves and patients. 17 measured the radiation doses received by radiation team members performing (90)Y-ibritumomab tiuxetan administration and found that the doses received by the index and thumb of the right hand and the index finger of the left hand of the radiation oncologist were significantly reduced by using the injection box method. It is also important for patients to be informed about the potential side effects of ibritumomab tiuxetan and to report any concerns to their doctor.

Limitations of the Research

The studies are limited in their scope and duration. Further research is needed to investigate the long-term effects and risks of ibritumomab tiuxetan. 14 investigated the optimization of the labeling of HD-Zevalin with special regard to simplicity, speed, safety and radiation protection. 17 measured the radiation doses received by radiation team members performing (90)Y-ibritumomab tiuxetan administration. More research is also needed to explore the optimal dosing and administration methods for ibritumomab tiuxetan.

Future Research Directions

Further research is needed to investigate the long-term effects and risks of ibritumomab tiuxetan. 14 investigated the optimization of the labeling of HD-Zevalin with special regard to simplicity, speed, safety and radiation protection. 17 measured the radiation doses received by radiation team members performing (90)Y-ibritumomab tiuxetan administration. More research is also needed to explore the optimal dosing and administration methods for ibritumomab tiuxetan. It is also crucial to further investigate strategies to minimize radiation exposure to both patients and healthcare workers.

Conclusion

Ibritumomab tiuxetan is an effective treatment for non-Hodgkin lymphoma. However, it carries a risk of radiation exposure, particularly to the fingers. 14 investigated the optimization of the labeling of HD-Zevalin with special regard to simplicity, speed, safety and radiation protection. 17 measured the radiation doses received by radiation team members performing (90)Y-ibritumomab tiuxetan administration. It is important for healthcare providers to use appropriate safety measures to minimize radiation exposure and for patients to be informed about the potential risks and side effects. Further research is needed to investigate the long-term effects and risks of ibritumomab tiuxetan and to explore new strategies to improve the safety and effectiveness of this treatment.

Literature analysis of 19 papers
Positive Content
17
Neutral Content
2
Negative Content
0
Article Type
5
1
0
1
19
1.

Dose dependent effects on bone resorption and formation of intermittently administered intravenous ibandronate.

Author: ChristiansenC, TankóL B, WarmingL, MoelgaardA, ChristgauS, QvistP, BaumannM, WieczorekL, HoyleN

Treats osteoporosis

Ibandronate is a bisphosphonate used to treat osteoporosis. This study looked at the effects of intermittent intravenous ibandronate on bone turnover markers in postmenopausal women. The results show that ibandronate effectively suppressed bone resorption, but the effect was not sustained. The suppression of bone formation was less than the suppression of bone resorption, which may contribute to the inefficacy of this dosing regimen.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies.

Author: BodyJ J, DielI J, LichinitzerM, LazarevA, PecherstorferM, BellR, TripathyD, BergstromB

Dosing convenience
Good tolerability
Prevention of skeletal complications
Upper GI AEs

Oral ibandronate, a bisphosphonate, was shown to be an effective and well-tolerated treatment for preventing skeletal complications in patients with metastatic bone disease. It offers similar efficacy to intravenous bisphosphonates with fewer side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

3.

Comparison of the effects of three oral bisphosphonate therapies on the peripheral skeleton in postmenopausal osteoporosis: the TRIO study.

Author: PaggiosiM A, PeelN, McCloskeyE, WalshJ S, EastellR

Bone density increase

This study compared the effects of oral alendronate, ibandronate, and risedronate on bone health over 2 years. Ibandronate and alendronate were found to have a greater effect on the central skeleton (spine) than risedronate, while all three drugs had similar effects on the peripheral skeleton (hip). These findings suggest that ibandronate may be a more effective option for increasing bone density at the spine compared to risedronate.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Dose-Effectiveness Relationships Determining the Efficacy of Ibandronate for Management of Osteoporosis: A Meta-Analysis.

Author: HouYanjie, GuKe, XuChao, DingHuiyong, LiuChangxin, TuohetiYilihamu

Improved BMD
Reduced bone resorption
Ineffective doses

This meta-analysis evaluated the efficacy of ibandronate, a medication used to treat osteoporosis, across different dosing regimens. Ibandronate significantly improved bone mineral density in the lumbar spine and total hip.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Effects of discontinuing oral bisphosphonate treatments for postmenopausal osteoporosis on bone turnover markers and bone density.

Author: NaylorK E, BradburnM, PaggiosiM A, GossielF, PeelN F A, McCloskeyE V, WalshJ S, EastellR

This study looked at the effects of stopping different types of bisphosphonate medications (ibandronate, alendronate, risedronate) used to treat osteoporosis in postmenopausal women. After stopping treatment, all groups experienced an increase in bone turnover markers (BTMs), indicating increased bone breakdown, and a decrease in bone mineral density (BMD) in the hip, although levels did not return to their original levels before treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

6.

Dosimetry in myeloablative (90)Y-labeled ibritumomab tiuxetan therapy: possibility of increasing administered activity on the base of biological effective dose evaluation. Preliminary results.

Author: ChiesaCarlo, BottaFrancesca, Di BettaErika, ColivaAngela, MaccauroMarco, AlibertiGianluca, BavusiSergio, DevizziLiliana, GuidettiAnna, SeregniEttore, GianniAlessandro Massimo, BombardieriEmilio

Extramedullary toxicity correlation
Stem cell autografting
Radioinduced myelodepression

(90)Y-labeled ibritumomab tiuxetan was administered in activity per kilo twice- and three times the maximum tolerable dose suggested for nonmyeloablative treatments. The dosimetric aim was to correlate possible extramedullary toxicities to the organ-absorbed doses or to the biologic effective dose (BED).

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

7.

Testicular uptake and radiation dose in patients receiving Zevalin and Pretarget CC49Fusion protein.

Author: ShenSui, MeredithRuby, DuanJun, ForeroAndres, BreitzHazel, KhazaeliM B, BrezovichIvan, LoBuglioAlbert

Lower testicular dose
Radiation exposure

Testicular doses from Zevalin were found to be much lower than originally reported, and the median testicular dose from Pretarget CC49Fusion protein was less than half that of Zevalin.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Extravasation of yttrium-90 ibritumomab tiuxetan: a case study.

Author: SiebeneckBettina M

Lymphoma treatment
Tissue damage

This case study describes a patient with B-cell non-Hodgkin lymphoma who experienced extravasation after treatment with ibritumomab tiuxetan, a radiolabeled monoclonal antibody. The case highlights the delayed onset of extravasation symptoms with Y-90 and provides information about treatment and management.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Absorbed dose and biologically effective dose in patients with high-risk non-Hodgkin's lymphoma treated with high-activity myeloablative 90Y-ibritumomab tiuxetan (Zevalin).

Author: ChiesaC, BottaF, ColivaA, MaccauroM, DevizziL, GuidettiA, Carlo-StellaC, SeregniE, GianniM A, BombardieriE

Effective for NHL
No non-hematological toxicity
Hematological toxicity

Using 45 MBq/kg of (90)Y-ibritumomab tiuxetan in association with stem cell autografting resulted in patients being free of toxicity in non-haematological organs. These findings were consistent with dose estimations considering both organ doses and BED values.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Dosimetry of 90Y-ibritumomab tiuxetan as consolidation of first remission in advanced-stage follicular lymphoma: results from the international phase 3 first-line indolent trial.

Author: DelaloyeAngelika Bischof, AntonescuCristian, LoutonThomas, KuhlmannJens, HagenbeekAnton

Improved Progression-Free Survival
Radiation Exposure

(90)Y-ibritumomab tiuxetan, a radioimmunotherapy, shows a positive correlation between radiation absorbed dose and progression-free survival in patients with follicular lymphoma.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Impact of rituximab treatment on (90)Y-ibritumomab dosimetry for patients with non-Hodgkin lymphoma.

Author: ShenSui, ForeroAndres, MeredithRuby F, ShahJatin J, KnoxSusan J, WisemanGregory A, UsreyMarc E, LobuglioAlbert F

ibritumomab efficacy

This trial investigated the potential enhancement of (90)Y-ibritumomab therapy by a full course of rituximab followed by a single dose of (90)Y-ibritumomab.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Efficacy and safety of yttrium-90 ibritumomab tiuxetan in Japanese patients with non-Hodgkin lymphoma.

Author: NakagawaMakoto, UikeNaokuni, ChoiIlseung, HayashiToshinobu, UeharaSatoru

NHL treatment response
Reduced hematologic side effects
Anemia
Thrombocytopenia

The overall response rate to RIT-Z was 85%, with a high complete remission rate of 60%.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Radiolabeling optimization and reduced staff radiation exposure for high-dose 90Y-ibritumomab tiuxetan (HD-Zevalin).

Author: PapiStefano, MartanoLuigi, GaraboldiLucia, RossiAnnalisa, CremonesiMarta, GranaChiara Maria, PaolucciDaniele, SansoviniMaddalena, PaganelliGiovanni, ChinolMarco

Reduced finger exposure
None mentioned

A safe and reproducible method for labeling high-dose (90)Y-Zevalin was developed, achieving high radiochemical purity, good stability, and low finger exposure. This optimized procedure may improve the safety of nuclear medicine professionals preparing Zevalin.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

15.

A phase I trial of immunostimulatory CpG 7909 oligodeoxynucleotide and 90 yttrium ibritumomab tiuxetan radioimmunotherapy for relapsed B-cell non-Hodgkin lymphoma.

Author: WitzigThomas E, WisemanGregory A, MaurerMatthew J, HabermannThomas M, MicallefIvana N M, NowakowskiGrzegorz S, AnsellStephen M, ColganJoseph P, InwardsDavid J, PorrataLuis F, LinkBrian K, ZentClive S, JohnstonPatrick B, ShanafeltTait D, AllmerCristine, AsmannYan W, GuptaMamta, BallasZuhair K, SmithBrian J, WeinerGeorge J

Lymphoma treatment

This Phase I trial studied the safety and efficacy of combining CpG 7909 with standard radioimmunotherapy (RIT) for relapsed indolent non-Hodgkin lymphoma. The combination was well-tolerated, with an overall response rate of 93% and a complete remission rate of 63%. Median progression-free survival was 42.7 months and median duration of response was 35 months.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Early assessment of therapy response in malignant lymphoma with the thymidine analogue [18F]FLT.

Author: BuckAndreas K, KratochwilClemens, GlattingGerhard, JuweidMalik, BommerMartin, TepsicDjurdja, VoggAndreas T J, MattfeldtTorsten, NeumaierBernd, MöllerPeter, ReskeSven N

Early detection

[(18)F]FLT detected early antiproliferative drug activity before changes in tumor size were visible in a lymphoma xenotransplant model.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Relative biologic effects of low-dose-rate alpha-emitting 227Th-rituximab and beta-emitting 90Y-tiuexetan-ibritumomab versus external beam X-radiation.

Author: DahleJostein, BrulandOyvind S, LarsenRoy H

Lymphoma treatment

227Th-rituximab was more effective per absorbed radiation dose unit than 90Y-tiuexetan-ibritumomab (Zevalin) or external beam X-radiation in a lymphoma xenograft model.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

The role of dosimetry in the high activity 90Y-ibritumomab tiuxetan regimens: two cases of abnormal biodistribution.

Author: AricòDemetrio, GranaChiara Maria, VanazziAnna, FerrariMahila, MalliaAndrew, SansoviniMaddalena, MartinelliGiovanni, PaganelliGiovanni, CremonesiMarta

Lymphoma treatment
Liver toxicity

Two patients undergoing radioimmunotherapy (RIT) with yttrium-90 ((90)Y)-ibritumomab-tiuxetan exhibited atypical pharmacokinetics and liver uptake, highlighting the importance of dosimetry in high-dose RIT to ensure safety.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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