Side Effects of bosutinib: A Synthesis of Findings from 29 Studies

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Original Abstract of the Article

Key Research Findings

Bosutinib is one of the five tyrosine kinase inhibitors currently approved for the treatment of chronic myeloid leukemia (CML). 10 It is a potent second-generation TKI that targets both Src and ABL kinases, and has been shown to be effective in patients who have failed other TKIs. 10

Bosutinib is approved for use in patients who have failed treatment with imatinib, nilotinib, or dasatinib. 10 It has also been studied for use as a first-line treatment, and results from the BFORE study suggest that bosutinib may soon be approved for this purpose. 10

Bosutinib has a unique side effect profile, with low rates of cardiovascular and thromboembolic events and minimal long-term safety issues. 10 The most common side effects are gastrointestinal, with diarrhea occurring in more than 80% of patients. 10

Reasons for Side Effects

The unique side effect profile of bosutinib is likely due to its dual inhibition of Src and ABL kinase, as well as its targeting of other kinases. 10

Common Side Effects

Diarrhea

Diarrhea is one of the most common side effects of bosutinib. 10 It has been reported in more than 80% of patients in clinical trials. 10

Gastrointestinal Symptoms

Other common gastrointestinal symptoms associated with bosutinib include nausea and vomiting. 26

Elevated Liver Enzymes

Elevated liver enzymes have also been reported as a side effect of bosutinib. 26

Myelosuppression

Bosutinib can cause myelosuppression, a condition where the bone marrow does not produce enough blood cells. 26

Pleural Effusion

Pleural effusion, a build-up of fluid in the space between the lungs and the chest wall, is a rare but possible side effect of bosutinib. 5

Side Effect Management

Diarrhea

Antidiarrheal medications such as loperamide may be effective in managing diarrhea caused by bosutinib. 10

Gastrointestinal Symptoms

Antiemetics or anti-nausea medications may be used to alleviate gastrointestinal symptoms. 26

Elevated Liver Enzymes

If elevated liver enzymes are observed, bosutinib treatment may need to be stopped or the dose reduced. 26

Myelosuppression

If myelosuppression is observed, bosutinib treatment may need to be stopped or the dose reduced. 26

Pleural Effusion

Pleural effusions are treated with drainage or medication. 5

Comparison of Studies

Similarities in Studies

Many studies have shown that bosutinib is effective in treating CML. 26 10 24 1 8

Studies also share a common finding that bosutinib is prone to causing gastrointestinal side effects. 10 26 22

Differences in Studies

There are differences in the efficacy and incidence of side effects of bosutinib in each study. For example, the BFORE study found that bosutinib was more effective than imatinib. 10 On the other hand, other studies have found that bosutinib is not significantly more effective than imatinib. 26

Differences also exist in the types and incidence of side effects reported in each study. For example, one study reported that pleural effusions caused by bosutinib are rare. 22 Another study, however, reported frequent pleural effusions caused by bosutinib. 5

Cautions for Real-World Application

Bosutinib is an effective drug for treating CML, but it is important to understand that there are risks of side effects. 10 26

Diarrhea is a common side effect. 10 Antidiarrheal medications such as loperamide may be effective in managing diarrhea. 10

It is important to have regular checkups with your doctor while taking bosutinib to carefully monitor for side effects. 10

Limitations of Current Research

Research on bosutinib is still insufficient. 26 10

In particular, research on long-term side effects is lacking. 26

Further research is needed to determine the optimal dosage and methods to minimize side effects. 10

Future Directions for Research

Research on the long-term safety of bosutinib is needed. 26

Research is also needed to determine the optimal dosage and methods to minimize side effects. 10

Further research is needed to identify other diseases where bosutinib may be effective. 10

Conclusion

Bosutinib is an effective drug for treating CML, but it has side effect risks. 10 26

It is important to have regular checkups with your doctor while taking bosutinib to carefully monitor for side effects. 10

Research on bosutinib is still insufficient. 26 10

Further research is needed on long-term side effects, optimal dosage, and methods to minimize side effects. 10

Keywords
Benefit Keywords
CML treatment
1
CML treatment
3
CML treatment
Ph+ ALL treatment
4
CML management
5
Improved quality of life
Treatment discontinuation
6
Improved CML survival
7
Safety comparison
8
Treatment of CML
9
CML treatment
Minimal long-term safety issues
10
CML treatment
Increased life expectancy
11
Liquid tumor treatment
12
Radioprotection
Salivary gland regeneration
13
CML treatment
TKI rotation
14
Durable responses to treatment
17
CML treatment
18
Improved CML outcome
Improved rates of response
Overall survival
19
CML treatment
20
Cancer treatment
21
Overcomes IM resistance
Potent inhibitor of CML
22
Clinical activity in CML and GIST
23
CML treatment
Oral bioavailability
24
CML treatment
25
Philadelphia chromosome-positive leukemia treatment
26
Effective for leukemia
27
CML treatment
28
CML treatment
29
Risk Keywords
Diarrhea
Liver enzyme elevation
Rash
1
Pleural effusion
Pulmonary toxicity
2
Cardiotoxicity
Edema
Heart failure
QT prolongation
3
Intolerance
Resistance
4
Interstitial lung disease
Pleural effusion
5
Long-term toxicities
6
Atrial fibrillation
VTE
7
Hematologic toxicity
8
Diarrhea
Pleural effusions
9
Gastrointestinal side effects
10
Long-term toxicities
11
Cutaneous adverse events
12
No impact on tumor
13
Thrombocytopenia
14
Bleeding disorders
15
Changes in bone metabolism
Delayed growth
Effects on puberty and fertility
Thyroid abnormalities
16
Cardiopulmonary side effects
Endocrine side effects
Gastrointestinal side effects
17
Adverse events
18
Metabolic changes
Off-target side effects
19
Gastrointestinal upsets
20
Cell adhesion/invasion issues
Side effects
21
Gastrointestinal side effects
Liver toxicity
22
Resistance
Side effects
23
Unique toxicity
24
Off-target complications
TKI side effects
25
Alanine aminotransferase elevation
Gastrointestinal issues
Myelosuppression
26
Diarrhea
High fever
Skin rash
29
Literature analysis of 29 papers
Positive Content
26
Neutral Content
1
Negative Content
2
Article Type
0
1
0
16
28
2.

Bosutinib-induced massive pleural effusion: Cross-intolerance with all tyrosine kinase inhibitors.

Author: AslanNevin Alayvaz, HıncalHande Oğul, ElverÖzde, ErolVeysel, GülerNil

Pleural effusion
Pulmonary toxicity

Tyrosine kinase inhibitors are medications used to treat chronic myeloid leukemia. This article discusses the side effects of tyrosine kinase inhibitors, particularly the occurrence of pleural effusion, a buildup of fluid in the space between the lungs and the chest wall.

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

4.

Serial evaluation of the pharmacokinetics of ponatinib in patients with CML and Ph + ALL.

Author: KawanoNoriaki, KimuraShinya, MiuraMasatomo, TochigiTaro, NakaikeTakashi, YamashitaKiyoshi, MashibaKoichi, KikuchiIkuo, TakahashiNaoto

CML treatment
Ph+ ALL treatment
Intolerance
Resistance

Ponatinib, a third-generation TKI, was effective in treating CML and Ph + ALL patients intolerant to other TKIs. Serial monitoring of ponatinib pharmacokinetics provided valuable information on its safety and efficacy, enabling personalized treatment adjustments.

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

5.

Bosutinib-associated interstitial lung disease and pleural effusion: A case report and literature review.

Author: LiuQiuying Selina, Ass'adNour Ali, Arana YiCecilia

CML management
Interstitial lung disease
Pleural effusion

Interstitial lung disease and pleural effusion are uncommon pulmonary side effects of bosutinib, a tyrosine kinase inhibitor used to treat chronic myeloid leukemia.

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.

Language : English

6.

The New ELN Recommendations for Treating CML.

Author: HehlmannRüdiger

Improved quality of life
Treatment discontinuation
Long-term toxicities

This article reviews the current treatment strategies for chronic myeloid leukemia (CML), a type of blood cancer. It discusses the use of tyrosine kinase inhibitors (TKIs), which have revolutionized treatment, and explores the importance of achieving sustained remission and potentially discontinuing treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Haematological adverse events associated with tyrosine kinase inhibitors in chronic myeloid leukaemia: A network meta-analysis.

Author: FachiMariana M, ToninFernanda S, LeonartLeticia P, RottaInajara, Fernandez-LlimosFernando, PontaroloRoberto

Safety comparison
Hematologic toxicity

This systematic review and network meta-analysis compares the safety profiles of different tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia. The analysis found that all TKIs are associated with haematological toxicities, but there are differences in the frequency and severity of these effects.

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.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Safety and efficacy of bosutinib in fourth-line therapy of chronic myeloid leukemia patients.

Author: García-GutiérrezValentín, MilojkovicDragana, Hernandez-BoludaJuan Carlos, ClaudianiSimone, Martin MateosMaría Luisa, Casado-MonteroLuis Felipe, GonzálezGloria, Jimenez-VelascoAntonio, BoqueConcepcion, Martinez-TrillosAlejandra, VázquezIsabel Mata, PayerÁngel Ramírez, SenínAlicia, Amustio DíezElena, GarcíaAbelardo Bárez, CarrascosaGuiomar Bautista, OrtíGuillermo, RuizBeatriz Cuevas, FernándezMaria Ángeles, Del Carmen García GarayMaría, GiraldoPilar, GuineaJose María, De Las Heras RodríguezNatalia, HernánNuria, PérezAna Iglesias, Piris-VillaespesaMiguel, LorenzoJose Luis López, Martí-TutusausJosep Maria Martí, VallansotRolando Omar, Ortega RivasFernando, PuertaJose Manuel, RamirezMaria Jose, RomeroEsperanza, RomoAndres, RosellAna, SaavedraSilvanna Saavedra, SebrangoAna, TallonJosé, ValenciaSandra, PorteroAngeles, SteegmannJuan Luis,

Treatment of CML
Diarrhea
Pleural effusions

Bosutinib was effective in 62 CML patients who had failed prior treatment with imatinib, nilotinib, and dasatinib. The overall probabilities of achieving complete cytogenetic response (CCyR) and major molecular response (MMR) were 25% and 24%, respectively. Bosutinib was well tolerated but pleural effusions and diarrhea were common 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.
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.

Language : English

11.

Bosutinib in chronic myeloid leukemia: patient selection and perspectives.

Author: IsfortSusanne, BrümmendorfTim H

CML treatment
Increased life expectancy
Long-term toxicities

This review focuses on the clinical efficacy, tolerability, and side effects of bosutinib treatment in CML patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

12.

Cutaneous Adverse Events of Targeted Therapies for Hematolymphoid Malignancies.

Author: RansohoffJulia D, KwongBernice Y

Liquid tumor treatment
Cutaneous adverse events

This article discusses the cutaneous adverse events (AEs) associated with targeted therapies for hematologic and lymphoid malignancies. It provides a comprehensive review of the AE profiles of various targeted agents, emphasizing the importance of early diagnosis and management of skin toxicities to minimize disruptions to care and optimize patient outcomes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

TKI rotation-induced persistent deep molecular response in multi-resistant blast crisis of Ph+ CML.

Author: ValentPeter, HerndlhoferSusanne, SchneeweißMathias, BoidolBernd, RinglerAnna, KubicekStefan, GleixnerKaroline V, HoermannGregor, HadzijusufovicEmir, MüllauerLeonhard, SperrWolfgang R, Superti-FurgaGiulio, MannhalterChristine

CML treatment
TKI rotation
Thrombocytopenia

This case report describes a patient with chronic myeloid leukemia (CML) who developed multi-resistant blast crisis. The patient received treatment with ponatinib and bosutinib, switching between the two drugs based on clinical response and side effects. This approach, known as TKI rotation, effectively suppressed resistant sub-clones and balanced efficacy with side effects. The study suggests that TKI rotation may be a promising treatment strategy for patients with advanced CML, but further clinical trials are needed to confirm its safety and effectiveness.

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

16.

Recognizing Endocrinopathies Associated With Tyrosine Kinase Inhibitor Therapy in Children With Chronic Myelogenous Leukemia.

Author: SamisJill, LeePaul, ZimmermanDonald, ArceciRobert J, SuttorpMeinolf, HijiyaNobuko

Changes in bone metabolism
Delayed growth
Effects on puberty and fertility
Thyroid abnormalities

The review critically evaluates the long-term endocrine side effects of tyrosine kinase inhibitors (TKIs) in pediatric patients with chronic myelogenous leukemia (CML), highlighting the importance of addressing endocrinopathies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Long-Term Side Effects of Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia.

Author: CaldemeyerLauren, DuganMichael, EdwardsJohn, AkardLuke

Durable responses to treatment
Cardiopulmonary side effects
Endocrine side effects
Gastrointestinal side effects

This article reviews the long-term toxicities of five BCR-ABL1 tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia. The article highlights the differences between cardiovascular, pulmonary, gastrointestinal, and endocrine toxicities, as well as possible second malignancies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Tyrosine kinase inhibitor therapy in chronic myeloid leukemia: update on key adverse events.

Author: CarneiroBenedito A, KaplanJason B, GilesFrancis J

CML treatment
Adverse events

This review provides an overview of the efficacy and safety of tyrosine kinase inhibitors approved for the treatment of chronic myeloid leukemia (CML), as well as recommendations for the management of key adverse events.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

How tyrosine kinase inhibitors impair metabolism and endocrine system function: a systematic updated review.

Author: BrecciaMassimo, MolicaMatteo, AlimenaGiuliana

Improved CML outcome
Improved rates of response
Overall survival
Metabolic changes
Off-target side effects

Tyrosine kinase inhibitors (TKIs) used for chronic myeloid leukemia can cause metabolic changes as off-target side effects, highlighting the importance of monitoring patients for these effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Clinical advances in the management of chronic myelogenous leukemia: focus on bosutinib and patient considerations.

Author: SweetKendra, Pinilla-IbarzJavier, ZhangLing

CML treatment
Gastrointestinal upsets

Bosutinib is a tyrosine kinase inhibitor that is used to treat chronic myeloid leukemia (CML). This review discusses the effectiveness and side effects of bosutinib. It concludes that bosutinib can be a valuable treatment option for patients with CML.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

22.

Bosutinib: a novel second-generation tyrosine kinase inhibitor.

Author: IsfortSusanne, Keller-v AmsbergGunhild, SchafhausenPhilippe, KoschmiederSteffen, BrümmendorfTim H

Overcomes IM resistance
Potent inhibitor of CML
Gastrointestinal side effects
Liver toxicity

Bosutinib is a new drug for treating chronic myeloid leukemia (CML) and works by inhibiting certain enzymes. It is effective for patients who are resistant or intolerant to other treatments, but may cause gastrointestinal side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

23.

Imatinib mesylate.

Author: WallerCornelius F

Clinical activity in CML and GIST
Resistance
Side effects

Imatinib mesylate is a tyrosine kinase inhibitor that targets BCR-ABL and other kinases. It has shown remarkable efficacy in treating chronic myeloid leukemia and gastrointestinal stromal tumors. Imatinib is generally well-tolerated, but resistance can occur due to mutations in BCR-ABL. Second- and third-generation tyrosine kinase inhibitors have been developed to address this issue.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

26.

Bosutinib safety and management of toxicity in leukemia patients with resistance or intolerance to imatinib and other tyrosine kinase inhibitors.

Author: KantarjianHagop M, CortesJorge E, KimDong-Wook, KhouryH Jean, BrümmendorfTim H, PorkkaKimmo, MartinelliGiovanni, DurrantSimon, LeipEric, KellyVirginia, TurnbullKathleen, BessonNadine, Gambacorti-PasseriniCarlo

Philadelphia chromosome-positive leukemia treatment
Alanine aminotransferase elevation
Gastrointestinal issues
Myelosuppression

This study evaluated the safety and tolerability of bosutinib in patients with Philadelphia chromosome-positive leukemia who had failed or were intolerant to other tyrosine kinase inhibitors. While bosutinib demonstrated acceptable safety, common side effects included diarrhea, nausea, vomiting, and myelosuppression.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

28.

Navigating the road toward optimal initial therapy for chronic myeloid leukemia.

Author: OkimotoRoss A, Van EttenRichard A

CML treatment

Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of chronic myeloid leukemia (CML), supplanting interferon and allogeneic stem cell transplantation. This review summarizes recent information on initial treatment of CML, including the drugs imatinib, nilotinib, dasatinib, and bosutinib.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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