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Effects of Bosutinib Treatment on Renal Function in Patients With Philadelphia Chromosome-Positive Leukemias



 

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Çʶóµ¨ÇÇ¾Æ ¿°»öü ¾ç¼º ¹éÇ÷º´[Philadelphia chromosome-positive, (Ph+) leukemias] ȯÀÚ¿¡°Ô º¸¼öƼ´Õ(bosutinib) Åõ¿©´Â ½ÅÀå±â´É¿¡ È¿°ú°¡ ÀÖ½À´Ï±î?

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Effects of Bosutinib Treatment on Renal Function in Patients With Philadelphia Chromosome-Positive Leukemias. Clinical Lymphoma, Myeloma & Leukemia, 2017-10-01, 17(10), 684-695. https://doi.org/10.1016/j.clml.2017.06.001

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Çʶóµ¨ÇÇ¾Æ ¿°»öü ¾ç¼º ¹éÇ÷º´(Ph+) ȯÀÚÀÇ ½ÅÀå±â´É¿¡ ´ëÇÑ º¸¼öƼ´Õ(bosutinib) ȤÀº À̸¶Æ¼´Õ(imatinib.)Ä¡·á¿¡ ´ëÇÑ ½ÅÀå±â´ÉÀ» Æò°¡Çϱâ À§ÇÔ

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Retrospective analysis of data from 2 open-label, multinational study

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First-line bosutinib (n = 248) or imatinib (n=251; phase III trial) =>  (N=499)

Second-line or later bosutinib (phase I/II trial; N= 570).

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First-line bosutinib (n = 248) or, second-line or later bosutinib (n = 570).

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Imatinib (n = 251)

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Incidence of renal adverse events (AEs)

Estimated Gomerular filtration rate (eGFR) rate

Serum creatinine

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-Incidence of renal adverse events (AEs):  µÎ ¹ø° ¶Ç´Â ±× ÀÌÈÄÀÇ º¸½ºÆ¼´ÕÀ» Åõ¿©¹ÞÀº (73/570¸í), 13%ȯÀÚ¿¡¼­ ³ªÅ¸³µ°í, ù ¹ø° º¸½ºÆ¼´Õ°ú À̸¶Æ¼´ÕÀ» Åõ¿©¹ÞÀº [22/248, (9 %) 16/251, (6 %)] ȯÀÚ¿¡¼­ º¸°íµÇ¾ú´Ù.

-BosutinibÀ» Åõ¿©¹ÞÀº ȯÀÚÀÇ eGFRÀº 2 Â÷ ¶Ç´Â ±× ÀÌÈÄÀÇ bosutinib (139/570, 24 %)·Î grade 3b eGFR (½ÅÀå Áúȯ¿¡¼­ÀÇ ½ÄÀÌ¿ä¹ý º¯°æ¿¡ µû¶ó 45 mL / min / 1.73 m2 ¹Ì¸¸) )°ú 1 Â÷ º¸½ºÆ¼´Õ (26/248, 10 %) ¹× À̸¶Æ¼´Õ (25/251, 10 %)Ä¡·á¿Í ºñ±³ÇßÀ» ¶§; Grade_3b eGFRÀº ¼¼ÄÁ¶óÀΠȤÀº ±× ÀÌÈÄÀÇ º¸½ºÆ¼´Õ Åõ¿© ½Ã¿¡ °¡Àå ª°Ô ³ªÅ¸³µ´Ù.

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Moderate

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ÀÇ°úÇבּ¸Á¤º¸¼¾ÅÍ(MedRIC)

Copyright © 2015. Medical Research Information Center (MedRIC) Editors


 

Ç¥1) Characteristics and Management of Renal Adverse Events


 

 

±×¸² 1) Median Change From Baseline in eGFR (A) and Serum Creatinine (B) Over Time in Both Studies. Baseline Was Defined as the Last Nonmissing Value Before the First Dose of Test Drug. Analyses for Each Time Interval Were Done Using Data With Nonmissing Baseline and Postbaseline Values. Per Protocol, Assessments at Months 27, 33, and 39 Were Not Done in the Phase I/II Study. 1 Month [ 4 Weeks. Nonparametric 95% Confidence Intervals Provided for the Median


 

±×¸² 2) Baseline and On-Treatment Time-Dependent Predictors of Time to First Grade ‡ 3b eGFR in CP CML Patients. Hazard Ratios < 1 Indicate Better Outcome for Group 1 Versus Group 2 (ie, Reference) or for a 1-Unit Increase for the Continuous Variables; 95% Confidence Intervals From the Cox Model Provided. Terms Used to Define Medical Histories Are Included in the Footnotes of Table 1. P Values Were Not Adjusted for Multiple Comparisons (*P < .05; yP £ .01; zP £ .001; xP £ .0001). eGFR Was Calculated on the Basis of the Modification in Diet in Renal Disease Method. Grading Is on the Basis of Kidney Disease Improving Global Outcomes Criteria Where Grade ‡ 3b is < 45 mL/min/1.73 m2 and Grade £ 3a Is ‡ 45 mL/min/1.73 m2. Patients Without Grade ‡ 3b Were Censored at the Last on-Treatment Laboratory Assessment. aForward Selection Was Used to Select Covariates for Inclusion in the Final Model (P[.20; Treatment Forced Into the Model for the  Phase III Study); Maximum Likelihood Estimates, P Values, and Hazard Ratios Are Shown for Covariates Included in the Final Model. bData From the BOS and IM Treatment Arms Were Combined in the Model for the Phase III Study. cNumber of Previous TKIs (0 vs. > 1 and 1 vs. > 1) Was Included Only in the Model for the Phase I/II Study; Treatment (BOS vs. IM) Was Included Only in the Model for the Phase III Study. These Covariates Were Included in the Respective Models Regardless of Their Statistical

significance



 

Reference:
 

Effects of Bosutinib Treatment on Renal Function in Patients With Philadelphia Chromosome-Positive Leukemias. Clinical Lymphoma, Myeloma & Leukemia, 2017-10-01, 17(10), 684-695.

Bosutinib treatment for Philadelphia chromosome-positive leukemias.Future Oncol. 2014 Feb;10(2):179-85. Doi: 10.2217/fon.13.268.


 


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