A study of the renal hypofunction and accompanying adverse events in breast cancer patients treated with palbociclb

Abstract

Abstract Background Palbociclb is an orally available selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) that is indicated for patients with hormone receptor-positive HER2-negative advanced or recurrent breast cancer with 3 weeks on/1 week off schedule. Previous report showed that elevated serum creatinine (Scr) was only 2.0% in frequency for all grade, without cases of grade 3 or more. Anecdotal episode of declined eGFR (implying elevated Scr) seems to be more frequent in daily clinical practice; however, the actual frequency of declined eGFR and its impact on severe toxicity has not been determined yet. Objective To investigate the frequency of declined eGFR in patients treated with palbociclib and to determine the association between declined eGFR and severe toxicity. Methods Consecutive patients treated with palbociclib at National Cancer Center Hospital East between December 1 2017 and May 31 2018 were retrospectively investigated. Patient characteristics, eGFR at cycle 1 day1 (C1D1) and C1D15, C2D1, C2D15, and C3D1 of palbociclib, grade 4 neutropenia, treatment discontinuation or interruption caused by toxicity were retrieved from medical records. The frequency of declined eGFR and its correlation with severe toxicity were analyzed. Results A total of 42 patients were included. Median age was 65 years (range 43-80), and 41 cases were female. Median eGFR at the start of palbociclib was 76 mL/min/1.73m2, which declined 12.5 in median (range 3.0-39.0) on C1D15. At C2D1, eGFR was recovered (change in median -3 mL/min/1.73m2; range -17.0 - +19.0). Declined eGFR was not correlated significantly with either grade 4 neutropenia or treatment discontinuation. Conclusions While eGFR was declined by median of 12.5 mL/min/1.73m2 with palbociclib administration on C1D15, eGFR recovered to the baseline by drug interruption. Declined eGFR was not correlated with severe toxicity such as grade 4 neutropenia or toxicities leading to treatment discontinuation.