Relationship between Serum Bortezomib Concentration and Emergence of Diarrhea in Patients with Multiple Myeloma and/or AL Amyloidosis

多发性骨髓瘤和/或 AL 淀粉样变性患者血清硼替佐米浓度与腹泻发生的关系

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作者:Yuki Fujimoto, Shikiko Ueno, Kazutaka Oda, Nao Gunda, Yumi Shimomura, Yuka Nishimura, Ayami Yamaguchi, Akari Kuwano, Yuki Ito, Yusuke Baba, Aina Nishigaki, Natsumi Michiwaki, Shota Uchino, Kayo Kurogi, Yawara Kawano, Masao Matsuoka, Hideyuki Saito, Yutaka Okuno, Hirofumi Jono

Background

multiple myeloma patients have benefited from bortezomib therapy, though it has often been discontinued owing to diarrhea. The

Conclusions

this study indicated the possible involvement of serum bortezomib concentration in the emergence of diarrhea in bortezomib therapy in patients with multiple myeloma.

Methods

this prospective, observational case-control, and monocentric study was performed with an approval by the Ethics Committee of Kumamoto University Hospital in 2015 (No. 1121) from February 2015 to April 2017. (3)

Results

twenty-four patients with bortezomib therapy were recruited; eight patients (33.3%) developed diarrhea at day 3 as median. Median measured trough bortezomib concentration at 24 h after first or second dose for patients with or without diarrhea was 0.87 or 0.48 ng/mL, respectively (p = 0.04, Wilcoxon signed rank test). Receiver operation characteristic (ROC) analysis produced the cut-off concentration of 0.857 ng/mL (area under the ROC curve of 0.797, sensitivity of 0.625, specificity of 0.875). The survival curves between patients with and without diarrhea were similar (p = 0.667); those between patients with higher and lower concentration than median value (0.61 ng/mL) were also similar (p = 0.940). (4) Conclusions: this study indicated the possible involvement of serum bortezomib concentration in the emergence of diarrhea in bortezomib therapy in patients with multiple myeloma.

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