TY - JOUR
T1 - Increasing diluent volume decreases bendamustine-induced venous irritation without reducing the therapeutic efficacy
AU - Ishida, Shigeru
AU - Morikawa, Hanae
AU - Watanabe, Hiroyuki
AU - Tsuji, Toshikazu
AU - Sugio, Takeshi
AU - Mori, Yasuo
AU - Miyamoto, Toshihiro
AU - Masuda, Satohiro
AU - Akashi, Koichi
AU - Egashira, Nobuaki
N1 - Funding Information:
Acknowledgments The present study was supported in part by a Grant-in-Aid for Scientific Research (KAKENHI) from the Ministry of Education, Culture, Sports, Science and Technology of Japan (MEXT, Grant numbers 16K08404, 17K08447).
Publisher Copyright:
© 2020 The Pharmaceutical Society of Japan
PY - 2020/3/1
Y1 - 2020/3/1
N2 - The intravenous injection of bendamustine often induces venous irritation, which reduces patients’ QOL. We previously reported that the dilution of the final volume of bendamustine from 250 to 500mL significantly decreased the incidence of venous irritation. However, the influence of this change on the therapeutic efficacy of bendamustine remains unclear. Therefore, the aim of this study was to evaluate the efficacy and safety profiles of bendamustine at different dilutions of the final volume, comparing with the correspondences of previous studies. Thirty-four patients, who received a total of 161 courses of bendamustine and rituximab chemotherapy, were included in this study. The overall response rate of this regimen was 94.1% in this study, which was comparable to that reported in the BRB study (94.2%, a phase II study of bendamustine plus rituximab therapy in Japanese patients). Additionally, the median progression-free survival was not inferior to that reported in the BRB study. Bendamustine-induced venous irritation was observed in 17.6% of the patients during the first treatment cycle administered at a final volume of 500mL, and was found to be lower than that observed in the control, where bendamustine was administered at a final volume of 250mL (85.7%). These results suggest that diluting bendamustine to 500mL, but not to 250mL, reduces the incidence of venous irritation without a negative impact on its therapeutic efficacy; thus, this simple strategy may be beneficial to ensure efficacy and safety in patients receiving regimens including bendamustine.
AB - The intravenous injection of bendamustine often induces venous irritation, which reduces patients’ QOL. We previously reported that the dilution of the final volume of bendamustine from 250 to 500mL significantly decreased the incidence of venous irritation. However, the influence of this change on the therapeutic efficacy of bendamustine remains unclear. Therefore, the aim of this study was to evaluate the efficacy and safety profiles of bendamustine at different dilutions of the final volume, comparing with the correspondences of previous studies. Thirty-four patients, who received a total of 161 courses of bendamustine and rituximab chemotherapy, were included in this study. The overall response rate of this regimen was 94.1% in this study, which was comparable to that reported in the BRB study (94.2%, a phase II study of bendamustine plus rituximab therapy in Japanese patients). Additionally, the median progression-free survival was not inferior to that reported in the BRB study. Bendamustine-induced venous irritation was observed in 17.6% of the patients during the first treatment cycle administered at a final volume of 500mL, and was found to be lower than that observed in the control, where bendamustine was administered at a final volume of 250mL (85.7%). These results suggest that diluting bendamustine to 500mL, but not to 250mL, reduces the incidence of venous irritation without a negative impact on its therapeutic efficacy; thus, this simple strategy may be beneficial to ensure efficacy and safety in patients receiving regimens including bendamustine.
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U2 - 10.1248/bpb.b19-00826
DO - 10.1248/bpb.b19-00826
M3 - Article
C2 - 32115507
AN - SCOPUS:85080839532
SN - 0918-6158
VL - 43
SP - 488
EP - 492
JO - Biological and Pharmaceutical Bulletin
JF - Biological and Pharmaceutical Bulletin
IS - 3
ER -