TY - JOUR
T1 - Nab-Paclitaxel for Previously Treated Advanced Non–Small Cell Lung Cancer
T2 - Analysis of Safety and Efficacy for Patients With Renal Impairment
AU - Yoneshima, Yasuto
AU - Morita, Satoshi
AU - Ando, Masahiko
AU - Nakamura, Atsushi
AU - Iwasawa, Shunichiro
AU - Yoshioka, Hiroshige
AU - Goto, Yasuhiro
AU - Takeshita, Masafumi
AU - Harada, Toshiyuki
AU - Hirano, Katsuya
AU - Oguri, Tetsuya
AU - Kondo, Masashi
AU - Miura, Satoru
AU - Hosomi, Yukio
AU - Kato, Terufumi
AU - Kubo, Toshio
AU - Kishimoto, Junji
AU - Yamamoto, Nobuyuki
AU - Nakanishi, Yoichi
AU - Okamoto, Isamu
N1 - Funding Information:
We thank the participating patients and their families as well as the investigators and institutions involved in this study. We also thank members of the Center for Clinical and Translational Research at Kyushu University Hospital for their contribution to this clinical trial as well as Hiroko Watanabe for the ad hoc analysis. This work was supported by Taiho Pharmaceutical Co. Ltd. and in part by the National Cancer Center Research and Development Fund ( 26-A-22, 29-A-15, 2020-A-13 ).
Funding Information:
We thank the participating patients and their families as well as the investigators and institutions involved in this study. We also thank members of the Center for Clinical and Translational Research at Kyushu University Hospital for their contribution to this clinical trial as well as Hiroko Watanabe for the ad hoc analysis. This work was supported by Taiho Pharmaceutical Co. Ltd. and in part by the National Cancer Center Research and Development Fund (26-A-22, 29-A-15, 2020-A-13).
Publisher Copyright:
© 2022
PY - 2022/11
Y1 - 2022/11
N2 - Background: Renal impairment can affect treatment tolerability and outcome in individuals with cancer. We aimed to assess the safety and efficacy of nab-paclitaxel for previously treated patients with advanced non–small cell lung cancer (NSCLC) and renal impairment enrolled in a phase 3 trial of nab-paclitaxel vs. docetaxel. Patients and Methods: Previously treated NSCLC patients were randomly allocated (1:1) to receive docetaxel (60 mg/m²) on day 1 or nab-paclitaxel (100 mg/m²) on days 1, 8, and 15 of a 21-day cycle. Safety and efficacy outcomes of treatment were evaluated according to renal function. Results: Among the 503 patients enrolled in the phase 3 trial, 17.3% had moderate renal impairment (creatinine clearance of ≤50 mL/min, n = 49 for docetaxel and n = 38 for nab-paclitaxel) and 53.1% had mild renal impairment (creatinine clearance of >50 to ≤80 mL/min, n = 133 for docetaxel and n = 134 for nab-paclitaxel). For patients with renal impairment, the incidence of febrile neutropenia was lower in the nab-paclitaxel group than in the docetaxel group. The difference in treatment efficacy for nab-paclitaxel vs. docetaxel among patients with moderate or mild renal impairment was similar to that among the overall study population. Conclusion: Nab-paclitaxel was found to be tolerable and beneficial for previously treated patients with advanced NSCLC and mild or moderate renal impairment.
AB - Background: Renal impairment can affect treatment tolerability and outcome in individuals with cancer. We aimed to assess the safety and efficacy of nab-paclitaxel for previously treated patients with advanced non–small cell lung cancer (NSCLC) and renal impairment enrolled in a phase 3 trial of nab-paclitaxel vs. docetaxel. Patients and Methods: Previously treated NSCLC patients were randomly allocated (1:1) to receive docetaxel (60 mg/m²) on day 1 or nab-paclitaxel (100 mg/m²) on days 1, 8, and 15 of a 21-day cycle. Safety and efficacy outcomes of treatment were evaluated according to renal function. Results: Among the 503 patients enrolled in the phase 3 trial, 17.3% had moderate renal impairment (creatinine clearance of ≤50 mL/min, n = 49 for docetaxel and n = 38 for nab-paclitaxel) and 53.1% had mild renal impairment (creatinine clearance of >50 to ≤80 mL/min, n = 133 for docetaxel and n = 134 for nab-paclitaxel). For patients with renal impairment, the incidence of febrile neutropenia was lower in the nab-paclitaxel group than in the docetaxel group. The difference in treatment efficacy for nab-paclitaxel vs. docetaxel among patients with moderate or mild renal impairment was similar to that among the overall study population. Conclusion: Nab-paclitaxel was found to be tolerable and beneficial for previously treated patients with advanced NSCLC and mild or moderate renal impairment.
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U2 - 10.1016/j.cllc.2022.08.011
DO - 10.1016/j.cllc.2022.08.011
M3 - Article
C2 - 36114096
AN - SCOPUS:85138019266
VL - 23
SP - 585
EP - 592
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
IS - 7
ER -