Innovator and generic cisplatin formulations: comparison of renal toxicity.
To compare the incidence and degree of renal toxicity associated with innovator and generic cisplatin formulations, increase in the serum creatinine (CRN) levels (mg/dL) and incidence of grade 2-3 CRN elevation during the first and all cycles of chemotherapy were retrospectively evaluated in patients treated with innovator (group 1, n = 296) and generic (group 2, n = 321) cisplatin formulations. There were no differences in the sex, age, performance status or number of chemotherapy cycles between groups 1 and 2. The median increases in CRN levels during the first cycle were 0.20 mg/dL regardless of the sex or group. There was no difference in the incidence of grade 2-3 CRN elevation between groups 1 and 2 among female or male patients. The median increases in CRN levels during all cycles were 0.2 (0-1.0) and 0.3 (0-1.8) in the female patients of groups 1 and 2, respectively (P = 0.68), and 0.3 (0-2.1) and 0.5 (0-3.6) in the male patients of groups 1 and 2, respectively (P < 0.001). Grade 2-3 CRN elevation was observed in 18.1% and 24.7% of the female patients in groups 1 and 2, respectively (P = 0.33), and 9.4% and 20.9% of the male patients in groups 1 and 2, respectively (P < 0.001). Renal toxicity was slightly more severe in patients treated with the generic cisplatin formulation than in those treated with the innovator formulation, especially among the male patients.
Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan. isekine@ncc.go.jp
Ikuo
I
Sekine
Kaoru
K
Kubota
Yosuke
Y
Tamura
Hajime
H
Asahina
Kazuhiko
K
Yamada
Hidehito
H
Horinouchi
Hiroshi
H
Nokihara
Noboru
N
Yamamoto
Tomohide
T
Tamura
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002945:Cisplatin / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood; D016568:Drugs, Generic / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007668:Kidney / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D012727:Sex Characteristics
D000970:Antineoplastic Agents; D016568:Drugs, Generic; D003404:Creatinine; D002945:Cisplatin