title: [Evaluation of the Safety of a Generic Formulation of Cisplatin in Patients with Thoracic Malignancies].
abstract: Cisplatin (CDDP) is a key drug in the systemic treatment of various solid tumors. Brand-name CDDP may differ across generic formulations considering various clinical parameters. Therefore, in this study, we aimed to assess the safety of a generic CDDP formulation. To compare brand-name CDDP with a generic formulation, the incidence of adverse events, especially renal toxicity, was investigated in 500 patients with thoracic malignancies who received chemotherapy with more than 60 mg/m2 of either brand-name or generic CDDP. We compared the maximum serum creatinine (Cr) level after chemotherapy in the 2 groups. The correlation coefficients between the pretreatment Cr and the maximum Cr after CDDP administration did not differ between brand-name CDDP and generic CDDP (0.610 and 0.644, respectively; p=0.528). Furthermore, the correlation coefficients did not differ in subgroup analysis according to sex or adjuvant therapy. The severity of adverse events was similar in the 2 groups. In conclusion, generic CDDP can safely be used as an alternative to brand-name CDDP in the clinical setting.
authors.affiliation: Dept. of Pharmacy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Ueda
authors.forename: Yoko
authors.initials: Y
authors.lastname: Kondo
authors.forename: Hidekazu
authors.initials: H
authors.lastname: Suzuki
authors.forename: Norio
authors.initials: N
authors.lastname: Okamoto
authors.forename: Naoko
authors.initials: N
authors.lastname: Morishita
authors.forename: Motohiro
authors.initials: M
authors.lastname: Tamiya
authors.forename: Takayuki
authors.initials: T
authors.lastname: Shiroyama
authors.forename: Akinori
authors.initials: A
authors.lastname: Kumode
authors.forename: Naoko
authors.initials: N
authors.lastname: Usui
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nakano
authors.forename: Masumi
authors.initials: M
authors.lastname: Sando
authors.forename: Emiko
authors.initials: E
authors.lastname: Tanaka
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hirashima
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects* / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D016568:Drugs, Generic / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013899:Thoracic Neoplasms / Q000188:drug therapy* / Q000628:therapy; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D016568:Drugs, Generic; D002945:Cisplatin