title: Comparison of hematological toxicities between innovator and generic cisplatin formulations in cervical cancer patients treated with concurrent chemoradiotherapy.
abstract: To compare the incidence and degree of hematological toxicity between innovator and generic cisplatin formulations, decreases in white blood cell (WBC) count (leukopenia) and platelet counts (thrombocytopenia) were retrospectively examined, using the Common Toxicity Criteria for Adverse Events ver. 4.0, in patients with uterine cervical cancer treated with concurrent chemoradiotherapy using innovator (innovator group, n = 22) or generic (generic group, n = 22) cisplatin formulations. There were no significant differences in patient characteristics except in the technique of external irradiation; larger numbers of patients in the innovator and generic groups were irradiated using the parallel-opposed two-field technique and the four-field box technique, respectively (P = 0.00012), which is in line with the historical progress of external beam radiation therapy. The numbers of patients showing Grade 1, 2, 3 and 4 leukopenia were 1 (4.5%), 14 (64%), 7 (32%) and 0 (0.0%) in the innovator group, and 1 (4.5%), 6 (27%), 13 (59%) and 2 (9.0%) in the generic group, respectively. The number of patients showing Grade 3-4 leukopenia was significantly greater in the generic group than in the innovator group (P = 0.034). There was no significant relationship between the incidence of Grade 3-4 leukopenia and the technique of external irradiation. There were no significant differences in the incidence and degree of thrombocytopenia between the two groups. These results indicate the possibility that the generic cisplatin formulation may have a different toxicity profile compared to the innovator formulation in terms of the incidence of leukopenia.
authors.affiliation: Department of Radiation Oncology, Gunma University Graduate School of Medicine, 3-39-22, Showa-machi, Maebashi, Gunma 371-8511, Japan. oiketakahiro@gmail.com
authors.forename: Takahiro
authors.initials: T
authors.lastname: Oike
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Ohno
authors.forename: Shin-ei
authors.initials: SE
authors.lastname: Noda
authors.forename: Hiro
authors.initials: H
authors.lastname: Sato
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Tamaki
authors.forename: Hiroki
authors.initials: H
authors.lastname: Kiyohara
authors.forename: Ken
authors.initials: K
authors.lastname: Ando
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakano
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D059248:Chemoradiotherapy / Q000009:adverse effects* / Q000379:methods; D002945:Cisplatin / Q000627:therapeutic use*; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D006402:Hematologic Diseases / Q000175:diagnosis / Q000209:etiology*; D006801:Humans; D008875:Middle Aged; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology*; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use; D035703:Therapies, Investigational / Q000009:adverse effects* / Q000379:methods; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000150:complications / Q000628:therapy*
chemical_list: D000970:Antineoplastic Agents; D016568:Drugs, Generic; D011838:Radiation-Sensitizing Agents; D002945:Cisplatin