Comparison of hematological toxicities between innovator and generic cisplatin formulations in cervical cancer patients treated with concurrent chemoradiotherapy

• Published in: Journal of radiation research Vol. 54; no. 3; pp. 474 - 478
• Main Authors: Oike, Takahiro, Ohno, Tatsuya, Noda, Shin-ei, Sato, Hiro, Tamaki, Tomoaki, Kiyohara, Hiroki, Ando, Ken, Nakano, Takashi
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.05.2013
• Subjects: Adult; Aged; Antineoplastic agents; Antineoplastic Agents - therapeutic use; Cancer; Cancer patients; Cancer treatment; Care and treatment; Cervical cancer; Chemoradiotherapy - adverse effects; Chemoradiotherapy - methods; Cisplatin - therapeutic use; Comparative analysis; Counting; Drugs, Generic - therapeutic use; Female; Formulations; Hematologic Diseases - diagnosis; Hematologic Diseases - etiology; Humans; Incidence; Irradiation; Leukopenia; Middle Aged; Oncology; Patients; Radiation Injuries - diagnosis; Radiation Injuries - etiology; Radiation-Sensitizing Agents - therapeutic use; Radiotherapy; Therapies, Investigational - adverse effects; Therapies, Investigational - methods; Toxicity; Treatment Outcome; Uterine Cervical Neoplasms - complications; Uterine Cervical Neoplasms - therapy; White blood cell count; generic drug; chemoradiotherapy; leukopenia; cisplatin; uterine cervical cancer
• ISSN: 0449-3060; 1349-9157
• DOI: 10.1093/jrr/rrs121

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.