BACKGROUND:Generic anticancer drugs represent an opportunity in terms of cost savings but there are some concerns about their tolerability. The safety profiles of generic versus branded oxaliplatin formulations have never been studied in detail. PATIENTS AND METHODS:We tested in vitro concentrations, stability and efficacy of branded versus generic oxaliplatin formulations, then we retrospectively collected data about hypersensitivity reactions (HSR) of 427 colorectal cancer patients treated with oxaliplatin-based regimens. RESULTS:No significant difference in oxaliplatin concentration or time-dependent antiproliferative activity between branded and generic oxaliplatin was detected. The incidence of HSR was 12.1% (33/273 patients) in those treated with branded and 9.8% (15/154 patients) in those treated with generic oxaliplatin (p=0.46). The occurrence of grade III-IV HSRs and severe HSRs leading to oxaliplatin discontinuation were comparable. CONCLUSION:No difference between generic and branded formulations of oxaliplatin were demonstrated in preclinical nor in clinical settings. Generic oxaliplatin can be considered a safe alternative to branded formulation.

Bioequivalence of Branded and Generic Oxaliplatin: From Preclinical Assessment to Clinical Incidence of Hypersensitivity Reactions

TAMPELLINI, MARCO;BARATELLI, Chiara;DI SCIPIO, FEDERICA;PIRRO, Elisa;SONETTO, Cristina;DI MAIO, Massimo;BERTA, Giovanni Nicolao;SCAGLIOTTI, Giorgio Vittorio
Last
2016

Abstract

BACKGROUND:Generic anticancer drugs represent an opportunity in terms of cost savings but there are some concerns about their tolerability. The safety profiles of generic versus branded oxaliplatin formulations have never been studied in detail. PATIENTS AND METHODS:We tested in vitro concentrations, stability and efficacy of branded versus generic oxaliplatin formulations, then we retrospectively collected data about hypersensitivity reactions (HSR) of 427 colorectal cancer patients treated with oxaliplatin-based regimens. RESULTS:No significant difference in oxaliplatin concentration or time-dependent antiproliferative activity between branded and generic oxaliplatin was detected. The incidence of HSR was 12.1% (33/273 patients) in those treated with branded and 9.8% (15/154 patients) in those treated with generic oxaliplatin (p=0.46). The occurrence of grade III-IV HSRs and severe HSRs leading to oxaliplatin discontinuation were comparable. CONCLUSION:No difference between generic and branded formulations of oxaliplatin were demonstrated in preclinical nor in clinical settings. Generic oxaliplatin can be considered a safe alternative to branded formulation.
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http://ar.iiarjournals.org/content/36/10/5163.long
Metastatic colorectal cancer; bioequivalence; generic oxaliplatin; hypersenstitivity reactions
Tampellini, Marco; Benedetto, Simone; Rubatto, Elena; Baratelli, Chiara; DI Scipio, Federica; Pirro, Elisa; Brizzi, Maria Pia; Sonetto, Cristina; DI Maio, Massimo; Berta, Giovanni Nicolao; Scagliotti, Giorgio Vittorio
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1610607
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