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Pharmacological bioquivalence of branded and generic oxaliplatin: from preclinical assessment to clinical incidence of hypersensitivity reactions in patients with colorectal cancer

Date

08 Oct 2016

Session

Poster Display

Presenters

Cristina Sonetto

Citation

Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370

Authors

C. Sonetto, C. Baratelli, M.P. Brizzi, M. Di Maio, G. Scagliotti, M. Tampellini

Author affiliations

  • Divison Of Medical Oncology, Azienda Ospedaliero-Universitaria ASOU San Luigi Gonzaga, 10043 - Orbassano/IT
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Resources

Abstract 1755

Background

Generic drugs represent a relevant, potential opportunity in terms of cost savings. However, several physicians are uncomfortable with the replacement of the branded drugs with generic equivalents, indicating among several reasons their hypothetical lower tolerability.

Methods

In the preclinical phase we in vitro tested the concentrations, stability and efficacy in CACO-2 cell line of branded versus two generic oxaliplatin formulations. In a second step we retrospectively collected safety and toxicity data from 427 colorectal cancer patients submitted to an oxaliplatin-based regimen between January 1994 and June 2014 at our institution. Patients were stratified according whether they received branded (BRAND group) or generic oxaliplatin (GENERIC group). Primary aim of this second step was the assessment of the hypersensitivity reaction (HSR) incidence. Secondary aims were the evaluation of hematological and non-hematological toxicities and, in metastatic patients, clinical outcomes.

Results

Preclinical tests did not demonstrated differences in concentration and stability in different storing conditions between branded and generic formulations. Furthermore, dose- and time-dependent anti-proliferative activities were similar.The incidence of HSRs was 12.1% in BRAND (33/273 patients) and 9.8% (15/154) in GENERIC group (p = 0.46). Occurrence of grade III-IV HSRs and severe HSRs leading to oxaliplatin discontinuation were comparable. In metastatic patients no significant difference in response rate was reported. A longer PFS was recorded in the BRAND group (14.4 vs 12.4 months, log rank p 

Conclusions

Tested generic and branded oxaliplatin formulations had equivalent concentrations of the active drug, and presented similar stability and in vitro efficacy. Likewise, the incidence of oxaliplatin-induced HSRs as well as toxicity profiles and clinical outcomes were similar. According to our data, generic oxaliplatin can be considered a safe and active alternative to the branded formulation.

Clinical trial identification

Legal entity responsible for the study

AOU San Luigi Gonzaga

Funding

AOU San Luigi Gonzaga

Disclosure

All authors have declared no conflicts of interest.

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