title: Bioequivalence of Branded and Generic Oxaliplatin: From Preclinical Assessment to Clinical Incidence of Hypersensitivity Reactions.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors: Division of Medical Oncology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Marco
authors: M
authors: Tampellini
authors: Division of Medical Oncology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Simone
authors: S
authors: Benedetto
authors: Division of Medical Oncology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Elena
authors: E
authors: Rubatto
authors: Division of Medical Oncology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Chiara
authors: C
authors: Baratelli
authors: Division of Pharmacology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Federica
authors: F
authors: DI Scipio
authors: Division of Pharmacology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Elisa
authors: E
authors: Pirro
authors: Division of Medical Oncology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Maria Pia
authors: MP
authors: Brizzi
authors: Division of Medical Oncology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy cristina.sonetto@gmail.com.
authors: Cristina
authors: C
authors: Sonetto
authors: Division of Medical Oncology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Massimo
authors: M
authors: DI Maio
authors: Division of Pharmacology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Giovanni Nicolao
authors: GN
authors: Berta
authors: Division of Medical Oncology, University of Torino, Department of Oncology, S. Luigi Hospital, Turin, Italy.
authors: Giorgio Vittorio
authors: GV
authors: Scagliotti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018938:Caco-2 Cells; D049109:Cell Proliferation / Q000187:drug effects; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D004342:Drug Hypersensitivity / Q000453:epidemiology / Q000209:etiology; D016568:Drugs, Generic / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000077150:Oxaliplatin; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D016568:Drugs, Generic; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin
keywords: Metastatic colorectal cancer; bioequivalence; generic oxaliplatin; hypersenstitivity reactions