Oxaliplatin-related neuropathy in Indian patients-no difference between generic and original molecules

Bhawna Sirohi, Vikas Ostwal, Shaheenah Dawood, Gilberto Lopes, Sanjay Talole, Chaitali Nashikkar, Shailesh Shrikhande

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Oxaliplatin-induced neuropathy is a dose-limiting toxicity that significantly affects patients' quality of life. The aim of this study was to compare its occurrence between a generic versus the original molecule in Indian patients. Materials and Methods: Between August 2012 and July 2013, 163 patients receiving oxaliplatin were prospectively enrolled. A data recording form was used in the clinic to record detailed information. Results: The median age of patients was 55 years (range, 19-79). Chemotherapy regimens used included: capecitabine, oxaliplatin (59), epirubicin, oxaliplatin, and capecitabine (20), docetaxel, oxaliplatin, and capecitabine (11), 5-FU, leucovorin, oxaliplatin (9), and gemcitabine-oxaliplatin (64). The median cumulative dose of oxaliplatin was 780 mg/m2. Eighty patients received the original version and 83 the generic one. Overall, 63 patients (38%) developed neuropathy. There was no significant difference in the incidence of neuropathy between the two forms of oxaliplatin used (P = 0.50). Forty-nine percent of female patients had neuropathy as compared to 30% of male patients (P = 0.014). Older patients had a trend toward a higher incidence of neuropathy: 44% of patients above age fifty developed neuropathy compared to 30% of patients younger than 50 (P = 0.06). Conclusion: This is the first study to specifically show that neuropathy rates do not vary with the use of generic versus original oxaliplatin.

Original languageEnglish (US)
Pages (from-to)271-277
Number of pages7
JournalIndian Journal of Medical and Paediatric Oncology
Volume37
Issue number4
DOIs
StatePublished - Oct 1 2016

Keywords

  • Generic
  • neuropathy
  • original molecule
  • oxaliplatin

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Oncology

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