title: Oxaliplatin-related neuropathy in Indian patients - no difference between generic and original molecules.
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.
  
  
  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).
  
  
  CONCLUSIONS
  This is the first study to specifically show that neuropathy rates do not vary with the use of generic versus original oxaliplatin.
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Bhawna
authors.initials: B
authors.lastname: Sirohi
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Vikas
authors.initials: V
authors.lastname: Ostwal
authors.affiliation: Department of Medical Oncology, Dubai Hospital, Dubai, United Arab Emirates.
authors.forename: Shaheenah
authors.initials: S
authors.lastname: Dawood
authors.affiliation: Sylvester Comprehensive Cancer Center at the University of Miami, FL, United States, and Oncoclínicas Group, Brazil.
authors.forename: Gilberto
authors.initials: G
authors.lastname: Lopes
authors.affiliation: Department of Biostatistics, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Talole
authors.affiliation: Department of GI and HPB Surgery, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Chaitali
authors.initials: C
authors.lastname: Nashikkar
authors.affiliation: Department of GI and HPB Surgery, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Shailesh
authors.initials: S
authors.lastname: Shrikhande
keywords: Generic; neuropathy; original molecule; oxaliplatin