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CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2016; 37(04): 271-277
DOI: 10.4103/0971-5851.195745
ORIGINAL ARTICLE

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

Bhawna Sirohi
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Vikas Ostwal
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Shaheenah Dawood
Department of Medical Oncology, Dubai Hospital, Dubai, United Arab Emirates
,
Gilberto Lopes
Sylvester Comprehensive Cancer Center at the University of Miami, FL, United States, and Oncoclínicas Group, Brazil
,
Sanjay Talole
Department of Biostatistics, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Chaitali Nashikkar
Department of GI and HPB Surgery, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Shailesh Shrikhande
Department of GI and HPB Surgery, Tata Memorial Centre, Mumbai, Maharashtra, India
› Author Affiliations Financial support and sponsorship Nil.
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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.

Keywords

Generic - neuropathy - original molecule - oxaliplatin


Publication History

Article published online:
12 July 2021

© 2016. Indian Society of Medical and Paediatric Oncology. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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  • References

  • 1 Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hiskish T, et al.. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 2004;350:2343-51.
  • 2 Conroy T, Desseigne F, Ychou M, Bouche O, Guimband R, Becouarn Y, et al.. Randomized phase III trial comparing FOLFIRINOX (F: 5FU/leucovorin [LV], irinotecan [I], and oxaliplatin [O]) versus gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma. N Engl J Med 2011;364:1817-25.
  • 3 André T, Tournigand C, Rosmorduc O, Provent S, Maindrault-Goebel F, Avenin D, et al. Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: A GERCOR study. Ann Oncol 2004;15:1339-43.
  • 4 Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, et al. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): A phase 3 open-label, randomised controlled trial. Lancet 2012;379:315-21.
  • 5 Tournigand C, André T, Bonnetain F, Chibaudel B, Lledo G, Hickish T, et al. Adjuvant therapy with fluorouracil and oxaliplatin in stage II and elderly patients (between ages 70 and 75 years) with colon cancer: Subgroup analyses of the Multicenter International Study of Oxaliplatin, Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer trial. J Clin Oncol 2012;30:3353-60.
  • 6 Gammon D, Bhargava P, McCormick MJ. Hypersensitivity reactions to oxaliplatin and the application of a desensitization protocol. Oncologist 2004;9:546-9.
  • 7 Pasetto LM, D'Andrea MR, Rossi E, Monfardini S. Oxaliplatin-related neurotoxicity: How and why? Crit Rev Oncol Hematol 2006;59:159-68.
  • 8 Gomber S, Dewan P, Chhonker D. Vincristine induced neurotoxicity in cancer patients. Indian J Pediatr 2010;77:97-100.
  • 9 Hertz DL, Roy S, Motsinger-Reif AA, Drobish A, Clark LS, McLeod HL, et al. CYP2C8*3 increases risk of neuropathy in breast cancer patients treated with paclitaxel. Ann Oncol 2013;24:1472-8.
  • 10 Lopes Gde L. Cost comparison and economic implications of commonly used originator and generic chemotherapy drugs in India. Ann Oncol 2013;24 Suppl 5:v13-6.
  • 11 Rasul KI, Kamal SA, Al-Najjar NM. Is there a diference between brand and generic oxaliplatin? Cancer Clin Oncol 2012;1:45-8.
  • 12 Gogineni K, Shuman KL, Emanuel EJ. Survey of oncologists about shortages of cancer drugs. N Engl J Med 2013;369:2463-4.
  • 13 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: National Cancer Institute, NIH Publication No. 09-5410, Revised June, 2010.
  • 14 Grothey A. Oxaliplatin-safety profile: Neurotoxicity. Semin Oncol 2003;30 4 Suppl 15:5-13.
  • 15 Grothey A, Goldberg RM. A review of oxaliplatin and its clinical use in colorectal cancer. Expert Opin Pharmacother 2004;5:2159-70.
  • 16 Alejandro LM, Behrendt CE, Chen K, Openshaw H, Shibata S. Predicting acute and persistent neuropathy associated with oxaliplatin. Am J Clin Oncol 2013;36:331-7.
  • 17 Goldberg RM, Tabah-Fisch I, Bleiberg H, de Gramont A, Tournigand C, Andre T, et al. Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer. J Clin Oncol 2006;24:4085-91.
  • 18 Uwah AN, Ackler J, Leighton JC Jr., Pomerantz S, Tester W. The effect of diabetes on oxaliplatin-induced peripheral neuropathy. Clin Colorectal Cancer 2012;11:275-9.