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Updated: Mar 8, 2026
Nerve Excitability Assessment in Chemotherapy-induced Neurotoxicity
Published on: April 26, 2012
Oxaliplatin-related neuropathy in Indian patients - no difference between generic and original molecules
Bhawna Sirohi1, Vikas Ostwal1, Shaheenah Dawood2
1Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
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.
Insights
Neuropathy rates are similar between generic and original oxaliplatin. This study found no significant difference in oxaliplatin-induced neuropathy incidence between the two forms in Indian patients.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Oxaliplatin-induced neuropathy is a significant dose-limiting toxicity impacting patient quality of life.
- Evaluating the safety and efficacy of generic versus original oxaliplatin is crucial for patient care.
Purpose of the Study:
- To compare the incidence of oxaliplatin-induced neuropathy between generic and original formulations.
- To assess the impact of oxaliplatin formulation on treatment toxicity in Indian patients.
Main Methods:
- Prospective enrollment of 163 patients receiving oxaliplatin between August 2012 and July 2013.
- Data collection using a standardized clinical form detailing patient demographics and treatment information.
- Comparison of neuropathy occurrence between patients receiving original (n=80) and generic (n=83) oxaliplatin.
Main Results:
- Overall, 38% of patients developed neuropathy. No significant difference in neuropathy incidence was observed between generic and original oxaliplatin (P=0.50).
- Neuropathy occurred more frequently in female patients (49%) compared to male patients (30%) (P=0.014).
- A trend towards higher neuropathy incidence was noted in older patients (44% >50 years vs. 30% <50 years) (P=0.06).
Conclusions:
- This study is the first to demonstrate comparable neuropathy rates between generic and original oxaliplatin.
- The findings suggest that formulation type does not influence the risk of oxaliplatin-induced neuropathy.
- Neuropathy incidence is influenced by patient sex and age, independent of oxaliplatin formulation.
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