P-0155 - Neuropathy post- oxaliplatin in Indian patients – no difference between generic and research molecule
|Date||28 June 2014|
|Event||World GI 2014|
|Topics|| Complications of Treatment
|Citation||Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165|
A. Singh, C. Nashikkar
Oxaliplatin induced neuropathy is a dose-limiting toxicity that significantly affects patients quality of life. There is limited information of its use in Indian setting for acute and chronic side effects. The aim of the study was to assess the acute toxicity, incidence of neuropathy and compare generic versus the research molecule.
Between August 2012 and July 2013 163 patients receiving oxaliplatin were prospectively enrolled. Information recorded included demographics, brand of oxaliplatin used, dose of drug as well as risk factors for neuropathy and toxicity. Information on pre-existing neuropathy, diabetes, use of alcohol, infusion related hypersensitivity reactions, and type of regimen was also collected.
Median age was 56 years (range, 19-80). 53% (n = 87) of patients were male. 53 pts had colorectal cancer, 43 stomach cancer, 7 patients had pancreatic cancers and 60 patients had biliary tract cancers. Chemotherapy regimens used were 59 Cap-Ox and 20 EOX given at 3 weekly intervals, 11 DOX, 9 mFOLFOX6 and 64 Gem-Ox given fortnightly. Median cumulated dose of oxaliplatin was 780mg/m2 (range 100 to 1300 mg/m2) 80 patients received dacotin (D-research molecule) and 83 patients received oxiplat (O-generic). Overall 38% (n = 63) of patients developed neuropathy of whom 35 were female and 28 were male. 44% of patients above 50 years developed neuropathy compared to 30% <50 years. 46 patients developed neuropathy while on chemotherapy, 13 developed neuropathy post chemotherapy and 4 had worsening pre existing neuropathy. Grade 1 neuropathy was seen in 44 (69%) patients, grade 2 in 14 (22%), and Grade 3 in 5 (7%) patients. 33 (41%) patients on dacotin while 30 (36%) patients on oxiplat developed neuropathy. Hypersensitivity reactions were seen in 5 patients. Neuropathy with different regimes was - CAPOX: 21/ 59 (35%), DOX: 5/11 (45%), EOX: 6/ 20 (30%), FOLFOX: 4/9 (44%), GEMOX: 27/64(42%.
Oxaliplatin neuropathy was seen in 38% patients, comparable to 24% to 49% seen in Western studies. Cumulative dose of Oxaliplatin in this study did not affect the incidence of neuropathy but the severity increased with increase in the dosage. Elderly patients and females have increased risk of neuropathy and diabetic patients did not have increased risk of neuropathy (44%) which has been observed in cross trail analysis. The brand of drug used whether generic or research molecule doesn't affect the incidence of neuropathy.