L-carnosine for prevention of oxaliplatin-induced neuropathy in colorectal cancer patients (pts)

Date

09 Oct 2016

Session

Poster display

Presenters

Amr Saad

Citation

Annals of Oncology (2016) 27 (6): 497-521. 10.1093/annonc/mdw390

Authors

A.S.T. Saad1, R.M. Yehia2, S.S. Mostafa3, H.S. Elabhar3, M.F. Schaalan2

Author affiliations

  • 1 Clinical Oncology Department, Ain Shams university Faculty of medicine, 11361 - Cairo/EG
  • 2 Clinical Pharmacy Department, misr international university, faculty of pharmacy, 44673 - Cairo/EG
  • 3 Clinical Pharmacology Department, cairo university, faculty of pharmacy, 17854 - Giza/EG
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Background

The study aims at investigating the use of anti-oxidant L-carnosine for prevention of acute oxaliplatin neurotoxicity in colorectal cancer pts and to observe L-carnosine effect on Tumor necrosis factor alpha (TNF α) as a neuro-inflammatory cytokine.

Methods

This is a pilot study that recruited 60 pts using prospective randomized controlled design. Eligible Pts (non-diabetic) were randomly assigned to two arms. Arm A (30 pts) received FOLFOX-6 regimen (oxaliplatin, 5FU & leucovorin) and Arm B (30 pts) received FOLFOX-6 regimen and oral L-carnosine 1000 mg daily all along the treatment. All recruited pts were followed for three months, then both arms were analyzed for neuropathy incidence/grade and any additional toxicities according to NCI-CTC version 4. Pre-treatment and after 3 months TNF α serum levels were collected and tested.

Results

No neuropathy were detected in 35.3% of pts in Arm B compared to only 3.3% in Arm A. Also 50 % of pts in Arm B developed grade I neuropathy compared to 36.7% in Arm A and only 2.9% of Arm B pts developed grade II neuropathy compared to 60 % of arm A pts. Regarding TNF α serum levels, Arm B and Arm A at base line had comparable mean serum levels (0.04ng/ml & 0.03ng/ml) however the percentage reduction of Arm B serum level was higher than Arm A (0.02ng/ml & 0.001ng/ml, respectively p value = 0.0001). No toxicities were observed due to L-carnosine addition.

Arm A and Arm B regarding the neuropathy grade and TNF before/after 3 months of treatment

Arm A (Control group) N = 30 Arm B (Test group) N = 30 P-value
Neuropathy grade 0 1 2 Drop out 1 (3.3%) 11 (36.7%) 18 (60.0%) 0 (0.0%) 12 (35.3%) 17 (50.0%) 1 (2.9%) 4 (11.8%) 0.0002
TNF before start of treatment (ng/ml) Mean ± SD Range 0.03 ± 0.01 0.021 – 0.06 0.04 ± 0.01 0.02 – 0.06 0.664
TNF after 3 months of treatment (ng/ml) Mean ± SD Range 0.03 ± 0.01 0.016 – 0.044 0.02 ± 0.01 0.01 – 0.04 0.0001

Conclusions

L-carnosine reduced the incidence of acute oxaliplatin induced neuropathy, delayed the onset of chronic neuropathy and decreased TNF α serum levels without additional toxicities. Further studies are warranted to examine the full potential of L-carnosine in chemotherapy induced neuropathy.

Clinical trial identification

Local registry: CairoUniv 387658

Legal entity responsible for the study

Faculty of Medicine, Ain Shams University

Funding

Faculty of Medicine, Ain shams university Misr international university

Disclosure

All authors have declared no conflicts of interest.

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