Neuroprotective effect of neurotropin on chronic oxaliplatin-induced neurotoxicity in stage II and stage III colorectal cancer patients: results from a prospective, randomised, single-centre, pilot clinical trial.
BACKGROUND
Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic neurotoxicity has been identified.


METHODS
We conducted a prospective pilot clinical trial to explore whether neurotropin has neuroprotective effects on chronic neurotoxicity. From May 1, 2010 to May 1, 2011, 80 stage II and III colorectal cancer patients who were eligible to receive oxaliplatin-based chemotherapy voluntarily enrolled in the trial. The patients were randomly divided into two groups, one of which received neurotropin treatment.


RESULTS
The patients in the control group experienced significantly ≥ grade 2 and ≥ grade 3 neurotoxicity (by NCI CTCAE grading) than those in the neurotropin group (60.9 vs. 21.1 %, for at least grade 2 neurotoxicity, P = 0.001; 39 vs. 2.7 %, for at least grade 3 neurotoxicity, P < 0.001). If neurotoxicity was assessed by oxaliplatin-specific neurotoxicity grading, the patients in the control group also experienced significantly more ≥ grade 2 neurotoxicity (51.2 vs. 12.5 %, P = 0.001). Neurotropin was the only factor that affected the incidence of ≥ grade 2 neurotoxicity in the multivariate Cox proportional hazards regression analysis.


CONCLUSIONS
Neurotropin combined with oxaliplatin decreases chronic neurotoxicity effectively and safely.
Department of Colorectal Surgery, Sun Yat-sen University Cancer Centre, Guangzhou, Guangdong, 510060, People's Republic of China. zhangrx@sysucc.org.cn
R X
RX
Zhang
Z H
ZH
Lu
D S
DS
Wan
X J
XJ
Wu
P R
PR
Ding
L H
LH
Kong
Z Z
ZZ
Pan
G
G
Chen
D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D020258:Neurotoxicity Syndromes / Q000209:etiology* / Q000473:pathology; D009944:Organoplatinum Compounds / Q000009:adverse effects*; D000077150:Oxaliplatin; D010865:Pilot Projects; D011134:Polysaccharides / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012307:Risk Factors
D018696:Neuroprotective Agents; D009944:Organoplatinum Compounds; D011134:Polysaccharides; D000077150:Oxaliplatin; C010491:neurotropin