556P - Neuroprotective effect of neurotropin on chronic oxaliplatin-induced neurotoxicity in stage I and stage II colorectal cancer patients: results from...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Complications of Treatment
Colon Cancer
Rectal Cancer
Presenter Rong-Xin Zhang
Authors R. Zhang1, G. Chen2, Z. Lu1, X. Wu1, D. Wan1, Z. Pan1
  • 1Colorectal Department, Sun Yat-Sen University Cancer Center, 510060 - Guangzhou/CN
  • 2Department Of Colorectal Surgery, Sun Yat-Sen University Cancer Center, 510060 - Guangzhou/CN

Abstract

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.

Materials and methods

We conducted a prospective pilot clinical trial to explore whether neurotropin has neuroprotective effects on chronic neurotoxicity. From May 1 2010 to July 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 2 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 did those in the neurotropin group (60.9% vs. 38%, 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

Treatment related AES

Toxicity Neurotropin group Control group P value
Peripheral neuropathy (NCI CTCAE version 4.0 )
≥ grade 1 38 (100%) 41 (100%)
≥ grade 2 8 (21.1%) 25 (60.9%) 0.001a
≥ grade 3 1 (2.7%) 16 (39%) <0.001c
Neurotoxicity (Oxaliplatin-Specific Neurotoxicity grading)
≥ grade 1 38 (100%) 41 (100%) —-
≥ grade 2 5 (12.5%) 21 (51.2%) 0.001b
≥ grade 3 0 (0%) 4 (9.8%) 0.117c
Hand-foot syndrome
≥grade 1 28 (73.7%) 23 (56.1%) 0.103a
≥grade 2 5 (13.2%) 3 (7.3%) 0.627b
≥grade 3 1 (2.6%) 0 (0%) 0.481c
White blood cell count decreased
≥grade 1 17 (44.7%) 15 (36.6%) 0.461a
≥grade 2 2 (5.3%) 4(9.8%) 0.958b
Thrombocytopenia
≥grade 1 3 (7.9%) 8 (19.5%) 0.244b
Diarrhea
≥grade 1 7 (18.4%) 9 (22%) 0.696a
Neutrophil count decreased
≥grade 1 14 (36.8%) 16 (39%) 0.842a
≥grade 2 3 (7.9%) 6 (14.6%) 0.557b
Hepatobiliary disorders
≥grade 1 8 (21.1%) 9 (22%) 0.923a
Renal disorder
≥grade 1 1 (2.6%) 2 (4.9%) 1.0c
Nausea
≥grade 1 25 (65.8%) 21 (51.2%) 0.190a
Vomiting
≥grade 1 6 (15.8%) 8 (19.5%) 0.665b

a&KHgr;2test

b Continuity correction

c Fisher's exact test

experienced significantly more ≥ grade 2 neurotoxicity (51.2% vs. 12.5%, P = 0.001) (Table-1). Neurotropin was the only factor that affected the incidence of ≥ grade 2 neurotoxicity in the Kaplan-Meier log rank and the multivariate Cox proportional hazards regression analysis.

Conclusion

Neurotropin combined with oxaliplatin decreases chronic neurotoxicity effectively and safely.

Disclosure

All authors have declared no conflicts of interest.