Abstract:

AIM: To investigate the clinical efficacy, pathological remission rate and safety of mFOLOFX6 regimen combined with durative transfusion recombinant human endostatin as neoadjuvant treatment for locally advanced rectal cancer.  METHODS: 62 patients who met the inclusion criteria were randomly assigned to mFOLFOX6 group (control group) and mFOLFOX6 combined with endostatin group (experiment group). The control group received oxaliplatin 85 mg/m² and leucovorin 200 mg/m² (i.v. drip) for 2 h on day 1,5-fluorouracil 400 mg/m2 (i.v. push), 5-fluorouracil 2.6 g/m² (continuous i.v. pump) right after leucovorin for 46 h every two weeks. The experiment group received daily endostatin 7.5 mg·m^-2·d^-1 (continuous i.v. pump) for 7 d, repeatedly every two weeks on the basis of mFOLFOX6. All patients received 4 to 6 cycles of treatment before surgery. RESULTS:62 patients received a total of 310 cycles of treatment with ratable clinical efficacy. The total response rate of experimental group was 62.5%, which was significant higher than 36.6% of the control group (P<0.05).The pathological complete remission rate of experimental group was 28.1%, which was significant higher than 6.7% of the control group (P < 0.05). The anus preservation rate of experimental group was 81.3%, which was significant higher than 56.7% of the control group (P<0.05).Two groups presented with minor toxic reactions (major grade I and II) and low-rate complications, no significant difference perceived (P>0.05). CONCLUSION: Endostatin combined with mFOLOFX6 regimen as neoadjuvant treatment for locally advanced rectal cancer can improve the response rate, pathologic complete response rate and anal preservation rate while maintain minor adverse reactions and complications, which is referential for clinical application.

Key words: endostatin, rectal cancer, neoadjuvant therapy, pathologic complete response rate, efficacy, toxicity