The Short-term Efficacy And Safety Study Of SOX Neoadjuvant Chemotherapy Used For Locally Advanced Rectal Cancer

PurposeThis study focused on evaluating the short-term efficacy and safety differences between S-1 combined with oxaliplatin and the first-line chemotherapy regimen of FOLFOX6 in locally advanced rectal cancer, to investigate whether or not S-1 combined with oxaliplatin can used as first-line chemotherapy regimen in locally advanced rectal cancer Methods59 patients with locally advanced rectal cancer?T₃ or T₄,any N, M0? were selected from department of colorectal surgery of the First Affiliated Hospital of Zhengzhou University in November 2013 to March 2015. The patients received neoadjuvant chemothrapy wered randomly divided into two groups, the I group?30 cases? used SOX chemotherapy regimen(OXA[130mg/m²] d₁ ivgtt,S-1[80 mg/?m².d?] d₁^d₁₄ p.o.,d₁₄^d₂₁), the group II?29 cases? as a control group used FOLFOX6 chemotherapy regimen?OXA[85mg/m²] d₁ ivgtt,CF[200mg/m²] d₁^d₂ ivgtt,5-Fu[400mg/m²] d₁ iv,5-Fu[2400mg/m²] ivgtt 46h?. Evaluated the difference of the adverse reactions, the effect of chemotherapy, the R₀ resection rate and the postoperative complications between the two groups, according to the clinical evaluation to determine whether the surgery treatment or not after four chemotherapy cycles. ResultsThere was no death in this study.?1?In the adverse reactions, according to the CTCAEv4.0 divided into 1⁴ which is the internationally standard term adverse effects of chemotherapy made by US National Cancer Institute. 27 cases in SOX group were mild adverse reactions?grade 1 and 2?, 3 case were serious adverse reactions?grade 3 and 4?. 20 cases in FOLFOX6 group were mild adverse reactions?grade 1 and 2?, 9 case were serious adverse reactions?grade 3 and 4?. SOX group was remarkably better than the FOLFOX6 group, the difference was statistically significant?P <0.05?.?2?In the 30 patients of SOX group, there were 3 patients with CR, 13 patients with PR, the RR was53.3%; in the 29 patients of FOLFOX6 group, there were 2 patients with CR, 12 patients with PR, the RR was 48.3%; the difference was no statistically significant?P > 0.05?, the response rate of chemotherapy in the two groups was similar.?3?There were 26 patients reached R₀ resection in SOX group, and 2 patients who had tumorigenesis advances were not resectable, the R₀ resection rate was 92.8%.In FOLFOX6 group, there were 27 patients reached R₀ resection, and 1 patients was unresectable, the R₀ resection rate was 96.4%; the difference in R₀ resection rate was no statistically significant between the two group?P> 0.05?.?4?There were 3?10%? patients in SOX group and 2?7%? patients in FOLFOX6 group achieving pCR in postoperative pathology, there were 13?46.4%? patients with T-downstaging and 14?50.0%? patients with N-downstaging in SOX group, and 14?50.0%? patients with T-downstaging and 14?50.0%? patients with N-downstaging in FOLFOX6 group,the difference was no statistically significant between?P > 0.05?. the two groups had similar efficacy in postoperative pathology.?5? Postoperative complications was assessmented according to Clavien grades. In the SOX group, there were 18 patients assessmented to Clavien 1?64.3%? and 10 patients were assessmented to Clavien 2⁴?35.7%? in SOX group. There were 21 patients assessmented to Clavien 1?75.0%? and 7 patients assessmented to Clavien 2⁴?25.0%? in the FOLFOX6 group. The difference was no statistically significant?P > 0.05?, compared with FOLFOX6, SOX program didn,t increase the risk of resection in adjuvant chemotherapy. Conclusions1.Compared with FOLFOX6, SOX chemotherapy regiment had similar efficacy in locally advanced colorectal cancer neoadjuvant chemotherapy.2.The SOX chemotherapy had lower toxicity than FOLFOX6 in neoadjuvant chemotherapy used for locally advanced colon cancer, administration was simple and the length of stay in the hostipal was short at the same time, so it was more acceptable.3.The R₀ resection rate, postoperative complications and postoperative pathology in SOX group were similar with FOLFOX6 group in neoadjuvant chemotherapy used for locally advanced colon cancer, and it did not increase the risk of surgery. So SOX project would be the first line of neoadjuvant chemotherapy for locally advanced rectal cancer. But continue follow-up study?PFS and overall survival rate, etc.? was needed, while the multi-center randomized clinical trial verification was necessary.