[Abstract] Objective To investigate the preoperative neoadjuvant chemotherapy affect the survival of low rectal cancer, to evaluate the safety and feasibility. Methods Retrospective analysis of our hospital from January 2002 to December 2006 surgical complete resection of low rectal cancer clinical data of 129 cases divided into neoadjuvant chemotherapy plus surgery group (B) with direct surgery group (A group), Life  table compare the two groups of 1,3,5-year survival rate differences, Kaplan  Meier method were compared cumulative survival rates and the median survival time and analysis of the whole group of patients with tumor stage, histological type and lymph node status is different due to survival difference (α = 0.05); Results 1 -, 3 – and 5-year survival rates of the two groups of low rectal cancer patients were in group A: 90%, 81%, 33%; B group: 93%, 84%, 42 %, the average survival time of postoperative were 39.5 and 46.1 months, the median survival time was 41.4 and 47.2 months, respectively, and the difference was statistically significant (P <0.05). The conclusions in the surgical treatment of low rectal cancer neoadjuvant chemotherapy plus surgery a more direct impact on the survival of surgery advantage neoadjuvant chemotherapy does not increase the difficulty of operation is safe and feasible.

Key words neoadjuvant chemotherapy; low rectal cancer; TME resection; survival rate

 Effect of Neoadjuvant Chemotherapy on Low  set Rectal Cancer Patients Receiving Total Mesorectal Excision-Survival Analysis of 129 Cases

    XIAO Hong, ZHANG Jian  yong, DUAN Yong  liang, PAN Jin  qiang

    Department of General Surgery, Traditional Chinese Medicine Hospital, Xinjiang Medical University, Urumqi 830011, ChinaAbstract: Objective To explore the safety and feasibility of neoadjuvant chemotherapy on low  set rectal cancer patients in stage Ⅲ receiving total mesorectal excision.Methods One hundred and twenty  nine cases of low  set rectal cancer patients in stage Ⅲ treated with total mesorectal excision (TME) from January 2002 to December 2006 in Xinjiang Traditional Chinese medicine Hospital which were reviewed retrospectively. According to the cure method, the patients were divided into group A (65 cases, control group without neoadjuvant chemotherapy) and group B (64 cases, preoperative neoadjuvant chemotherapy group). Life  table law compares the difference of survival rate of 1, 3, 5 years of two groups, Kaplan  Meier law compares the cumulate survival time, mean and medians time between two groups (α = 0.05). Results The 1,3,5 survival rate of post  operation was 90%, 81%, 33% in A group; 93%, 84%, 42 % in B group respectively.The average survival time of the two groups is 39.5 (A group), 46.1 (B group) months respectively; and the median survival time of the two groups was 41.4,47.2 months respectively.There was significant difference between them (P <0.05). Conclusion Neoadjuvant chemotherapy plus surgery has ascendancy compared with Operation directly as influenced on the survival time in resectable low  set rectal cancer patients in stage Ⅲ, Neoadjuvant chemotherapy dose not increase the difficulty of operation in some degree, and it is still safe and feasible in patients with low  set rectal cancer patients in stage Ⅲ.

    Key words: Neoadjuvant chemotherapy; Low  set rectal cancer; Total mesorectal excision; Survival rate

Treatment of rectal cancer in recent years a more consistent view is that the multidisciplinary treatment of resectable low rectal need surgery. Preoperative neoadjuvant chemotherapy is still hotly debated. This retrospective analysis of General Surgery of our hospital from January 2002 to December 2006 surgical complete resection of low rectal cancer clinical data of 129 cases, divided into A (direct surgical), B (neoadjuvant chemotherapy plus surgery) were comparing two changes in the survival of patients, to explore the various factors, the analysis of the survival rate of change reasons and to explore the significance of neoadjuvant chemotherapy.

    1 Data and methods

    1.1 General Information

    Clinical data of 129 cases were confirmed by preoperative clinical examination of the system, including preoperative history taking, physical examination, chest radiograph, the low barium enema, pots, abdominal CT and B ultrasound, colonoscopy, bone scintigraphy, tumor-associated antigens 80分,能耐受手术。">determine tumor confined to distant metastases, no other serious organic disease, KPS> 80, can tolerate surgery. All patients were confirmed by pathology or cytology preoperative definitive diagnosis of rectal adenocarcinoma, according to the 1997 revised by the International Union Against Cancer (UICC) TNM classification, the two groups of patients with resected after histopathological diagnosis of III rectal adenocarcinoma . 0.05),见表1。">General clinical data of the two groups of patients and preoperative complications was similar, the difference was not statistically significant (P> 0.05), see Table 1. Table 1 A, B two sets of low rectal cancer patients with general clinical data comparison

    1.2 Inclusion and exclusion criteria

    Inclusion criteria: complete resection of low rectal cancer patients. Implemented preoperative 5  fluorouracil + leucovorin (5  Fu + CF) program two cycles by. Exclusion criteria: postoperative diagnosis of low rectal Ⅰ, Ⅱ and Ⅳ; malignancies past history; Multiple primary malignant tumors in patients; generally poor, heart, liver, lung, kidney function is poor, and can not be tolerated surgery.

    1.3 Treatment

    64 cases into the test group neoadjuvant chemotherapy, 65 cases of direct surgery. Test group selected cases were confirmed by preoperative adjuvant chemotherapy for two cycles, the program: calcium folinate (the calcium folinate CF) 200mg/m2 IV bolus, day 1, 2; 5  Fu 400mg/m2 bolus, and then 5  Fu 600mg/m2, continuous chemotherapy pump drops to maintain more than 22h, 1 and 2 days. The above scenario is repeated once every two weeks, 28 days for one cycle of chemotherapy, completed 2 cycles the Clinical Evaluation underwent surgery, during chemotherapy patients, such as bone marrow suppression, gastrointestinal adverse reactions given symptomatic treatment, all patients with chemotherapy end After 2 to 3 weeks of rest, determining surgical contraindications underwent surgery. Additional radiotherapy, postoperative radiotherapy adopt a common external irradiation dose (45 to 50) Gy / (5 to 6) weeks after 4 weeks of follow-up treatment, according to the pathological diagnosis and radical surgery.

    1.4 Follow-up

    From the date of surgery, to October 2006, after a total follow-up of 120 cases, nine cases lost to follow-up rate was 93.02% (120/129), the median follow-up time of 40.2 months. Lost to the last calculation followed up. Completely lost to the cases and non-cancer deaths as censored data in the statistical analysis requirements.

    1.5 statistical methods

    General clinical data were compared with the χ2 test in SPSS12.0 statistical software, complication rates, procedure-related mortality differences (α = 0.05); Life table analysis postoperative 1 to 5-year survival rate differences (α = single factor of 0.05); Kaplan  Meier method were compared cumulative survival rate and median survival time (α = 0.05); survival period from the day of surgery to death or lost to date.

    2 Results

    Of 2.1 surgical treatment and postoperative complications, perioperative death

    Two groups of patients underwent total mesorectal excision (TME), all surgery completed by the same group of physicians. The total removal of pelvic lymph node 2322, remove the lymph nodes of 18 per case. Neoadjuvant chemotherapy group with direct surgery group, the average blood loss were (245.74 ± 47.32) ml and (313.35 ± 50.76) ml, operative time (171.52 ± 13.98) min and (185.36 ± 15.24) min, showed no statistical 0.05)。">significance (P> 0.05). Postoperative complications: arrhythmia in each two cases, anastomotic leakage, anastomotic stricture, acute respiratory failure, abdominal wound dehiscence, aspiration pneumonia in each group, Total Group A complications accounted for 12.31% 0.05)。">(8/65), B group accounted for 10.93% (7/64), the difference was not statistically significant (P> 0.05). 0.05)。">Perioperative death in group A, 1.5% (1/65), B group, 1.5% (1/64), the situation is similar to the difference was not statistically significant (P> 0.05).

    Postoperative survival of 220 patients

    The 1 -, 3 – and 5-year survival rates of the two groups of low rectal cancer patients were in group A: 90%, 81%, 33%; B group: 93%, 84%, 42%, and the difference was statistically significant (P < 0.05), Table 2. Kaplan  Meier method Univariate analysis showed that the A, B postoperative average survival time were 39.5,46.1 months, the median survival time of 41.4,47.2 month postoperative survival of the difference was statistically significant (P <0.05 ), Table 3, Figure 1. Table 2 A, B postoperative 1 -, 3 -, and 5-year survival rates compare (Life table) Table 3 A, B In both groups, the average survival time, median survival time (Log  rank)

    3 Discussion

    View, TME surgical treatment is the standard treatment of low rectal cancer [1], but due to the limitations of the pelvic anatomy, surgery, cancer organizations cleared more difficult, despite the complete removal of the tumor, but the surgical results are still not satisfied, there are still 15 % to 50% of patients with pelvic recurrence after conventional surgery [2]. After 5-year survival rate hovering around 50% [3]. How to improve low rectal cancer cure rate and reduce the rate of local recurrence after the surgeon facing problems. Europe and the United States to implement the new adjuvant therapy (preoperative combined radiotherapy and chemotherapy) treatment of rectal cancer can reduce tumor burden varying degrees reduce tissue reactivity edema, to shrink the tumor, clinical stage reduced [4  5], has gradually caused domestic the attention of clinicians. Preoperative neoadjuvant chemotherapy for colorectal clinical research has become a hot topic.

    Edition NCCN2005 colorectal cancer, especially rectal cancer preoperative adjuvant therapy limited in T3 and any T, N1 of the patients [6]. Order to explore new treatments, chemotherapy and radiotherapy on low rectal resection, adjuvant therapy to neoadjuvant therapy in order to improve the therapeutic effect of low rectal cancer. For some relatively late rectal cancer, especially through the anus DRE fixed rectal cancer, preoperative neoadjuvant therapy has become more important.

    Mehta et al [7] of 322 cases of T3 rectal cancer patients in the preoperative radiotherapy and 5  Fu + CPT  11 combination chemotherapy, 23 cases (71%) patients with tumor stage decline, no increase in surgical hospitalization time. Germany an Ⅲ clinical trials (CAO / ARO / AIO  94) [8] is divided into preoperative neoadjuvant chemotherapy and postoperative chemoradiotherapy two groups, the chemotherapy drug 5-Fu, radiotherapy total dose of 50.4 Gy single dose 1.8Gy, put interval of six weeks of chemotherapy and surgery, surgical total mesorectal excision as the standard. Early efficacy of the two groups in radiotherapy and chemotherapy complications, blood loss, anastomosis fistula, wound healing was no significant difference in The results of this study show that: the average amount of bleeding and surgery time, there was no statistically significant difference in the two groups of patients, the incidence of postoperative complications of neoadjuvant therapy with a single surgical group compared with no significant increase. 0.05)。">The two groups of various complications incidence compared were not statistically significant (P> 0.05). Prompted neoadjuvant therapy for low rectal incidence of postoperative complications and mortality without a significant impact. Description preoperative neoadjuvant therapy is a safe, well tolerated treatment.

    Different reports of low rectal cancer neoadjuvant therapy can improve long-term survival. Some low rectal cancer neoadjuvant treatment group reported a single surgical group compared not significantly improve long-term survival, even surgical resection of low rectal cancer patients should not be given neoadjuvant treatment [9]. Contrary reported in the literature that preoperative neoadjuvant therapy beneficial [10]. Uzcudun et al [11] conducted a II clinical study of 38 patients with T3 ~ T4, N0 ~~ rectal cancer patients in the preoperative radiation therapy and oral chemotherapy (Alternate fluoridation + uracil + CF), surgical histology confirmed phased reduction of 23 patients (60%) achieved a complete remission of four cases (10.5%), partial remission in 20 cases (52.6%). Preservation of the anal sphincter cases, preoperative estimated 39% rising to 60% after neoadjuvant therapy. The 3-year disease-free survival and overall survival rates were 83% and 90% local control rate of 92%. Allen PJ, et al [12] in 1995 to 2000, continuous observation of 106 cases of colorectal cancer cases, the average follow-up time of 30 months. Found that whether the 5-year survival rate in neoadjuvant chemotherapy is no difference between (43% and 35%, respectively), but the line neoadjuvant chemotherapy effective cases did not undergo neoadjuvant chemotherapy cases compare survival rates have improved significantly (85% and 35% ). The author believes that neoadjuvant chemotherapy is prognostic indicator of the survival of the guidance on treatment options. The results of this study show that: 1 -, 3 -, and 5-year survival rate after neoadjuvant chemotherapy plus surgery group patients with low rectal; than direct surgery group, the difference was statistically significant (P <0.05), postoperative average survival time in The median survival of significant differences.

    In summary, we study the number of cases is small, but with over contrast neoadjuvant chemotherapy treatment of rectal cancer has a positive meaning, does not increase the risk of surgery to prolong survival in patients with the Integrated therapy and prognosis of low rectal important.