| Objective:To evaluate the efficacy of cellular immunotherapy(CIT)in the adjuvant treatment of early breast cancer patients who have completed surgery,to explore the general clinical characteristics of the people who benefit from CIT,and to provide clinical reference and evidence-based medicine evidence for the application of CIT in early breast cancer.Methods:From January 2010 to December 2014,the clinicopathological characteristics,treatment plan and other data of early breast cancer patients who went to the cancer center of the first hospital of Jilin University and completed breast cancer surgery were analyzed retrospectively.The local recurrence,distant metastasis and survival of the patients were obtained through follow-up.According to the entry criteria,723 patients were finally selected,including 118 patients who received CIT after operation,who were CIT group,and the rest 605 patients were control group.The follow-up time was 5 years.The survival differences between the cit group and the control group were analyzed.The primary end point was disease free survival(DFS),and the secondary end point was overall survival(OS).Results:(1)The DFS of CIT group was better than that of control group.Among 723 patients with complete clinicopathological data and follow-up results,118 patients in cit group had disease-free survival rates of 100%,96.61%,92.37%,88.14% and 86.44% respectively in1-5 years,and 605 patients in control group had disease-free survival rates of 98.34%,91.24%,87.11%,80.50% and 78.51% respectively in 1-5 years.The disease-free survival rates of 3-year and 5-year in cit group were higher than those in control group,but the difference was statistically significant in 5-year survival rates The statistical significance(P= 0.045)suggested that CIT,as an adjuvant treatment,could significantly improve DFs in patients with breast cancer.(2)Compared with the control group,the OS of CIT group has a trend of prolongation.The 1-5-year overall survival rate of CIT group was 100%,100%,98.31%,96.61% and94.07%,while that of control group was 99.83%,99.67%,98.19%,96.03% and 92.40%,respectively.The 3-year and 5-year overall survival rate of CIT group was higher than that of control group,but the difference was not statistically significant(P = 0.838).(3)Results of subgroup analysis:(1)Molecular typing:TNBC patients: the 5-year DFS rate of CIT group and control group was 81.48% vs69.44%(Iog rank,P = 0.185),and the 5-year OS rate was 92.59% vs 83.33%(Iog rank,P =0.233),respectively.There was no significant difference between the two groups in DFS and OS.ER/ PR + HER2-patients: the 5-year DFS rate of CIT group and control group was88.14% vs 84.53%(Iog rank,P = 0.241),and the 5-year OS rate was 94.92% vs 94.87%(Iog rank,P = 0.984),respectively.There was no significant difference between the two groups in DFS and OS.HER2 +(negative or positive receptor)patients: the 5-year DFS rate of CIT group and control group was 87.50% vs 76.27%(Iog rank,P = 0.152),and the 5-year OS rate was96.88% vs 92.37%(Iog rank,P = 0.371),respectively.The 5-year DFS rate and OS rate of CIT group were higher than those of control group,and DFS and OS had an extended trend,but there was no statistical significance.(2)Axillary lymph node metastasis:N0 patients: the 5-year DFS rate of CIT group and control group was 92.19% vs88.86%(Iog rank,P = 0.424),and the 5-year OS rate was 98.44% vs 96.77%(Iog rank,P =0.479),respectively.There was no significant difference between the two groups in DFS and OS.N1-3 patients: the 5-year DFS rate of CIT group and control group was 85.90% vs68.20%(Iog rank,P = 0.003),and the difference was statistically significant;the 5-year OS rate was 88.89% vs 86.61%(Iog rank,P = 0.624),and here was no significant difference between the two groups in OS.(3)TNM stage:Stage I / II patients: the 5-year DFS rate of CIT group and control group was 91.40% vs86.14%(Iog rank,P = 0.163),and the 5-year OS rate was 97.85% vs 96.59%(Iog rank,P =0.529),respectively.There was no significant difference between the two groups in DFS and OS.Stage III patients: the 5-year DFS rate of CIT group and control group was 68.00% vs42.06%(Iog rank,P = 0.0.029),and the difference was statistically significant;the 5-year OS rate of CIT group and control group was 80.00% vs 72.90%(Iog rank,P = 0.456),respectively.There was no significant difference between the two groups in DFS and OS.(4)Differentiation degree of primary focus:G1-2 patients: the 5-year DFS rate of CIT group and control group was 92.75% vs81.59%(Iog rank,P = 0.021),the difference was statistically significant;the 5-year OS rate was 100.00% vs 93.96%(Iog rank,P = 0.038),the difference was statistically significant.G3 patients: the 5-year DFS rate of CIT group and control group was 77.55% vs73.44%(Iog rank,P = 0.571),and the 5-year OS rate was 85.71% vs 85.06%(Iog rank,P =0.772),and here was no significant difference between the two groups in OS.(4)Impact of CIT cycles on DFS and OS:There were statistically significant differences in DFS and OS between patients who completed three cycles of CIT and those who completed four or more cycles(DFS: 76.92%vs 91.14%,Iog rank,P = 0.034;OS: 87.18% vs 97.47%,Iog rank,P = 0.026).(5)Cox regression single factor and multi factor analysis of DFS and OS:Cox regression univariate analysis: tumor length(?2cm,>2cm),axillary lymph node metastasis(N0,N1-3),differentiation degree of primary focus(G1-2,G3),operation mode(radical operation,breast conserving operation),radiotherapy(yes,no),vessel or nerve infiltration(yes,no),TNBC(yes,no),tumor TNM stage(I-II,III),group(CIT group,control group)are the influencing factors The length of tumor(?2cm,>2cm),axillary lymph node metastasis(N0,N1-3),differentiation degree of primary focus(G1-2,G3),operation mode(radical operation,breast conserving operation),radiotherapy(yes,no),vascular or neural infiltration(yes,no),TNBC(yes,no),TNM stage(I-II,III)are the factors affecting patients' OS.Cox regression multivariate analysis: radiotherapy(yes,no),TNBC(yes,no),tumor TNM stage(I-II,III),group(CIT group,control group)are independent risk factors for DFS;TNBC(yes,no),tumor TNM stage(I-II,III)are independent risk factors for OS.Conclusions:(1)CIT,as a means of tumor biological immunotherapy,can improve DFS and OS of patients with early breast cancer who have completed surgery.(2)Axillary lymph node metastasis,late tumor stage and high degree of primary cell differentiation may be the potential beneficiaries of CIT.(3)At least 4 cycles of CIT are related to the better prognosis.(4)CIT is an independent risk factor for DFS in patients with early breast cancer. |
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