Evaluating the effect and mechanism of Yiqi Huayu Jiedu decoction combined with FLOT regimen neoadjuvant chemotherapy for the patients with locally advanced gastric cancer:protocol for a prospective,double-arm,randomized controlled clinical trial

Background:Neoadjuvant chemotherapy plays a vital role in the treatment of advanced gastric cancer(GC),however,optimizing its effectiveness remains an important research focus.Traditional Chinese medicine(TCM),a promising adjunctive therapy,has shown enhanced clinical outcomes when combined with postoperative adjuvant chemotherapy.Therefore,this study is designed to evaluate the clinical efficacy of Yiqi Huayu Jiedu decoction combined with neoadjuvant chemotherapy FLOT in the treatment of advanced GC.Methods:This study is a prospective,double-arm,randomized controlled trial.It involves a total of 260 patients diagnosed with advanced GC,who will be randomly assigned to two groups-a TCM treatment group and a control group,each comprising 130 patients.All patients will receive standard FLOT chemotherapy,and patients in the TCM treatment group will additionally receive TCM treatment with Yiqi Huayu Jiedu decoction.After four cycles of chemotherapy,GC D2 radical surgery will be performed.The primary objective is to evaluate the postoperative pathological response rate of the tumor.The secondary objectives include evaluating the perioperative nutritional status,the efficacy of TCM syndrome,and adverse events associated with both chemotherapy and surgery.Discussion:Currently,no trials have investigated the impact of TCM in combination with neoadjuvant chemotherapy on the preoperative treatment in patients with advanced GC.Accordingly,it is imperative to conduct this prospective study to evaluate the clinical efficacy and safety of this regimen,meanwhile providing high-level clinical evidence for TCM combined with neoadjuvant chemotherapy and introducing an innovative regimen for preoperative comprehensive treatment of GC.

Effects of neoadjuvant chemotherapy vs chemoradiotherapy in the treatment of esophageal adenocarcinoma:A systematic review and meta-analysis

BACKGROUND Neoadjuvant therapy is an essential modality for reducing the clinical stage of esophageal cancer;however,the superiority of neoadjuvant chemotherapy(nCT)or neoadjuvant chemoradiotherapy(nCRT)is unclear.Therefore,a discussion of these two modalities is necessary.AIM To investigate the benefits and complications of neoadjuvant modalities.METHODS To address this concern,predefined criteria were established using the PICO protocol.Two independent authors performed comprehensive searches using predetermined keywords.Statistical analyses were performed to identify significant differences between groups.Potential publication bias was visualized using funnel plots.The quality of the data was evaluated using the Risk of Bias Tool 2(RoB2)and the GRADE approach.RESULTS Ten articles,including 1928 patients,were included for the analysis.Significant difference was detected in pathological complete response(pCR)[P<0.001;odds ratio(OR):0.27;95%CI:0.16-0.46],30-d mortality(P=0.015;OR:0.4;95%CI:0.22-0.71)favoring the nCRT,and renal failure(P=0.039;OR:1.04;95%CI:0.66-1.64)favoring the nCT.No significant differences were observed in terms of survival,local or distal recurrence,or other clinical or surgical complications.The result of RoB2 was moderate,and that of the GRADE approach was low or very low in almost all cases.CONCLUSION Although nCRT may have a higher pCR rate,it does not translate to greater long-term survival.Moreover,nCRT is associated with higher 30-d mortality,although the specific cause for postoperative complications could not be identified.In the case of nCT,toxic side effects are suspected,which can reduce the quality of life.Given the quality of available studies,further randomized trials are required.

Application of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy in curative surgery for esophageal cancer:A metaanalysis

BACKGROUND The effectiveness of neoadjuvant therapy in esophageal cancer(EC)treatment is still a subject of debate.AIM To compare the clinical efficacy and toxic side effects between neoadjuvant chemoradiotherapy(nCRT)and neoadjuvant chemotherapy(nCT)for locally advanced EC(LAEC).METHODS A comprehensive search was conducted using multiple databases,including PubMed,EMBASE,MEDLINE,Science Direct,The Cochrane Library,China National Knowledge Infrastructure,Wanfang Database,Chinese Science and Technology Journal Database,and Chinese Biomedical Literature Database Article.Studies up to December 2022 comparing nCRT and nCT in patients with EC were selected.RESULTS The analysis revealed significant differences between nCRT and nCT in terms of disease-free survival.The results indicated that nCRT provided better outcomes in terms of the 3-year overall survival rate(OSR)[odds ratio(OR)=0.95],complete response rate(OR=3.15),and R0 clearance rate(CR)(OR=2.25).However,nCT demonstrated a better 5-year OSR(OR=1.02)than nCRT.Moreover,when compared to nCRT,nCT showed reduced risks of cardiac complications(OR=1.15)and pulmonary complications(OR=1.30).CONCLUSION Overall,both nCRT and nCT were effective in terms of survival outcomes for LAEC.However,nCT exhibited better performance in terms of postoperative complications.

Ki-67 Change in Anthracyline-containing Neoadjuvant Chemotherapy Response in Breast Cancer

Objective Anthracycline-containing regimens are irreplaceable in neoadjuvant chemotherapy(NAC)for breast cancer(BC)at present.However,30% of early breast cancer(EBC)patients are resistant to anthracycline-containing chemotherapy,leading to poor prognosis and higher mortality.Ki-67 is associated with the prognosis and response to therapy,and it changes after NAC.Methods A total of 105 BC patients who received anthracycline-containing NAC were enrolled.Then,the optimal model of Ki-67 was selected,and its predictive efficacy was analyzed.Immunohistochemistry(IHC)was used to determine the estrogen receptor(ER),progesterone receptor(PR),and human epidermal growth factor receptor 2(HER-2)status and Ki-67 level.Fluorescent in situ hybridization(FISH)was used to verify the HER-2 when the IHC score was 2+.Results The post-NAC Ki67 level after treatment with anthracycline drugs was lower than pre-NAC Ki-67(19.6%±23.3%vs.45.6%±23.1%,P<0.001).Furthermore,patients with the Ki-67 decrease had a border line higher pathological complete response(pCR)rate(17.2%vs.0.0%,P=0.068),and a higher overall response rate(ORR)(73.6%vs.27.8%,P<0.001),when compared to patients without the Ki-67 decrease.The ΔKi-67 and ΔKi-67%were valuable markers for the prediction of both the pCR rate and ORR.The area under the curve(AUC)for ΔKi-67 on pCR and ORR was 0.809(0.698-0.921)and 0.755(0.655-0.855),respectively,while the AUC for ΔKi-67% on pCR and ORR was 0.857(0.742-0.972)and 0.720(0.618-0.822),respectively.Multivariate logistic regression model 1 revealed thatΔKi-67 was an independent predictor for both pCR[odds ratio(OR)=61.030,95% confidence interval(CI)=4.709-790.965;P=0.002]and ORR(OR=10.001,95%CI:3.044-32.858;P<0.001).Multivariate logistic regression model 2 revealed thatΔKi-67%was also an independent predictor for both pCR(OR=408.922,95%CI=8.908-18771.224;P=0.002)and ORR(OR=5.419,95%CI=1.842-15.943;P=0.002).Conclusions The present study results suggest thatΔKi67 andΔKi67%are candidate predictors for anthracycline-containing NAC response,and that they may provide various information for further systematic therapy after surgery in clinical practice.

Development of a novel staging classification for Siewert Ⅱ adenocarcinoma of the esophagogastric junction after neoadjuvant chemotherapy

BACKGROUND Stage classification for Siewert Ⅱ adenocarcinoma of the esophagogastric junction(AEG)treated with neoadjuvant chemotherapy(NAC)has not been established.AIM To investigate the optimal stage classification for Siewert Ⅱ AEG with NAC.METHODS A nomogram was established based on Cox regression model that analyzed variables associated with overall survival(OS)and disease-specific survival(DSS).The nomogram performance in terms of discrimination and calibration ability was evaluated using the likelihood-ratio test,Akaike information criterion,Harrell concordance index,time-receiver operating characteristic curve,and decision curve analysis.RESULTS Data from 725 patients with Siewert type Ⅱ AEG who underwent neoadjuvant therapy and gastrectomy were obtained from the Surveillance,Epidemiology,and End Results database.Univariate and multivariate analyses revealed that sex,marital status,race,ypT stage,and ypN stage were independent prognostic factors of OS,whereas sex,race,ypT stage,and ypN stage were independent prognostic factors for DSS.These factors were incorporated into the OS and DSS nomograms.Our novel nomogram model performed better in terms of OS and DSS prediction compared to the 8th American Joint Committee of Cancer pathological staging system for esophageal and gastric cancer.Finally,a user-friendly web application was developed for clinical use.CONCLUSION The nomogram established specifically for patients with Siewert type Ⅱ AEG receiving NAC demonstrated good prognostic performance.Validation using external data is warranted before its widespread clinical application.

Development of a clinical nomogram for prediction of response to neoadjuvant chemotherapy in patients with advanced gastric cancer

BACKGROUND The efficacy of neoadjuvant chemotherapy(NAC)in advanced gastric cancer(GC)is still a controversial issue.AIM To find factors associated with chemosensitivity to NAC treatment and to provide the optimal therapeutic strategies for GC patients receiving NAC.METHODS The clinical information was collected from 230 GC patients who received NAC treatment at the Central South University Xiangya School of Medicine Affiliated Haikou Hospital from January 2016 to December 2020.Least absolute shrinkage and selection operator logistic regression analysis was used to find the possible predictors.A nomogram model was employed to predict the response to NAC.RESULTS In total 230 patients were finally included in this study,including 154 males(67.0%)and 76 females(33.0%).The mean age was(59.37±10.60)years,ranging from 24 years to 80 years.According to the tumor regression grade standard,there were 95 cases in the obvious response group(grade 0 or grade 1)and 135 cases in the poor response group(grade 2 or grade 3).The obvious response rate was 41.3%.Least absolute shrinkage and selection operator analysis showed that four risk factors significantly related to the efficacy of NAC were tumor location(P<0.001),histological differentiation(P=0.001),clinical T stage(P=0.008),and carbohydrate antigen 724(P=0.008).The C-index for the prediction nomogram was 0.806.The calibration curve revealed that the predicted value exhibited good agreement with the actual value.Decision curve analysis showed that the nomogram had a good value in clinical application.CONCLUSION A nomogram combining tumor location,histological differentiation,clinical T stage,and carbohydrate antigen 724 showed satisfactory predictive power to the response of NAC and can be used by gastrointestinal surgeons to determine the optimal treatment strategies for advanced GC patients.

Post-operative morbidity after neoadjuvant chemotherapy and resection for gallbladder cancer: A national surgical quality improvement program analysis

BACKGROUND Gallbladder cancer is the most common malignancy of the biliary tract.Neo-adjuvant chemotherapy(NACT)has improved overall survival by enabling R0 resection.Currently,there is no consensus of guidelines for neoadjuvant therapy in gallbladder cancer.As investigations continue to analyze the regimen and benefit of NACT for ongoing care of gallbladder cancer patients,we examined American College of Surgeons National Surgical Quality Improvement Program(NSQIP)database to determine if there was higher morbidity among the neo-adjuvant group within the 30-day post-operative period.We hypothesized patients who underwent NACT were more likely to have higher post-operative morbidity.AIM To investigate the 30-day post-operative morbidity outcomes between patients who received NACT and underwent surgery and patients who only had surgery.METHODS A retrospective analysis of the targeted hepatectomy NSQIP data between 2015 and 2019 was performed to determine if NACT in gallbladder cancer increased the risk for post-operative morbidity(bile leak,infection rate,rate of converting to open surgery,etc.)compared to the group who only had surgery.To calculate the odds ratio for the primary and secondary outcomes,a crude logistic regression was performed.RESULTS Of the 452 patients,52 patients received NACT prior to surgery.There were no statistically significant differences in the odds of morbidity between the two groups,including bile leak[odds ratio(OR),0.69;95%confidence interval(95%CI):0.16-2.10;P=0.55],superficial wound infection(OR,0.58;95%CI:0.03-3.02;P=0.61),and organ space wound infection(OR,0.63;95%CI:0.18-1.63;P=0.61).CONCLUSION There was no significant difference in the risk of 30-day post-operative morbidity between the NACT and surgery group and the surgery only group.

Evaluation of the efficacy of neoadjuvant chemotherapy for intermediate and advanced breast cancer by 3.0T MR and ultrasound combined with tumour markers

Objective:To evaluate the efficacy of neoadjuvant chemotherapy before and after neoadjuvant chemotherapy for intermediate and advanced breast cancer using 3.0T MR and ultrasound in combination with tumour markers(CEA,CA-153,CA125),and to provide therapeutic references for the clinicians,so as to better satisfy the needs of treatment for intermediate and advanced breast cancer patients.Methods:The team collected 30 patients who were diagnosed with intermediate and advanced breast cancer by biopsy and received neoadjuvant chemotherapy,and divided them into sensitive and insensitive groups according to the MP grading of postoperative pathological results.The team retrospectively analysed the changes in the values of serum CEA,CA-153,and CA 125 before and after the neoadjuvant chemotherapy,the changes in the average ADC of the lesions before and after the observation by MRI,and the changes in the volume and size of lesions before and after the observation by ultrasonography to assess the effects of neoadjuvant chemotherapy individually,and the results of neoadjuvant chemotherapy were evaluated individually.The effect of neoadjuvant chemotherapy was assessed independently.Each of the above was evaluated independently,and the accuracy of each item was calculated by comparing the evaluation results with the pathological examination results,and the accuracy of the single item was compared with the accuracy of the three combined tests to determine whether the combined evaluation was more consistent.Results:All three examination and testing methods can achieve high accuracy,and the combined evaluation of the three is more accurate than the evaluation of the single way,and the difference is statistically significant(P<0.05).Conclusion:In neoadjuvant chemotherapy for breast cancer patients,the combined assessment of MR,CDFI and tumour markers can more comprehensively and accurately assess the effect of ADC,and more accurately guide the clinical treatment and determine the prognosis.

Application Progress of Ultrasound Radiomics in the Evaluation and Prediction of Neoadjuvant Chemotherapy for Breast Cancer

Breast cancer is a malignant tumor with the highest incidence in women. In recent years, the incidence of breast cancer has shown an increasing trend, especially in younger patients, which seriously threatens the life and health of women. In order to improve the treatment effect of breast cancer, neoadjuvant chemotherapy has become a reliable strategy to cooperate with surgical treatment and improve the prognosis of advanced breast cancer, which is conducive to quickly and accurately curbing the growth of cancer cells, controlling the patients’ condition, reducing their pain, and improving the cure rate of breast cancer patients. This paper analyzes the development history of ultrasound radiomics, explores its application in the evaluation and prediction of neoadjuvant chemotherapy for breast cancer, and clarifies the research results of multimodal ultrasound radiomics in the analysis of high-order characteristics of breast cancer tumors and the evaluation of tumor heterogeneity, so as to provide references for the clinical treatment of breast cancer.

Sequential neoadjuvant chemotherapy using pegylated liposomal doxorubicin and cyclophosphamide followed by taxanes with complete trastuzumab and pertuzumab treatment for HER2-positive breast cancer: A phase Ⅱ single-arm study

Objective: Despite cardiotoxicity overlap, the trastuzumab/pertuzumab and anthracycline combination remains crucial due to significant benefits. Pegylated liposomal doxorubicin(PLD), a less cardiotoxic anthracycline, was evaluated for efficacy and cardiac safety when combined with cyclophosphamide and followed by taxanes with trastuzumab/pertuzumab in human epidermal growth factor receptor-2(HER2)-positive early breast cancer(BC).Methods: In this multicenter, phase II study, patients with confirmed HER2-positive early BC received four cycles of PLD(30-35 mg/m^(2)) and cyclophosphamide(600 mg/m^(2)), followed by four cycles of taxanes(docetaxel,90-100 mg/m^(2) or nab-paclitaxel, 260 mg/m^(2)), concomitant with eight cycles of trastuzumab(8 mg/kg loading dose,then 6 mg/kg) and pertuzumab(840 mg loading dose, then 420 mg) every 3 weeks. The primary endpoint was total pathological complete response(tp CR, yp T0/is yp N0). Secondary endpoints included breast p CR(bp CR),objective response rate(ORR), disease control rate, rate of breast-conserving surgery(BCS), and safety(with a focus on cardiotoxicity).Results: Between May 27, 2020 and May 11, 2022, 78 patients were treated with surgery, 42(53.8%) of whom had BCS. After neoadjuvant therapy, 47 [60.3%, 95% confidence interval(95% CI), 48.5%-71.2%] patients achieved tp CR, and 49(62.8%) achieved bp CR. ORRs were 76.9%(95% CI, 66.0%-85.7%) and 93.6%(95% CI,85.7%-97.9%) after 4-cycle and 8-cycle neoadjuvant therapy, respectively. Nine(11.5%) patients experienced asymptomatic left ventricular ejection fraction(LVEF) reductions of ≥10% from baseline, all with a minimum value of >55%. No treatment-related abnormal cardiac function changes were observed in mean N-terminal pro-BNP(NT-pro BNP), troponin I, or high-sensitivity troponin.Conclusions: This dual HER2-blockade with sequential polychemotherapy showed promising activity with rapid tumor regression in HER2-positive BC. Importantly, this regimen showed an acceptable safety profile,especially a low risk of cardiac events, suggesting it as an attractive treatment approach with a favorable risk-benefit balance.

Current Status and Research Progress of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer

Gastric cancer is one of the most common malignant tumours worldwide, with a high degree of malignancy and a poor prognosis. While early gastric cancer can be cured by surgical treatment, locally advanced gastric cancer requires neoadjuvant therapy to shrink the tumour, suppress potential metastases, achieve down-staging, and provide patients with the opportunity for radical surgery to prolong their survival. This article reviews the current status and progress of neoadjuvant chemotherapy for locally advanced gastric cancer.

Value of Pretreatment Inflammation-nutrition Score to Predict Non-response to Neoadjuvant Chemotherapy in Locally Advanced Rectal Cancer

Objective To investigate the value of pretreatment inflammatory-nutritional biomarkers in predicting the pathological response of locally advanced rectal cancer(LARC)after neoadjuvant chemotherapy(nCT).Methods This retrospective study included eligible participants who underwent nCT followed by radical surgery.Pretreatment inflammatory nutritional biomarkers were calculated within one week prior to nCT.Correlations between biomarkers and pathological responses were analyzed.The cut-off values of the pretreatment biomarkers for predicting non-response were determined using receiver operating characteristic(ROC)curve analysis.The inflammation-nutrition score was calculated using the lymphocyte level,neutrophil-to-lymphocyte ratio(NLR),and prognostic nutritional index(PNI).Results A total of 235 patients were retrospectively recruited between January 2017 and September 2022.Lower lymphocyte levels,lymphocyte monocyte ratio(LMR),and PNI,and higher NLR and platelet-to-lymphocyte ratio(PLR)were observed in patients without response.Multivariate logistic regression analysis revealed that NLR could independently predict non-response to nCT in patients with LARC.The sensitivity and specificity of the inflammation-nutrition score for predicting nonresponse were 71.2%and 61.7%,respectively.Conclusion The pretreatment inflammation-nutrition score is a practical parameter for predicting nonresponse to nCT in patients with LARC.Patients with high scores were more likely to respond poorly to nCT.

Comparison between upfront surgery and neoadjuvant chemotherapy in patients with locally advanced gastric cancer:A systematic review

BACKGROUND Gastric cancer(GC)is a major health concern worldwide.Surgical resection and chemotherapy is the mainstay treatment for gastric carcinoma,however,the optimal approach remains unclear and should be different in each individual.Chemotherapy can be administered both pre-and postoperatively,but a multidisciplinary approach is preferred when possible.This is particularly relevant for locally advanced GC(LAGC),as neoadjuvant chemotherapy(NAT)could potentially lead to tumor downsizing thus allowing for a complete resection with curative intent.Even though the recent progress has been impressive,European and International guidelines are still controversial,thus attenuating the need for a more standardized approach in the management of locally advanced cancer.AIM To investigate the effects of NAT on the overall survival(OS),the disease-free survival(DFS),the morbidity and the mortality of patients with LAGC in comparison to upfront surgery(US).METHODS For this systematic review,a literature search was conducted between November and February 2023 in PubMed,Cochrane Library and clinicaltrials.gov for studies including patients with LAGC.Two independent reviewers conducted the research and extracted the data according to predetermined inclusion and exclusion criteria.The Preferred Reporting Items for Systematic Reviews and Meta-Analyses was used to form the search strategy and the study protocol has been registered in the International Prospective Register of Systematic Reviews.RESULTS Eighteen studies with 4839 patients with LAGC in total were included in our systematic review.Patients were separated into two groups;one receiving NAT before the gastrectomy(NAT group)and the other undergoing upfront surgery(US group).The OS ranged from 41.6%to 74.2%in the NAT group and from 30.9%to 74%in the US group.The DFS was also longer in the NAT group and reached up to 80%in certain patients.The complications related to the chemotherapy or the surgery ranged from 6.4%to 38.1%in the NAT group and from 5%to 40.5%in the US group.Even though in most of the studies the morbidity was lower in the NAT group,a general conclusion could not be drawn as it seems to depend on multiple factors.Finally,regarding the mortality,the reported rate was higher and up to 5.3%in the US group.CONCLUSION NAT could be beneficial for patients with LAGC as it leads to better OS and DFS than the US approach with the same or even lower complication rates.However,patients with different clinicopathological features respond differently to chemotherapy,therefore currently the treatment plan should be individualized in order to achieve optimal results.

Effect of postoperative adjuvant chemotherapyon the prognosis of patients with ypT0-3N0 rectalcancer undergoing neoadjuvant chemoradiotherapy

Objective The aim of this study was to investigate the effect of adjuvant chemotherapy (AC) on theprognosis of patients with ypT0-3N0 rectal cancer undergoing neoadjuvant chemoradiotherapy.Methods The study participants were 110 patients with locally advanced rectal cancer. Thirty-fourpatients did not receive postoperative AC treatment, and the other 76 patients received postoperative ACtreatment. The differences in the 5-year overall survival (OS) and disease-free survival (DFS) between thetwo groups were compared.Results Age was an important determinant of the patients’ decision to undergo postoperative treatment.Patients who did not receive AC treatment were significantly older than those who received AC treatment(P < 0.05). The tumor location (distance above anal margin) in the AC group was significantly larger thanthat in the non-AC group (P < 0.05). Moreover, there was no significant difference in the 5-year DFS andOS between the two groups. Postoperative AC did not significantly improve the prognosis of patients withrectal cancer. Age, tumor differentiation, and the number of resected lymph nodes were independent factorsaffecting the OS of patients (P < 0.05). Older patients, patients with lower degree of tumor differentiation,and patients with <12 resected lymph nodes showed worse prognosis (P < 0.05).Conclusion Patients with rectal cancer whose ypT0-3N0 stage is reduced after neoadjuvantchemoradiotherapy, especially those without adverse prognostic factors, do not need AC after surgery.

Oxaliplatin plus S-1 or capecitabine as neoadjuvant or adjuvant chemotherapy for locally advanced gastric cancer with D2lymphadenectomy: 5-year follow-up results of a phase II-III randomized trial

Objective： To compare the effect of neoadjuvant chemotherapy （NACT） with adjuvant chemotherapy （ACT） using oxaliplatin plus S-1 （sex） or capecitabine （CapeOX） on gastric cancer patients with D2 lymphadenectomy. Methods： This was a two-by-two factorial randomized phase Ⅱ-Ⅲ trial, and registered on ISRCTN registry （No. ISRCTN12206108）. Locally advanced gastric cancer patients were randomized to neoadjuvant sex, neoadjuvant CapeOX, adjuvant sex, or adjuvant CapeOX arms. Primary analysis was performed on an intention- to-treat （ITT） basis using overall survival （OS） as primary endpoint. Results： This trial started in September 2011 and closed in December 2012 with 100 patients enrolled. Treatment completion rate was 56%, 52%, 38% and 30% in the four arms, respectively. NACT group had fewer dropouts due to unacceptable toxicity （P=0.042）. Surgical complication rate did not differ by the four groups （P=0.986）. No survival signifcant difference was found comparing NACT with ACT （P=0.664; 5-year-OS： 70% vs. 74% respectively）, nor between the sex and CapeOX groups （P=0.252; 5-year-OS： 78% vs. 66% respectively）. Subgroup analysis showed sex significantly improved survival in patents with diffuse type （P=0.048）. Conclusions： No significant survival difference was found between NACT and ACT. sex and CapeOX had good safety and efficacy as neoadjuvant regimens. Diffuse type patients may survive longer due to sex.

Effect of neoadjuvant chemotherapy on the expression of hormone receptors and Ki67 in Chinese breast cancer patients:A retrospective study of 525 patients

This study was designed to investigate the effect of neoadjuvant chemotherapy on the expression of hormone receptors and Ki67 in Chinese female breast cancer patients. The expression of estrogen receptor（ER）, progesterone receptor（PR） and Ki67 among 525 neoadjuvant chemotherapy cases was studied by immunohistochemistry.Differences between specimens made through preoperative core needle biopsy and excised tissue biopsy were observed. The positive rates of ER, PR and Ki67 in core needle biopsy and excised tissue biopsy were 65.3% and 63.2%, 51.0% and 42.6%, 65.6% and 43.4%, respectively. The expression of ER, PR and Ki67 in core needle biopsy and excised tissue biopsy had no statistically significant difference. However, after neoadjuvant chemotherapy, the discordance rates of ER, PR and Ki67 were 15.2%（79/521）, 26.9%（140/520） and 44.8%（225/502）, respectively. The ER, PR and Ki67 status changed from positive to negative in 7.5%（39/521）, 13.3%（69/520） and 21.1%（106/502） of the patients, whereas ER, PR and Ki67 status changed from negative to positive in 7.7%（40/521）, 13.6%（71/520）and 23.7%（119/502） of the patients, respectively. These results showed that the status of some biomarkers changes after neoadjuvant chemotherapy and biomarker status needs to be reexamined to optimize adjuvant systemic therapy and better prognosis assessment.

Effects of Neoadjuvant Chemotherapy on Multiple Cytokines in Patients with Tri-negative Breast Cancer

The novel ET therapy is that doxorubicin and paclitaxel are used in neoadjuvant chemotherapy for tri-negative breast cancer(TNBC).The study mainly investigated the efficacy of ET therapy and its impact on tumor markers and cytokines.Firstly extracted from August 2017 to August 2020,84 cases of TNBC patients were as experimental group in our hospital,and the patients were randomly divided into two groups,including the control group(42 cases)underwent conventional chemotherapy and observation group(42 cases)to accept ET neoadjuvant chemotherapy.To compare the therapeutic effect of two groups,levels of cytokines,tumor markers,and survival were detected.The results showed that the total efficiency of the control group was 80.95%,significantly lower than that of the observation group(95.24%),and the difference between the two groups was statistically significant(P<0.05).The survival rate of the control group was 78.57%,which was significantly lower than that of the observation group(95.24%).In addition,CEA,CA19-9,CA125 and VEGF of the control group were significantly higher than those of the observation group(P<0.05).Therefore,the ET therapy of neoadjuvant chemotherapy has an ideal effect on the treatment of TNBC,which can reduce the levels of tumor markers and cytokines,prolonging the survival rate of patients.

Surgical outcome after docetaxel-based neoadjuvant chemotherapy in locally-advanced gastric cancer

AIM:To investigate feasibility,morbidity and surgical mortality of a docetaxel-based chemotherapy regimen randomly administered before or after gastrectomy in patients suffering from locally-advanced resectable gastric cancer.METHODS:Patients suffering from locally-advanced(T3-4 any N M0 or any T N1-3 M0)gastric carcinoma,staged with endoscopic ultrasound,bone scan,computed tomography,and laparoscopy,were assigned to receive four 21 d/cycles of TCF(docetaxel 75 mg/m 2 day 1,cisplatin 75 mg/m 2 day 1,and fluorouracil 300 mg/m 2 per day for days 1-14),either before(Arm A)or after(Arm B)gastrectomy.Operative morbidity,overall mortality,and severe adverse events were compared by intention-to-treat analysis.RESULTS:From November 1999 to November 2005,70 patients were treated.After preoperative TCF(Arm A),thirty-two(94%)resections were performed,85% of which were R0.Pathological response was complete in 4 patients(11.7%),and partial in 18(55%).No surgical mortality and 28.5%morbidity rate were observed,similar to those of immediate surgery arm(P= 0.86).Serious chemotherapy adverse events tended to be more frequent in arm B(23%vs 11%,P=0.07),with a single death per arm.CONCLUSION:Surgery following docetaxel-based chemotherapy was safe and with similar morbidity to immediate surgery in patients with locally-advanced resectable gastric carcinoma.

A pilot phase Ⅱ study of neoadjuvant triplet chemotherapy regimen in patients with locally advanced resectable colon cancer

Objective： This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced resectable colon cancer.Methods： Patients with clinical stage IIIb colon cancer received a perioperative triple chemotherapy regimen（oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with folinic acid 200 mg, 5-fluorouracil 500 mg bolus and then 2,400 mg/m2 by 44 h infusion or capecitabine 1 g/m2 or S-1 40–60 mg b.i.d orally d 1–10, repeated at 2-week intervals） for 4 cycles. Complete mesocolic excision was scheduled 2–6 weeks after completion of neoadjuvant treatment and followed by a further 6 cycles of FOLFOXIRI or XELOX. Primary outcome measures of this stage II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.Results： All 23 patients received neoadjuvant chemotherapy and underwent surgery. Twenty-one patients（91.3%） had reductions in tumor volume after neoadjuvant treatment, and 13 patients（56.5%） had grade 3–4toxicity. No patients had severe complications from surgery. Preoperative therapy resulted in significant downstaging of T-stage and N-stage compared with the baseline clinical stage including one pathological complete response.Conclusions： Neoadjuvant triple chemotherapy has high activity and acceptable toxicity and perioperative morbidity, and is feasible, tolerable and effective for locally advanced resectable colon cancer.

Timing of surgery after neoadjuvant chemotherapy for gastric cancer: Impact on outcomes

AIM To evaluate whether the neoadjuvant chemotherapy(NAc T)-surgery interval time significantly impacts the pathological complete response(pc R) rate and longterm survival.METHODS One hundred and seventy-six patients with gastric cancer undergoing NAc T and a planned gastrectomy at the chinese p LA General hospital were selected from January 2011 to January 2017. Univariate and multivariable analyses were used to investigate the impact of NAc T-surgery interval time(< 4 wk, 4-6 wk, and > 6 wk) on pc R rate and overall survival(OS).RESULTS The NAc T-surgery interval time and clinician T stage were independent predictors of pc R. The interval time > 6 wk was associated with a 74% higher odds of pc R as compared with an interval time of 4-6 wk(p = 0.044), while the odds ratio(OR) of clinical T3 vs clinical T4 stage for pc R was 2.90(95%c I: 1.04-8.01, p = 0.041). In cox regression analysis of long-term survival, postneoadjuvant therapy pathological N(yp N) stage significantly impacted OS(N0 vs N3: h R = 0.16, 95%c I: 0.37-0.70, p = 0.015; N1 vs N3: h R = 0.14, 95%c I: 0.02-0.81, p = 0.029) and disease-free survival(DFS)(N0 vs N3: h R = 0.11, 95%c I: 0.24-0.52, p = 0.005; N1 vs N3: h R = 0.17, 95%c I: 0.02-0.71, p = 0.020). The surgical procedure also had a positive impact on OS and DFS. The hazard ratio of distal gastrectomy vs total gastrectomy was 0.12(95%c I: 0.33-0.42, p = 0.001) for OS, and 0.13(95%c I: 0.36-0.44, p = 0.001) for DFS.CONCLUSION The NAc T-surgery interval time is associated with pc R but has no impact on survival, and an interval time > 6 wk has a relatively high odds of pc R.