Predict the benefit of metronomic capecitabine maintenance in early-stage triple-negative breast cancer: Results from the SYSUCC-001 study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 521-521
Author(s):  
Zhongyu Yuan ◽  
Xin Hua ◽  
Wang-Zhong Li ◽  
Heng Huang ◽  
Li Cai ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Prediction Model ◽  
Triple Negative Breast Cancer ◽  
Lymphovascular Invasion ◽  
Triple Negative ◽  
Validation Cohort ◽  
Early Stage ◽  
Disease Free Survival ◽  
Survival Prediction

521 Background: Recent clinical trials and meta-analysis have suggested the benefit of adding capecitabine to standard chemotherapy in early-stage triple negative breast cancer (TNBC). We aimed to develop an individualized prediction model to quantify the clinical benefit of metronomic capecitabine maintenance in TNBC. Methods: Patients from the SYSUCC-001 trial, randomized to standard treatment with or without metronomic capecitabine maintenance, were pooled. Candidate covariates included age, tumor size, lymph node, histological grade, Ki-67 percentage, lymphovascular invasion, chemotherapy regimen and capecitabine medication. The primary endpoint was disease-free survival (DFS). The nonlinear effect of continuous covariate was modelled by restricted cubic spline. We developed a survival prediction model using the Cox proportional hazards model. Results: A total of 434 patients were recruited (306 in development cohort and 128 in validation cohort). The estimated 5-year DFS in the development cohort and validation cohort were 77.8% (95% CI, 72.9-82.7%) and 78.2% (95% CI, 70.9-85.5%), respectively. Age and lymph node had significant nonlinear effects on DFS. Four covariates significantly associated with DFS in the final prediction model were age, lymph node, lymphovascular invasion and capecitabine medication. The model demonstrated suitable calibration and fair discrimination ability with a C-index of 0.722 (95% CI, 0.662-0.781) and 0.764 (95% CI, 0.668-0.859) in the development cohort and validation cohort, respectively. We design an easy-to-use online calculator based on the model, capable of predicting capecitabine maintenance benefit. Conclusions: The evidence-based prediction model could identify those patients who most warrant metronomic capecitabine maintenance and thus help treatment decision making in daily clinical practice. Clinical trial information: NCT01112826.

scholarly journals The role of capecitabine-based neoadjuvant and adjuvant chemotherapy in early-stage triple-negative breast cancer: a systematic review and meta-analysis

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xingfa Huo ◽  
Jinming Li ◽  
Fuxing Zhao ◽  
Dengfeng Ren ◽  
Raees Ahmad ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Adjuvant Chemotherapy ◽  
Triple Negative Breast Cancer ◽  
Randomized Clinical Trials ◽  
Triple Negative ◽  
Early Stage ◽  
Meta Analysis ◽  
Disease Free Survival

Abstract Background The role of capecitabine in neoadjuvant and adjuvant chemotherapy for early-stage triple-negative breast cancer (TNBC) is highly controversial. Our meta-analysis was designed to further elucidate the effects of capecitabine on survival in early-stage TNBC patients and its safety. Methods PubMed, Embase, and papers presented at several main conferences were searched up to December 19, 2019, to investigate capecitabine-based versus capecitabine-free neoadjuvant and adjuvant chemotherapy in TNBC patients. Heterogeneity was assessed using I2 test, combined with hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CI) computed for disease-free survival (DFS), overall survival (OS), and over grade 3 adverse events (AEs). Results A total of 9 randomized clinical trials and 3842 TNBC patients were included. Overall, the combined capecitabine regimens in neoadjuvant and adjuvant chemotherapy showed significantly improved DFS (HR = 0.75; 95% CI, 0.65–0.86; P < 0.001) and OS (HR = 0.63; 95% CI, 0.53–0.77; P < 0.001). In subgroup analysis, there were improvements in DFS in the groups with addition of capecitabine (HR = 0.64; 95% CI, 0.53–0.78; P < 0.001), adjuvant chemotherapy (HR = 0.73; 95% CI, 0.63–0.85; P < 0.001), and lymph node positivity (HR = 0.62; 95% CI, 0.44–0.86; P = 0.005). Capecitabine regimens were related to higher risks of diarrhea (OR = 2.88, 95% CI 2.23–3.74, P < 0.001), stomatitis (OR = 2.01, 95% CI 1.53–2.64, P < 0.001) and hand–foot syndrome (OR = 8.67, 95% CI 6.70–11.22, P < 0.001). Conclusion This meta-analysis showed that neoadjuvant and adjuvant chemotherapy combined with capecitabine significantly improved both DFS and OS in early-stage TNBC patients with tolerable AEs. There were benefits to DFS in the groups with the addition of capecitabine, adjuvant chemotherapy, and lymph node positivity.

ALEXANDRA/IMpassion030: A phase III study of standard adjuvant chemotherapy with or without atezolizumab in early-stage triple-negative breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS598-TPS598
Author(s):  
Heather L. McArthur ◽  
Michail Ignatiadis ◽  
Sebastian Guillaume ◽  
Andrew Bailey ◽  
Jorge Luis Martinez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Early Stage ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Lymph Node Status ◽  
Phase 3 ◽  
Metastatic Setting

TPS598 Background: Early stage triple negative breast cancer (TNBC) is associated with a high risk of distant relapse. Because TNBC does not currently have specific targeted agents approved for use in the early setting it is treated primarily with chemotherapy. TNBC may be more immunogenic than other subtypes of breast cancer and promising clinical activity has been reported with the anti–PD-L1 antibody, atezolizumab, in Phase 1/1b metastatic TNBC trials. Furthermore, the randomized phase 3 IMpassion130 study demonstrated enhanced anti-tumor activity when atezolizumab was co-administered with chemotherapy in the first line metastatic setting, with benefit mainly observed in PD-L1+ cohort. ALEXANDRA/IMpassion030 will evaluate the efficacy and safety of atezolizumab in combination with standard anthracycline/taxane adjuvant chemotherapy in early TNBC patients. Methods: ALEXANDRA/IMpassion030 is a global, prospective, randomized, open-label, phase 3 trial investigating the efficacy, safety and pharmacokinetic profile of adjuvant atezolizumab plus standard chemotherapy versus chemotherapy alone in early TNBC. In total, 2300 patients with operable stage II or III TNBC, confirmed by central pathology review, will be randomized. Patients are stratified by type of surgery, nodal status, and centrally assessed PD-L1 status. Adjuvant treatment will consist of weekly paclitaxel 80 mg/m2 for 12 weeks followed by dose dense anthracycline (epirubicin 90 mg/m2 or doxorubicin 60 mg/m2) and cyclophosphamide 600 mg/m2 for 4 doses every 2 weeks or the same chemotherapy regimen (T-EC/AC) given concomitantly with atezolizumab 840 mg every 2 weeks followed by maintenance atezolizumab 1200 mg every 3 weeks until completion of 1 year of atezolizumab. The primary end-point is invasive disease-free survival (iDFS) and secondary end-points include iDFS by PD-L1 and lymph node status, overall survival, safety, patient functioning and health related quality of life (HRQoL). Tumor tissue and blood samples will be collected for biomarker research. The first patient was enrolled on August 2nd 2018, and approximately 430 sites are expected to be opened globally in 30 countries. Clinical trial information: NCT03498716.

scholarly journals Survival Study of Triple-Negative and Non–Triple-Negative Breast Cancer in a Brazilian Cohort

2018 ◽  
Vol 12 ◽  
pp. 117955491879056 ◽  
Author(s):  
Homero Gonçalves ◽  
Maximiliano Ribeiro Guerra ◽  
Jane Rocha Duarte Cintra ◽  
Vívian Assis Fayer ◽  
Igor Vilela Brum ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Disease Free Survival ◽  
Lymph Node Involvement ◽  
Free Survival ◽  
Node Involvement ◽  
Brazilian Cohort ◽  
Disease Free

Objective: To analyze the clinical, pathological, and sociodemographic aspects between triple-negative breast cancer (TNBC) and non-TNBC in a Brazilian cohort and identify potential prognostic factors. Methods: This hospital-based retrospective cohort study included 447 women with breast cancer treated at referral centers in Southeastern Brazil. Overall and disease-free survival were compared; prognostic factors were evaluated. Results: Triple-negative breast cancer corresponded to 19.5% of breast cancer diagnosis and was more prevalent among nonwhite and less educated women. The patients with TNBC tended to present with stage III cancer, high p53 expression, lymphocytic infiltration, and multifocality and treated with radical surgery and chemotherapy. The 5-year overall and disease-free survival were 62.1% and 57.5% for TNBC and 80.8% and 75.3% for non-TNBC, respectively ( P < .001). The TNBC recurrence was associated with multicentricity, whereas lymph node involvement increased the risk of both recurrence and death. Non-TNBC worse clinical course was associated with nonwhite ethnicity, lower education level, lymph node involvement, and advanced stage. Conclusions: Triple-negative breast cancer exhibited a more aggressive behavior, earlier and more frequent recurrence, and worse survival compared with non-TNBC. While biological and social variables were associated with poorer prognosis in non-TNBC, only lymph node involvement and multicentricity were correlated with worse clinical outcomes in TNBC.

scholarly journals Epidemiology, Pattern of Recurrence and Survival in Triple-negative Breast Cancer

2020 ◽  
Vol 5 (2) ◽  
pp. 87-94
Author(s):  
Dharmendra Singh ◽  
Niladri Roy ◽  
Sumana Maiti Das
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Health Care Access ◽  
Triple Negative ◽  
Early Stage ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Breast Cancer Patients ◽  
Duration Of Symptoms ◽  
Epidemiological Characteristics

Background: Breast cancer is the most common cancer in the world. Triple-negative breast cancer (TNBC) characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and Her2neu receptor. This study investigated the epidemiological characteristics and survival in non-metastatic TNBC. Materials and methods: Data from medical records of patients with breast cancer between 20014 and 2018 were retrieved, and patients with TNBC were identified and analyzed for demographic and clinicopathological features. Survival analyses were performed using the Kaplan–Meier method for disease-free survival (DFS) and overall survival (OS). Results: A total of 457 nonmetastatic breast cancer patients were registered at our institute from January 2014 to August 2018, of which 137 were triple-negative breast cancer (TNBC). This accounted for 29.9% of nonmetastatic breast cancer during this period. With the median age of 45 years at diagnosis, the most common presenting complaint was breast lump. The median duration of symptoms was 30 months. The most commonly affected age group was 41-50 years. The majority of the patients were in a locally advanced stage (69.3%) while 30.7% were in the early stage. 29.2% recurrence at 38 months of median follow up. Recurrence was statistically significantly correlating with age ≤ 35 (p= < 0.001), pathological stage (p= < 0.001), nodal status at diagnosis (p= < 0.001), perineural invasion (PNI) (p= < 0.001), number of positive lymph nodes (p= < 0.001). The mean DFS and OS were 43.6 and 46 months respectively. 3-year DFS and OS were 65.5% and 66.2 % respectively. Conclusion: TNBCs are high-grade tumors mostly presented in locally advanced stages and most of the patients are young. TNBCs are clinically aggressive with high risk of metastasis to visceral organs. The survival of TNBCs in the Indian scenario is poor in comparison to Western populations, probably due to racial factors, socioeconomic factors and health care access facility.  

ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in patients with early-stage triple-negative breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS597-TPS597
Author(s):  
Shigehira Saji ◽  
Heather L. McArthur ◽  
Michail Ignatiadis ◽  
Andrew Bailey ◽  
Sarra El-Abed ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Early Stage ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Phase 3 ◽  
Meaningful Improvement

TPS597 Background: Early stage triple negative breast cancer (TNBC) is associated with a high risk of distant relapse. Because TNBC does not currently have specific targeted agents approved for use in the early setting, it is treated primarily with chemotherapy. TNBC may be more immunogenic than other subtypes of breast cancer. Atezolizumab (an anti–PD-L1 antibody), in combination with nab-paclitaxel has been approved in >70 countries for the treatment of PD-L1-positive unresectable locally advanced or metastatic TNBC based on the results of the randomized phase 3 IMpassion130 trial. The phase 3 IMpassion031 study, evaluating atezolizumab in combination with chemotherapy (nab-paclitaxel followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy as neoadjuvant treatment demonstrated a statistically significant and clinically meaningful improvement in pCR in both PD-L1 positive and PD-L1 negative tumors. ALEXANDRA/IMpassion030 is a global, prospective, randomized, open-label, phase 3 trial currently investigating the efficacy, safety and pharmacokinetic profile of adjuvant atezolizumab plus standard anthracycline/taxane adjuvant chemotherapy versus chemotherapy alone in early stage TNBC. Methods: ALEXANDRA/IMpassion030 will randomize 2300 patients with operable stage II-III TNBC, confirmed by central pathology review. Patients are stratified by type of surgery, nodal status, and centrally assessed PD-L1 status. Adjuvant chemotherapy consist of weekly paclitaxel 80 mg/m2 for 12 weeks followed by dose dense anthracycline (epirubicin 90 mg/m2 or doxorubicin 60 mg/m2) and cyclophosphamide 600 mg/m2 for 4 doses every 2 weeks or the same chemotherapy regimen (T-EC/AC) given concomitantly with atezolizumab 840 mg every 2 weeks followed by maintenance atezolizumab 1200 mg every 3 weeks until completion of 1 year of atezolizumab. The primary endpoint is invasive disease-free survival (iDFS) and secondary endpoints include, iDFS in the PD-L1 selected tumour status (IC1/2/3) and node-positive subpopulations, overall survival, safety, patient functioning and health related quality of life (HRQoL). Tumor tissue and blood samples will be collected for biomarker research. The first site was activated on May 4 2018, and approximately 373 sites in 30 countries are currently participating in this trial. This trial is sponsored by F. Hoffmann-La Roche Ltd and conducted in partnership with the Breast International Group, Frontier Science and Technology Research Foundation, Institute Jules Bordet and Alliance Foundation Trials. Clinical trial information: NCT03498716.

scholarly journals A Nomogram Based on Radiomics with Mammography Texture Analysis for the Prognostic Prediction in Patients with Triple-Negative Breast Cancer

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Xian Jiang ◽  
Xiuhe Zou ◽  
Jing Sun ◽  
Aiping Zheng ◽  
Chao Su
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Early Stage ◽  
Disease Free Survival ◽  
Textural Features ◽  
Lasso Regression ◽  
Clinical Model ◽  
Pn Stage ◽  
Prognostic Prediction

Objectives. To develop and validate a radiomics-based nomogram with texture features from mammography for the prognostic prediction in patients with early-stage triple-negative breast cancer (TNBC). Methods. The study included 200 consecutive patients with TNBC (training cohort: n = 133, validation cohort: n = 67). A total of 136 mammography-derived textural features were extracted, and LASSO (least absolute shrinkage and selection operator) was applied to select features for building the radiomics score (Rad-score). After univariate and multivariate logistic regression, a radiomics-based nomogram was constructed with independent prognostic factors. The discrimination and calibration power were assessed, and further the clinical applicability of the nomograms was evaluated. Results. Among the 136 mammography-derived textural features, fourteen were used to build the Rad-score after LASSO regression. A radiomics nomogram that incorporates Rad-score and pN stage was constructed. This nomogram achieved a C-index of 0.873 (95% CI: 0.758–0.989) for predicting iDFS (invasive disease-free survival), which outperformed the clinical model. Moreover, it is feasible to stratify patients into high-risk and low-risk groups based on the optimal cut-off point of Rad-score. The validations of the nomogram confirmed favorable discrimination and considerable predictive efficiency. Conclusions. The radiomics nomogram that incorporates Rad-score and pN stage exhibited favorable performance in the prediction of iDFS in patients with early-stage TNBCs.

Triple-negative and non–triple-negative breast cancer in a south Indian cohort.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13110-e13110
Author(s):  
Narayanankutty Edavalath Warrier ◽  
Uma V Sankar ◽  
Sreedharan P S ◽  
Ajmal Sherif
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Triple Negative Breast Cancer ◽  
Rural Women ◽  
Triple Negative ◽  
Disease Free Survival ◽  
Lymph Node Involvement ◽  
Free Survival ◽  
Node Involvement ◽  
Disease Free

e13110 Background: The heterogeneity of breast cancer explains in part the differences in the morbidity and mortality of this disease. Triple-negative breast cancer (TNBC) is a specific subset of tumors characterized by the absence of the 3 most commonly targeted biomarkers considered for breast cancer treatment: Estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor (HER2). TNBC accounts for 15% to 20% of all breast cancer diagnoses and usually has a more aggressive clinical course, with worse evolution within the first 3 to 5 years after diagnosis; early and higher rates of distant recurrences, typically visceral; and poor survival. Methods: To analyze the clinical, pathological, and sociodemographic aspects between triple-negative breast cancer (TNBC) and non-TNBC in a Kerala cohort and identify potential prognostic factors. This hospital-based retrospective cohort study (From January 2017 till December 2018) included 465 women with breast cancer treated at MVR Cancer Centre & Research Institute in North Kerala. Overall and disease-free survival was compared; prognostic factors were evaluated. Results: Triple-negative breast cancer corresponded to 16.3% of breast cancer diagnosis and was more prevalent among rural women. The patients with TNBC tended to present with stage III cancer, high p53 expression, lymphocytic infiltration, and multifocality and treated with radical surgery and chemotherapy. The 2-year overall and disease-free survival were 52.1% and 43.5% for TNBC and 83.8% and 73.4% for non-TNBC, respectively ( P < .001). The TNBC recurrence was associated with multicentricity, whereas lymph node involvement increased the risk of both recurrence and death. Non-TNBC worse clinical course was associated with rural women, younger age, lymph node involvement, and advanced stage. Conclusions: Triple-negative breast cancer exhibited a more aggressive behavior, earlier and more frequent recurrence, and worse survival compared with non-TNBC. While biological and social variables were associated with poorer prognosis in non-TNBC, only lymph node involvement and multicentricity were correlated with worse clinical outcomes in TNBC.

scholarly journals Pilot Study on MAGE-C2 as a Potential Biomarker for Triple-Negative Breast Cancer

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Qian Zhao ◽  
Wen-ting Xu ◽  
Tuluhong Shalieer
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Triple Negative Breast Cancer ◽  
Lymphovascular Invasion ◽  
Triple Negative ◽  
Tnm Stage ◽  
Clinicopathological Parameters ◽  
Lymph Node Status ◽  
Node Status ◽  
Expression Status

Objective. In the current study, we measured the expression status of melanoma antigen gene c2 (MAGE-C2) in triple-negative breast cancer (TNBC) and analyzed its prognostic with the clinical pathological features of patients with TNBC. Methods. The expressions statuses of MAGE-C2 were detected in TNBC tissues and paracarcinoma tissues by immunohistochemistry, reverse transcription-polymerase chain reaction (RT-PCR), and western blotting. Then, we investigated the relationship of MAGE-C2 expression status and clinicopathological parameters of TNBC patients by the chi-squared test. Finally, we discussed the relations of MAGE-C2 expression state and prognosis of patients with TNBC by Kaplan-Meier method and Cox proportional hazards model. Results. High MAGE-C2 expression was found in 38.18% (42/110) of TNBC tissues. In adjacent tissues it was 9.09% (10/110). High MAGE-C2 expression in TNBC patients was closely associated with lymph node status, tumor node metastasis (TNM) stage, and lymphovascular invasion (P<0.001). TNBC patients with high MAGE-C2 expression had significantly shorter survival time than low expression patients. We also found that age, lymph node status, TNM stage, lymphovascular invasion, and MAGE-C2 expression status were closely associated with overall survival of TNBC patients (P<0.05). Conclusion. High MAGE-C2 expression may serve as an independent prognostic factor for TNBC patients.

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