Comparative efficacy of neoadjuvant to adjuvant chemotherapy for the treatment of early-stage HER2 negative breast cancer: A population-based analysis.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12100-e12100
Author(s):  
Nathalie LeVasseur ◽  
Christine E. Simmons ◽  
Lovedeep Gondara ◽  
Caroline Speers ◽  
Rekha M. Diocee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Residual Disease ◽  
Early Stage ◽  
Tumour Size ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Population Based ◽  
Comparative Efficacy

e12100 Background: The use of neoadjuvant treatment has increased over the past decade due to its ability to assess tumour sensitivity to systemic treatment in vivo, and to downstage women for increased breast conserving surgery. Recent studies have stratified patients with residual disease to receive additional treatment, which has resulted in meaningful improvements in survival. However, meta-analysis data suggest similar long-term outcomes for patients treated with neoadjuvant chemotherapy (NACT) compared to adjuvant chemotherapy (ACT) in historical randomized trials. The comparative efficacy in a real-world setting utilizing modern chemotherapy regimens is unknown. Methods: A retrospective review of the BC Cancer Breast Cancer Outcomes Unit (BCOU) was performed to identify patients with stage I-III HER-2 negative breast cancer treated with chemotherapy at the BC Cancer Agency from 2005-2010. Patients were then divided into 2 groups: those who received neoadjuvant chemotherapy (NACT) and those who received adjuvant chemotherapy (ACT). A matched analysis (age, stage, subtype) for patients treated with NACT vs ACT (matched 1:3) was then performed using a propensity scoring method to compare distant disease-free survival (DDFS), breast cancer specific survival (BCSS) and overall survival (OS). No patients received adjuvant chemotherapy for residual disease after NACT. Results: A total of 656 patients met the inclusion criteria, consisting of 164 NACT and 492 ACT cases. Median age was 49 years (37-68) in the NACT group vs 49 (37-65) in the ACT group (p = 0.71). The majority had stage 3 disease, 64% in both groups (p = 1.0). Most were hormone receptor positive (HR+), 67.1% vs 70.7% in the NACT vs ACT groups, respectively (p = 0.41). 5-year DDFS was 75% with NACT (95%CI 67, 82) and 77% with ACT (95%CI 72, 81), p = 0.87. 5-year OS for patients treated with NACT was 77% (95%CI 71, 84) and 80% (95%CI 75, 85) for patients treated with ACT, p = 0.33. 5-year BCSS was 80% with NACT (95% CI 70, 86) and 82% (95%CI 77, 86) with ACT, p = 0.75. Multivariate analysis for tumour size, nodal involvement and subtype are ongoing. Conclusions: The use of NACT compared to ACT in a population-based setting did not result in significant differences in DDFS, OS or BCSS. Acknowledging the comparative efficacy of these approaches will be informative to determine if the addition of subsequent adjuvant treatment for patients with residual disease after NACT will lead to differential benefits in a population-based setting.

Population-based outcomes of patients (pt) with early-stage HER2-positive breast cancer treated with adjuvant trastuzumab (T).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11079-e11079
Author(s):  
Krista Noonan ◽  
Joy S. McCarthy
Keyword(s):  
Breast Cancer ◽  
Prognostic Factors ◽  
Early Stage ◽  
Tumour Size ◽  
Disease Free Survival ◽  
Clinical Effectiveness ◽  
Population Based ◽  
The Body ◽  
Phase Iii ◽  
Her2 Positive

e11079 Background: Phase III trials have shown clinical efficacy of T when combined with chemotherapy in HER2-positive early stage breast cancer, decreasing recurrence by 50% and increasing survival by 30%. 15-20% of early stage breast cancers demonstrate amplification of the HER2 gene, which is associated with a poor prognosis. The aims of this study were to evaluate the clinical effectiveness of T, and explore potential prognostic factors. Methods: Pts with stage I-III breast cancer overexpressing HER2 from 2005 to 2010, assessed in Newfoundland and Labrador’s cancer centre were retrospectively identified from the Provincial Tumour Registry. Pt, treatment, and tumour characteristics were extracted. Kaplan-Meier curves were used for survival analysis, and Cox Proportional Hazards Models were used to identify prognostic factors and evaluate their impact on outcomes. Results: A total of 148 pts were identified. The median age was 56 years, and 76% received T. At a median follow-up of 25 months, overall survival (OS) was 97% (p=0.0002), and disease-free survival was 96% (p<0.00) for pts receiving T. Younger age, smaller tumour size, and lymph node negativity were favorable prognostic factors. There was an 83% decrease in risk of breast cancer recurrence in the patients receiving T. Discontinuation of T occurred in 6.2% of patients due to a decreased ejection fraction. Conclusions: This population-based analysis demonstrates T’s favorable impact on 25-month DFS, OS, and safety. This adds to the body of literature, showing clinical effectiveness and tolerability of T. [Table: see text]

scholarly journals Clinical and laboratory criteria used for patient selection for adjuvant chemotherapy in post-operative breast cancer

Mastology ◽  
2020 ◽  
Vol 30 (Suppl 1) ◽  
Author(s):  
Bianca Pamela Soares ◽  
Grasiela Benini dos Santos Cardoso ◽  
Marcia Fernanda Roque da Silva ◽  
Roberto Odebrecht Rocha
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Hormone Receptors ◽  
Early Stage ◽  
Effective Means ◽  
Breast Cancer Incidence ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Cross Sectional

Introduction: Breast cancer remains the second most common type of cancer in the world and the first among women, with breast cancer incidence rates doubling in the last thirty years. In 2013, the St Gallen Consensus recommended the use of a study of the multigene profile and phenotyping to indicate adjuvance by use of the MammaPrint and Oncotype4 applications; however, as they are not available in the Unified Health System (Sistema Único de Saúde–SUS), clinical predictive criteria and laboratory tests are used for indication of adjuvant therapy. Objective: Evaluation of clinical and laboratory criteria in the selection of patients with breast cancer after surgery for adjuvant chemotherapy and quantification of the factors used in the selected patients and their results. Method: This is a retrospective, cross-sectional observational study with patients over 18 years of age, without gender and race restriction, diagnosed with breast cancer at a public hospital in São Paulo, from 09/10/18 to 10/12/18, who underwent surgical treatment and discussed adjuvant therapy. Patients with metastatic neoplasia and/or undergoing neoadjuvant treatment were excluded. Data collected were: TNM staging, histological type and hormone receptors, age and comorbidities in all medical records collected. Results: 1,390 consultations were carried out, with 42 patients selected, according to the study criteria. Since 40% of the patients were outside the recommended range for breast cancer screening, regarding TNM, late diagnoses were evidenced, with 69% presenting ≥T2 and 36% with lymph node involvement. Of the 42 patients, 98% received adjuvant therapy. Conclusion: It was evidenced by Paik et al., that 92.1% of the 668 patients enrolled in the NSABP B-14 study were considered of intermediate or high risk according to the NCCN and St. Gallen criteria, and by Oncotype DX, 50.6% of the patients were classified as at low risk of recurrence. However, as these are not available in SUS, the present study shows the need to use clinical and laboratory factors to indicate adjuvant therapy, and with these, of the 42 patients, 98% had indication, showing that they are not such effective means in the use of genetic tests, and patients treated by SUS initiate their treatments late, which impacts disease-free survival, since less than 10% of patients received care with early stage neoplasia.

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.

A phase III, randomized trial of docetaxel plus carboplatin (TP) versus epirubicin plus cyclophosphamide followed by docetaxel (EC-T) as adjuvant treatment for triple-negative, early-stage breast cancer in Chinese patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS1135-TPS1135
Author(s):  
Peng Yuan ◽  
Binghe Xu
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Triple Negative ◽  
Early Stage ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Radical Mastectomy ◽  
Phase Iii ◽  
Chinese Patients ◽  
Her2 Breast Cancer

TPS1135 Background: Triple-negative [estrogen receptor (ER)-/progesterone receptor (PR)-/HER2-] breast cancer (TNBC) accounts for about 15% of all breast cancers and is associated with very poor prognosis. A combination of anthracycline and taxanes represents the most commonly used adjuvant chemotherapy for TNBC patients. BRCA1, a protein responsible for repair upon DNA damage, is often dysfunctional in TNBC. As a result, TNBC is often sensitive to DNA-damaging agents (e.g., cisplatin and carboplatin). A phase II study of docetaxel plus carboplatin as neoadjuvant treatment for TNBC achieved promising response rate (Chang, CANCER, 2010). Encouraged by this important finding, we are currently conducting a phase III trial to examine docetaxel plus carboplatin as adjuvant chemotherapy in patients with early-stage TNBC (registration number at www.ClinicalTrials.gov: NCT 01150513). Methods: All participants received radical mastectomy or breast-conserving surgery for pT1-3N0-2 breast cancer. All cancers were negative for ER, PR, HER2/Neu. All participants had adequate organ function and performance status. The age ranged from 18 to 70 years. Patients randomly received a TP regimen (docetaxel 100 mg/m2 plus carboplatin AUC=6 on day 1, 21 days a cycle for 6 cycles) or a EC-T regimen (epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 on d1, 21 days a cycle for 4 cycles; followed by docetaxel 100 mg/m2 on d1, 21 days a cycle for 4 cycles). Adjuvant radiotherapy was permitted in both arms. The primary endpoint is disease-free survival (DFS). Secondary endpoints included adverse event and quality of life (QoL). The study planned to recruit 500 subjects over a period of 5 years, with 5-year follow-up (once every 6 months). Target hazard ratio is 0.86 (5 year DFS of 74.0% vs. 71.0%). The estimated power is 0.80; 1-sided type 1 error was set at 0.05). The study was activated in June 2010 with enrollment of 110 subjects.

scholarly journals Contrast-enhanced spectral mammography in the radiological assessment of response to neoadjuvant chemotherapy in breast cancer

2021 ◽  
pp. e521
Author(s):  
Anna Grażyńska ◽  
Sofija Antoniuk ◽  
Katarzyna Steinhof-Radwańska
Keyword(s):  
Breast Cancer ◽  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Neoadjuvant Chemotherapy ◽  
Residual Disease ◽  
Tumour Size ◽  
Breast Cancer Diagnosis ◽  
Chemotherapy Response ◽  
Resonance Imaging ◽  
Contrast Enhanced

Accurate morphological assessment and measurement of the residual disease following neoadjuvant chemotherapy are vital for the effective surgical treatment in patients with breast cancer. Neoadjuvant chemotherapy response is measured by RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors), and the classification of the specific therapeutic responses is based on the difference in the tumour size prior to and after chemotherapy. There are currently a few methods of imaging used in the assessment of the neoadjuvant chemotherapy response. Conventional mammography remains the most popular method, whereas magnetic resonance imaging is considered the most effective ones. Nonetheless, the available methods tend to be imperfect and limited, and therefore, new methods are constantly investigated. Contrast-enhanced spectral mammography is a relatively new method used in breast cancer diagnosis, which involves the phenomenon of neoangiogenesis of cancerous tumours, allowing contrast enhancement in the areas of vessel proliferation in the background of the surrounding breast tissue. Contrast-enhanced spectral mammography presents sensitivity similar to magnetic resonance imaging in breast cancer detection, and can be an efficient method used in monitoring neoadjuvant chemotherapy response.

scholarly journals Efficacy and Safety of Albumin-Bound Paclitaxel Compared to Docetaxel as Neoadjuvant Chemotherapy for HER2-Negative Breast Cancer

2022 ◽  
Vol 11 ◽  
Author(s):  
Zhi-Dong Lv ◽  
Hong-Ming Song ◽  
Zhao-He Niu ◽  
Gang Nie ◽  
Shuai Zheng ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Neoadjuvant Chemotherapy ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Lymph Node Status ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Paclitaxel Group ◽  
Docetaxel Group

BackgroundNanoparticle albumin-bound paclitaxel (nab-paclitaxel) as neoadjuvant chemotherapy (NAC) for breast cancer remains controversial. We conducted a retrospective study to compare the efficacy and safety of nab-paclitaxel with those of docetaxel as neoadjuvant regimens for HER2-negative breast cancer.MethodsIn this retrospective analysis, a total of 159 HER2-negative breast cancer patients who had undergone operation after NAC were consecutively analyzed from May 2016 to April 2018. Patients were classified into the nab-paclitaxel group (n = 79, nab-paclitaxel 260 mg/m2, epirubicin 75 mg/m2, and cyclophosphamide 500 mg/m2) and the docetaxel group (n = 80, docetaxel 75 mg/m2, epirubicin 75 mg/m2, and cyclophosphamide 500 mg/m2) according to the drug they received for neoadjuvant treatment. The efficacy and adverse events were evaluated in the two groups.ResultsThe pathological complete response (pCR)(ypT0/isN0) rate was significantly higher in the nab-paclitaxel group than in the docetaxel group (36.71% vs 20.00%; P = 0.031). The multivariate analysis revealed that therapeutic drugs, lymph node status, and tumor subtype were the most significant factor influencing treatment outcome. At a median follow-up of 47 months, disease-free survival (DFS) was not significantly different in those assigned to nab-paclitaxel compared with docetaxel (82.28% vs 76.25%; P = 0.331). The incidence of peripheral sensory neuropathy in the nab-paclitaxel group was higher than that in the docetaxel group (60.76% vs 36.25%; P = 0.008), while the incidence of arthralgia was observed more frequently in the docetaxel group (57.50% vs 39.97%; P = 0.047).ConclusionsCompared with docetaxel, nab-paclitaxel achieved a higher pCR rate, especially those patients with triple-negative breast cancer or lymph node negative breast cancer. However, there was no significant difference in DFS between the two groups. This study provides a valuable reference for the management of patients with HER2-negative breast cancer.

Pathologic response and disease-free survival (DFS) after neoadjuvant trastuzumab (T) for HER2+ breast cancer (BC): Results from the National Cancer Institute (NCI) of Mexico.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e11533-e11533
Author(s):  
Cynthia Mayte Villarreal-Garza ◽  
Enrique Soto-Perez-de-Celis ◽  
Erika Sifuentes ◽  
Yanin Chavarri Guerra ◽  
Santiago Ruano ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Neoadjuvant Chemotherapy ◽  
Ductal Carcinoma ◽  
Residual Disease ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Rank Test ◽  
Her2 Breast Cancer

e11533 Background: The most accurate definition of pathologic complete response (pCR) in HER2+ BC patients (pts) receiving T-based neoadjuvant chemotherapy associated with improved DFS is controversial, particularly regarding the role of residual ductal carcinoma in situ (ypTis) and focal invasive residuals (ypT1mic). The effect of pCR on DFS in various subgroups of HER2+ BC is also uncertain. Methods: Pts with localized HER2+ BC that received T-based neoadjuvant chemotherapy at NCI between January 2007 and May 2012 were identified. We conducted an exploratory analysis of DFS in pts according to their tumor response. DFS curves were derived from Kaplan-Meier estimates and compared by log-rank test. Multivariate analysis was performed using Cox’s regression model. Results: 243 pts were included for analysis. Median follow-up was 39 months (mo). 49% of pts had no invasive and no in situ residuals at surgery (ypT0), 14.4% had ypTis/ypT1mic residuals and 36.6% had gross residual BC. DFS was significantly superior in pts with both ypT0 and ypTis/ypT1mic (no gross invasive residual BC) compared with those with gross residual disease (60.6 and 62.7 mo respectively vs. 51.6 mo, p=0.011 and 0.017). There was no difference in DFS between ypT0 and ypTis/ypT1mic pts (p=0.402). The rate of no gross invasive residual BC was significantly superior in pts with ER-PR- tumors compared with patients with ER+/PR+ tumors (69.9% vs. 56.7%, p=0.034). No gross invasive residual BC was associated with improved DFS in pts with HER2+ ER-/PR- (60.3 vs. 49.0 mo; p=0.005), as opposed to HER2+ ER+/PR+ tumors (61.0 vs. 51.6 mo; p=0.100). Multivariate analysis showed that tumor size (p=0.013) and no gross invasive residual BC (p=0.13) were associated with improved DFS in all subgroups. Conclusions: The absence of gross invasive residual BC was associated with improved DFS in pts with HER2+ BC treated with T-based neoadjuvant chemotherapy, particularly in those with HER2+ ER-/PR- BC. Our data suggest a comparable DFS in HER2+ BC patients with no gross invasive residual BC regardless of the presence or absence of both ypTis and ypT1mic disease after neoadjuvant treatment.

Taxanes-based neoadjuvant chemotherapy in advanced nonmetastatic breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e12033-e12033
Author(s):  
Tahir Mehmood ◽  
Muhammad Ali ◽  
Kamran Saeed ◽  
Atif Munawar ◽  
Sadaf Usman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Pathological Response ◽  
Free Survival ◽  
Neo Adjuvant Chemotherapy ◽  
Disease Free

e12033 Background: Pakistan has the highest rate of breast cancer for any South Asian population and majority of the patients present with locally advanced or metastatic disease. We report on response and survival of primary locally advanced non-metastatic breast cancer in women treated with neoadjuvant Adriamycin/Taxanes (AT) based regimens at our institute. Methods: Between 1995 to 2009 the hospital information system identified 517 women with pathologically confirmed locally advanced breast cancer. All patients received neoadjuvant chemotherapy with AT based regimen followed by surgery. Median age was 43 years (range 17-71 years). AJCC stage; stage II 54% and stage III 46% of the patients. Axillary nodes were palpable in 72% of the patients at presentation. Histological sub-types; infiltrating ductal carcinoma 95%, infiltrating lobular carcinoma 3% and others 2% respectively. Pathological grade was I/II in 44% and grade III 56% of the patients. ER, PR, and Her2-neu receptors were positive in 44%, 40% and 24% of the patients respectively. Twenty one percent of the patients had triple negative breast cancer. Post operative radiotherapy was delivered to 94% of the patients. Patients with positive ER/PR receptors also received hormonal manipulation. Results: Following neo-adjuvant chemotherapy, pathological response was; complete response (CR) 13.5%, partial response 21%, stable disease 52% and progressive disease in 13% of the patients respectively. Breast conservation was possible in 36% of the patients. The 5 year disease free survival in patients with and without CR was 81% and 36% respectively. On multivariate analysis, T stage (p = 0.001) and response to neo-adjuvant chemotherapy (p = 0.001) were found to be independent predictors for disease free survival. Conclusions: Pathological response to neoadjuvant chemotherapy is a predictor of long term survival. Chemotherapy regimens with high response rates merit evaluation in randomized trials to improve outcome in locally advanced breast cancer.

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.

Neoadjuvant biweekly dose-dense chemotherapy with fluouracil, epirubicin, and cyclophosphamide (FEC 90), followed by docetaxel in patients with HER2-neu negative primary breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 596-596
Author(s):  
D. Rodriguez-Abreu ◽  
A. Murias ◽  
M. García ◽  
V. Vega ◽  
C. Garcia ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Response Rate ◽  
Early Stage ◽  
Tumour Size ◽  
Disease Free Survival ◽  
Pathological Response ◽  
Hematological Toxicity ◽  
Preoperative Treatment ◽  
Skin Reactions ◽  
Dose Dense

596 Background: A primary goal of therapy for large early stage breast cancers is to achieve breast conserving surgery (BCS) through tumor mass reduction with neoadjuvant chemotherapy. In addition, induction of pathological complete response (pCR) is reported to prolong disease-free survival. Encouraged by results from recent studies of dose-dense chemotherapy in the adjuvant setting, we studied preoperative treatment with biweekly 5-fluorouracil, epirubicin, and cyclophosphamide followed sequentially by triweekly docetaxel. Methods: Eighty-one women with stage IIA to IIIB breast cancer were entered into this trial between August 2003 and April 2008. Patients received 5-fluorouracil 600mg/m2, epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 (q2w x 4 cycles) followed by docetaxel 100 mg/m2 (q3w x 4 cycles). Granulocyte colony-stimulating factor was administered each cycle to reduce the risk of neutropenic complication. After chemotherapy, patients underwent surgery, and received standard adjuvant radiotherapy and hormone therapy as usual clinical practice. The primary endpoint of this trial was pathological response rate and the secondary endpoints were BCS rate and toxicity. Results: A total of 79 patients were analyzed. The median age was 50y (28–74), the median tumour size was 4 cm. 50 patients (63.2%) were ER positive and/ o PR positive. 48 patients (60.7%) were pre-menopausal. Median follow-up was 36m, 64 patients had stage II (81%) and 15 had stage III (19%). Clinical response was seen in all cases. A pCR with no evidence of tumor in the breast and lymph nodes was confirmed in 21 patients (26.5%). BSC was performed in 61 patients (77.2%). Treatment was well tolerated, 8 patients (10.1%) had grade 3/4 hematological toxicity. Others adverse events including, anorexia, fatigue, nausea, vomiting, mucositis, myalgia, nail changes, peripheral neuropathy, hand-foot skin reactions were mild and manegeable. Conclusions: The neoadjuvant biweekly dose-dense chemotherapy with fluouracil, epirubicin and cyclophosphamide (FEC 90), followed by docetaxel is safe and demostrates a high pathological response rate (pCR) of 26.5% with an increase rate of BCS of 77.2%. No significant financial relationships to disclose.

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