Timing of adjuvant chemotherapy administration for early breast cancer.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 62-62
Author(s):  
Andrew L. Salner ◽  
Shelby Smith ◽  
Peter Paul Yu

62 Background: Adjuvant chemotherapy treatment has contributed to the reduction in cause-specific mortality from early stage breast cancer by reducing the risk of recurrence and metastasis. The initiation of adjuvant chemotherapy is typically started within 4-8 weeks following surgery. Although earlier treatment does not necessarily render a better prognosis, treatment delayed beyond 12 weeks may result in an unfavorable decrease in disease-free survival. In order to explore quality data for each of our 5 cancer centers and their breast surgeons, we conducted a quality outcomes project to examine our data and factors which could result in delay. Methods: We conducted a retrospective review evaluating all cases of patients diagnosed with stage 1 and 2 breast cancer at all of our cancer centers during the 2015 and 2016 calendar years, utilizing patient lists obtained from our cancer registries. Patients who received neoadjuvant chemotherapy or who had inadequate data were excluded. Variables included stage at diagnosis, percent of nodal positivity, age at diagnosis, race and ethnicity, attending surgeon, type of surgery (breast conservation vs. mastectomy +/- reconstruction), and number of days from final breast surgery to initiation of adjuvant chemotherapy treatment. Results: 757 and 319 patients with Stage I and II breast cancer respectively were identified in our 5 cancer centers. 16% had nodal positivity, and 25.6% received adjuvant chemotherapy. Average age at diagnosis was 62.5, and average age for node positive and adjuvant chemotherapy were 58.5 and 56.8. Days to chemotherapy ranged from 3-208, with 94% of patients treated in less than 12 weeks and ranges of mean days to begin chemotherapy 35.6 to 55.4 in our cancer centers. No significant differences were noted by age, race, ethnicity, stage, surgery type, surgeon, or hospital. Conclusions: This study reveals outcomes suggesting that our breast cancer teams at our cancer centers are meeting the current standard of care for initiation of adjuvant chemotherapy, and points to the value of quality studies in assuring standards of care.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS598-TPS598
Author(s):  
Heather L. McArthur ◽  
Michail Ignatiadis ◽  
Sebastian Guillaume ◽  
Andrew Bailey ◽  
Jorge Luis Martinez ◽  
...  

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.


Mastology ◽  
2020 ◽  
Vol 30 (Suppl 1) ◽  
Author(s):  
Bianca Pamela Soares ◽  
Grasiela Benini dos Santos Cardoso ◽  
Marcia Fernanda Roque da Silva ◽  
Roberto Odebrecht Rocha

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.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1069-1069
Author(s):  
Tithi Biswas ◽  
Shreya Prasad ◽  
Timothy Zagar ◽  
Jimmy Efird ◽  
Sarah E. James ◽  
...  

1069 Background: TNBC accounts for about 15-20% of all breast cancer. TNBC has particularly aggressive clinical course and accounts for a disproportionate number of breast cancer relapses and deaths in early stage disease. TNBC also have worse prognosis especially in African American (AA) women compared with white women. This retrospective study aims to investigate various clinical and demographic prognostic factors in TNBC. Methods: 476 TNBC patients who were treated at Eastern Carolina University and University of North Carolina, CH between 4/96 and 9/11 were included in this analysis. We collected data on age, race, grade, lymphovascular invasion (LVI), stage, treatments including surgery, chemotherapy, radiation, chemotherapy drugs, insurance type and year of treatment. Overall Survival (OS) was computed from the date of diagnosis to the date of death or last FU. For disease free survival (DFS), patients were scored if they failed either locally or distally. The Cox proportional-hazards regression model was used to compute hazard ratios. Results: The median age was 52 years (21-88 years) with median FU of 3.7 years. 49% women were white race followed by AA 223 (47%) and Hispanic or other race (5%). Stage (p<0.001), grade (p=0.02), surgery (p<0.0001), adjuvant chemotherapy (p=0.025), LVI (p=0.05) and type of insurance were significant predictor of OS. Similarly, stage (p<0.0001), surgery (p<0.0001), LVI (p=0.03) and insurance were significant predictors for DFS. On multivariate analysis, stage, surgery and adjuvant chemotherapy remained statistically significant predictors. Medicaid vs. Private Insurance also remained a significant detriment of survival (OS: HR=3.6, p<0.0001; DFS: HR=2.8, p<0.0001) as did having No Insurance for OS (HR=2.0, p=0.0074). Conclusions: To our knowledge, this is a largest retrospective study showing type of insurance to be a strong predictor of outcome in this very specific breast cancer subtype which remained significant after adjusting all other variables. Further insight is needed to determine the cause of this finding.


2009 ◽  
Vol 27 (24) ◽  
pp. 3881-3886 ◽  
Author(s):  
Raymond Tubbs ◽  
William E. Barlow ◽  
G. Thomas Budd ◽  
Eric Swain ◽  
Peggy Porter ◽  
...  

PurposeAmplification and deletion of the TOP2A gene have been reported as positive predictive markers of response to anthracycline-based therapy. We determined the status of the HER2 and TOP2A genes in a large cohort of breast cancer patients treated with adjuvant doxorubicin (A) and cyclophosphamide (C).Patients and MethodsTOP2A/CEP17 and HER2/CEP17 fluorescent in situ hybridization (FISH) were performed on tissue microarrays (TMAs) constructed from 2,123 of the 3,125 women with moderate-risk primary breast cancer who received equivalent doses of either concurrent adjuvant chemotherapy with A plus C (n = 1,592) or sequential A followed by C (n = 1,533).ResultsAn abnormal TOP2A genotype was identified for 153 (9.4%) of 1,626 patients (4.0% amplified; 5.4% deleted). An abnormal HER2 genotype was identified for 303 (20.4%) of 1,483 patients (18.8% amplified; 1.6% deleted). No significant differences in either overall survival (OS) or disease-free survival (DFS) were identified for TOP2A. In univariate analysis, OS and DFS rates were strongly and adversely associated only with higher levels of HER2 amplification (ratio ≥ 4.0). Survival was not associated with low-level HER2 amplification (ratio ≥ 2; OS hazard ratio [HR], 1.14; P = .39; DFS HR, 1.07; P = .62), but it was associated for a ratio ≥ 4 (OS HR, 1.45; P = .03; DFS HR, 1.38; P = .033), in which analysis was adjusted for menopausal status, hormone receptor status, treatment, number of positive nodes, and tumor size.ConclusionIn this population of patients with early-stage breast cancer who were treated with adjuvant AC chemotherapy, TOP2A abnormalities were not associated with outcome. HER2 high-level amplification was a prognostic marker in anthracycline-treated patients.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS597-TPS597
Author(s):  
Shigehira Saji ◽  
Heather L. McArthur ◽  
Michail Ignatiadis ◽  
Andrew Bailey ◽  
Sarra El-Abed ◽  
...  

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.


2011 ◽  
Vol 10 (3) ◽  
pp. 209-212
Author(s):  
Federico L. Ampil ◽  
Quyen Chu ◽  
Gloria Caldito ◽  
Benjamin D.L. Li ◽  
Gary V. Burton ◽  
...  

AbstractGuidelines concerning early stage breast cancer do not clearly recommend tumour bed boost dose after breast conserving surgery and irradiation when the resection margins are negative. Because the number of these patients is expected to increase, we evaluated the results of our treatment scheme in which the additional tumour bed dose was omitted. One hundred consecutive individuals with ductal carcinoma in-situ or stage I or II cancer of the breast were identified for this retrospective analysis. The observed ipsilateral breast tumour recurrence and 10-year disease-free survival rates were 4% and 91% respectively. Univariate analysis indicated that triple receptor negative tumour is the most independent prognostic risk factor. In conclusion, the observed low rate of local recurrence and many long-term survivors in this study seem to legitimize the omission of the tumour bed boost dose after whole breast irradiation in women with early carcinoma of the breast and free breast conserving surgical margins.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xingfa Huo ◽  
Jinming Li ◽  
Fuxing Zhao ◽  
Dengfeng Ren ◽  
Raees Ahmad ◽  
...  

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.


2021 ◽  
Vol 11 (21) ◽  
pp. 9800
Author(s):  
Annarita Fanizzi ◽  
Maurizio Cosmo Ressa ◽  
Gianluca Gatta ◽  
Cristian Cristofaro ◽  
Valerio De Santis ◽  
...  

Several retrospective analyses of large amounts of contemporary data have shown the superiority of breast conservative surgery (BCS) over mastectomy carried out in the early stage of breast cancer. The characteristics of the patients and cancers that are most likely to benefit from BCS remain unclear. In our work, we analyzed the disease-free survival (DFS) of a cohort of patients treated with BCS or mastectomy between 1995 and 2018 in our institute with pT1-2, pN0, or cM0 breast cancer. The DFS curves of patients treated with both mastectomy and quadrantectomy were compared in the different subsamples with respect to the clinical and histopathological characteristics. We identified 188 eligible patients treated with BCS and 64 patients treated with mastectomy. DFS was not found to be statistically higher in patients treated with BCS compared to those treated with mastectomy, who achieved a 5-year DFS of 89.9% vs. 81.3% and a 10-year DFS of 78.9% vs. 79.3%, respectively. No significant differences were detected for the DFS curves when patients were differentiated by the type of surgical treatment received, age, and the tumor histological characteristics. We verified a p-value just above the 10% significance threshold for patients with tumor dimensions between 20 mm and 50 mm and molecular sub-type Luminal B. In our experience, treatment with mastectomy is not associated with improved DFS compared to treatment with BCS in women with early-stage tumors.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12100-e12100
Author(s):  
Nathalie LeVasseur ◽  
Christine E. Simmons ◽  
Lovedeep Gondara ◽  
Caroline Speers ◽  
Rekha M. Diocee ◽  
...  

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.


Open Medicine ◽  
2009 ◽  
Vol 4 (4) ◽  
pp. 454-458
Author(s):  
Ahmet Alacacioglu ◽  
Baha Zengel ◽  
Ali Denecli

AbstractAdjuvant chemotherapy decreases the risk of breast cancer recurrence in patients with breast cancer. In addition, it increases the rate of survival. Therefore, various chemotherapy regimens are administered in the treatment of breast cancer. The efficacy of taxane-based adjuvant chemotherapies has been demonstrated in various trials. This trial was designed to retrospectively evaluate the efficacy of taxane-based chemotherapies in lymph node-positive, early-stage Turkish breast cancer patients. 29 patients receiving TAC regimen and 29 patients receiving AC+P regimen were evaluated. 6 courses of TAC regimen were administered every 3 weeks (docetaxel 75 mg/m2, doxorubicine 50 mg/m2, cyclophosphamide 500 mg/m2). The other patient group was administered AC+P regimen (4 courses of doxorubicin 60mg/m2, cyclophosphamide 600 mg/m2 combination every 2 weeks, followed by paclitaxel 175 mg/m2 for 4 courses every 2 weeks). The 1-year, 2-year and 3-year disease-free survival (DFS) rates were 96.3%, 81.1% and 72.8% respectively. No significant difference was detected in DFS between premenopausal and postmenopausal patients on the taxane regimen (p=0.82). There was no significant difference in DFS between estrogen or progesterone receptor positive and negative patients (p=0.46). Disease-free survival of patients receiving TAC and AC+P adjuvant chemotherapy regimen was compared. The follow-up period of patients on AC+P chemotherapy was longer than those receiving TAC (AC+P mean 38.6±12.8 months, TAC mean 17.1±5.4 months). No significant difference was observed upon evaluation of both treatment arms with respect to DFS (p=0.92). In conclusion, this trial once more demonstrated that taxane-based adjuvant chemotherapy was effective and safe in lymph node-positive, early-stage Turkish breast cancer patients.


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