Long-term outcomes of patients with node-negative (N0), triple-negative breast cancer (TNBC) who did not receive adjuvant chemotherapy according to stromal TILs (sTILs).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 548-548
Author(s):  
Roberto Antonio Leon-Ferre ◽  
Jodi M Carter ◽  
David W. Hillman ◽  
Kathleen S. Tenner ◽  
David Zahrieh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Systemic Therapy ◽  
Early Stage ◽  
Disease Free Survival ◽  
Predictive Biomarker ◽  
Locoregional Therapy ◽  
Rank Test ◽  
Long Term Outcomes

548 Background: sTILs are a well-established prognostic and predictive biomarker in patients with operable TNBC receiving pre or postoperative systemic therapy. We1 and others2,3 have also shown that sTILs are prognostic in patients who did not receive adjuvant chemotherapy. Here, we detail the outcomes of systemically untreated patients with N0 TNBC according to sTIL score. We focused on the N0 subset as a group of patients who may be candidates for future prospective therapy de-escalation trials. Methods: From a clinically annotated cohort of 605 patients with centrally confirmed TNBC (ER/PR < 1% and HER2 negative) with long-term outcomes data, we identified 182 patients treated with locoregional therapy only (breast surgery +/- radiation therapy and no chemotherapy). The clinicopathological characteristics of this cohort have previously been published1. In this analysis, we report the 5- and 10-year invasive disease-free survival (iDFS) and overall survival (OS) rates of patients with N0 TNBC according to sTIL levels. IDFS and OS were defined as per the STEEP classification and estimated using the Kaplan–Meier method. Comparisons of the survival distributions between groups were assessed by the log-rank test. sTILs were assessed as a continuous parameter according to the International TIL Working Group guidelines. For comparisons of outcomes between groups, tumors were classified as lymphocyte-predominant TNBC (defined as containing ≥50% sTILs) vs non-lymphocyte-predominant ( < 50% sTILs). Results: Of 182 systemically untreated patients, 149 (82%) were N0 and most (78%) were post-menopausal. T stage distribution was T1: 68%, T2: 28%, T3/4: 4%. Among N0 patients, 31 (21%) had lymphocyte-predominant TNBC, and in this group the 5-year iDFS and OS were 89% (95% CI 76-100) and 96% (95% CI 89-100), while the 10-year iDFS and OS were 89% (95% CI 76-100) and 87% (95% CI 73-100), respectively. In contrast, outcomes for patients with non-lymphocyte predominant TNBC were significantly worse. For this group, 5-year iDFS and OS were 62% (95% CI 53-73) and 78% (95% CI 71-86) while the 10-year iDFS and OS were 45% (95% CI 36-58) and 66% (95% CI 68-76), respectively ( log-rank p = 0.02 for iDFS and log-rank p = 0.03 for OS). Conclusions: sTIL quantification identifies a subset of patients with early-stage N0 TNBC with an exceedingly good prognosis, even in the absence of adjuvant chemotherapy. These data provide support for the evaluation of sTILs as part of prospective investigation of systemic therapy de-escalation strategies in N0 TNBC. References:1Leon-Ferre et al, Breast Cancer Res Treat (2018) 167:89-99 2Park et al, Ann Oncol (2019) 12:1941-1949 3De Jong et al, ESMO 2020

scholarly journals Best Foot Forward: Neoadjuvant Systemic Therapy as Standard of Care in Triple-Negative and HER2-Positive Breast Cancer

2020 ◽  
pp. e1-e16
Author(s):  
Priyanka Sharma ◽  
Roisin M. Connolly ◽  
Evanthia T. Roussos Torres ◽  
Alastair Thompson
Keyword(s):  
Breast Cancer ◽  
Systemic Therapy ◽  
Residual Disease ◽  
Early Stage ◽  
Treatment Strategies ◽  
Long Term Outcomes ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

Neoadjuvant systemic treatment of early-stage breast cancer has been used to improve resectability and reduce the extent of breast and axillary surgery. More recently, several other merits of neoadjuvant systemic treatment have emerged, including the ability to tailor clinically available adjuvant systemic therapy options based on pathologic response and to serve as a platform for early assessment of novel agents and response biomarkers and as an avenue for treatment optimization investigations (local and systemic therapy escalation and de-escalation trials guided by pathologic response). Attainment of a pathologic complete response (pCR) is associated with excellent long-term outcomes; conversely, the presence of residual disease is associated with a high risk of recurrence for patients with HER2-positive breast cancer and triple-negative breast cancer (TNBC). Treatment strategies in early-stage HER2-positive breast cancer include regimens incorporating trastuzumab, pertuzumab, ado-trastuzumab emtansine, and neratinib, resulting in high pCR rates and overall excellent long-term outcomes. Currently available cytotoxic regimens yield pCR for 35% to 55% of patients with TNBC, and immune checkpoint inhibition is showing early promise for this subtype. New drug and predictive biomarker evaluations in the neoadjuvant setting aim to develop optimal treatment strategies for the individual patient, with the ultimate goal of maximizing efficacy and minimizing toxicity. Research efforts involving novel agents are being undertaken to address the high risk of recurrence for patients with residual disease. Omission of breast surgery following neoadjuvant chemotherapy requires further development of imaging and biopsy techniques to accurately assess the extent of residual disease before clinical application.

scholarly journals Neoadjuvant radiotherapy of early-stage breast cancer and long-term disease-free survival

2017 ◽  
Vol 19 (1) ◽  
Author(s):  
Jan Poleszczuk ◽  
Kimberly Luddy ◽  
Lu Chen ◽  
Jae K. Lee ◽  
Louis B. Harrison ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Disease Free Survival ◽  
Early Stage Breast Cancer ◽  
Neoadjuvant Radiotherapy ◽  
Free Survival ◽  
Disease Free

5-Year Results of Dose-Intensive Sequential Adjuvant Chemotherapy for Women With High-Risk Node-Positive Breast Cancer: A Phase II Study

1999 ◽  
Vol 17 (4) ◽  
pp. 1118-1118 ◽  
Author(s):  
C. Hudis ◽  
M. Fornier ◽  
L. Riccio ◽  
D. Lebwohl ◽  
J. Crown ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Pilot Study ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Dose Dense ◽  
Disease Free

PURPOSE: We conducted a phase II pilot study of dose-intensive adjuvant chemotherapy with doxorubicin followed sequentially by high-dose cyclophosphamide to determine the safety and feasibility of this dose-dense treatment and to estimate the disease-free and overall survival in breast cancer patients with four or more involved axillary lymph nodes. PATIENTS AND METHODS: Seventy-three patients received adjuvant treatment with four cycles of doxorubicin 75 mg/m2 as an intravenous bolus every 21 days, followed by three cycles of cyclophosphamide 3,000 mg/m2 every 14 days with granulocyte colony-stimulating factor support. RESULTS: Seventy-one patients were assessable, and all but two completed all planned chemotherapy. There was no treatment-related mortality. The most common toxicity was neutropenic fever, which occurred in 39% of patients. Median disease-free survival is 66 months (95% confidence interval, 34 to 98 months), and median overall survival has not yet been reached. At 5 years of follow-up, the disease-free survival is 51.7%, and overall survival is 60.0%. There is no long-term treatment-related toxicity, and no cases of acute myelogenous leukemia or myelodysplastic syndrome have been observed. CONCLUSION: Our pilot study of doxorubicin followed by cyclophosphamide demonstrates the safety and feasibility of the sequential dose-dense plan. Long-term follow-up, although noncomparative, is promising. However, this regimen is associated with a higher incidence of toxicity (and also higher costs) than the standard dose and schedule of doxorubicin and cyclophosphamide, and therefore it should not be used as conventional therapy in the absence of demonstrated improvement of outcome. Randomized trials testing the dose-dense approach have been completed but not yet reported. Because the sequential plan can decrease overlapping toxicities, it is an appropriate platform for the addition of newer active agents, such as taxanes or monoclonal antibodies.

Long-term outcomes in women with low-risk hormone-sensitive early-stage breast cancer.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e12583-e12583
Author(s):  
Jinani Jayasekera ◽  
Clyde Schechter ◽  
Joseph A. Sparano ◽  
Suzanne C. O'Neill ◽  
Jeanne S. Mandelblatt
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Low Risk ◽  
Early Stage Breast Cancer ◽  
Long Term Outcomes ◽  
Hormone Sensitive

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.

Preoperative Breast MRI for Early-Stage Breast Cancer: Effect on Surgical and Long-Term Outcomes

2014 ◽  
Vol 202 (6) ◽  
pp. 1376-1382 ◽  
Author(s):  
Janice S. Sung ◽  
Jie Li ◽  
Glenys Da Costa ◽  
Sujata Patil ◽  
Kimberly J. Van Zee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Breast Mri ◽  
Early Stage Breast Cancer ◽  
Long Term Outcomes ◽  
Preoperative Breast Mri

scholarly journals Impact of Exercise on Chemotherapy Tolerance and Survival in Early-Stage Breast Cancer: A Nonrandomized Controlled Trial

2020 ◽  
Vol 18 (12) ◽  
pp. 1670-1677
Author(s):  
Amy A. Kirkham ◽  
Karen A. Gelmon ◽  
Cheri L. Van Patten ◽  
Kelcey A. Bland ◽  
Holly Wollmann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Weight Gain ◽  
Adjuvant Chemotherapy ◽  
Dose Reduction ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Rank Test ◽  
Historical Cohort ◽  
Log Rank Test ◽  
Treatment Tolerance

Background: Available preliminary evidence is conflicting on whether exercise can positively influence antineoplastic treatment tolerance and in turn improve survival. Patients and Methods: This study compared chemotherapy treatment tolerance and survival among women receiving adjuvant chemotherapy for early-stage breast cancer who participated in a single-arm trial of supervised aerobic and resistance exercise programming versus a historical cohort that did not receive structured exercise programming. Results: The exercise group (EX; n=73) and control group (CTR; n=85) participants were matched on age and treatment and balanced on medical history, cancer diagnosis, and body mass index. Attendance in the EX group was 64% ± 27% of 3 offered sessions per week. For all chemotherapy agents combined, the relative risk (RR) of a chemotherapy dose reduction (RR, 0.78; 95% CI, 0.54–1.11) or delay (RR, 1.05; 95% CI, 0.62–1.80) did not differ between groups. However, the EX group had reduced relative and absolute risks of a dose reduction in doxorubicin by 60% and 18%, respectively. For all agents combined, there were no differences between groups in risk of anemia, neutropenia, or weight gain. In the EX group, dose reductions due to neutropenia (P=.027), other infections (P=.049), and fatigue (P=.037) were less common, whereas mucositis was more common (P=.023), compared with the CTR group. The EX group had reduced relative and absolute risks of weight gain on the docetaxel + cyclophosphamide regimen by 38% and 30%, respectively. After a median follow-up of 70 months (range, 54–84 months), there was no difference between the EX and CTR groups in disease-free survival events (n=8 [11%] vs n=9 [11%], respectively; log-rank test, P=.78) or overall survival events (n=5 [7%] vs n=6 [7%], respectively; log-rank test, P=.974). Conclusions: Overall, exercise programming during adjuvant chemotherapy does not appear to impact treatment tolerance or survival in women receiving common modern regimens of adjuvant chemotherapy for early-stage breast cancer. However, exercise may provide selective benefits, depending on the treatment regimen received.

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.

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