scholarly journals Radiological and pathological assessment of response to neoadjuvant CDK4/6 inhibitor and endocrine treatments in a real-life setting—initial results

2021 ◽  
Vol 10 (8) ◽  
pp. 205846012110306
Author(s):  
Mikko Moisander ◽  
Annukka Salminen ◽  
Arja Jukkola ◽  
Antti Sassi ◽  
Maija Tervo ◽  
...  
Keyword(s):  
Residual Disease ◽  
Real Life ◽  
Metastatic Breast ◽  
Endocrine Treatment ◽  
Breast Cancers ◽  
Response Evaluation ◽  
Neoadjuvant Endocrine Therapy ◽  
Residual Cancer Burden ◽  
Real Life Setting ◽  
Radiological Response

Background Neoadjuvant endocrine therapy is an alternative to neoadjuvant chemotherapy in women with inoperable luminal-like breast cancers. Neoadjuvant cyclin-dependent kinase 4/6 inhibitor treatment combined with endocrine treatment (CDK4/6I + E) is interesting given the combination’s utility in the treatment of metastatic breast cancer. Currently, the literature on the radiological response evaluation of patients treated with neoadjuvant CDK4/6I + E in a real-life setting is scarce. Purpose To conduct a radiological response evaluation of patients treated with neoadjuvant CDK4/6I + E in a real-life setting. Material and methods We retrospectively reviewed clinical, pathological, and radiological findings of six patients with luminal-like breast cancers treated with neoadjuvant CDK4/6I + E treatment. The radiological neoadjuvant CDK4/6I + E response was evaluated with the RECIST 1.1 criteria and the pathological residual disease was assessed using the Residual Cancer Burden (RBC) criteria. Results None of the patients achieved a complete radiological magnetic resonance imaging (MRI)–determined response or a complete pathological response; three (50%) patients had a partial radiological response; in the three others, the disease remained stable radiologically. All of the tumors were rendered susceptible to surgical treatment. Two out of six (33.3%) patients had a moderate response (RBC-II); four (66.7%) had an extensive residual disease (RBC-III) in the final surgical sample. Conclusion Although none of the patients achieved a pathologically complete response, neoadjuvant CDK4/6I + E treatment rendered all tumors operable. MRI appears to be reliable in the assessment of the neoadjuvant CDK4/6I + E treatment response in a real-life setting. Larger studies are warranted to confirm these results.

scholarly journals Metronomic chemotherapy (mCHT) in metastatic triple-negative breast cancer (TNBC) patients: results of the VICTOR-6 study

2021 ◽  
Author(s):  
M. E. Cazzaniga ◽  
I. Vallini ◽  
E. Montagna ◽  
D. Amoroso ◽  
R. Berardi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Real Life ◽  
Tumour Response ◽  
Metastatic Breast ◽  
Metronomic Chemotherapy ◽  
Clinical Activity ◽  
Breast Cancers ◽  
Real Life Setting

Abstract Purpose Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks the expression of oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER2): TNBC accounts for approximately 20% of newly diagnosed breast cancers and is associated with younger age at diagnosis, greater recurrence risk and shorter survival time. Therapeutic options are very scarce. Aim of the present analysis is to provide further insights into the clinical activity of metronomic chemotherapy (mCHT), in a real-life setting. Methods We used data included in the VICTOR-6 study for the present analysis. VICTOR-6 is an Italian multicentre retrospective cohort study, which collected data of metastatic breast cancer (MBC) patients who have received mCHT between 2011 and 2016. Amongst the 584 patients included in the study, 97 were triple negative. In 40.2% of the TNBC patients, mCHT was the first chemotherapy treatment, whereas 32.9% had received 2 or more lines of treatment for the metastatic disease. 45.4% out of 97 TNBC patients received a vinorelbine (VRL)-based regimen, which resulted in the most used type of mCHT, followed by cyclophosphamide (CTX)-based regimens (30.9%) and capecitabine (CAPE)-based combinations (22.7%). Results Overall response rate (ORR) and disease control rate (DCR) were 17.5% and 64.9%, respectively. Median progression free survival (PFS) and overall survival (OS) were 6.0 months (95% CI: 4.9–7.2) and 12.1 months (95% CI: 9.6–16.7). Median PFS was 6.9 months for CAPE-based regimens (95% CI: 5.0–18.4), 6.1 months (95% CI: 4.0–8.9) for CTX-based and 5.3 months (95% CI: 4.1–9.5) for VRL-based ones. Median OS was 18.2 months (95% CI: 9.1-NE) for CAPE-based regimens and 11.8 months for VRL- (95% CI: 9.3–16.7 and CTX-based ones (95%CI: 8.7–52.8). Tumour response, PFS and OS decreased proportionally in later lines. Conclusion This analysis represents the largest series of TNBC patients treated with mCHT in a real-life setting and provides further insights into the advantages of using this strategy even in this poor prognosis subpopulation.

scholarly journals PD-L1 Expression after Neoadjuvant Chemotherapy in Triple-Negative Breast Cancers Is Associated with Aggressive Residual Disease, Suggesting a Potential for Immunotherapy

Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 746
Author(s):  
Beatriz Grandal ◽  
Manon Mangiardi-Veltin ◽  
Enora Laas ◽  
Marick Laé ◽  
Didier Meseure ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Triple Negative ◽  
Residual Disease ◽  
Checkpoint Inhibitors ◽  
Rapid Development ◽  
Complete Response ◽  
Tumor Burden ◽  
Small Subset ◽  
Breast Cancers ◽  
Residual Cancer Burden

The consequences of neoadjuvant chemotherapy (NAC) for PD-L1 activity in triple-negative breast cancers (TNBC) are not well-understood. This is an important issue as PD-LI might act as a biomarker for immune checkpoint inhibitors’ (ICI) efficacy, at a time where ICI are undergoing rapid development and could be beneficial in patients who do not achieve a pathological complete response. We used immunohistochemistry to assess PD-L1 expression in surgical specimens (E1L3N clone, cutoff for positivity: ≥1%) on both tumor (PD-L1-TC) and immune cells (PD-L1-IC) from a cohort of T1-T3NxM0 TNBCs treated with NAC. PD-L1-TC was detected in 17 cases (19.1%) and PD-L1-IC in 14 cases (15.7%). None of the baseline characteristics of the tumor or the patient were associated with PD-L1 positivity, except for pre-NAC stromal TIL levels, which were higher in post-NAC PD-L1-TC-positive than in negative tumors. PD-L1-TC were significantly associated with a higher residual cancer burden (p = 0.035) and aggressive post-NAC tumor characteristics, whereas PD-L1-IC were not. PD-L1 expression was not associated with relapse-free survival (RFS) (PD-L1-TC, p = 0.25, and PD-L1-IC, p = 0.95) or overall survival (OS) (PD-L1-TC, p = 0.48, and PD-L1-IC, p = 0.58), but high Ki67 levels after NAC were strongly associated with a poor prognosis (RFS, p = 0.0014, and OS, p = 0.001). A small subset of TNBC patients displaying PD-L1 expression in the context of an extensive post-NAC tumor burden could benefit from ICI treatment after standard NAC.

Analysis according to prognostic factors in patients (pts) treated with first-line bevacizumab (BEV) combined with paclitaxel (PAC) for HER2-negative metastatic breast cancer (mBC) in a routine oncology practice study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1077-1077 ◽  
Author(s):  
Iris Schrader ◽  
Frank Gerhard Foerster ◽  
Andreas Schneeweiss ◽  
Matthias Geberth ◽  
Lars Hahn ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Real Life ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Real Life Setting ◽  
Long Term Follow Up ◽  
Practice Study ◽  
Oncology Practice

1077 Background: 1st-line BEV combined with weekly PAC significantly improves progression-free survival (PFS) and response rate (RR) vs PAC alone in HER2-negative mBC, as shown in E2100. We analyzed data from a German routine oncology practice study of 1st-line BEV–PAC according to prognostic factors. Methods: Pts who had received no prior chemotherapy for mBC received BEV–PAC according to the European label. Efficacy and safety were documented for up to 1 y (or until progression, death, or BEV discontinuation if earlier) with additional long-term follow-up. Efficacy was analyzed in clinically important subgroups. Results: Efficacy data were available for 818 pts. The median duration of follow-up was 11.4 mo. The composition of the pt population with respect to the subgroups below was generally similar to the population treated in E2100, except for a higher proportion of pts with visceral disease or metastases in <3 organs. RR was very similar across all subgroups analyzed. Differences in median PFS and OS were generally in line with the differing prognoses according to clinical characteristics. Conclusions: These data suggest that 1st-line BEV–PAC is typically associated with median PFS >9 mo in the real-life setting, irrespective of baseline characteristics. [Table: see text]

scholarly journals PD-L1 expression is associated with higher residual cancer burden in triple-negative breast cancers with residual disease after neoadjuvant chemotherapy

2020 ◽  
Author(s):  
Beatriz Grandal ◽  
Manon Mangiardi-Veltin ◽  
Enora Laas ◽  
Marick Laé ◽  
Didier Meseure ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Triple Negative ◽  
Residual Disease ◽  
Checkpoint Inhibitors ◽  
Rapid Development ◽  
Small Subset ◽  
Breast Cancers ◽  
Residual Cancer ◽  
Cancer Burden ◽  
Residual Cancer Burden

AbstractThe consequences of neoadjuvant chemotherapy (NAC) for PD-L1 activity in triple-negative breast cancers (TNBC) are not well understood. This is an important issue as immune checkpoint inhibitors (ICI) are undergoing rapid development and could be beneficial in patients who do not achieve a pathological complete response. We used immunohistochemistry to assess PD-L1 expression (E1L3N clone, cutoff for positivity: ≥ 1%) on both tumor (PD-L1-TC) and immune cells (PD-L1-IC) from a cohort of surgical specimens of T1-T3NxM0 TNBCs treated with NAC. PD-L1-TC was detected in 17 cases (19.1%) and PD-L1-IC in 14 cases (15.7%). None of the baseline characteristics of the tumor or the patient were associated with PD-L1 positivity, except for pre-NAC stromal TIL levels, which were higher in post-NAC PD-L1-TC-positive than in negative tumors. PD-L1-TC were significantly associated with a higher residual cancer burden (p=0.035) and aggressive post-NAC tumor characteristics, whereas PD-L1-IC were not. PD-L1 expression was not associated with DFS (p=0.38) or OS (p=0.48), but high Ki67 levels after NAC were strongly associated with a poor prognosis (DFS p=0.0014 and OS p=0.001). A small subset of TNBC patients displaying PD-L1 expression in the context of an extensive post-NAC tumor burden could benefit from ICI treatment after standard NAC.

Treatment Algorithms for Hormone Receptor-Positive Advanced Breast Cancer: Applying the Results from Recent Clinical Trials into Daily Practice—Insights, Limitations, and Moving Forward

2013 ◽  
pp. e20-e27
Author(s):  
Sheridan Wilson ◽  
Stephen K. Chia
Keyword(s):  
Breast Cancer ◽  
Hormone Receptor ◽  
Acquired Resistance ◽  
Mammalian Target Of Rapamycin ◽  
Real Life ◽  
Metastatic Breast ◽  
Predictive Biomarkers ◽  
Endocrine Treatment ◽  
First Line ◽  
Hormone Receptor Positive

Hormone receptor–positive (HR+) breast cancer is the most prevalent subtype of breast cancer in both early- and advanced-stage disease. Thus, the treatment of HR+ breast cancer has had the greatest global influence in improving clinical outcomes overall. Although the first-line metastatic breast cancer (MBC) trials comparing a third-generation aromatase inhibitor (AI) to tamoxifen have favored the AI, one of the challenges in translating these findings into clinical practice stems from the influence of prior adjuvant endocrine therapy, particularly the increasing use of adjuvant AIs today, on the choice of endocrine agent in the advanced setting because of the development of acquired resistance. Because the majority of patients enrolled into these studies were either endocrine-treatment naïve or exposed to tamoxifen only, the “real-life” applicability of the evidence is unclear. Because a superior dose of the selective estrogen receptor (ER) downregulator fulvestrant has now been established, its role as first-line therapy is being re-established. We are now starting to see the promise realized with blocking cross-talking growth factor pathways in addition to the ER pathway. The greatest efficacy is seen with the mammalian target of rapamycin (mTOR) inhibitor everolimus in combination with exemestane and, perhaps to a lesser extent, anti-HER2–directed therapy in combination with an AI. Future gains will likely involve a greater understanding of the redundancy and compensation induced by blocking these pathways, trials involving blocking multiple pathways in addition to hormonal agents, and the molecular interrogation of the individual's tumor in search of predictive biomarkers and “actionable” genomic aberrations.

registHER: Treatment outcomes in patients with HER2-positive (HER2+), hormone receptor-positive (HR+) metastatic breast cancer (MBC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1057-1057
Author(s):  
D. Tripathy ◽  
P. Kaufman ◽  
A. Brufsky ◽  
M. Mayer ◽  
M. Yood ◽  
...  
Keyword(s):  
Growth Regulation ◽  
Randomized Trials ◽  
Real Life ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Breast Cancers ◽  
Her2 Positive ◽  
Treatment Regimens ◽  
Hormone Receptor Positive ◽  
Academic Settings

1057 Background: Approximately 50% of HER2+ breast cancers are HR+ (defined as estrogen receptor [ER] and/or progesterone receptor [PR] positive). Cross talk between growth factor and ER-dependent signaling pathways may affect growth regulation in HER2+ breast cancers. Blockade of both pathways appears to be more active than blocking either alone based on randomized trials performed in selected populations. However, the outcomes of HER2+ and HR+ MBC patients relative to those in real- life clinical practice have not been evaluated in large cohort studies. Methods: registHER is a prospective observational study of 1023 patients with newly diagnosed (within 6 months [mo]) HER2+ MBC treated in community/academic settings, enrolled from 12/03 to 2/06. Median follow-up from MBC diagnosis was 25 mo at data cutoff (1/02/08). Treatment patterns and outcomes in patients with HER2+/HR+ MBC receiving 1st-line therapy (i.e., therapies received prior to 1st progression) are described in this analysis. Results: Of the 963 (94%) treated HER2+ patients with recorded HR tumor status, 55% (533) were HR+ and 45% (430) were HR-negative. 1st-line MBC treatment regimens for HER2+/HR+ patients included endocrine therapy (E) only, 57 (10.7%); E + trastuzumab (T), 50 (9.4%); chemotherapy (C) ± E, 41 (7.7%); and C + trastuzumab (T) ± E, 361 (67.7%). Progression-free survival (PFS) and overall survival (OS) by 1st line treatment groups are in the table. Conclusions: In registHER, HER2+/HR+ patients treated with E+T had longer PFS than patients treated with E alone; E- alone median PFS is consistent with findings in prospective randomized trials. These data provide further information regarding trastuzumab's role in targeting dual pathways in HER2+/HR+ MBC patients in a real-world setting. Multivariate analysis to address potential bias from known prognostic factors that may influence treatment choice will be presented. [Table: see text] [Table: see text]

scholarly journals Accuracy of breast MRI in patients receiving neoadjuvant endocrine therapy: comprehensive imaging analysis and correlation with clinical and pathological assessments

2020 ◽  
Vol 184 (2) ◽  
pp. 407-420
Author(s):  
Joana Reis ◽  
Jonas Christoffer Lindstrøm ◽  
Joao Boavida ◽  
Kjell-Inge Gjesdal ◽  
Daehoon Park ◽  
...  
Keyword(s):  
Residual Disease ◽  
Tumour Size ◽  
Locally Advanced ◽  
Tumour Response ◽  
Growth Factor Receptor ◽  
Breast Mri ◽  
Clinical Results ◽  
Post Treatment ◽  
Endocrine Treatment ◽  
Neoadjuvant Endocrine Therapy

Abstract Purpose To assess the accuracy of magnetic resonance imaging (MRI) measurements in locally advanced oestrogen receptor-positive and human epidermal growth factor receptor 2-negative breast tumours before, during and after neoadjuvant endocrine treatment (NET) for evaluation of tumour response in comparison with clinical and pathological assessments. Methods This prospective study enrolled postmenopausal patients treated neoadjuvant with letrozole and exemestane given sequentially in an intra-patient cross-over regimen. Fifty-four patients were initially recruited, but only 35 fulfilled the inclusion criteria and confirmed to participate with a median age of 77. Tumours were scanned with MRI prior to treatment, during the eighth week of treatment and prior to surgery. Additionally, changes in longest diameter on clinical examination (CE) and tumour size at pathology were determined. Pre- and post-operative measurements of tumour size were compared in order to evaluate tumour response. Results The correlation between post-treatment MRI size and pathology was moderate and higher with a correlation coefficient (r) 0.64 compared to the correlation between CE and pathology r = 0.25. Post-treatment MRI and clinical results had a negligible bias towards underestimation of lesion size. Tumour size on MRI and CE had 0.82 cm and 0.52 cm lower mean size than tumour size measured by pathology, respectively. Conclusions The higher correlation between measurements of residual disease obtained on MRI and those obtained with pathology validates the accuracy of imaging assessment during NET. MRI was found to be more accurate for estimating complete responses than clinical assessments and warrants further investigation in larger cohorts to validate this finding.

scholarly journals Nab-paclitaxel (nab-P) in metastatic breast cancer (MBC) in elderly patients: A real life setting (NEREIDE study)

2018 ◽  
Vol 29 ◽  
pp. viii102
Author(s):  
V. Adamo ◽  
G.R.R. Ricciardi ◽  
S. Schifano ◽  
A. Russo ◽  
V. Gebbia ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Elderly Patients ◽  
Real Life ◽  
Metastatic Breast ◽  
Real Life Setting
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