scholarly journals Oral metronomic vinorelbine combined with endocrine therapy in hormone receptor-positive HER2-negative breast cancer: SOLTI-1501 VENTANA window of opportunity trial

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Barbara Adamo ◽  
Meritxell Bellet ◽  
Laia Paré ◽  
Tomás Pascual ◽  
Maria Vidal ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
Statistical Significance ◽  
Stage I ◽  
High Expression ◽  
Luminal A ◽  
Proliferative Effect ◽  
Hormone Receptor Positive ◽  
Metronomic Vinorelbine

Abstract Background The biological effect of oral metronomic vinorelbine (mVNB) alone or in combination with endocrine therapy in patients with hormone receptor-positive (HR+)/HER2-negative breast cancer has been scarcely addressed. Methods Postmenopausal women with untreated stage I–III HR+/HER2-negative breast cancer were randomized (1:1:1) to receive 3 weeks of letrozole (LTZ) 2.5 mg/day, oral mVNB 50 mg 3 days/week, or the combination. The primary objective was to evaluate, within PAM50 Luminal A/B disease, if the anti-proliferative effect of LTZ+mVNB was superior to monotherapy. An anti-proliferative effect was defined as the mean relative decrease of the PAM50 11-gene proliferation score in combination arm vs. both monotherapy arms. Secondary objectives included the evaluation of a comprehensive panel of breast cancer-related genes and safety. An unplanned analysis of stromal tumor-infiltrating lymphocytes (sTILs) was also performed. PAM50 analyses were performed using the nCounter®-based Breast Cancer 360™ gene panel, which includes 752 genes and 32 signatures. Results Sixty-one patients were randomized, and 54 paired samples (89%) were analyzed. The main patient characteristics were mean age of 67, mean tumor size of 1.7 cm, mean Ki67 of 14.3%, stage I (55.7%), and grades 1–2 (90%). Most baseline samples were PAM50 Luminal A (74.1%) or B (22.2%). The anti-proliferative effect of 3 weeks of LTZ+mVNB (− 73.2%) was superior to both monotherapy arms combined (− 49.9%; p = 0.001) and mVNB (− 19.1%; p < 0.001). The anti-proliferative effect of LTZ+mVNB (− 73.2%) was numerically higher compared to LTZ (− 65.7%) but did not reach statistical significance (p = 0.328). LTZ+mVNB induced high expression of immune-related genes and gene signatures, including CD8 T cell signature and PDL1 gene and low expression of ER-regulated genes (e.g., progesterone receptor) and cell cycle-related and DNA repair genes. In tumors with ≤ 10% sTILs at baseline, a statistically significant increase in sTILs was observed following LTZ (paired analysis p = 0.049) and LTZ+mVNB (p = 0.012). Grade 3 adverse events occurred in 3.4% of the cases. Conclusions Short-term mVNB is well-tolerated and presents anti-proliferative activity alone and in combination with LTZ. The high expression of immune-related biological processes and sTILs observed with the combination opens the possibility of studying this combination with immunotherapy. Further investigation comparing these biological results with other metronomic schedules or drug combinations is warranted. Trial registration NCT02802748, registered 16 June 2016.

scholarly journals Correlation of radiotherapy with the prognosis of elderly patients with hormone receptor-positive breast cancer according to immunohistochemical subtyping.

2019 ◽  
Vol 5 (suppl) ◽  
pp. 108-108
Author(s):  
Jin Zhang
Keyword(s):  
Breast Cancer ◽  
Elderly Patients ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
Breast Conserving Surgery ◽  
Luminal A ◽  
Luminal B ◽  
Hormone Receptor Positive ◽  
Significant Difference ◽  
Positive Breast Cancer

108 Background: The present study examined the effect of radiotherapy on recurrence and survival in elderly patients with hormone-receptor-positive early breast cancer. Methods: A retrospective analysis of 327 patients aged ≥65 years with stage I-II, hormone receptor positive breast cancer who underwent breast conserving surgery and received endocrine therapy (ET) or radiotherapy plus endocrine therapy (ET+RT) was performed. Both groups were divided into luminal A type and luminal B type subgroups. Evaluation criteria were 5-year disease free survival (DFS), local relapse rate (LRR), overall survival (OS), and distant metastasis rate (DMR). Results: There were significant differences in 5-year DFS (HR 1.59, 95% CI 1.15–2.19, P=0.005) and LRR (HR 3.33, 95% CI 1.51–7.34, P=0.003), whereas there were no significant differences in OS and DMR between the two groups. In luminal A type, there was no significant difference in 5-year DFS, LRR, OS, and DMR between the ET group and the ET+RT group. In luminal B type, there were statistically significant differences in 5-year DFS (HR 2.188, 95% CI 1.37–3.49, P=0.001), LRR (HR 5.447, 95% CI 1.65–17.98, P=0.005), and OS (HR 1.752, 95% CI 1.01–3.054, P=0.048) between the two groups. In the ET group, there were significant differences between luminal A type and luminal B type in 5-year DFS (HR 1.841, 95% CI 1.23–2.75, P=0.003) and OS (HR 1.763, 95% CI 1.07–2.91, P=0.026). Conclusions: After breast conserving surgery, radiotherapy can reduce the LRR and improve the DFS and OS of luminal B type elderly patients, whereas luminal A type elderly patients do not benefit from radiotherapy. Without radiotherapy, luminal A type patients have better DFS and OS than luminal B type patients.

Correlation analysis of radiotherapy and prognosis of elderly patients with hormone receptor-positive breast cancer in different immunohistochemical subtyping.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12061-e12061
Author(s):  
Jin Zhang
Keyword(s):  
Breast Cancer ◽  
Survival Rate ◽  
Elderly Patients ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
Breast Conserving Surgery ◽  
Luminal A ◽  
Luminal B ◽  
Hormone Receptor Positive ◽  
Significant Difference

e12061 Background: Our study aimed to assess the effect of radiotherapy on the recurrence and survival in elderly patients with hormone-receptor-positive early breast cancer. Methods: We performed a retrospective analysis of 327 breast cancer patients who were 65 years or older with stage I-II, hormone-receptor-positive, after breast-conserving surgery and who received endocrine therapy(ET) or radiotherapy plus endocrine therapy(ET+RT). ET group was subgroup analyzed according to luminal A type and luminal B type, the same as ET+RT group. Evaluation Criterias were five-year local relapse rate(LRR),distant metastasis rate(DMR), disease-free survival rate (DFS) and overall survival rate (OS). Results: There were significant differences in five-year LRR (HR 3.33, 95% CI 1.51-7.34, P=0.0028) and DFS (HR 1.59, 95% CI 1.15-2.19, P=0.0045), but there were no significant differences in DMR and OS between the two groups. In luminal A type, there was no significant difference in five-year LRR, DMR,DFS, and OS between the ET group and the ET + RT group. In luminal B type, the difference was statistically significant in five-years LRR(HR 5.447, 95% CI 1.65-17.98, P=0.0054), DFS (HR 2.188, 95% CI 1.37-3.49, P=0.0010) and OS (HR 1.752, 95% CI 1.01-3.054, P=0.0478). In ET group, there were significant differences between luminal A type and luminal B type in five-years DFS (HR 1.841, 95% CI 1.23-2.75, P=0.0028) and OS (HR 1.763, 95% CI 1.07-2.91, P=0.0264). Conclusions: After breast-conserving surgery, radiotherapy can reduce the LRR and improve the DFS and OS of luminal B type elderly early patients, but luminal A type elderly early patients can not benefit from radiotherapy. Without radiotherapy, luminal A type patients have a better OS and DFS than luminal B.

scholarly journals Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study

2021 ◽  
Vol 13 ◽  
pp. 175883592098765
Author(s):  
Raffaella Palumbo ◽  
Rosalba Torrisi ◽  
Federico Sottotetti ◽  
Daniele Presti ◽  
Anna Rita Gambaro ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Real World ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Her2 Receptor ◽  
Treatment Line ◽  
Hormone Receptor Positive

Background: The CDK4/6 inhibitor palbociclib combined with endocrine therapy (ET) has proven to prolong progression-free survival (PFS) in women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC). Few data are available regarding the efficacy of such a regimen outside the clinical trials. Patients and methods: This is a multicentre prospective real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary aim was the clinical benefit rate (CBR); secondary aims were the median PFS, overall survival (OS) and safety. Patients received palbociclib plus letrozole 2.5 mg (cohort A) or fulvestrant 500 mg (cohort B). Results: In total, 191 patients (92 in cohort A, 99 in cohort B) were enrolled and treated, and 182 were evaluable for the analysis. Median age was 62 years (range 47–79); 54% had visceral involvement; 28% of patients had previously performed one treatment line (including chemotherapy and ET), 22.6% two lines and 15.9% three. An overall response rate of 34.6% was observed with 11 (6.0%) complete responses and 52 (28.6%) partial responses. Stable disease was achieved by 78 patients (42.9%) with an overall CBR of 59.8%. At a median follow-up of 24 months (range 6–32), median PFS was 13 months without significant differences between the cohorts. When analysed according to treatment line, PFS values were significantly prolonged when palbociclib-based therapy was administered as first-line treatment (14.0 months), to decrease progressively in second and subsequent lines (11.7 and 6.7 months, respectively). Median OS was 25 months, ranging from 28.0 months in 1st line to 18.0 and 13.0 months in 2nd and subsequent lines, respectively. Conclusions: Our data indicate that palbociclib plus ET is active and safe in HR+/HER2− MBC, also suggesting a better performance of the combinations in earlier treatment lines.

scholarly journals Top 3 abstracts concerning hormone-receptor-positive early breast cancer

2021 ◽  
Author(s):  
Simon Peter Gampenrieder ◽  
Gabriel Rinnerthaler ◽  
Richard Greil
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Endocrine Therapy ◽  
Early Breast Cancer ◽  
Hormone Receptor ◽  
Menopausal Status ◽  
Pathologic Complete Response ◽  
Oncotype Dx ◽  
Hormone Receptor Positive ◽  
Her2 Breast Cancer

SummaryThe three top abstracts at the 2020 virtual San Antonio Breast Cancer Symposium regarding hormone-receptor-positive early breast cancer, from our point of view, were the long-awaited results from PenelopeB and RxPONDER as well as the data from the ADAPT trial of the West German Study Group. PenelopeB failed to show any benefit by adjuvant palbociclib when added to standard endocrine therapy in patients without pathologic complete response after neoadjuvant chemotherapy. RxPONDER demonstrated that postmenopausal patients with early hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2−) breast cancer, 1–3 positive lymph nodes and an Oncotype DX Recurrence Score of less than 26 can safely be treated with endocrine therapy alone. In contrast, in premenopausal women with positive nodes, adjuvant chemotherapy plays still a role even in case of low genomic risk. Whether the benefit by chemotherapy is mainly an indirect endocrine effect and if ovarian function suppression would be similarly effective, is still a matter of debate. The HR+/HER2− part of the ADAPT umbrella trial investigated the role of a Ki-67 response to a short endocrine therapy before surgery in addition to Oncotype DX—performed on the pretreatment biopsy—to identify low-risk patients who can safely forgo adjuvant chemotherapy irrespective of menopausal status.

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