Abstract 3525
Background
The anti-proliferative effect of oral metronomic vinorelbine (mVNB) alone or in combination with endocrine therapy in patients with hormone receptor (HR)-positive/HER2- breast cancer has been scarcely addressed.
Methods
Postmenopausal women with untreated stage I-III breast cancer were randomized (1:1:1) to receive 3 weeks of letrozole (LTZ) 2.5mg/day, oral mVNB 50mg 3 days/week or the combination. The 1ary objective was to evaluate, within PAM50 Luminal A/B disease, if the anti-proliferative effect of mVNB+LTZ was superior to monotherapy. An anti-proliferative effect was defined as the mean relative decrease of the PAM50 11-gene Proliferation Score in each arm. 2ary objectives included safety and the comparison of the anti-proliferative effect between arms. An unplanned analysis of stromal tumor infiltrating lymphocytes (TILs) was performed. PAM50 analyses were performed using the nCounter®-based Breast Cancer 360TM panel.
Results
A total of 61 patients were randomized and 54 paired samples (89%) were analyzed. Main patient characteristics were mean age 67, mean tumor size 1.7 cm, stage I (55.7%) and grade 1-2 (90%). Grade 3 toxicities occurred in 3.3% of cases. Most baseline samples were Luminal A (74.1%) or B (22.2%). The anti-proliferative effect of mVNB+LTZ (-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 mVNB+LTZ (-73.2%) was higher compared to LTZ (-65.7%) but did not reach statistical significance (p = 0.328). Stromal TILs (≥10% at week 3) were observed across arms in 6.6% (mVNB), 15% (LTZ) and 26% (mVNB+LTZ) of the cases. In tumors with ≤10% TILs at baseline, a significant increase in TILs was observed following VNB+LTZ (paired analysis p = 0.012).
Conclusions
mVNB is well-tolerated and presents antiproliferative activity alone and in combination with LTZ. Further investigation comparing these biological results with other metronomic schedules or drug combinations is warranted. Of note, the increase of TILs observed with the combination opens the possibility of studying this combination with immunotherapy.
Clinical trial identification
NCT02802748.
Legal entity responsible for the study
SOLTI Breast Cancer Research Group.
Funding
Pierre Fabre Médicament.
Editorial Acknowledgement
Disclosure
A. Prat: Consultancy: Pfizer, Eli Lilly, Novartis, Nanostring Technologies; Research funding: Novartis, Nanostring Technologies; Scientific advisory board: Oncolytics Biotech. J.A. Perez Fidalgo: Advisory board: Clinigen, Pharmamar, Clovis; Other: Substantiate relationships (speaker) Roche, Pharmamar, AstraZeneca, Ipsen. All other authors have declared no conflicts of interest.
Resources from the same session
1836 - Clinical and Psychometric validation of the BreSAS Questionnaire for Symptom Assessment among Breast Cancer Survivors.
Presenter: Raffaele Giusti
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
5973 - Association of phase angle and chemotherapy toxicity among Mexican patients with non‐metastatic breast cancer
Presenter: Maria Tereza Nieto Coronel
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
5993 - Hepatitis screening for patients to undergo chemotherapy in Cyprus
Presenter: Panteleimon Kountourakis
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4872 - Hepatitis B virus (HBV), Hepatitis C virus (HCV) and Human Immunodeficiency virus (HIV) screening prior to chemotherapy initiation among patients with solid tumors.
Presenter: Sharon Giordano
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4764 - Rapid identification of bloodstream infection pathogens
Presenter: Natalia Panova
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4753 - Pathogens and characteristics of candidemia in hospitals of Rostov-on-Don. Multicenter study in Russia
Presenter: Olga Kutsevalova
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4388 - Antiviral Prophylaxis Cannot Reduce the Risk of Hepatitis B Reactivation During Chemotherapy for non HCC Solid Tumor Patients with Lower HBV DNA Titer：A Retrospective Cohort Study.
Presenter: qiong qin
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
1371 - Prospective observational study to evaluate the persistence of treatment with denosumab (dmab) in patients (pts) with bone metastases (BM) from solid tumors (ST) in routine clinical practice: final analysis
Presenter: Ferdinand Haslbauer
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
1438 - A multicenter retrospective investigation on the efficacy of perioperative oral management in cancer patients
Presenter: Shin-ichi Yamada
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
1921 - Correlation between fatigue evaluated with a visual analog scale (VAS) and quality of life (QoL) in cancer patients treated with biosimilar epoetin alfa for chemotherapy-induced anemia (CIA): the CIROCO study
Presenter: Jérôme Desrame
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract