Abstract 2781
Background
Aromatase inhibitors (AI) are standard as postoperative adjuvant therapy for hormone positive postmenopausal breast cancer. In recent years, the administration period tends to be longer, and bone loss which is a side effect has become a serious problem. We have already reported the effect of denosumab up to 24 months on postmenopausal early breast cancer patients with low bone mineral density (BMD) receiving AIs as adjuvant hormonal therapy. BMD in the lumber spine was found to increase, and the combination of denosumab revealed useful for blocking bone mineral loss in Japanese women receiving AIs.
Methods
Study design: A non-randomized, prospective study at three institutions was conducted in Japan. Patients administered 60 mg of denosumab subcutaneously every 6 months. The BMD of the lumbar spine and bilateral femoral neck was measured at baseline and at 6, 12, 18, 24, 30 and 36 months. The levels of serum tartrate-resistant acid phosphatase isoform 5b (TRAP5b), bone alkaline phosphatase (BAP), albumin-corrected serum calcium concentration was measured at baseline and 1, 6, 12, 18, 24, 30 and 36 months. Patients: Postmenopausal women with early-stage hormone receptor-positive invasive breast cancer who were scheduled to receive an AI as adjuvant hormonal therapy or receiving AI adjuvant therapy were included in the analysis. We also included those who had completed a chemotherapy regimen ≥ 4 weeks before entering the study and patients with low BMD (lumbar spine, right femoral neck, and left femoral neck BMD: -2.5< T-score <-1.0). Endpoints: The primary endpoint was the change in percentage of the BMD of the lumbar spine (L1–L4) from baseline to 12 months.
Results
A total of 103 patients were enrolled. Seventy-three patients completed the study. At 36 months, the BMD of the lumbar spine increased by 8.8%. The BMD of the right and left femoral neck increased by 4.4% and 2.7%, respectively. Symptomatic clinical fractures did not occur in patients receiving AI and denosumab.
Conclusions
At 36 months, as with the data to the previous 24 months, in combination of denosumab for Japanese women receiving adjuvant AI treatment, an increase in BMD was noted.
Clinical trial identification
UMIN-CTR, UMIN 000016173.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
T. Taguchi: Research grant / Funding (institution): Chugai Pharmaceutical Co., Ltd.; Research grant / Funding (institution): Taiho Pharmaceutical Co., Ltd.; Research grant / Funding (institution): Daiichi Sankyo Co., Ltd.; Research grant / Funding (institution): Eisai Co. Ltd. All other authors have declared no conflicts of interest.
Resources from the same session
4331 - STING Agonist, ADU-S100, Yields Potent Antitumor Activity and Therapeutically Favorable Immune Profile in an Esophageal Adenocarcinoma Model
Presenter: Ali Zaidi
Session: Poster Display session 2
Resources:
Abstract
1770 - Increased assessment of HER2 in metastatic gastroesophageal cancer patients: a nationwide population-based cohort study
Presenter: Willemieke Dijksterhuis
Session: Poster Display session 2
Resources:
Abstract
3755 - A new docetaxel (DOC)-based triplet regimen does not improve the outcome of metastatic (M) or locally advanced (LA) gastric cancer (GC) as compared with an epirubicin (EPI) standard triplet regimen: a GISCAD trial.
Presenter: Roberto Labianca
Session: Poster Display session 2
Resources:
Abstract
2439 - The analysis of T cell subsets and clinical efficacy of immune checkpoint blockades in patients with advanced gastric cancer using multiplex immunohistochemistry
Presenter: Tae-yong Kim
Session: Poster Display session 2
Resources:
Abstract
2211 - First-line pembrolizumab (P), trastuzumab (T), capecitabine (C) and oxaliplatin (O) in HER2-positive metastatic esophagogastric adenocarcinoma.
Presenter: Yelena Janjigian
Session: Poster Display session 2
Resources:
Abstract
3046 - Monitoring patient-specific mutation in ctDNA and CTC for tumor response evaluation after neoadjuvant chemotherapy in locally advanced gastric cancer (NCT03425058)
Presenter: Tao Fu
Session: Poster Display session 2
Resources:
Abstract
4628 - Gastric cancer screening in BRCA 2 gene mutation carriers: should it be recommended?
Presenter: Inês Oliveira
Session: Poster Display session 2
Resources:
Abstract
2127 - Interim analysis of an observational/translational study for nivolumab treatment in advanced gastric cancer: JACCRO GC-08 (DELIVER trial)
Presenter: Yu Sunakawa
Session: Poster Display session 2
Resources:
Abstract
2264 - Prediction of S-1 adjuvant chemotherapy efficacy in Stage II/III gastric cancer treatment based on comprehensive gene expression analysis
Presenter: Masanori Terashima
Session: Poster Display session 2
Resources:
Abstract
2444 - Assessing the clinical utility of circulating tumour DNA through longitudinal liquid biopsy sampling in Oesophageal adenocarcinoma
Presenter: Emma Ococks
Session: Poster Display session 2
Resources:
Abstract