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
3907 - Exploration of efficacious alternative regorafenib regimens to manage hand-foot-skin-reaction (HFSR)
Presenter: Axel Grothey
Session: Poster Display session 2
Resources:
Abstract
3958 - Quality of Life (QoL) in Metastatic Colorectal Cancer (mCRC) in the Real World: Final Results of a European Survey
Presenter: Zorana Maravic
Session: Poster Display session 2
Resources:
Abstract
3563 - BISQUIT: A Randomized Phase II Study of the Administration of Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy for Patients With Squamous Cell Carcinoma of the Anal Canal
Presenter: Rachel Riechelmann
Session: Poster Display session 2
Resources:
Abstract
1184 - iSCORE: Immunotherapy Sequencing in COlon and REctal Cancer
Presenter: Fiona Turkes
Session: Poster Display session 2
Resources:
Abstract
3346 - Phase II study of preoperative (PREOP) chemoradiotherapy (CTRT) plus avelumab (AVE) in patients (PTS) with locally advanced rectal cancer (LARC): The AVANA Study
Presenter: Lisa Salvatore
Session: Poster Display session 2
Resources:
Abstract
3895 - A phase II study of capecitabine plus concomitant radiation therapy followed by durvalumab (MEDI4736) as preoperative treatment in rectal cancer: PANDORA study.
Presenter: Maria Aurelia Barbera
Session: Poster Display session 2
Resources:
Abstract
2012 - Open Label Phase III Study of Arfolitixorin vs. Leucovorin in mFOLFOX-6 for First Line Treatment of Metastatic Colorectal Cancer: AGENT
Presenter: Josep Tabernero
Session: Poster Display session 2
Resources:
Abstract
2198 - SOLSTICE, a phase 3, randomized, open label study of trifluridine/tipiracil+bevacizumab (bev) versus capecitabine+bev for the 1L treatment of patients with unresectable metastatic colorectal cancer (mCRC) who are not candidates for intensive therapy
Presenter: Thierry Andre
Session: Poster Display session 2
Resources:
Abstract
2921 - A Phase Ib/ II Trial to Assess the Safety and Efficacy of CXD101 in Combination with the PD-1 Inhibitor Nivolumab in Patients with Metastatic, Previously-Treated, Microsatellite-Stable (MSS) Colorectal Carcinoma (short title CAROSELL)
Presenter: Mark Saunders
Session: Poster Display session 2
Resources:
Abstract
3695 - A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation
Presenter: Heinz Josef Lenz
Session: Poster Display session 2
Resources:
Abstract