Abstract 5020
Background
The antitumor effect of melatonin (MLT) and metformin (MTF) has been shown in vitro/in vivo. According to recent data both MLT and MTF may become a new drug which can be used in combination with standard cancer treatment, however, this hypothesis needs confirmation in clinical trials.
Methods
A total of 54 patients with estrogen receptor-positive locally advanced breast cancer (ER+BC) were included in the study of MLT or MTF efficiency in combination with toremifene (TOR) neoadjuvant hormone therapy (clinicalTrials.gov NCT02506790). The average patients’ age was 68 years. All patients had no history of diabetes mellitus. All patients were randomized for 1:1:1 ratio. The first group (n = 19) received 120 mg of oral TOR daily, the second one (n = 16) received TOR in combination with 3 mg overnight dose of oral MLT, the third group (n = 19) received TOR in combination with oral MTF (850 mg twice a day). For all patient groups the hormone therapy duration was 4 months, then surgery was performed.
Results
An objective response rate for three studied groups was 31.6%, 86.7%. and 47.3% accordingly. Adding MLT to TOR lead to significant increase in response rate compared to TOR monotherapy group (χ2 = 10.32, p=0.001). The decrease in Ki67 expression in TOR group was observed in 42%, TOR+ MLT group in 56%, and TOR+MTF group in 74% of patients. According to multivariate analysis of results the TOR combination with MTF leads to 4.2-fold higher Ki-67 expression decrease probability compared to TOR group (OR 4.23 [95% CI 1.044-17.139], p=0.043). Also this group is the only one to display a significant correlation (Spearman) between Ki67 expression decrease dynamics and abnormal BMI values (p=0.015). No pathomorphological response (pCR) was observed. Adding MLT or MTF to standard hormone therapy did not lead to decrease in the quality of life (EORTC-QLQ-C30), about 50% of TOR+MLT therapy recipients had better sleep quality.
Conclusions
MLT and MTF showed encouraging results in combination with neoadjuvant hormonotherapy. However, these data require confirmation in larger randomized studies.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
T. Semiglazova.
Funding
Federal State Budget Institution "National Medical Research Center of Oncology na N.N. Petrov" Ministry of Healthcare of Russian Federation.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3963 - Robot-assisted natural orifice specimen extraction surgery for radical resection of colorectal cancer
Presenter: Zhengchuan Niu
Session: Poster Display session 2
Resources:
Abstract
3989 - Bevacizumab as adjuvant treatment for colon cancer: Updated results from the AVANT phase III Study by the GERCOR Group
Presenter: Thierry André
Session: Poster Display session 2
Resources:
Abstract
4741 - Real world data on adjuvant chemotherapy for high-risk stage II colorectal cancer – the role of tumor side
Presenter: Camila Araujo de Carvalho
Session: Poster Display session 2
Resources:
Abstract
4973 - Oncological Outcome and Safety of Bevacizumab (BV) Therapy in Patients with Occlusive Colon Cancer and Self-Expandable Metal Stents (SEMS)
Presenter: Vilma Pacheco-Barcia
Session: Poster Display session 2
Resources:
Abstract
2295 - Active chronic hepatitis B increases the risk of liver metastasis of colorectal cancer- a retrospective clinical study of 7187 consecutive cases of newly diagnosed colorectal cancer
Presenter: Lei Zhao
Session: Poster Display session 2
Resources:
Abstract
3845 - Comprehensive Evaluation of Recurrence Risk (CERR) Score for Colorectal Liver Metastases: Development and Validation
Presenter: Wei Ye
Session: Poster Display session 2
Resources:
Abstract
1976 - BRAF-mutated colorectal metastases: what is the benefit of liver surgery? Results from a cohort of 91 patients.
Presenter: Sahir Javed
Session: Poster Display session 2
Resources:
Abstract
2688 - The smallest colorectal liver metastasis size as a prognosis factor after laparoscopic liver resection
Presenter: Baptiste Cervantes
Session: Poster Display session 2
Resources:
Abstract
4961 - Validation of GAME score risk groups in resected colorectal cancer liver metastases and the prognostic relevance of KRAS, NRAS and BRAF mutation analysis
Presenter: Berta Martin-Cullell
Session: Poster Display session 2
Resources:
Abstract
5295 - Predictive factors and survival outcomes with stereotactic body radiation therapy in treatment of oligometastases in colorectal cancer
Presenter: Vibhay Pareek
Session: Poster Display session 2
Resources:
Abstract