Abstract 5082
Background
According to in vitro/in vivo studies both melatonin (MLT) and metformin (MTF) may exhibit an antitumor effect. Furthermore, in accordance to epidemiological studies MTF reduces the risk of developing breast cancer (BC) among patients with diabetes mellitus; as well as “light at night”can inhibit endogenic MLT synthesis and increase risk of breast cancer. Thus, MLT and MTF need to be investigated in clinical oncology.
Methods
A total of 53 patients with locally advanced BC (ER positive/HER2 negative -68%, ER positive/HER2 positive -25% and ER negative/HER2 negative -7%), were included in the study of MLT or MTF efficiency in combination with anthracyclin and taxan-containing neoadjuvant chemotherapy (NACT) (clinicalTrials.gov NCT02506777). The average patients’ age was 56 years. All patients had no history of diabetes mellitus. All patients were randomized into 3 groups. The first group (n = 20) received NACT, the second one (n = 21) received NACT in combination with 3 mg overnight dose of oral MLT, the third group (n = 12) received NACT in combination with oral MTF (850 mg twice a day). For all patient groups the NACT duration was 6 cycles, then surgery was performed.
Results
An objective response rate for three studied groups was 85%, 85.7% and 75% respectively. According to multivariate analysis of results the NACT combination with MLT and MTF does not lead to increase of pathomorphological response (pCR) rate compared to NACT group (OR 0.482 [95% CI 0,083-2,792], p=0.416; OR 0.602 [95% CI 0,085-4,284], p=0.612). pCR rate was in 25%, 14,2% и 16,6% accordingly. The quality of life was assessed by EORTC-QLQ-C30. In the group of patients who received NACT+MLT, in contrast to the group of patients who received only NACT, the values on the role functioning (RF), fatigue (FA) and sleep (SL) scales did not decrease during the treatment (p = 0.008, p = 0.004, p = 0.014 respectively).
Conclusions
MLT and MTF did not show influence on pCR and objective response rates, however, MLT used during NACT may improve the quality of life.
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
4250 - Phase II study of avelumab in combination with cetuximab as a rechallenge strategy in pre-treated RAS wild type metastatic colorectal cancer patients: CAVE (cetuximab-avelumab) Colon.
Presenter: Erika Martinelli
Session: Poster Display session 2
Resources:
Abstract
5234 - The ORCHESTRA trial; A phase III trial of adding tumor debulking to systemic therapy versus systemic therapy alone in multi-organ metastatic colorectal cancer (mCRC).
Presenter: Lotte Bakkerus
Session: Poster Display session 2
Resources:
Abstract
5294 - EMERGE: Epigenetic Modulation of the Immune Response in Gastrointestinal cancers
Presenter: Elizabeth Cartwright
Session: Poster Display session 2
Resources:
Abstract
913 - Phase III, international, multicenter, randomized, open-label trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) alone for surgically resected pancreatic adenocarcinoma (APACT): subgroup analyses
Presenter: Margaret Tempero
Session: Poster Display session 2
Resources:
Abstract
1668 - FOLFIRINOX in locally advanced (LA) and borderline resectable (BR) pancreatic adenocarcinoma : update of the AGEO cohort.
Presenter: Edouard Auclin
Session: Poster Display session 2
Resources:
Abstract
2559 - Impact of adjuvant treatment with nab-paclitaxel and gemcitabine (nab-P+GEM) vs gemcitabine alone (GEM) on health-related quality of life (QoL) in patients (pts) with surgically resected pancreatic adenocarcinoma (PA) in the Adjuvant Pancreatic Adenocarcinoma Clinical Trial (APACT)
Presenter: Hanno Riess
Session: Poster Display session 2
Resources:
Abstract
4897 - Early detection of pancreatic ductal adenocarcinoma using methylation signatures in circulating tumor DNA
Presenter: Xiao-ding Liu
Session: Poster Display session 2
Resources:
Abstract
1755 - Evaluation of minimal important difference (MID) for the European Organisation for Research and Treatment of Cancer (EORTC) Pancreatic Cancer Module (PAN26) in patients with surgically resected pancreatic adenocarcinoma
Presenter: Michele Reni
Session: Poster Display session 2
Resources:
Abstract
2876 - Multispectral analysis of lymphocyte complexity in periampullary adenocarcinoma
Presenter: Sebastian Lundgren
Session: Poster Display session 2
Resources:
Abstract
1902 - Phase II trial of preoperative modified FOLFIRINOX (mFOLFIRINOX) followed by postoperative gemcitabine (GEM) in patients (pts) with borderline resectable (BR) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC)
Presenter: Jae Ho Jeong
Session: Poster Display session 2
Resources:
Abstract