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
3879 - Efficacy of derazantinib (DZB) in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) expressing FGFR2-fusion or FGFR2 mutations/amplifications
Presenter: Michele Droz Dit Busset
Session: Poster Display session 2
Resources:
Abstract
4679 - It’s Not Only About Weight Loss: Tackling Pancreatic Cancer-Associated Cachexia
Presenter: Ana Leonor Matos
Session: Poster Display session 2
Resources:
Abstract
2276 - Frequency and clinicopathological characteristics of biliary tract carcinomas harboring the FGFR2-fusion gene: a prospective observational study (PRELUDE study)
Presenter: Masafumi Ikeda
Session: Poster Display session 2
Resources:
Abstract
2773 - Post-hoc analyses of a subgroup of patients with advanced biliary tract cancer (BTC) who crossed over to treatment with etoposide toniribate (EDO-S7.1) in a randomized Phase II study
Presenter: Ulrich-Frank Pape
Session: Poster Display session 2
Resources:
Abstract
4479 - Capecitabine +Best supportive care (BSC) or Erlotinib +BSC has Overall survival (OS) benefit over BSC alone in unresectable/metastatic Gall bladder cancer(GBC) patients with ECOG PS-III. Results from a phase II Randomised controlled trial (RCT)
Presenter: Babita Kataria
Session: Poster Display session 2
Resources:
Abstract
4843 - FGFR2 fusions and its effect of patient (pt) outcomes in intrahepatic cholangiocarcinoma (iCCA)
Presenter: Daniel Almquist
Session: Poster Display session 2
Resources:
Abstract
2324 - The Clinical Outcomes of Systemic Chemotherapy in Patients with Unresectable or Metastatic Combined Hepatocellular-cholangiocarcinoma (HCC-CCA): Retrospective Study of 120 Patients
Presenter: Eojin Kim
Session: Poster Display session 2
Resources:
Abstract
3678 - High PD-L1 expression is associated with treatment response to pembrolizumab in patients with advanced biliary tract cancer.
Presenter: Gilhyang Kim
Session: Poster Display session 2
Resources:
Abstract
3901 - Genomic profiling in Chinese biliary tract cancer patients with PI3K/AKT/mTOR pathway and RAS gene mutations
Presenter: Jingyu Cao
Session: Poster Display session 2
Resources:
Abstract
4390 - Phase II trial of trifluridine/tipiracil (TAS-102) in patients with advanced refractory biliary tract cancer (BTC)
Presenter: Sakti Chakrabarti
Session: Poster Display session 2
Resources:
Abstract