What’s new in metastatic pancreatic cancer management? (ID 1785)

Poster display session Poster Display

64P - Entrectinib in locally advanced/metastatic ROS1 and NTRK fusion-positive non-small cell lung cancer (NSCLC): Updated integrated analysis of STARTRK-2, STARTRK-1 and ALKA-372-001

Presentation Number
64P
Lecture Time
06:00 PM - 06:00 PM
Session Name
Speakers
  • Filippo De Braud
Location
Exhibition area, Singapore, Singapore, Singapore
Date
Sat, 23.11.2019
Time
06:00 PM - 07:00 PM
Authors
  • Filippo De Braud
  • Salvatore Siena
  • Fabrice Barlesi
  • Alexander Drilon
  • Brian Simmons
  • Xinhui Huang
  • Stuart Osborne
  • Robert C. Doebele

Abstract

Background

Entrectinib is a systemic and central nervous system (CNS)-active potent inhibitor of ROS1 and TRKA/B/C. Primary data showed that entrectinib was tolerable and achieved high objective response rates (ORR) in patients (pts) with ROS1-positive (ROS1+), ROS1 inhibitor-naive NSCLC, and in pts with NTRK fusion-positive (NTRK+) NSCLC, including pts with baseline CNS disease. We present data from an additional 5 months of follow-up.

Methods

Pts with locally advanced/metastatic ROS1+ or NTRK+ tumors (with or without baseline CNS disease) confirmed by nucleic acid-based methods, enrolled in global phase 1/2 entrectinib trials (ALKA-372-001 [EudraCT 2012-000148-88], STARTRK-1 [NCT02097810], STARTRK-2 [NCT02568267]) were included. Disease burden was assessed per blinded independent central review (BICR) using RECIST v1.1, after cycle 1 (4 wks) then every 8 wks. Primary endpoints were ORR and duration of response (DOR) by BICR. Secondary endpoints included ORR and DOR in pts with or without baseline CNS disease, and safety. Intracranial (IC) ORR and DOR were evaluated in pts with baseline CNS disease.

Results

There were 53 efficacy-evaluable pts with treatment-naïve, ROS1+ NSCLC and 10 pts with NTRK+ NSCLC. As of 30 Oct 2018 (additional 5 months’ follow-up), BICR ORR: ROS1+ 79.2% (95% CI 65.9–89.2) and NTRK+ 70.0% (95% CI 34.75–93.33) with complete responses in 5 (9.4%) pts and 1 (10.0%) pt, respectively. In ROS1+ NSCLC, median DOR: 24.6 mo (95% CI 12.6–34.8); in pts with and without baseline CNS disease, ORR was 73.9% (95% CI 51.6–89.8) and 83.3% (95% CI 65.3–94.4); IC ORR was 55.0% (95% CI 31.5–76.9); and median IC DOR was 12.9 mo (95% CI 5.6–not estimable). Additional efficacy for NTRK+ NSCLC pts will be presented. Entrectinib was well tolerated with a safety profile consistent with that previously reported; there were no new or unexpected safety findings.

Conclusions

In line with the primary data, in pts with ROS1+ and NTRK+ NSCLC after an additional 5 months of follow-up, entrectinib was well tolerated and showed clinically meaningful, durable systemic and intracranial responses.

Clinical trial identification

ALKA-372-001 [EudraCT 2012-000148-88] STARTRK-1 [NCT02097810] STARTRK-2 [NCT02568267].

Editorial acknowledgement

Medical Writing support was provided by Laura Vergoz and Charlotte Kennerley, PhD of Gardiner-Caldwell Communications and was funded by F. Hoffmann-La Roche.

Legal entity responsible for the study

F. Hoffman-La Roche.

Funding

F. Hoffman-La Roche.

Disclosure

F. de Braud: Advisory / Consultancy, Officer / Board of Directors: TizianaLife Sciences, BMS, Celgene, Novartis, Servier, Pharm Research Associated, Daiichi Sankyo, Ignyta, Amgen, Pfizer, Octimet Oncology, Incyte, Teofarma, Pierre Fabre, Roche, EMD Serono ; Honoraria (self): BMS, Eli Lilly, Roche, Amgen, AstraZeneca, Gentili, Fondazione Menarini, Novartis, MSD, Ignyta, Bayer, Noema S.r.l., ACCMED, Dephaforum S.r.l., Nadirex, Roche, Biotechspert Ltd, PriME Oncology, Pfizer . S. Siena: Advisory / Consultancy: Amgen, Bayer, BMS, CheckmAb, Celgene, Daiichi-Sankyo, Incyte, Merck, Novartis, Roche-Genentech, and Seattle Genetics. F. Barlesi: Research grant / Funding (self), Travel / Accommodation / Expenses: Astra-Zeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Novartis, Merck, MSD, Pierre Fabre, Pfizer and Takeda; Research grant / Funding (institution): AbbVie, ACEA, Amgen, Astra-Zeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eisai, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Genentech, Ipsen, Ignyta, Innate Pharma, Loxo, Novartis, Medimmune, Merck, MSD, Pierre Fabre, Pfizer, Sanofi-Aventis; Non-remunerated activity/ies: Principal Investigator for Astra-Zeneca, BMS, Merck, Pierre Fabre and Roche sponsored trials (or ISR). A. Drilon: Honoraria (self), Advisory / Consultancy: Ignyta/Genentech/Roche Loxo/Bayer/Lilly Takeda/Ariad/Millenium TP Therapeutics AstraZeneca Pfizer Blueprint Medicines Helsinn Beigene BergenBio Hengrui Therapeutics Exelixis Tyra Biosciences Verastem MORE Health; Research grant / Funding (institution): Pfizer Exelixis GlaxoSmithKlein Teva Taiho PharmaMar; Research grant / Funding (self): Foundation Medicine; Licensing / Royalties: Wolters Kluwer; Travel / Accommodation / Expenses: Merck - Food/Beverage Puma - Food/Beverage; Honoraria (self): Medscape, OncLive, PeerVoice, Physicians Education Resources, Targeted Oncology, Research to Practice. B. Simmons: Full / Part-time employment: Roche (Genentech). X. Huang: Shareholder / Stockholder / Stock options, Full / Part-time employment: Genentech. S. Osborne: Full / Part-time employment: Roche. R.C. Doebele: Shareholder / Stockholder / Stock options: Rain Therapeutics; Advisory / Consultancy: Chair of Scientific Advisory Board for Rain Therapeutics; Honoraria (self): Guardant; Advisory / Consultancy: Pfizer, Trovagene, Ariad, Takeda, AstraZeneca, Genentech/Roche, Ignyta, Loxo, Rain.; Research grant / Funding (self): Ignyta, Loxo, Mirati; Licensing / Royalties: Abbott Molecular, Rain Therapeutics, GVKbio, Chugai, Loxo, Ignyta, Genentech, Ariad, Foundation Medicine, Black Diamond.

Collapse
Poster display session Poster Display

322P - Three-year overall survival update from the PACIFIC trial

Presentation Number
322P
Lecture Time
06:00 PM - 06:00 PM
Session Name
Speakers
  • Yi-Long Wu
Location
Exhibition area, Singapore, Singapore, Singapore
Date
Sat, 23.11.2019
Time
06:00 PM - 07:00 PM
Authors
  • Yi-Long Wu
  • Jhanelle E. Gray
  • Augusto Villegas
  • Davey B. Daniel
  • David Vicente
  • Shuji Murakami
  • Rina Hui
  • Takayasu Kurata
  • Alberto Chiappori
  • Ki Hyeong Lee
  • Byoung Chul Cho
  • David Planchard
  • Luis Paz-Ares
  • Corinne Faivre-Finn
  • Johan F. Vansteenkiste
  • David R. Spigel
  • Maria Taboada
  • Phillip A. Dennis
  • Mustafa Özgüroğlu
  • Scott J. Antonia

Abstract

Background

In the phase 3 PACIFIC study of patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT), durvalumab demonstrated significant improvements versus placebo in the primary endpoints of progression-free survival (HR, 0.52; 95% CI, 0.42–0.65; P < 0.0001) and overall survival (OS; HR, 0.68; 95% CI, 0.53–0.87; P = 0.00251). Safety was similar and durvalumab had no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study.

Methods

Patients with WHO PS 0/1 (any tumor PD-L1 status) who received ≥2 cycles of platinum-based CRT were randomized (2:1), 1–42 days following CRT, to receive durvalumab 10 mg/kg intravenously every 2 weeks or placebo, up to 12 months, and stratified by age, sex, and smoking history. OS was analyzed using a stratified log-rank test in the ITT population. Medians and OS rates at 12, 24 and 36 months were estimated by Kaplan-Meier method.

Results

In total, 713 patients were randomized of whom 709 received treatment (durvalumab, n = 473; placebo, n = 236). The last patient had completed the protocol-defined 12 months of study treatment in May 2017. As of January 31, 2019 (data cutoff), 48.2% of patients had died (44.1% and 56.5% in the durvalumab and placebo groups, respectively). The median duration of follow-up was 33.3 months (range, 0.2–51.3). Updated OS remained consistent with that previously reported (stratified HR 0.69, 95% CI, 0.55–0.86), with the median not reached (NR; 95% CI, 38.4 months–NR) with durvalumab versus 29.1 months (95% CI, 22.1–35.1) with placebo. The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively. After discontinuation, 43.3% and 57.8% in the durvalumab and placebo groups, respectively, received subsequent anticancer therapy (9.7% and 26.6% subsequently received immunotherapy). OS subgroup results will be presented.

Conclusions

Updated OS data from PACIFIC, including 3-year survival rates, underscore the long-term clinical benefit with durvalumab following CRT and further establish the PACIFIC regimen as the standard of care in this population.

Clinical trial identification

NCT02125461.

Editorial acknowledgement

Medical writing support during the preparation of this abstract, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Hashem Dbouk, of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

Y-L. Wu: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self): Eli Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self): Pierre Fabre; Honoraria (self): Pfizer; Honoraria (self): Sanofi; Advisory / Consultancy: Merck; Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim. J.E. Gray: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Takeda; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Genentech; Honoraria (self), Advisory / Consultancy: Eli Lilly; Honoraria (self), Advisory / Consultancy: Triptych Health Partners; Research grant / Funding (institution): Array; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Epic Sciences; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Trovagene; Research grant / Funding (institution): Loxo; Research grant / Funding (institution): Blueprint; Research grant / Funding (institution): Novartis. A. Villegas: Honoraria (self): AstraZeneca; Honoraria (self): Seattle Genetics. D.B. Daniel: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): E R Squibb & Sons; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Roche; Research grant / Funding (institution): E1 Therapeutics. D. Vicente: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS; Advisory / Consultancy: Merck; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Roche. S. Murakami: Research grant / Funding (institution): Takeda; Honoraria (self): AstraZeneca; Honoraria (self): Chugai; Honoraria (self): Ono; Honoraria (self): Merck Sharp and Dohme. R. Hui: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Merck Sharp and Dohme; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb. T. Kurata: Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self): Ono; Honoraria (self), Research grant / Funding (institution): Bristol Myers Squibb; Honoraria (self), Research grant / Funding (institution): Chugai; Honoraria (self): Lilly; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Research grant / Funding (institution): MSD. A. Chiappori: Speaker Bureau / Expert testimony: Genentech; Speaker Bureau / Expert testimony: Merck; Speaker Bureau / Expert testimony: Takeda; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Speaker Bureau / Expert testimony: Celgene; Research grant / Funding (institution): Bristol Myers Squibb. B.C. Cho: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): MOGAM Institute; Research grant / Funding (institution): Dong-A ST; Research grant / Funding (institution): Champions Oncology; Advisory / Consultancy, Research grant / Funding (institution): Janssen; Advisory / Consultancy, Research grant / Funding (institution): Yuhan; Advisory / Consultancy, Research grant / Funding (institution): Ono; Research grant / Funding (institution): Dizal Pharma; Advisory / Consultancy, Research grant / Funding (institution): MSD; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Roche; Advisory / Consultancy: BMS; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Takeda; Shareholder / Stockholder / Stock options: TheraCanVac Inc. D. Planchard: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: BMS; Advisory / Consultancy: Celgene; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD; Advisory / Consultancy: Roche; Advisory / Consultancy: prIME Oncology; Advisory / Consultancy: PeerCME. L. Paz-Ares: Leadership role: Genomica; Honoraria (self), Travel / Accommodation / Expenses, Spouse / Financial dependant: Roche; Honoraria (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: MSD; Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self), Travel / Accommodation / Expenses: Lilly; Honoraria (self), Travel / Accommodation / Expenses, Spouse / Financial dependant: Pfizer; Honoraria (self): Merck Serono; Honoraria (self): Pharma Mar; Honoraria (self), Spouse / Financial dependant: Novartis; Honoraria (self): Celgene; Honoraria (self): Sysmex; Honoraria (self), Spouse / Financial dependant: Amgen; Honoraria (self): Incyte; Spouse / Financial dependant: Ipsen; Spouse / Financial dependant, Leadership Role: European Medicines Agency; Spouse / Financial dependant: SERVIER; Spouse / Financial dependant: Sanofi; Spouse / Financial dependant: Merck. C. Faivre-Finn: Advisory / Consultancy, Speaker Bureau / Expert testimony, To institution: AstraZeneca. J.F. Vansteenkiste: Honoraria (self), Research grant / Funding (institution): MSD; Honoraria (self): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Eli-Lilly; Honoraria (self): Apotex; Honoraria (self): Roche. M. Taboada: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. P.A. Dennis: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. M. Özgüroğlu: Advisory / Consultancy: Janssen. S.J. Antonia: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy: Memgen; Advisory / Consultancy, Travel / Accommodation / Expenses: FLX Bio; Honoraria (self), Shareholder / Stockholder / Stock options: CBMG. All other authors have declared no conflicts of interest.

Collapse
ESMO – JSMO Collaborative Session: Guideline harmonisations and international consensus Collaborative session

Overview of the (ESMO Clinical Practice) Guidelines adaptation initiative

Lecture Time
02:35 PM - 02:55 PM
Speakers
  • George Pentheroudakis
Location
Room 324, Singapore, Singapore, Singapore
Date
Fri, 22.11.2019
Time
02:30 PM - 04:00 PM
Authors
  • George Pentheroudakis
Biosimilars use in oncology: Clarifying concepts Special Session

Panel discussion

Lecture Time
05:35 PM - 05:55 PM
Location
Room 311, Singapore, Singapore, Singapore
Date
Fri, 22.11.2019
Time
04:30 PM - 06:00 PM

Next generation approach in 1L RCC: IO-TKI combination (ID 1818)

Poster display session Poster Display

97P - The role of adjuvant chemotherapy according to the status of surgical margin in rectal cancer

Presentation Number
97P
Lecture Time
06:00 PM - 06:00 PM
Session Name
Speakers
  • Jong Hoon Lee
Location
Exhibition area, Singapore, Singapore, Singapore
Date
Sat, 23.11.2019
Time
06:00 PM - 07:00 PM
Authors
  • Jong Hoon Lee

Abstract

Background

Adjuvant chemotherapy has been recommended for patients who have locally advanced rectal cancer. However, the role of adjuvant chemotherapy in patients with positive surgical margin has not been clarified. We investigated the benefit of adjuvant chemotherapy according to the surgical margin in locally advanced rectal cancer.

Methods

A total of 1801 rectal cancer patients staging cT3-4N0-2M0 were included. The patients were eligible when tumors were pathologically confirmed adenocarcinoma, located within 10cm from anal verge, and staged cT3-4N0-2M0. Before surgery, all patients received radiation therapy at a dose of 50.4 Gy in 28 fractions with concurrent 5-fluorouracil or capecitabine. Curative surgery including TME was performed 4 to 8 weeks after radiotherapy. Adjuvant chemotherapy was performed after 4-6 weeks after surgery.

Results

Adjuvant chemotherapy was given to 1531 patients (85.0%). Patients with positive circumferential resection margin or distal resection margin were 205 (11.4%). With patients with positive surgical margin (n = 205), the 5-year recurrence-free survival (RFS) showed a significant difference between adjuvant chemotherapy group and no adjuvant chemotherapy group (50.3% vs. 30.9%, p = 0.01). The 5-year overall survival rate was 72.6% in adjuvant chemotherapy group and 57.2% in no adjuvant chemotherapy group (p = 0.09). With patients with the negative margin (n = 1596), the 5-year RFS rate did not show any difference between two groups (75.6% vs. 76.8%, p = 0.94). On multivariate analysis, adjuvant chemotherapy was significantly associated with RFS in patients who had the positive surgical margin (Hazard ratio (HR): 0.48, 95% confidence interval (CI): 0.25-0.94, p = 0.032). In contrast, there was no significant association between adjuvant chemotherapy and RFS in those with negative surgical margin (HR: 0.99, 95% CI: 0.72-1.35, p = 0.94).

Conclusions

Patients who received adjuvant chemotherapy showed a significantly improved 5-year RFS rate compared with those who did not receive adjuvant chemotherapy if the patients had positive surgical margin. The benefit of adjuvant chemotherapy was more remarkable in patients with positive surgical margin compared to those with negative surgical margin.

Legal entity responsible for the study

The author.

Funding

Has not received any funding.

Disclosure

The author has declared no conflicts of interest.

Collapse
Poster display session Poster Display

361P - The role of volunteers in quality palliative care delivery

Presentation Number
361P
Lecture Time
06:00 PM - 06:00 PM
Session Name
Speakers
  • NABANITA MANDAL
Location
Exhibition area, Singapore, Singapore, Singapore
Date
Sat, 23.11.2019
Time
06:00 PM - 07:00 PM
Authors
  • NABANITA MANDAL

Abstract

Background

Here in India almost 75% of cancer patient die a sad death of neglect due to lack of awareness about palliative care and low economic level. Surveys in India show that two third of cancer patient do not get proper care during the terminal phase of their life. Palliative care through volunteers can make a significant difference in this respect. To identify and try to solve, to the extent possible, the main difficulties in giving palliative care to the terminal cancer patients of the area. And evaluate the impact of volunteer’s direct care of palliative patients and their families.

Methods

Feedback from patients and their relatives regarding the palliative care they receive from nursing home and from volunteers and compare the two. Also feedback from volunteers regarding their positive and negative experience while delivering palliative care service. Then evaluate the data to compare and improve the quality of service.

Results

We carried out two studies. One study was undertaken in nursing home palliative care and another was in home setting by volunteers. Both studies were in adult palliative care services. Since January 2018, 416 cases were studied to enquire about their experience in both home based care and nursing home care. Both the studies fulfilled our quality appraisal criteria. One found that those families and patients who received home visits from volunteers were significantly more satisfied. The study highlighted the value of the role of volunteers in better satisfaction of patients and their families.

Conclusions

Further research is needed to evaluate the role of volunteers in palliative care and how it can be delivered appropriately and effectively. We also wish to compare our findings with similar studies elsewhere.

Legal entity responsible for the study

The author.

Funding

Has not received any funding.

Disclosure

The author has declared no conflicts of interest.

Collapse
Mini Oral session - Breast cancer Mini Oral session

Discussion led by moderators

Lecture Time
02:40 PM - 02:50 PM
Speakers
  • Peter Dubsky
  • Boon Chua
Location
Hall 405, Singapore, Singapore, Singapore
Date
Sun, 24.11.2019
Time
02:30 PM - 03:40 PM
Authors
  • Peter Dubsky
  • Boon Chua

Conclusion (ID 1850)

Poster display session Poster Display

134P - Identification, development and validation of a circulating miRNA-based diagnostic signature for early detection of gastric cancer

Presentation Number
134P
Lecture Time
06:00 PM - 06:00 PM
Session Name
Speakers
  • Daisuke Izumi
Location
Exhibition area, Singapore, Singapore, Singapore
Date
Sat, 23.11.2019
Time
06:00 PM - 07:00 PM
Authors
  • Daisuke Izumi
  • Feng Gao
  • Yuetong Chen
  • Takatsugu Ishimoto
  • Kei Horino
  • Shinya Shimada
  • Yasuhiro Kodera
  • Hideo Baba
  • Jinfei Chen
  • Xin Wang
  • Ajay Goel

Abstract

Background

Although endoscopic surveillance remains the gold standard for diagnosing asymptomatic gastric cancer (GC) patients, associated costs and its invasive nature render it inadequate as a screening approach. Development of less invasive tests is needed for surveillance of early stage GCs. Over the last decade, tumor-derived miRNAs in peripheral blood are emerging as promising disease biomarkers. Herein we have conducted a comprehensive miRNA expression profiling, followed by bioinformatic analysis to establish a novel serum-based miRNA signature for the diagnosis of patients with GC.

Methods

We analyzed tissue miRNA expression profiles in three patient cohorts (n = 602) in an in-silico discovery step, during which the robustness of candidate biomarkers was tested and validated. The performance of this miRNA signature was evaluated in a serum training cohort (n = 327). Using a logistic regression model, the panel was further refined, and this circulating miRNA signature was validated in two prospective cohorts (n = 174, 175).

Results

Genome-wide analysis of miRNA expression data resulted in identification of 10-miRNAs that distinguished cancer tissues from normal mucosa in three independent datasets (AUC = 0.984, 0.939 and 1.000). Using a serum training cohort, the miRNA candidates were further refined to six-circulating-miRNA signature. This miRNA signature demonstrated a robust diagnostic value in the training cohort. Subsequently we demonstrated robustness of the signature in two prospective cohorts (AUC = 0.87, 0.86). Remarkably, the 6-circulating-miRNA signature was able to detect early stage GC patients robustly (AUC = 0.855). Furthermore, the signature was significantly superior at identifying patients with GC to conventional tumor markers, CEA (P = 0.0001) and CA19-9 (P = 0.0001).

Conclusions

Using a comprehensive data analysis followed by substantial clinical validations, involving over 1600 GC tissue and serum specimens across 7 independent cohorts, we developed a novel 6-circulating-miRNA signature, which demonstrated an unprecedented diagnostic value and a great promise for early non-invasive detection of GC.

Legal entity responsible for the study

Daisuke Izumi.

Funding

NIH.

Disclosure

All authors have declared no conflicts of interest.

Collapse
Poster display session Poster Display

399P - Prevalence of colorectal cancer risk factors in apparently healthy adults in Suluhan Village, Bali

Presentation Number
399P
Lecture Time
06:00 PM - 06:00 PM
Session Name
Speakers
  • Cindy G. Trisina
Location
Exhibition area, Singapore, Singapore, Singapore
Date
Sat, 23.11.2019
Time
06:00 PM - 07:00 PM
Authors
  • Cindy G. Trisina
  • Cindy L. Driansha
  • Cindy L. Driansha
  • Randy Martianus
  • Leonardo W. Soesilopranoto
  • I Wayan Sudarsa

Abstract

Background

Currently in Indonesia, colorectal cancer (CRC) is the third most commonly occurring cancer in men and the fourth in women. CRC is mostly diagnosed in the advanced stage, it’s probably caused by the difficulties in detecting colorectal cancer. Identifying risk factors of CRC is very crucial to prevent CRC. CRC risk is expected to rise continually due to dietary patterns, smoking, lack of physical activities, and other practices. This study describes the prevalence of risk factors for CRC in healthy residents of Suluhan village, Bangli District, Bali Province.

Methods

A pre-experimental cross-sectional study-based community was conduct on 18th – 19th May 2019 in Suluhan village to collect data from 77 healthy residents using validated questionnaire. We measured sociodemographic characteristics, physical activity, dietary habits, and lifestyle as risk factors of CRC. Analysis of data using chi-square with p-value ≤0.05 is categorized as significant.

Results

77 respondents were involved in this study with a mean age of 41.94 ± 9.448 years. The majority of participants were female (61 %). Mostly the residents didn’t know CRC (80.6%). The commonest risk factors for CRC among the participants were overconsumption of red meat (2 times/week and >3 times/week) (67.6 %), overweight and obesity (62.4 %), limited consumption of vegetables (62.3 %), low of physical activities (44.1%), smoking (28.6%), and limited consumption of diet fiber (10.4%). Lack of physical activity was found significantly higher in females (p = 0,000), otherwise smoking (p = 0,000) is higher in males.

Conclusions

We conclude that the highest risk factor of CRC in Suluhan village is the overconsumption of red meat, followed by overweight and obesity, limited consumption of vegetables, low physical activities, smoking, and limited consumption of diet fiber sequentially. Dietary and lifestyle risk factors for CRC are prevalent in Suluhan village and likely to increase CRC incidence if educational interventions are not implemented. Greater attention in improving residents’ knowledge of CRC risk is needed to prevent CRC in Suluhan village.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Collapse