Documente Academic
Documente Profesional
Documente Cultură
Hitoshi Nakagama
President
1
History and Current Situation
in Japan
2
Trends in Crude Mortality Rate for Leading
Causes of Death (1947-2016)
Cancer
1981
3
Expected Cancer Deaths by Site (2017)
4
Expected Cancer Incidence by Site (2017)
5
Why cancer control in Japan?
~ attributable causes of cancer ~
≈ 55% of cancer among men
Passive was attributable to preventable
smoking risk factors in Japan. The
corresponding figure was lower
Infection among women, being nearly 30%.
( H. pylori, HCV,
Smoking HBV, HPV, EBV, Salt intake (6g and over / day)
HTLV-1)
BMI
(25 and over)
Alcohol
drinking Fruit intake
(Lowest intake group) Annals of Oncology, 2011,
Attributable causes of
Others Vegetable intake cancer in Japan in 2005—
systematic assessment to
(Lowest intake group) estimate current burden of
Physical inactivity cancer attributable to
known preventable risk
Exogenous hormone factors in Japan
(M. Inoue, N. Sawada, T.
use (current use) Matsuda, et al.)
6
History of Promote Cancer
Control Programs
1984 Comprehensive Ten-Year Strategy for Cancer
Control
Research on… 1. Human oncogene, 2. Viral oncogenesis, 3. Control of oncogenesis, 4.
Development of new early checkup technology, 5. Development of the treatments by a
new theory, 6. Control mechanism and control substance of immunity
7
Cancer Control ACT (June, 2006)
(2007)
8
Cancer Control Act (2006)
• The Cancer Control Act, the first comprehensive national
cancer control plan, was approved in 2006 in response to
cancer patient groups’ advocacy for cancer research
promotion, and for ensuring nationwide availability of
cancer care.
• The Basic Plan to Promote Cancer Control Program in
conformity to the Act was drawn up in 2007, in which both
HBCR (hospital-based cancer registry) and PBCR
(population-based cancer registry) were recognized as a
central component of cancer control.
– The Basic Plan made hospital-based registries (HBCR) in
designated cancer care hospitals compulsory = Indirect
involvement of the national government in cancer registration
9
1st Basic Plan to Promote Cancer
Control Programs (2007-11)
Focus areas
Relief of all cancer patients and their families
Reduction of Reduction of burden
cancer death (-20%) Improvement of QOL
5 1 3
Early Chemotherapy & Cancer
Palliative
Detection Radiotherapy, education care
of medical specialists care
6 support &
Cancer 4 Cancer Registry Information
Prevention service
2 Development of medical facilities
7 Cancer Research
9
10% add. decrease of mortality
Goals of the Basic Plan (2007)
Evidence- Mortality
Strategic
based Scenario reduction in
objectives
Methods 2015 (%)
Tobacco (1) 50% reduction -1.6
Smoking rate
control (2) 75% reduction -2.9
(3) Increase to 50% -3.9
Screening Participating rate
(4) Increase to 70% -6.0
Equalize 5 year survival (5) 5 major sites -3.2
quality in rate: improve to (6) All sites (10 years) -4.9
cancer care current ideal level (7) All sites (7 years) -6.8
(1)+(3)+(5) -8.7
Total (1)+(3)+(6) -10.4
(2)+(4)+(7) -15.7
12
3rd Basic Plan to Promote Cancer
Control Programs (2017-22)
1 We, incl. patients, aim at overcoming cancer, by knowing cancer
1. Evidence-based prevention and screening, 2. Patient-oriented treatment,
3. Building a secure society where patients live with dignity
2
2. Fulfilling treatment 3. Living with cancer
1. Genomic Medicine, 2. Surgery, Radiotherapy, 1. Palliative care from
1. Prevention Chemotherapy and Immunotherapy, 3. Team diagnosis, 2. Patient
1.Prevention medical care, 4. Rehabilitation, 5. Supportive consultation, 3. Social
2. Early detection/ care, 6. Rare cancer, 7. Childhood and AYA network, cancer control and
Screening cancer, 8. Pathology, 9. Cancer registry, 10. patient support, 4.
Early development and introduction of drugs Employment of patient, 5. Life
and devices stages and cancer control
4. Development of infrastructure
3
Related affairs for comprehensive cancer control (budget etc.)
13
Challenges and Solutions
in Cancer Control Program
13
1. Planning and Prevention Cancer Registry (2016.01~)
14
1. Planning and Prevention
Transition of Smoking
Proportion (%)
Male 20-29 Female 20-29
100 30-39 30 30-39
40-49 40-49
90
50-59 25 50-59
80
60+ 60+
70
20
60
50 15
40
10
30
20
5
10 increase in 50’s
0 0
1969
2005
1965
1973
1977
1981
1985
1989
1993
1997
2001
2009
2013
1969
2005
1965
1973
1977
1981
1985
1989
1993
1997
2001
2009
2013
16
2. Early Detection
Cancer Screening Rates
17
2. Early Detection
5 year cancer survival in Japan
diagnosed at 1993-6 to 2006-8
62.1%
19
3. Treatment
18
Basic Plan to Promote Cancer Control Programs (3rd term)
Section 1 : Overall goals
“People including cancer patients, To understand cancer, To overcome cancer”
(1) Improvement of cancer prevention and cancer screening based on scientific basis
(2) Realization of patient-oriented cancer treatment
(3) Establishment of a society in which cancer patients can live peacefully while maintaining dignity
Section 3 : Necessary items to promote cancer control measures comprehensively and systematically
1. Further strengthening collaboration among relevant organs 5. Implementation of necessary financial measures
2. Prefectures formulate prefectural cancer control plans Efficiency and prioritizing of budget
3. Endeavor of citizens included cancer patients 6. Assessment of the goal achievement status
4. Cooperation with the patient community 7. Reviewing Basic Plan to Promote Cancer Control Programs 20
NCC-Clinical Sequencing
Biobank
Candidate Patients
Gene B mutation Protein B signal inhibitor
for chemotherapy
21
NCC-Clinical Sequencing Lab with Quality Assurance
(Oct 13, Open & Nov 13, 2015, Press release)
Division of Pathology & Clinical Laboratories
Pre-PCR Room
Department of Genetic Medicine and Services (GeMS)
Doctor Pathologist
Expert panel
meeting
Patient Pathology info
info
Report draft
Doctor
Approval
For Clinical
Mutation Sequencing
data
SCI-Lab Validation
Sysmex Cancer
Innovation Laboratory
KIF5B Tyrosine
RET -RET kinase RET TKIs
Ch10
inversion fusion
Tyrosine
Ch2
kinase ALK TKIs
inversion
23
Nation-wide Program for Genomic Cancer Medicine
- Response to vandetanib in RET-rearranged NSCLC -
(n = 19: ITT population)
Participation
Participation and
vandetanib 医師主導治験
24
3. Treatment Rare Cancer Center at NCC
Launched in June 2014 as a multidisciplinary team to take measures
against the innate problems associated with rare cancers.
Mission Statements
1. Establishing a vital network of diagnosis, treatment and research for rare
cancers in the National Cancer Center.
2. Reviewing the problems associated with rare cancers in Japan and making
proposals and taking up the issues as medical professionals.
Homepage
Clinics
Molecular Diagnostic
testing (NGS, IHC, etc)
Registry part
• Rare cancer I.C. May 2017 ~
• Rare histological Registration
subtype
• Carcinoma of
unknown primary Review biomarker
status
Biomarker
Biomarker A Biomarker B Biomarker C
negative
32
3. Treatment
Rare Cancers
MASTER KEY PROJECT
Collaboration between INDUSTRIES AND ACADEMIA
Astellas Pharma
Eisai
Ono Pharmaceutical
Kyorin Pharmaceutical
Daiichi Sankyo
Taiho Pharma
Takeda Kyoto Univ.
Chugai Pharmaceutical NCC
Novartis hospital
Pfizer
Ignyta
33
Collaboration among
ANCCA members
1. Planning and Prevention
2. Early Detection
3. Treatment
22
1. Planning and Prevention
Cancer Registration
GICR – IARC Regional Hubs
The Global Initiative for Cancer Registry Development (GICR)
is a multi-partner response to the disparity in robust cancer
statistics across the globe, led by the International Agency for
Research on Cancer (IARC) and Union for International Cancer
Control (UICC).
23
1. Planning and Prevention
Cancer Registration
IARC/GICR (Global Initiative for Cancer Registry Development)
Collaborating Centres in Asia
24
1. Planning and Prevention
Cancer Registration
Activities up to now
31
1. Planning and Prevention
Asia Cohort Consortium
The Asia Cohort Consortium Since 2004
A consortium of 30 cohort studies in 10 countries in Asia (n=1.5 million)
More than 150 researchers across Asia, US, and the World.
Aim and scope
Serve as a platform for cross-cohort
collaborative projects and combined analysis.
Act as an incubator for new cohorts.
EPIC
UK Mongolia
NCI Cohort Consortium
BiobanK NCI-supported cohorts
China Korea Japan
Iran Bangladesh Other US cohorts
India Taiwan
Malaysia
ACC Research Collaboration with the US
Singapore
A member of NCI Cohort Consortium
Many collaborating researchers are based in
the US (1/3 of the researchers in ACC are
from NCI, Vanderbilt Univ., Univ. Chicago,
NYU, Mt Sinai Med. Sch., Univ. Hawaii and
others)
The ACC Coordinating Center (2014-) Key Research
Publication Ideas and Skills
1. NIHDiabetologia
Funding for theDiabetes
specific
andresearch
Center for Public Health Sciences, NCC, Tokyo project
(2017) cancer mortality
2. Am J Epidemiol (2015) Prostate cancer mortality
Activities 3. PLoS Medicine (2014) Total and cause-specific
Meeting: Annual (2017 NCC, Tokyo) mortality
Analysis: onsite or remote access analysis 4. BMJ (2013) Cardiovascular disease.
Working groups by research project 5. Am J Clin Nutr (2013) Meat intake
6. Eur J Cancer Prev (2013) Pancreas cancer
Discuss issues on the cohorts and projects
7. Ann Onco(l (2012) Cancer of the small intestine
8. PLoS One (2011) Diabetes.
9. N Engl J Med (2011) Body mass index and risk of
death
29
2-3. Early Detection
and Treatment Cancer Precision Medicine
NCC Oncopanel
Scope of
DNA template Determine base Analysis application
sequence
NCC Oncopanel DNA sequencer Analytical program
Raw data
DNA extraction
レポート
Analysis
Reporting
Patient ID: xxxxx
Genetic
aberrations:
AKT1 E17K
・・・・
Database ・・・・
30
2-3. Early Detection
and Treatment Cancer Precision Medicine
Center for Cancer Genomics and Advanced
Therapeutics (C-CAT)
Established in June 2018, responding to the final report from the Expert Meeting for Cancer Genomic Medicine Promotion
Consortium June 2017, appointed by the Ministry of Health, Labour and Welfare. The Meeting called for a new agency to construct
and operate a “Cancer Genomics Information Repository”, a master database for cancer genomic medicine and research in Japan.
Certified
Mission laboratories
for genomic testing
1. Control quality and advance
genomic diagnosis of cancer: Specimens
Accumulate clinical and genomic information of Sequence Sharing and
Japanese cancer patients and establish a data research use of
database optimized to serve the populace cancer
Provide support to Expert Panels at Designated genomics data
Core Hospitals for Cancer Genomic Medicine
Communicate genomic medicine-related Designated Core
information with the public, and advocate policy Hospitals C-CAT
underpinned by nation-wide statistics of cancer for Cancer Genomic Medicine
genomic medicine
alization
Novel targets, individu-
New therapy, diagnosis
Cancer Genomics
2. Lead data sharing: Information Repository
Promote data sharing among designated and Clinical (genomic and clinical)
cooperative hospitals of cancer genomic medicine info
following appropriate protocol, and promote cancer
care covered by national healthcare insurance
3. Promote clinical trials, research Incl.
AI analyses
and development:
Establish data utilization as foundation for clinical
trials including investigator-initiated trials, and for
drug/device development and precision medicine Expert Panel
CKDB
for cancer patients
utilized in developing drugs
4. Conduct research, and nurture collaborating with core and cooperative
"Genomic test hospitals, pharma, and relative
talent in preparation for the CKDB report" ministries to maximizing therapy for
introduction of Whole Genome Cooperative annotating clinical Japanese patients
31
3.Treatment
Collaboration in Drug
Development (Phase 1)
26
3.Treatment
Collaboration in Drug
Development (Phase 3)
Endpoints
Stratified Expected Outcome
PE: PFS • Detect PFS improvement from 8.25 months to 13.3
• 1st line vs 2nd line
SEs: OS, OR, DR, CBR, • Menopausal status
months (HR=0.62) with 80% power, 1-sided α=0.025
PK/PD/PGx, Safety (pre/peri vs post) • Accrual Duration: 24 months
• Observation Time: 36 months
27
3.Treatment
Collaboration in Drug
Development (Phase 3)
CRO
・Monitoring
Pfizer ・Data Management
・IP Manufacture NCCH ・QA(Audit)
・Research Funding Study Chair:
・CSR
Kenji Tamura
IDMC Sponsor
・Taizo Hirata (JP) (ICH-GCP) Other Vendors
・Harukaze Yamamoto
(JP)
・IP labeling, Storage,
・Daniel SW Tan (SG) Delivery
・IRT
・Central Lab
IRRC
・Ukihide Tateishi (JP)
・Mitsuhiro Kishino (JP)
・Takashi Ogura (JP)
KCSG
Korean Cancer
Study Group
The goal of the PATHWAY trial is to obtain simultaneous drug approval (label change) and
establish a new standard treatment in the participating countries
28
3.Treatment
Training of overseas doctors
34
3.Treatment
Training of overseas doctors
0 10 20 30 40 50 60 70 80 90 100
China 42 53
2017
Taiwan 31 29
Thailand 23 14
India 9 3
Hong Kong 6 4
Viet Nam 2 6
Korea 5 2
Philippines 3 3
Singapore 2 2 Nb of trainees 2017 2016 2015
Indonesia 10 China 95 50 82
Pakistan 10
Taiwan 60 45 63
Malaysia 10
Myanmar Thailand 37 44 9
India 12 9 3
2016 32 18 Hong Kong 10 2 4
38 7
23 21 Viet Nam 8 9 7
8 1 Korea 7 11 16
20
2 7 Philippines 6 6 7
4 7 Singapore 4 3 2
1 5
21 Training > 4 days Indonesia 1 1 1
10 Pakistan 1 0 0
0 Short term training
6 1
Malaysia 1 7 5
1 Myanmar 0 1 1
0 10 20 30 40 50 Total
60 242 188 200
35
3.Treatment
28
Thank you !
Slides of cancer statics were cited and modified from "Cancer Statistics in Japan - 2015",
Foundation for Promotion Cancer Research of which information originally came from
Division of Cancer Control and Health Promotion, Health Services Bureau, MHLW
41
Backup
国立がん研究センタ ー
がん対策情報センタ ー
National Cancer Center
Center for Cancer Control and Information Services
42
History of Cancer Control and Research Programs by Government
2017
3rd- Basic Plan (2017~2022)
2nd - Basic Plan (2012-2016) 2012
Basic Plan to Promote Cancer Control 1. Clarification of cancer itself
(2007-2011) 2. Application of basic research results to prevention,
2007 diagnosis, and treatment
Cancer Control Act (2006) 3. Development of innovative prevention, diagnosis,
3rd-term Comprehensive 10- treatment methods
4. Reduction of lifetime cancer morbidity through
year Strategy for Cancer promotion of cancer prevention
Control (2004-2013) 5. Dissemination of high-quality cancer medical services
2004
1. Research on molecular mechanism of carcinogenesis
2. Research on metastasis, infiltration, and characteristics of
New 10-year Strategy to cancer cells
Overcome Cancer 3. Research on cancer predisposition and immunity
(1994-2003) 4. Research on cancer prevention
1994 5. Research on development of new diagnosis technologies
6. Research on development of new treatments
7. Research on QOL of cancer patients
46
5 year cancer survival in Japan 国立がん研究センタ ーがん対策情報センタ ー
All sites
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Oropharyngeal
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Esophagus
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Stomach
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Colon
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Rectum
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Liver
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Gallbladder
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Pancreas
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Larynx
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Lung
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Female breast
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Uterus
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Cervix uteri
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Corpus uteri
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Ovary
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Prostate
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Bladder
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Thyroid
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Malignant lymphoma
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Multiple myeloma
1997-1999
2000-2002
2003-2005
2006-2008
1993-1996
Leukaemia
1997-1999
2000-2002
2003-2005
2006-2008
47
Cancer Control Act
The first comprehensive national cancer control plan, first approved in
2006 in response to patient advocacy. With further revisions in 2016,
it establishes the policies of promoting:
1. Prevention and early detection
2. High treatment quality standards throughout the Nation
3. Cancer Research, and utilization of its outcomes
4. Patients’ employment
5. Inclusion of cancer in national curriculum
All sites
400
All sites
300
200
Colon
Lung
Prostate
10
Rectum
Corpus uteri
Ovary
Rectum Liver Cervix uteri
1
1975 1980 1985 1990 1995 2000 2005 2010 1975 1980 1985 1990 1995 2000 2005 2010
2012 2012
49