Download SIOG 2015 NR report

Japan
NR: Fumio Nagashima
In 2015, Ministry of Health, Labour and Welfare of Japan has financed about 6 clinical
trials for elderly cancer patients. Agency for medical research and development (AMED),
being established this year, follows these projects.
A. Geriatric Study Committee of the JCOG
Due to the rapidly aging population in Japan, the specific clinical studies for elderly
cancer patients are needed. Since we have not had enough experience of such studies,
we organized the Geriatric Study Committee (GSC) of the Japan Clinical Oncology
Group (JCOG) in 2013.
Missions of the GSC are the followings; (1) To define “elderly” in JCOG trials. (2) To
determine the standard tools of geriatric assessment (GA). (3) To establish the
methodological schemes for clinical trials of elderly cancer patients. For these purposes,
the GSC held quarterly meetings with disease/modality-oriented JCOG subgroups and
discussed above issues.
(1) We defined “elderly” by treatment tolerance, not by chronological age. We
categorized elderly into three conceptual groups. “fit patients” is the group which can
undergo standard therapy same as young patients. “frail patients” is the group for
which best supportive care or palliative care should be indicated. “vulnerable patients”
is the group as between “fit patients” and “frail patients”. “vulnerable patients” would
be a subject of most clinical trials for elderly.
(2) We determined recommended tools for GA from the viewpoint of simplicity and
discriminative power. G8, a geriatric screening tool, is to be used in all JCOG geriatric
studies. IADL (Instrumental Activities of Daily Living), CCI (Charlson Comorbidity
Index) and social situation, are strongly recommended. Other appropriate tools can be
applied depending on a purpose of each disease/modality-oriented study.
(3) We classified the typical study designs for elderly adopted in JCOG are: (i) a
randomized controlled trial for "vulnerable patients" and (ii) an observational study for
broader population to explore predictive factors for survival, functional impairment or
QOL decline.
B. Management of Prostate Cancer patients to the Japanese population
SIOG is adapting its international recommendations on the Management of Prostate
Cancer in Older patients to the Japanese population with the support of recognized
Japanese experts in the field. SIOG has formed a Japan Prostate Cancer Board –
composed of Japanese Prostate cancer experts who have met with two international
leading experts (Jean-Pierre Droz and Matti Aapro) on June 7 in Tokyo.