Validation of the G8 screening 

Validation of the G8 screening

tool in geriatric oncology: 
The ONCODAGE project 
Pierre Soubeyran, Carine Bellera, Jean Goyard, Damien 
Heitz, Hervé Curé, Hubert Rousselot, Gilles Albrand, 
Véronique Servent, Olivier St Jean, Caroline Roy, Simone 
Mathoulin‐Pélissier, Muriel Rainfray
 Background

• Standard evaluation of older patients

– May lead to overtreatment and toxicity
– May lead
May lead to
to undertreatment
undertreatment and loss
and loss of efficacy
of efficacy
• Geriatric evaluation as an opportunity
– To better evaluate risks
– To better appreciate chances
– To better define adequate treatment strategy
• Geriatric evaluation is time‐consuming
– A screening strategy appears necessary
 The G8 screening questionnaire

• Eight
g questions
q
• By a trained nurse
• 5 to 10 min to perform
5 to 10 min to perform
– Appetite, Weight loss, BMI
– Mobility
– Mood d and cognition
d ii
– Number medications
– Patient‐related health
– Age categories
• Abnormal if ≤14
– Preliminary analysis
– Se: 89.6% ; Sp: 60.4%
 ONCODAGE study
ONCODAGE study

• French national prospective study
• 23 participating centers
• Mostly Pilot Units of Geriatric Oncology
(INC
(INCa-sponsored
d UPCOG)

• All with oncologist and geriatrician together

 ONCODAGE study: Inclusion criteria
ONCODAGE study:  Inclusion criteria

• Older than 70
• Histological diagnosis of:
– Breast, Colon, Lung, Prostate or Head and neck cancer
– Lymphoma
• First‐line treatment
– Before the first occurrence of any
the first occurrence of any treatment (surgery, 
(surgery,
radiotherapy, chemotherapy, targeted treatment…)
 Study flow
Study flow
Patient included in Oncology
Informed consent
G8 and VES13 passation
Appointments

Oncology  Geriatric assessment
CIRS G, MMS, ADL, IADL, MNA,
CIRS-G,
pretreatment work‐up Timed Get up and go, GDS15, QLQ-C30

Geriatric intervention ?
Geriatric intervention ?

1‐year and 5‐year survival
 ONCODAGE study: Primary endpoint
To validate the diagnostic accuracy of the G8 questionnaire 
Gold standard: Impaired Multidimensional Geriatric Assessment (MGA)
Setting: Patients >70 with cancer

Impaired
p MGA if 
≥ one abnormal questionnaire
– CIRS‐G :  at least one grade  3
– ADL :  score ≤ 5
– IADL :  score ≤ 7
– Timed Get up and Go :  > 20 s
– MNA :  score ≤ 23,5
– MMSE :  score ≤ 23
– GDS
GDS‐15
15 : 
: score  6
score 
 Flow chart
Flow chart
1668 included Not loaded in database: 11
Withdrawal of consent: 7
Missing informed consent: 4
1646 kept in 
database
Exclusion criteria 56

1590 eligible
li ibl Protocol violation 75
Patient’s refusal 25
MGA not performed 20
Early death 3
G8 missing 2
MGA too late 15
1425 eligible
1425 eligible Other causes 25
and evaluable
 Characteristics ‐ 1
• Mean Age: 
Age: 78 
78 (70 –
(70 – 98) ECOG N %
0 546 40.7
• ECOG PS:  75% 0‐1 1 472 35.2

• Gender:  70% female 2 195 14.5

3 82 6.1
Age N % 4 46 3.4
70 – 74 444 31.2
75 – 79 426 39.9
Gender N %
80 – 84 353 24.8
Male 433 30.4
85 + 202 14.2
Female 992 69.6
Mean 78.2 +/- 5.5
Min, max [70 - 98]
 Characteristics ‐ 2

• M
Mainly
i l breast
b cancer Tumor site N %
Breast 766 53.7
• Mainly non metastatic Colorectal 203 14.3
Lung 149 10.5
Prostate 122 8.6
L
Lymphoma
h 112 79
7.9
Tumor stage N % H&N 73 5.1
Non metastatic (M0) 707 49.6
Metastatic (M1) 228 16.0
Not available (MX, missing) 490 34.4
 Results – Geriatric Assessment
• Duration of CGA 67.7 mn +/‐ 24.6
• Prevalence of abnormal MGA 80%
– At least one abnormal questionnaire (Gold standard)
– Questionnaire with missing question(s) considered abnormal
1425 pts Anormal n %
ADL <6 217 15.2
IADL <8 682 47.9
GDS15 ≥6 457 32.1
MMS <24 290 20 3
20.3
MNA ≤23,5 623 43.7
Timed Get up & Go >20 s 328 23
CIRS G
CIRS-G Grade 3
3-4
4 595 41 8
41.8

– Variations according to metastatic status and type of disease

 Results – VES13 vs G8 
VES13 vs G8
VES13 G8
Administered By the nurse 80% 88%

By the oncologist 8% 12%

By the patient 12% ‐

Completed in Median 4.3 +/‐ 4.6 4.4 +/‐ 2.9

Less than 5 min 75% 75%

Less than 10 min 96.7% 98.7%

Abnormal in 60.1% 68.5%

 Primary endpoint – G8
N Altered G8 Normal G8 Total
%
874 267 1141
Abnormal MGA 61.33 18.74 80.07
101 183 284
N
Normal
l MGA 7.09 12.84 19.93
975 450 1425
Total
68.42 31.58 100.00 Altered Normal
N Total
VES13 VES13
%
784 357 1141
Altered MGA 25.05
55.02 80.07
73 211 284
Normal MGA 5.12 14.81 19.93
Total 857 568 1425
60.14 39.86 100.00
 Validity: G8 versus VES13
Validity: G8 versus VES13

Se Sp PPV NPV k Time

(mn)

G8 76.6% 64.4% 89.6% 40.7% 0.65 4.4 +/- 2.9

(74-79) (58 6-70) (87.6-91.5)
(58.6-70) (87 6-91 5) (36.1-45.4)
(36 1-45 4)

VES13 68.7% 74.3% 91.5% 37.1% 0.64 4.3 +/- 4.6

(65.9-71.4) (68.8-79.3) (89.4-93.3) (33.2-41.3)

G8 slightly superior to VES13

in terms of sensitivity
 Conclusions
• A large series of 1668 patients 
– 6 types of cancer before treatment
– 1425 patients eligible and evaluable
• Geriatric
G i i assessment abnormal
b l in 80%
i 80%
• G8 questionnaire abnormal (≤ 14) in 68.5%
– Good reproducibility
Good reproducibility (K = 0.65)
(K 0 65)
– Completed by nurse (88%) in less than 10’ (98.7%)
• Primary endpoint
– Se: 76.6% ; Sp: 64.4%
• G8 slightly superior to VES13
 Acknowledgements

IDMC Members
R. Audisio
M. Extermann
X. Paoletti
ONCODAGE Investigators G. Zulian