Validation of the G8 screeningValidation 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
BackgroundBackground
• Standard evaluation of older patients– May lead to overtreatment and toxicityMay lead to undertreatment and loss of efficacy– May lead to undertreatment and loss 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 questionsg q• By a trained nurse• 5 to 10 min to perform5 to 10 min to perform
– Appetite, Weight loss, BMI– Mobility
d d i i– Mood and cognition– Number medications– Patient‐related health– Age categories
• Abnormal if ≤14Preliminary analysis– Preliminary analysis
– Se: 89.6% ; Sp: 60.4%
ONCODAGE studyONCODAGE study
• French national prospective study• 23 participating centers23 participating centers
• Mostly Pilot Units of Geriatric Oncology(INC d UPCOG)(INCa-sponsored UPCOG)
• All with oncologist and geriatrician together
ONCODAGE study: Inclusion criteriaONCODAGE study: Inclusion criteria
• Older than 70• Histological diagnosis of:• Histological diagnosis of:
– Breast, Colon, Lung, Prostate or Head and neck cancer– LymphomaLymphoma
• First‐line treatment– Before the first occurrence of any treatment (surgery,Before the first occurrence of any treatment (surgery,
radiotherapy, chemotherapy, targeted treatment…)
Study flowStudy flowPatient included in Oncology
Informed consentG8 and VES13 passation
Appointments
Oncology Geriatric assessmentCIRS-G, MMS, ADL, IADL, MNA,
pretreatment work‐upCIRS G, MMS, ADL, IADL, MNA,
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 MGA if p≥ 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‐15 : score 6GDS 15 : score 6
Flow chartFlow chart
1668 included Not loaded in database: 11Withdrawal of consent: 7Missing informed consent: 4
1646 kept in
li ibl
databaseExclusion criteria 56
1590 eligible Protocol violation 75Patient’s refusal 25MGA not performed 20
1425 eligible
Early death 3G8 missing 2MGA too late 15Other causes 251425 eligible
and evaluableOther causes 25
Characteristics ‐ 1Characteristics 1
• Mean Age: 78 (70 – 98) ECOG N %• Mean Age: 78 (70 – 98)• ECOG PS: 75% 0‐1
ECOG N %0 546 40.71 472 35.2
• Gender: 70% femaleAge N %
2 195 14.53 82 6.14 46 3.4
70 – 74 444 31.275 – 79 426 39.980 – 84 353 24.8
Gender N %
85 + 202 14.2Mean 78.2 +/- 5.5
Male 433 30.4
Female 992 69.6
Min, max [70 - 98]
Characteristics ‐ 2Characteristics 2
M i l b• Mainly breast cancer• Mainly non metastatic
Tumor site N %Breast 766 53.7Colorectal 203 14.3Colorectal 203 14.3Lung 149 10.5Prostate 122 8.6L h 112 7 9
Tumor stage N %Non metastatic (M0) 707 49.6
Lymphoma 112 7.9H&N 73 5.1
Metastatic (M1) 228 16.0Not available (MX, missing) 490 34.4
Results – Geriatric AssessmentResults 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 15.2ADL <6 217 15.2IADL <8 682 47.9GDS15 ≥6 457 32.1MMS <24 290 20 3MMS <24 290 20.3MNA ≤23,5 623 43.7Timed Get up & Go >20 s 328 23CIRS G Grade 3 4 595 41 8
– Variations according to metastatic status and type of disease
CIRS-G Grade 3-4 595 41.8
Results – VES13 vs G8Results VES13 vs G8
VES13 G8VES13 G8Administered 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 – G8Primary endpoint G8N%
Altered G8 Normal G8 Total%
Abnormal MGA874
61.33267
18.741141
80.07
N l MGA101 183 284
N AlteredVES13
Normal VES13 Total
Normal MGA 7.09 12.84 19.93
Total 97568.42
45031.58
1425100.00
% VES13 VES13
Altered MGA784
55.02
35725.05
1141
80.0773 211 284
Normal MGA73
5.12211
14.81284
19.93Total 857
60.14568
39.861425
100.00
Validity: G8 versus VES13Validity: G8 versus VES13
Se Sp PPV NPV k Time(mn)(mn)
G8 76.6%(74-79)
64.4%(58 6-70)
89.6%(87 6-91 5)
40.7%(36 1-45 4)
0.65 4.4 +/- 2.9(74-79) (58.6-70) (87.6-91.5) (36.1-45.4)
VES13 68.7%(65.9-71.4)
74.3%(68.8-79.3)
91.5%(89.4-93.3)
37.1%(33.2-41.3)
0.64 4.3 +/- 4.6
G8 slightly superior to VES13in terms of sensitivity
ConclusionsConclusions• A large series of 1668 patients
– 6 types of cancer before treatment– 1425 patients eligible and evaluableG i i b l i 80%• Geriatric assessment abnormal in 80%
• G8 questionnaire abnormal (≤ 14) in 68.5%Good reproducibility (K 0 65)– Good reproducibility (K = 0.65)
– Completed by nurse (88%) in less than 10’ (98.7%)• Primary endpointPrimary endpoint
– Se: 76.6% ; Sp: 64.4%• G8 slightly superior to VES13
Acknowledgements
IDMC MembersIDMC MembersR. Audisio
M. ExtermannX. Paoletti
G. ZulianONCODAGE Investigators