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