Patient Reported Outcomes Measures (PROMs) in geriatric patients undergoing major surgery for solid

cancer. 90-day preliminary report on 643 patients from the Geriatric Oncology Surgical Assessment and

Functional rEcovery after Surgery (GOSAFE) study

Montroni I, Ugolini G, Spinelli A, Ercolani G, Jacklitsh M, Rostoft S, Somasundar P, Van Leuween B, De Liguori Carino N, Saur N, Ferrari G, Ghignone F, Sermonesi G, Di Candido F, Foca F, Zingaretti C, Vertogen B, Audisio R, and the SIOG surgical task force/ESSO GOSAFE study group

Isacco Montroni MD, PhD, FASCRS Colorectal Surgery, Ospedale per gli Infermi Faenza, AUSL Romagna, Italy

DISCLOSURE

IM: Olympus EU, Faculty at taTME international courses

The GOSAFE study did not receive any form of funding by any private company or State agency

EUROCARE-5 (2015) unfavorable cancer-related survival among senior adults

Why are we performing poorly?Disparities in treatments

De Angelis et al. Lancet Oncol 2014National Cancer Intelligence Network www.ncin.org.uk

Why are we performing poorly? (1) Difference between Chronological vs Biological age

Chronological ageBiological agePete Frates, 34, ALS pt He inspired the ice bucket challenge ‘Boston College baseball star’

Random Italian elderly gentleman, around 80, hospital cafeteria

‘The leopard can not change its spots’

Frailty assessment

ISACCO MONTRONI MD,PhD

(2) Gap between research trials and the real world

0-18 years

18 - 64years ≥64years

Clinical Trial

Population Actual users

Why are we performing poorly?

SIOG plenary session, Milan 2016

ISACCO MONTRONI MD,PhD

DFS/PFS has a little value for elderly ptsOS, Functional recovery, regaining independence are outcomes that matter to pts

89,574 pts with cancer from the Medicare database Disability and lack of independence seem to impact cancer patients more than the cancer prognosis per se

DFS/PFS have a little value for elderly ptsOS, Functional recovery, regaining independence are outcomes that matter to pts

(3) Asking the wrong questions

Why are we performing poorly?

ISACCO MONTRONI MD,PhD

What is necessary to make it better?

@GOSAFE study

To put outcomes relevant to patients at the center of a large collaborative study

Collaboration of a multidisciplinary group from the ESSO and the SIOG Surgical Task Force

clinicaltrials.gov (Identifier: NCT03299270)

REAL WORLD INVESTIGATION Observational Study – 26 centers

Feb-1

7

Mar

-17

Apr-17

May

-17

Jun-1

7

Jul-1

7

Aug-17

Sep-1

7

Oct-17

Nov-17

Dec-1

7

Jan-1

8

Feb-1

8

Mar

-18

Apr-18

May

-18

Jun-1

8

Jul-1

8

Aug-18

Sep-1

8

Oct-18

Nov-18

Dec-1

8

Jan-1

9

Feb-1

9

0

5

10

15

20

25

30

0

200

400

600

800

1000

1200

Cumulative accrualN. Active sitesActual accrualPredicted accrual

N. A

ctiv

e si

tes

N. P

ts

ISACCO MONTRONI MD,PhD

8

Ospedale per gli Infermi, FaenzaHumanitas Research HospitalManchester Royal InfirmaryOspedale Morgagni di Forli, AUSL RomagnaGroningen University HospitalOspedale Niguarda Clinica S. Rita Jagiellonian University Medical CollegeOspedale di DesioOspedale S. Martino Genova Ospedale di Riccione AUSL RomagnaOslo university HospitalOspedale di Piacenza, Azienda USL PiacenzaRabin Medical CenterBrigham and Women's HospitalOspedale San Martino Genova

Hospital General Universitario de Elche, Alicante

Ospedale S. Matteo degli InfermiAristotle University Hospital of Thessaloniki

Istituto Tumori Giovanni Paolo II

University of Pennsylvania Medical Center

Hospital Sao Francisco Xavier, LisbonOspedale Sant’Andrea RomsCleveland Clinic Foundation, Weston (FL)Roger William Medical Centre Providence Hospital Universitario y Politécnico La Fe

26 - Enrolling centers

Inclusion Criteria

All patients aged ≥70 years

elective major surgery with curative or palliative intent for solid malignancy (cognitive impairment was not considered an exclusion criterion)

Exclusion criteria

Patients undergoing emergent/urgent surgery

planned hospital stay less than 48 hours

Centers were asked to provide the minimum 20 consecutive patients, if not possible centers were excluded from the analysis of the primary and secondary outcome.

Outcome measures

10

Primary outcome

QoL- EQ5D-3L (3-point scale: mobility, selfcare, usual activities, pain/discomfort, anxiety/depression)

• Comparing the EQ 5D-3L index at 3-6m

• Comparing the EQ 5D-3L VAS at 3-6m

Williams A. Heal Policy 1990 Huisman MG et al EJSO 2016Montroni I et al EJSO 2018 Katz S Int J Heal Serv 2005GOSAFE study group JGO 2019

Outcome measures

11

Secondary outcomes

Functional recovery (FR) restoration of ADL, mobility, and cognitive status at 3-6m

• Composite measure of ADL (≥5), TUG (<20 sec) and MiniCog (>2)• Complete FR (cFR) preservation/improvement of baseline results of all the three reported tests• Partial FR (pFR) preservation/improvement of 2/3 of the functional assessment tests• Functional deterioration (FD) decline of 3 domains

3- and 6- month postoperative morbidity and mortalityCorrelation between risk factors (data from the frailty assessment) and postop outcomes, QoL and FR

Williams A. Heal Policy 1990 Huisman MG et al EJSO 2016Montroni I et al EJSO 2018 Katz S Int J Heal Serv 2005GOSAFE study group JGO 2019

GOSAFE study group JGO 2019

Overalln=643 (%)

Gender Male 332 (52.8) Female 311 (47.2)Age Median, [range] 78 [70-94]Age ≥70 and <75 211 (32.8) ≥75 and <80 196 (30.5) ≥80 and <85 152 (23.6) ≥85 84 (13.1)Living situation Home independent 292 (45.4) Home with family/caregiver 347 (54) Residential care 4 (0.6) Missing 0Polipharmacotherapy None 40 (6.2) Number of drugs, median [range] 4 [1-28] Missing 0History of falls 6 months prior to operation 75 (11.7)Previous delirium 34 (5.3)

Demographic data(February 2017-September 2018)

643 pts underwent major cancer surgery curative (94%) vs. palliative (6%) intent

388 pts Minimally Invasive Surgery (60.3%)

506 with 90-day postop comprehensive assessment

14

Test N(%) 643 Test N(%) 643

G-8 Total score fTRST – Variables

G-8 ≤14 434 (67.6) 0 159 (24.8) G-8 >14 208 (32.4) 1 237 (38.5)

Missing 1 ≥2 246 (36.7)ADL SCORE Missing 1 <5 52 (8.2) MINICOG Total score ≥5 589 (91.8) 0-2 pos screen dementia 134 (21.1)

Missing 2 3-5 neg screen dementia 500 (78.9)

ASA score Missing 9 1-2 305 (48.0) Time up and Go 3-4 330 (52.0) ≤ 20 sec 546 (93.8)Missing 8 >20 sec 36 (6.2)PS ECOG

ECOG 0 349 (54.5) Nutritional status score ECOG 1 190 (29.7) Normal 407 (63.9) ECOG≥2 101 (15.8) Mildly impaired 163 (25.6)Missing 3 Moderately impaired 53 (8.3)CACI Severely impaired 14 (2.2) 3-6 401 (64.1) Missing 6 ≥7 225 (35.9)Missing 17

Frailty screening and

Variability

30-90 day Postoperative outcomes

30-day Mortality90-day Mortality

25 pts (5%) 35 pts (7%)

Fit (ADL>5, TUG<20sec, Minicog>2) 18/329 (4.2%)

Two impaired (ADL>5, TUG<20sec, Minicog>2) 2/23 (8.7%)

All impaired (ADL>5, TUG<20sec, Minicog>2) 2/9 (22.2%)

506 pts

90-day morbidity 236 (50%), 105>1 (22.3%)

CD 1-2 183 (38.8%)

CD 3-4 53 (11.2%)

Fit (ADL>5, TUG<20sec, Minicog>2) 144/311 (46.3%)

Two impaired (ADL>5, TUG<20sec, Minicog>2) 16/21 (76%)

All impaired (ADL>5, TUG<20sec, Minicog>2) 5/7 (71%)

471 pts

EQ-5D VAS (471pts)

296 (67.0%)

28 (6.3%)49 (11.1%)

69 (15.6%)

0,0

5,0

10,0

15,0

20,0

25,0

30,0

35,0

40,0

45,0

50,0

0,2 1,7 2,3 3,60,8 2,5 2,5 1,7

8,14,0

25,127,0

11,013,4

22,7

28,9

40,1

25,3

36,3

26,1

Moderate problem Extreme problem%

EQ-5D index (471 pts)M

od

erat

e to

sev

ere

sym

pto

ms

Mean Postop 0.80 (SD 0.22)

Mean Preop 0.76 (SD 0.21)

90 day Functional Recovery (471pts)

29,10%

39,95%

30,95%

Functional Decline(ADL+TUG+MiniCog)

Partial Functional Recovery(decline in ADL or TUG or MiniCog)

Complete Functional Recovery(ADL≥5 + TUG<20sec + MiniCog>2)

22,58%

34,95%

42,47%

105 Pts with >1 complication

Conclusion

• GOSAFE study provides a real world picture of unselected older patients with cancer undergoing major surgery

• Enrolment and 6m follow-up completed (Oct 31th, 2019) 1007 patients (471 presented today)

• Single frailty screening provides inconsistent estimate (combination?)

• Mortality and Morbidity data prove that major surgery in senior adult can be safe

• 1/3 of patients who undergo surgery have a severe functional decline at 90 days 2/3 of patients who undergo surgery return to be independent (partial and complete FR at 90 days)

• QoL improves after surgery above all in terms of reduction of pain anxiety and depression

• Final data will allow to improve understanding QoL and FR

• Correlation between risk factors (data from the frailty assessment) and postop outcomes, QoL and FR