S olving U nknown P rimary canc ER SUPER National prospective cohort study Established in 2014 Overall Project Aims To establish a cohort of CUP patients with associated biospecimens clinical quality of life and psychosocial data ID: 921061
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Slide1
11 metropolitan and rural sites across Australia
S
olving
Unknown Primary cancER (SUPER)
National prospective cohort study
Established in 2014
Slide2Overall Project Aims
To establish a cohort of CUP patients with associated biospecimens, clinical, quality of life and psychosocial data
To determine the clinical management patterns when genomics test results provided to treating clinician
To establish the experiences, quality of life, psychosocial needs of patients with CUP compared to a matched sample of patients with metastatic cancer of a known primary and investigate differences between rural vs urban CUP patients
Slide31
st patient recruited November 2013Site
TotalPeter Mac
131Westmead 26Nepean15Blacktown15Flinders
14Geelong
29
Warrnambool
11
Cabrini
6Bendigo22Darwin6Healthscope5Border MO14TOTAL RECRUITMENT294
SUPER – 31
st March 2019
Recruiting ~6 per month294 participants in totalStudy target – 350
Total Recruitment
Slide4AIM 1SUPER – Establishing a CUP cohort (1st
April) 2019)
Item
NumberTarget = 350
294 (84%)56 remaining
Recruitment rate
6
per
month on average
Projection: 30th Nov 2019TestItem
NumberPhase 2 data128 samples CCPComplete81 (63%) Incomplete
41 (32%)
Pending 6 (5%)
SUPERDx
Complete
77 (60%)
Incomplete
44 (34%) Pending7 (6%)CombinedComplete both72 (56%) Incomplete both 36 (28%) Complete either86 (67%)
ItemNumberFemale (%)Age (SD)Rural (%)Deceased < 3 M (%)< 6 M< 9 M< 12 MPhase 1 [2013-15]16892 (55)63 (13)28 (17)30 (18)50 (30)67 (40)81 (48)Phase 2 [2017 – ] 12868 (53)65 (13)51 (40)11* (10)18* (23)20* (32)23* (46)Combined294159 (54)63 (13)79 (27)44* (15)68* (28)87* (38)104* (48)
* Number of included participants vary in P2 data as their duration on study will vary according to when they where recruited
Slide5AIM 2SUPER – Impacting clinical decisions
Specific Aims:Describe the molecular landscape of CUP patients and correlate molecular test results with demographic and clinical characteristics
Determine the impact site-of-origin and mutation profiling has had on treatment decisions taken by the treating clinician
13
Slide6Clinical impact of molecular testingDr Tharani Sivakumaran
Design: Pre/post survey of clinical management prior to and post receiving genomic resultsAnalysis ongoing
Slide7Early Results: Phase ILikely site of origin: CUPguide
CUPGuide was completed for ~78% (97 of 124) of samples
Primary site prediction was made in ~87% (84 of 97)Predictions resulted in:
a change in management in ~12% (10 of 84)confirmed current management in ~63% (53 of 84)Mutation profiling: CCP version 1Comprehensive Cancer Panel (CCP) was completed in ~83% (103 of 124) Actionable gene mutations where identified in ~10% (10 of 103) Germline gene mutations were identified in 6% (6 of 103)Predictions resulted in:a change in treatment for 30% (3 of 10) of patients because the targeted therapy was available.
Slide8AIM 3SUPER – Quality of life and psychosocial needs
Specifically, we seek:
To establish reliable estimates for quality of life and psychosocial needs across the CUP illness trajectory
To identify similarities and differences between CUP and non-CUP patients from baseline to 12-month follow-upTo identify similarities and differences between urban and rural/regional CUP patients from baseline to 12-month follow-up
Slide9What do we know about the experience of CUP?Compared to known primaries, CUP patients were:
less likely to receive written information about their type of cancer, diagnostic tests and any operations they hadLess likely to understand the results of their testsLess likely to completely understand the explanation of their illness
Less likely to feel their views were taken into account in treatment discussions
Slide10Communicating with CUP patients
86 oncologist responded.99% prepared to make a diagnosis of CUP if no primary located BUT 27% prefer to provide a ‘best guess’ rather than CUP as an diagnostic entity
83% would assign a primary site to obtain PBS drug funding
62% did not have a specific treatment protocol for CUPDifferent ways of describing Dx: “No I don’t use CUP, I usually talk about my best guess primary” vs “The primary (parent) appears of have regressed but metastases(children) have grown”
Slide11METHODSDesign
A prospective, longitudinal study with matched control group at baselineCUP patients recruited from both urban and rural/regional Patient reported outcome data will be collected at baseline and at 3, 6, 9 and 12 months post-baseline (or to death).
Slide12MeasuresPhysical, social and mental health Patient Reported Outcomes Measurement Interactive System (PROMIS
®) : Anxiety; Depression; Fatigue; Pain Interference; Pain Intensity; Sleep Disturbance; Physical Function; Satisfaction with Social Roles and ActivitiesCancer-specific health-related quality of life
EORTC Quality of Life Questionnaire – C30 (EORTC QLQ-C30)
Medical communication/information and psychological needs: Needs Assessment for Advanced Lung Cancer Patients (NA-ALCP)Hopelessness : Hopelessness Assessment in Illness (HAI)Communication about and understanding of illness and treatment: a purpose-built questionnaire drawn from UK National Cancer Patient Experience Survey
Slide13Psychological distress in CUP patients: the role of communication
AimTo investigate the impact of patient-oncologist communication practices and socio-demographic factors on the anxiety and depression of CUP patients
Design
Cross-sectional survey: data drawn from baseline data from SUPER study.
Dr
Kamil
Wolyniec
Slide14Patients’ communication experiences
Item
Response scale Percentage
How well do you feel you understand your cancer?Very wellWellNot so wellNot well at all20%43%25%12%Were you given written information about the type of cancer you had?Yes, and it was easy to understandYes, but it was difficult to understandNo, I was not given written informationI did not need written informationDon’t know/can’t remember26%9%57%7%0%
How do you feel about the way you were told you had advanced cancer?It was done sensitivelyIt should have been done a bit more sensitivelyIt should have been done
a lot
more sensitively
78%
16%
7%
Slide15Results
CUP patients who felt they understood their cancer very well reported lower levels of anxiety and depression than those who did not.
p
=.004p=.040p=.006Very well well
Not so well Not well at all
Patient’s understanding of cancer
Mean Depression scores
Patient’s understanding of cancer
p
=.029p=.006Mean Anxiety scoresVery well well Not so well
Not well at all
Slide16Key findings
Only 20% felt they understood their cancer very well and this was linked to lower levels of anxiety and depression
Less than half received written information about cancer or information about support but not linked to psychological distress.
Younger CUP patients reported higher anxiety and depression
28
Slide17Conclusions
Locating and retaining CUP patients in a cohort study remains challenging;
as is successful
genomic testing
Rapid advances in genomic testing to assist in the diagnosis and treatment but at present these advances don’t appear to be translating into clinical management change
Genomic testing advances represent a challenge for both clinician communication and patient understanding
Good patient understanding may alleviate psychological distress
Younger patients may require additional support and referral to psychological services