Download Symptom Benefit Presentation

Symptom Benefit Working group
Chicago, Thursday, May 29, 2014
02:00-04:00
Chairs: F Joly, Co-Chair J McAlpine
Renewal Chair and co-chair
• Chair : F Joly
• Co-Chair : E Avall-Lundqvist
• Past Co-Chair : J McAlpine
Agenda
• Update publications brainstorming Leiden
• General topic
F Joly
- Impact of lifestyle on gynecologic cancers
M McCaroll
• Working group session
- Lesson from previous QOL substudies
M Friedlander
- Paola QoL Substudy
I Ray Coquard – E Pujade
Lauraine et al
• Ongoing studies
- SB Study
- Elderly
EWOC study
GOG 273
- Patient satisfaction (expression III/IV)
- Survivorship- Ovquest, Most Opal, Echo, Review
- Vivrovaire, Others
• Projects
M Friedlander
F Joly for G Freyer
F Joly for G Fleming
J McAlpine for J Sehouli
M Friedlander
F Joly, al
J McAlpine , F Joly and al
Survivorship in endometrial cancer: patients: discussion and action items
FUTURE ideas –Translational research - discussion
Update of the publications of the brainstorming
session, PRO and endometrial cancer (Leiden)
International Journal of Gynecological Cancer
Paper 1 : Quality of Life and Patient-Reported-Outcomes in endometrial cancer
clinical trials- a call for action
F Joly, J.N. Mc Alpine, R.A. Nout, E Avall-Lundqvist, E Shash, M Friedlander and on
behalf of the Gynaecologic Cancer Intergroup (GCIG)
•
Paper 2: Quality of life research in endometrial cancer: what is needed to
advance progress in this disease site?
Methodologic Considerations from the GCIG Symptom Benefit Working Group
Brainstorming Session, Leiden 2012
JN McAlpine, E Greimel, LA Brotto, RA Nout , E Shash, E Avall-Lundqvist, ML
Friedlander, F Joly on behalf of the Gynecologic Cancer Intergroup (GCIG)
•
In minor revisions!
Impact of lifestyle on
gynecologic cancers
Michele L. McCarroll, PhD
Women’s Health Research Director, Summa Health System
Assistant Professor, Department of Obstetrics and Gynecology
Northeast Ohio Medical University (NEOMED)
That’s more than healthcare. That’s smartcare.
INTERVENTIONS
 Published interventions like the SUCCEED trial to
promote weight loss and a healthy lifestyle using
traditional, “face-to-face” approaches have been
successful in reducing weight and improving
lifestyle
 von Gruenigen et al. Gynecol Oncol. 2012 Jun
 Basen-Engquist K, Health Psychol. 2013 Nov
That’s more than healthcare. That’s smartcare.
Working group – QoL Paola Substudy
• Lessons from Icon 7 and GOG 218 previous
QoL Substudies (M Friedlander)
Questions QOL Paola Substudy
• Is Pro assessment important? And why?
• What do we want to capture?
• Definition of our PRO a-priori hypothesis (ses)
• Choice of the tools and methods
• Patients self reported toxicities?
• QOL questionnaires?
• Qtwist?
• Patients preferences?
• Timing of measure
GCIG QoL PAOLA substudy committee
Urgence to have guidelines for PRO
analysis in the area of maintenance
therapy!
Special working group on QOL Assessment in
Ovarian cancer
Tokyo Consensus conference, 2015
Ongoing studies
• SB Study
• Survivorship : Ovquest, Most Opal, Echo,
Review, Vivrovaire
• Elderly Ewoc study
GOG 273 study
• Expression IV
11
SYMPTOM BENEFIT
Does palliative chemotherapy improve
symptoms in women with recurrent
ovarian cancer?
Principal Investigator: Michael Friedlander
GCIG Meeting, Chicago, May 2014
Hyatt Canberra | 26–29 March 2014
The aims of the study are to;

Determine the validity, reliability and statistical efficiency of a new patientreported outcome measure, the MOST

Develop criteria for defining subjective symptom benefit and defining
minimally important difference

Determine what proportion of women with platinum resistant recurrent
ovarian cancer have subjective benefit with palliative chemotherapy and

Develop a prognostic model to predict likelihood of benefit of
chemotherapy, time to progression and survival in this heterogeneous group
of patients.
Trial Status
13
Study will close to recruitment end of 2014
Currently 748 patients
Accrual rate ~50/month
Country
# pts
ANZGOG
132
ICORG
62
AGO
79
MITO
74
PMHC
56
GINECO
141
NSGO
32
CRUK
98
JGOG/GOTIC
65
COGI
9
GCIG Meeting, Chicago, May 2014
Hyatt Canberra | 26–29 March 2014
www.anzgog.org.au or
www.ovariancancer.net.au
Collaboration with
UK – Sarah Blagden /
USA Coleman/Hertzog
Ovarian Cancer National Alliance
Canada Jessica McAlpine -Ovarian Cancer Canada
15
MOST -OPAL
Objectives:
Primary objectives:
To (i) investigate the acceptability of the MOST
questionnaire and its ability to detect symptoms of
recurrence and (ii) document the frequency and impact of
late-effects of treatment in women with advanced ovarian
cancer during follow up after completion of first line
chemotherapy.
Hyatt Canberra | 26–29 March 2014
The ECHO trial: Exercise during
CHemotherapy for Ovarian cancer.
Study design: Randomised, controlled trial (RCT) evaluating the
effect of an exercise intervention among women undergoing
chemotherapy for ovarian cancer on physical wellbeing,
chemotherapy-related adverse effects, chemotherapy adherence,
physical function, quality of life, progression-free survival and health
care costs.
The aim of this study is to determine the enduring effects on
survivorship of an exercise intervention during first-line
adjuvant chemotherapy for epithelial ovarian cancer
PI Sandi Hayes- Pilot funded – large grant submitted
Vivrovaire
Pr Florence JOLY
09/06/2014
17
09/06/2014
18
EWOC-1
Elderly Women Ovarian Cancer
Multicenter, randomized trial of carboplatin +/- paclitaxel in vulnerable elderly
patients with stage IIB-IV advanced ovarian cancer
First ENGOT-GCIG international study of
elderly patients in Ovarian Cancer
Participating Groups
GINECO, AGO, MITO, ANZGOG, Canada, JGOG, GOTIC, NSGO
19
Patient
identification
EWOC-1 Flow chart
70 years old
Stage III-IV ovarian cancer
Initial diagnosis
GVS consent
Not
eligible
NO
YES
GVS screening
score ADL < 6
score IADL < 25
score HADS > 14
albuminemia < 35g/L
lymphopenie < 1G/L
 Vulnerable patient?
Registry
NO
Chemotherapy
per
investigator
choice
Registry should
include 500 patients
(Ewoc-1 and non
vulnerable patients )
YES
EWOC-1 consent
NO
NO
YES
Inclusion and exclusion
criteria respect?
YES
Ewoc-1 randomization
240 patients
Arm A
carboplatin AUC 5 + paclitaxel
175mg/m² q21
X 6 cycles
Arm B
carboplatin AUC 5-6
q21
X 6 cycles
Intervall debulking is
allowed
Arm C
carboplatin AUC 2 + paclitaxel
60 mg/m² weekly q28 (d1, d8, d15) x 6 cycles
PRIMARY ENDPOINT
To compare the rate of success to deliver 6 courses of chemotherapy
without progression at 6 months or unacceptable toxicity* of 3 different
regimens in vulnerable elderly patients
Screening
Chemotherapy 6 cycles
GVS>3 Imagery
QOL (Fact-O)
+/- Interval
debulking
(stratified)
6 month
visit
Follow-up every 3 mo.
(up to 2 years)
Imagery
QOL (Fact-O)
* Unacceptable Toxicity = is defined as a major adverse event related to
chemotherapy or treatment procedures leading either to early treatment
stopping, to an unplanned hospital admission or to death.
21
EWOC-1 Recruitment
EWOC-1
300
250
39%
No randomised
61%
200
150
Randomised
Planned Randomized
Actual randomizations
100
0
GINECO
First Patient In
12/12/2013
7
Dec 2013
janv-14
Feb
March
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
janv-15
Feb
March
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
janv-16
Feb
March
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
50
GOG 273 Update
Chemotherapy Toxicity in Elderly Women
with Ovarian , Primary Peritoneal or Fallopian
Tube Cancer
Gini Fleming
Chair GOG Working Group on Elderly
StudyChair
Vivian E. von Gruenigen, MD
GOG-0273
• Liberal eligibility criteria
• Patient and physician
therapy choices-not
randomized
• Prospective geriatric
assessment
• Allows neoadjuvant
chemotherapy
• Targeted initial accrual
185
GOG-0273
•Accrual for regimen I and II closed 8/12/2013
•A third regimen (every three week carboplatin
with weekly paclitaxel) opened at that time
(n=100); will close after accrual of nine more
patients
GOG-0273
The primary objectives
•Determine if Instrumental Activities of Daily Living
(IADL) at entry is associated with the ability to complete
chemotherapy
• Sequential Pros (patient-related outcomes)
•Estimate by regimen the % pts who are able to complete
chemotherapy w & w/o dose reductions or delays and
•Compare actual and calculated Carboplatin AUC
Future Directions
• Analysis of PK results
• Analysis of third arm
• Launch of new DCP-approved trial testing an
abbreviated Geriatric Assessment prior to
initial cytoreductive surgery
Discussion
• Minimal geriatric assessment in new ovarian
clinical trials (for the subgroup of patients > 70
years
Expression IV
What do primary and recurrent ovarian
cancer (OC) patients expect from
maintenance therapy? (ENGOT-ov22)
Survey
Timeline
2014
2013
May
Sep
Nov Dec
Feb
Autumn
Ethic approval in 2013-05-16
Start Germany
Start Romania
Start Slovenia
Start Belgium/Austria/Italy
Other countries will follow as soon as possible (Serbia, France, Spain, Finland,
Poland, Turkey)
First evaluation autumn 2014
number of participants
400
350
participants
300
250
online
200
paper
150
100
50
0
Germany Austria
Belgium Slovenia
Italy
Country
status: 2014-05-15
Romania
Total
Projects
• Endometrial cancer survey patients ( J
McAlpine)
QoL and Survivorship in Endometrial
Cancer: Where are we now?
J McAlpine on behalf of the SB Group
Components EMQuest survey
Series of initial questions re demographics, weight and height,
stage, histology, prior treatment including how many lines, what
drugs, participation in a clinical trial+/- targeted Rx?, etc
New Questions teasing out:
• Community size
• Attending a major cancer center?
• Comorbidities
• Self perceived weight category
• Diet and exercise regimen pre and post dx
• Inherited syndromes
• Radiation and hormonal therapy
UPDATES since last meeting
 Papers (2) generated from Leiden meeting accepted
 EMQUEST poised to launch-disease site changes, host in
Canada, Aus, France, French translation in process
KEEN TO HAVE NEW COUNTRIES OR CA CENTERS
JOIN!
Other languages? Advocacy and hosting.
Survey can start in 2 or 3 months
Questions?