Download Symptom control in patients with recurrent ovarian cancer

Symptom control in patients with
recurrent ovarian cancer
Measuring the benefit of palliative chemotherapy in women
with platinum refractory/ resistant ovarian cancer
UPDATE
Study Schema
Target Population
>18yrs
During Trial
platinum resistant/
refractory epithelial
ovarian cancer
/ > 3 LINES
ECOG 0-3
Able to commence
treatment within 2wks
of registration
Sufficient English
language skills to
complete QoL forms
independently
R
E
G
I
S
T
E
R
Stage1-100
• Complete 7 QoL
forms
• 20 subjects will be
asked to participate in
additional QoL
telephone interview
Stage2-400+
Determine the optimal
number of QoL forms
from Stage1
Data
Collection
4 Treatment
cycles
or
Disease
progression
Stage 1 identify and investigate
• The symptoms and aspects of HRQL
that are rated as most severe,
troublesome and important by patients.
• The improvements in scores for these
aspects that occur with treatment.
• The optimal items and questionnaires
for measuring these improvements.
• The criteria for defining a clinically
significant improvement.
Stage 2
Primary Objective
• The proportion of women benefiting from palliative
chemotherapy as defined by a clinically significant
improvement in HRQL scores.
Secondary Objectives
• The proportion of women who receive treatment because
they are (a) symptomatic, (b) have rising tumor markers
alone, and or (c) have imaging evidence of disease
progression alone.
• The most common and important symptoms as defined by
the patients themselves.
• Whether these patient defined symptoms improve with
chemotherapy
• Whether improvements in symptoms and HRQL correlate
with objective response/CA125 response.
• The effects of treatment, objective response and
subjective response on scores for anxiety, depression and
hope.
• Develop a prognostic index to predict benefit
QoL Instruments
•
•
•
•
•
•
•
•
Symptom Representation Questionnaire SRQ
FACT-O
QLQ-C30
Ov-28( includes FOSI)
Pt DATA Form
Expected & perceived benefit
HADS
Herth Hope Index
Patient identified major symptoms
Possible Symptoms
Those that may improveAbdominal distension- Ascites
Abdominal painIntermittent SBO
Pelvic symptoms- mass effect
Anorexia- liver metastases
Dyspnoea – pleural effusion
PFS
3 m.
Makhija S et al. Proc
ASCO 2007;Abstract 5507.
Makhija S et al. Proc
ASCO 2007;Abstract 5507
Makhija S et al. Proc
ASCO 2007;Abstract 5507
FOSI 8 items (subset of FACT-O), 1 scale
Prognostic Models
variables
No. of lines of therapy
Performance status
Volume of disease
Sites of disease
CA125 velocity
LDH; Hb; Albumin; Platelets
Inflammatory markers
Grade; histological subtype
Psammoma bodies
Platinum Resistant Ovarian Cancer
OS
Platinum Resistant Ovarian Cancer
Hypothetical Risk Groups
OS
Plans
• Continue accrual to stage 1- completed by end
of year
• Seamless Transition through to stage 2 without
stopping recruitment- drop questionnaires
• Potential for other groups to now prepare ethics
and open across multiple sites
• Options- link to clinical trials in platinum resistant
OC eg Aurelia, NOGGO etc as well non trial
population in selected sites
Potential SIGNIFICANCE
• Development of better methods to assess and measure the
clinical benefit of palliative chemotherapy
• Applicable to trials of palliative therapy in ovarian cancer as
well has having broad clinical utility.
• Insight into how women with recurrent ovarian cancer are
treated in different countries and among different member
groups of the GCIG.
• Better understanding of the reasons why treatment is given,
what proportion of women have symptoms related to disease,
what their expectations of benefit are and what price they pay
in terms of toxicity.
• Develop a prognostic index
• This information will influence clinical practice and help
physicians and patients make informed decisions regarding
treatment options.