Chemotherapy in Anal cancer ?Lessons for vulva ANZGOG 2013 Michelle Vaughan.
ANZGOG – 0701
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Transcript of ANZGOG – 0701
NHMRC Clinical Trials CentreNHMRC Clinical Trials CentreANZGOG AGM, 2 April 2009, NoosaNHMRC Clinical Trials CentreNHMRC Clinical Trials Centre
Symptom Benefit Study
Measuring the Benefit of Palliative Chemotherapy in women with platinum refractory/ resistant
ovarian cancer
ANZGOG – 0701
NHMRC Clinical Trials CentreNHMRC Clinical Trials CentreANZGOG AGM, 2 April 2009, NoosaNHMRC Clinical Trials CentreNHMRC Clinical Trials Centre
Study Background
• The aim is to develop a method to measure the benefit of chemotherapy, which takes into account BOTH subjective and objective responses
• Document time to symptom progression as an additional endpoint as well as symptom benefit
• Better insight into patterns of care and reasons for treatment with platinum resistant or refractory ovarian cancer
• Develop a prognostic index that better defines outcomes and test in a separate group
NHMRC Clinical Trials CentreNHMRC Clinical Trials CentreANZGOG AGM, 2 April 2009, NoosaNHMRC Clinical Trials CentreNHMRC Clinical Trials Centre
Objective
• Stage 1: To determine the symptoms and aspects of HRQL that are rated most severe, troublesome in patients and identify best instruments to use in stage 2
• Stage 2: To determine the proportion of women benefiting from palliative chemotherapy as defined by a clinically significant improvement in HRQL scores and improvement of symptoms and time to symptom progression.
NHMRC Clinical Trials CentreNHMRC Clinical Trials CentreANZGOG AGM, 2 April 2009, NoosaNHMRC Clinical Trials CentreNHMRC Clinical Trials Centre
REGISTER
Target Population
>18yrs
platinum resistant/ refractory epithelial ovarian cancer
ECOG 0-3
Able to commence treatment within 2wks of registration
Ability to complete QoL formsindependently
During Trial
Stage1• Complete QoL questionnaires at each cycle
• 20 subjects will participate in additional QoL telephone interviews
Stage2
Determine the optimal QoL forms from Stage1Longer follow-upPrognostic data collected at baseline
Data Collection
4 Treatment
cycles or
Disease progression
Proposed longer
follow-up for Stage 2
Study Schema
ANZGOG AGM, Noosa 2 April 2009NHMRC Clinical Trials Centre
Current status
Fourteen sites open to recruitment
Twelve in Australia
Two in CanadaA further nine Australian sites are currently awaiting final ethics approval
Total recruitment
46
26 Australia
20 Canada
ANZGOG AGM, Noosa 2 April 2009NHMRC Clinical Trials Centre
Baseline Demographics
Symptom control/palliation + rising CA125 + radiological progression 28
Rising CA125 + radiological progression 9
Symptom control/palliation + rising CA125 6
Symptom Control + radiological evidence 1
Radiological Evidence only 1
Rising CA125 only 1
N = 46
Reason for treatment at enrolment
ANZGOG AGM, Noosa 2 April 2009NHMRC Clinical Trials Centre
Baseline Demographics cont’d
Major symptoms reported at baseline:
1. Pain
2. Fatigue
3. Abdominal Bloating
ECOG 0 = 17 (N = 45 - missing data for one patient)
1 = 26
2 = 2
3 = 0
ANZGOG AGM, Noosa 2 April 2009NHMRC Clinical Trials Centre
Stage 1 QoL Questionnaires
1. Symptom Representation Questionnaire
2. FACT-O (includes FOSI)
3. EORTC QLQ-C30
4. EORTC QLQ-OV28
5. Patient Data Form
6. Expected and Perceived Benefit Scale7. HAD Scale (Baseline & End of Treatment only)
8. Herth Hope Index (Baseline & End of Treatment only)
ANZGOG AGM, Noosa 2 April 2009NHMRC Clinical Trials Centre
Results: Top 10 Symptoms of the ‘Three Most Noticed Symptoms in the last week’
at baseline Rank Symptom
No. who nominated this symptom in her
Top 3 (n=31)
1 Fatigue 17
2 Pain - general 11
3 Abdominal bloating 10
4 Sleep disturbance 9
5 Nausea and vomiting 8
6 Appetite 7
7 Shortness of breath 6
8 Bowel disturbances (including constipation) 6
9 Pain - abdominal 5
10 Urinary problems 3
ANZGOG AGM, Noosa 2 April 2009NHMRC Clinical Trials Centre
Coverage of Top 10 symptoms by candidate questionnaires
Symptom SRQ Pt DATA FACT-O FOSI QLQ-C30 QLQ-OV28
Fatigue 2 1 1 1 3 -
Pain - general 1 1 1 1 2 -
Abdominal bloating 1 1 1 1 - 1
Sleep disturbance 1 1 1 - 1 -
Nausea and vomiting 2 2 2 2 2 -
Appetite 1 2 1 - 1 1
Shortness of breath 1 1 - - 1 -
Bowel disturbances 1 3 1 - 2 3
Pain - abdominal - 1 1 1 - 1
Urinary problems 1 1 - - - 1
# items covering Top 10 12 15 9 6 12 9
Total # items in q’aire 24 18 39 8 30 28
% 50% 83% 23% 75% 40% 32%
ANZGOG AGM, Noosa 2 April 2009NHMRC Clinical Trials Centre
DecisionsRetain modified Pt DATA Form – Ovarian to measure key symptoms• Enhance coverage of the Top 10• Allow measurement of both current status and change• Modifications by developer and OSBS investigators
OSBS Recent Status Form (after each cycle) OSBS Change Form (after every 2nd cycle)
• Develop a separate Side Effects Form for net clinical benefitRetain FACT-O (including FOSI) to measure QOLFACT-O• Has fewer items: 39 (incl. 8 for FOSI) vs. 58 in the
QLQ-C30/Ov28• Provides summary scores: overall QOL, Trial Outcome Index,
FOSI• Overall QOL based on all itemsQLQ-C30• 22 sub scales• Duplication of single-item symptoms with Pt DATA Form• Global QOL based on 2 items
ANZGOG AGM, Noosa 2 April 2009NHMRC Clinical Trials Centre
Prognostic Modelvariables
No. of lines of therapy Performance status Volume of disease Sites of disease CA125 velocity LDH; Hb; Albumin; Platelets Inflammatory markers Grade; histological subtype
ANZGOG AGM, Noosa 2 April 2009NHMRC Clinical Trials Centre
Platinum Resistant Ovarian CancerHypothetical Risk Groups
PFS