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


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


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.


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


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


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


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)


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


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%


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


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


Platinum Resistant Ovarian CancerHypothetical Risk Groups

PFS

ANZGOG – 0701

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