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ANZGOG – 0701

Symptom Benefit Study Measuring the Benefit of Palliative Chemotherapy in women with platinum refractory/ resistant ovarian cancer. ANZGOG – 0701. Study Background.

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ANZGOG – 0701

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  1. Symptom Benefit StudyMeasuring the Benefit of Palliative Chemotherapy in women with platinum refractory/ resistant ovarian cancer ANZGOG – 0701

  2. 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

  3. 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.

  4. Study Schema • 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 Stage1 • Longer follow-up • Prognostic data collected at baseline Target Population >18yrs platinum resistant/ refractory epithelial ovarian cancer ECOG 0-3 Able to commence treatment within 2wks of registration Ability to complete QoL forms independently Data Collection 4 Treatment cycles or Disease progression Proposed longer follow-up for Stage 2 REGISTER

  5. Current status Fourteen sites open to recruitment Twelve in Australia Two in Canada A further nine Australian sites are currently awaiting final ethics approval Total recruitment 46 26 Australia 20 Canada

  6. Baseline Demographics Reason for treatment at enrolment N = 46

  7. 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

  8. Stage 1 QoL Questionnaires • Symptom Representation Questionnaire • FACT-O (includes FOSI) • EORTC QLQ-C30 • EORTC QLQ-OV28 • Patient Data Form • Expected and Perceived Benefit Scale • HAD Scale (Baseline & End of Treatment only) • Herth Hope Index (Baseline & End of Treatment only)

  9. Results: Top 10 Symptoms of the ‘Three Most Noticed Symptoms in the last week’at baseline

  10. Coverage of Top 10 symptoms by candidate questionnaires

  11. Decisions Retain 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 benefit Retain FACT-O (including FOSI) to measure QOL FACT-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 items QLQ-C30 • 22 sub scales • Duplication of single-item symptoms with Pt DATA Form • Global QOL based on 2 items

  12. 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

  13. Platinum Resistant Ovarian CancerHypothetical Risk GroupsPFS

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