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Symptom Benefit ANZGOG-0701. Does Palliative Chemotherapy Improve Symptom Control in Platinum Resistant Ovarian Cancer. , START UP MEETING FOR STAGE 2. Response Rates in Phase 3 Trials. Patients with good PS entered into clinical trials- 2 nd Line Therapy. Symptom Benefit Study.

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Symptom BenefitANZGOG-0701

Does Palliative Chemotherapy

Improve Symptom Control in Platinum Resistant Ovarian Cancer


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Response Rates in Phase 3 Trials

Patients with good PS entered into clinical trials- 2nd Line Therapy

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Symptom Benefit Study

Expectation is that Symptom Benefit > Response Rate

( otherwise why would we treat so many patients )

  • How to best measure the impact of chemotherapy on symptom improvement ?

  • Can we use Symptom Benefit Measures as an alternative outcome measure

  • Can we identify patients most likely to benefit from palliative chemotherapy?

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Stage 1-Primary Aim

  • The symptoms and aspects of HRQL that are rated as most severe, troublesome and important by patients.

  • The optimal items and questionnaire/s for measuring these improvements.

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Study Schema

  • Target Population

  • >18yrs

  • platinum resistant/ refractory epithelial ovarian cancer

  • /> 3 lines of therapy

  • ECOG 0-3

  • Able to commence treatment within 2wks of registration

  • Sufficient English to complete QoL forms

  • independently

  • Stage1

  • 100 patients

  • Complete 7 QoL

  • forms

  • 20 subjects will

  • participate in

  • additional QoL

  • telephone interview

Data Collection

4 Treatment cycles


Disease progression


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Stage 1 QoL Questionnaires

  • Symptom Representation Questionnaire

  • FACT-O (includes FOSI)



  • Patient Data Form

  • Expected and Perceived Benefit Scale

  • HAD Scale (Baseline & End of Treatment)

  • Herth Hope Index (Baseline & End of Treatment only)

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  • Majority Platinum Resistant

  • Compliance 96%

    All questionnaires were completed to a very high compliance rate with few or no missing data

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Improvement in quality of life AE’s at baseline(Prior to Cycle 3 N=72)

Is your symptom improvement enough to affect your overall quality of life?

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Stage 1-outcome AE’s at baseline

Results have led to development of

MOST(Measure of Ovarian cancer Symptoms and Treatment concerns)

Modification of Patient Data Form


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MOST AE’s at baselineMeasure of Ovarian cancer Symptoms and Treatment concerns

Comprises of 35 individual items on a discrete scale of 0-10, where major symptomatic distress is represented by 10.

The first 15 items refer to disease symptoms

Items 16 and 17 refer to physical and emotional well-being

Item 18 is a question referring to overall well-being

Items 19-35 deals with side effects and other concerns

The study will examine the extent of clinical improvement by examining changes in these items from baseline at each time point- to determine MCID

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  • Target Population AE’s at baseline

  • Informed consent

  • ≥18yrs

  • Platinum Resistant/Refractory

  • ECOG 0-3

  • Life expectancy > 3 months

  • Able to commence treatment within 2wks of registration

  • Able to complete questionnaires independently









  • Data Collection

  • Baseline

  • Each treatment cycle

  • One month post completion of treatment or until disease progression

Schema – Stage 2

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Stage 2 AE’s at baseline

Primary Objective To determine:

The criteria for defining a clinically significant subjective improvement and the optimal instrument/s to measure benefit

Secondary Objectives

  • The proportion of women benefiting from palliative chemotherapy

  • The time to symptom deterioration

  • The proportion of women who receive treatment because they are (a) symptomatic, (b) have rising tumor markers alone, or (c) have imaging evidence of disease progression

  • The percentage of patients who complete 4 or more cycles of treatment

  • The most common, most severe and most noticed symptoms as perceived by patients.

  • Develop a prognostic index

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Stage 2 AE’s at baseline

  • MOST

  • FACT-O


  • EORTC OV28

  • Expected and Perceived Benefits

    These forms will be completed at Baseline and after each cycle until chemotherapy ceases.

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Prognostic Factors AE’s at baseline

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Recruitment AE’s at baseline

The recruitment target is 600 evaluable patients

(~780 enrolled patients)

The estimated recruitment period is until December 2011

Currently there are 20 sites activated and 101 patients recruited with a further 40+ sites to open

International participation

Canada (additional sites) To be confirmed

United Kingdom Japan

Ireland Spain

Germany Scandinavia

Italy France

USA- selected sites

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Central Study Contacts AE’s at baseline

Study Chair: Professor Michael Friedlander ANZGOG

Coordinating Centre: Symptom Benefit

NHMRC Clinical Trials Centre

Locked Bag 77



Study team:

Central Coordinator: Kim Gillies +61 2 9562 5032

Data Manager: Lisa Martyn +61 2 9562 5394

Program Manager: Julie Martyn +61 2 9562 5092