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UPDATE

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 platinum resistant/ refractory epithelial ovarian cancer / > 3 LINES

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UPDATE

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  1. Symptom control in patients with recurrent ovarian cancerMeasuring the benefit of palliative chemotherapy in women with platinum refractory/ resistant ovarian cancer UPDATE

  2. Study Schema Target Population >18yrs 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 • During Trial • 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 REGISTER

  3. 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.

  4. 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

  5. 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

  6. Possible Symptoms Those that may improve- Abdominal distension- Ascites Abdominal pain- Intermittent SBO Pelvic symptoms- mass effect Anorexia- liver metastases Dyspnoea – pleural effusion

  7. PFS 3 m. Makhija S et al. Proc ASCO 2007;Abstract 5507.

  8. Makhija S et al. Proc ASCO 2007;Abstract 5507

  9. Makhija S et al. Proc ASCO 2007;Abstract 5507

  10. FOSI 8 items (subset of FACT-O), 1 scale

  11. Prognostic Modelsvariables 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

  12. Platinum Resistant Ovarian CancerOS

  13. Platinum Resistant Ovarian CancerHypothetical Risk GroupsOS

  14. 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

  15. 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.

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