Symptom control in patients with recurrent ovarian cancer Measuring the benefit of palliative chemotherapy in women with platinum refractory/ resistant ovarian cancer

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Symptom control in patients with recurrent
ovarian cancerMeasuring the benefit of
palliative chemotherapy in women with platinum
refractory/ resistant ovarian cancer
UPDATE
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Study Schema
Target Population gt18yrs platinum
resistant/ refractory epithelial ovarian
cancer / gt 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
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• 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.

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• 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

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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

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Possible Symptoms

• Those that may improve-
• Abdominal distension- Ascites
• Abdominal pain-
• Intermittent SBO
• Pelvic symptoms- mass effect
• Anorexia- liver metastases
• Dyspnoea pleural effusion

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PFS 3 m.
Makhija S et al. Proc ASCO 2007Abstract 5507.
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Makhija S et al. Proc ASCO 2007Abstract 5507
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Makhija S et al. Proc ASCO 2007Abstract 5507
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FOSI 8 items (subset of FACT-O), 1 scale
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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

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Platinum Resistant Ovarian CancerOS
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Platinum Resistant Ovarian CancerHypothetical
Risk GroupsOS
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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

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• 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.