Measuring subjective improvement as well as objective response to estimate the benefit of palliative chemotherapy in women with platinum-resistant or -refractory ovarian cancer: The symptom benefit study (ANZGOG-0701/GCIG/PoCoG).
Friedlander M., Stockler MR., King M., Oza AM., Voysey M., Martyn J., Gillies K., Sjoquist KM., Butow P., Australia New Zealand Gynaecological Oncology Group (ANZGOG), Psycho-Oncology Group (PoCoG), Gynecologic Cancer Intergroup (GCIG) None.
TPS241 Background: The major objective of chemotherapy in patients with platinum resistant/refractory recurrent ovarian cancer (PRR ROC) is palliation. The symptoms in patients with PRR ROC are not well documented and the impact of chemotherapy on symptom benefit unclear. The Symptom Benefit study is a 2 stage study investigating how to best measure the benefit of chemotherapy. The overall aim is to develop a better measure of benefit from palliative chemotherapy that can be used in clinical trials in this patient population. METHODS: Prospective observational cohort study in women with PRR ROC about to commence palliative chemotherapy. Stage 2 will assess changes in Quality of Life (QoL) scores from baseline to post treatment assessment using both standard QoL instruments and a new measure of symptoms, the Measure of Ovarian Cancer Symptoms and Treatment Concerns (MOST), developed based on results of stage 1. The individual QoL and MOST scores will be summarized by standard descriptive statistical measures, and improvement will be assessed by calculating absolute changes from baseline for individual symptoms, domain subscales and total scores. Relative changes from baseline will also be examined. The MOST will be internally validated and compared against standard QoL instruments for common domains and symptoms. Eligibility: Stage 2 will enrol women with PRR epithelial ovarian, primary peritoneal or fallopian tube cancer with life expectancy > 3 months, ECOG PS 0-3 and about to start palliative (second- or subsequent line) chemotherapy. Trial status: Currently open in 20 centres in Australia/Canada with 121 patients enrolled in Stage 1 (at Jan 2011). Stage 2 planned to open in Feb 2011 with target recruitment 750 patients in 10 countries. SUMMARY: This is the first study to prospectively evaluate symptom burden, toxicity and outcomes in PRR ROC. Stage 2 will assess symptom benefit from palliative chemotherapy and validate a new tool for measuring symptoms in this population. This is an important and hitherto neglected area.