Dr. Felicia Roncolato
The Gynecologic Cancer Intergroup (GCIG) Symptom Benefit Study was initiated to further develop the methods of quantifying symptom improvement in patients receiving chemotherapy for recurrent ovarian cancer. Dr. Roncolato explained that because there is no evidence that chemotherapy increases overall survival (OS) in a platinum-refractory setting, there is a need to identify patients who are most likely to benefit from chemotherapy in that setting.
One goal of the Symptom Benefit Study, and the focus of Dr. Roncolato’s presentation, was to identify baseline characteristics or prognostic factors significantly associated with early stopping of chemotherapy and shorter OS in patients with platinum-resistant or platinum-refractory ovarian cancer.
The analysis included 570 patients, 52% of whom had primary disease. Nearly three-quarters of patients (73%) had cancer-related symptoms, 41% had crampy abdominal pain or intermittent or incomplete bowel obstruction, and 26% had symptomatic ascites. Importantly, 88% had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. The median progression-free survival (PFS) and median OS ranged from 3.6 months and 11.1 months, respectively, in the overall cohort and 1.3 months and 2.9 months, respectively, in the subset of patients who stopped chemotherapy within 8 weeks, who represented 19% of the study population.
Dr. Molly Brewer
Given that the vast majority of patients had an excellent ECOG performance status, the researchers concluded that a quality-of-life assessment was more informative than the clinician-assessed ECOG performance status for predicting prognosis.
These same quality-of-life domains were also associated with early stopping of treatment within 8 weeks. Among 109 evaluable patients who discontinued chemotherapy by 8 weeks, the most frequently cited reasons for stopping therapy early were disease progression (45.9%), death (18.3%), and patient preference (11.9%).
Investigators concluded that the incorporation of both baseline health-related quality-of-life and clinical prognostic variables improves survival prediction in these patients. Dr. Roncolato said that the availability of additional prognostic information could improve clinical trial stratification, patient–doctor communication about prognosis, and clinical decision making.
Molly Brewer, DVM, MD, MS, of the University of Connecticut, discussed the study results, which, she noted, will require validation. The Symptom Benefit Study “sets the groundwork to try to determine which patients we should maybe not be treating,” because morbidity and cost may outweigh potential benefit, she said.
–Melinda Tanzola, PhD