The use of cediranib as concurrent treatment with chemotherapy and as maintenance therapy in relapsed ovarian cancer was not associated with declines in quality of life (QOL), according to an analysis of the ICON6 trial.
The phase III ICON6 trial previously showed that cediranib, an angiogenesis inhibitor, can improve survival outcomes in patients with relapsed epithelial ovarian cancer. “The effects of new cancer therapies on patients’ quality of life should be assessed alongside their effects on clinical outcomes,” wrote study authors led by Dan P. Stark, MBBChir, FRCP, PhD, of the University of Leeds in the United Kingdom.
The trial included 456 women, randomized to standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with concurrent cediranib that was continued as maintenance therapy. The results of the new QOL analysis were published online ahead of print in Cancer.
QOL was assessed using the Quality of Life Questionnaire Core 30 (QLQ-C30) and the Quality of Life Questionnaire for Ovarian Cancer 28 (QLQ-OV28). These were completed by 410 women at baseline (90%), and 1-year data were available for 259 women (76% of those in follow-up); data for both time points were available for 235 women.
The mean global QOL score at baseline was 68.9 for chemotherapy alone, 73.2 for concurrent cediranib, and 73.3 in the maintenance group. At 1 year, these scores were 62.6, 72.5, and 68.7, respectively. The difference in change after 1 year was +8.3 for the concurrent group vs chemotherapy alone (P = .01), and +4.5 for the maintenance group vs chemotherapy alone (P = .18). During the maintenance period, the mean QOL score dropped by an additional 1 point in the chemotherapy alone group, but rose by 5.5 in the concurrent cediranib group and by 2.5 in the maintenance therapy group.
Subscales of the two questionnaires did not reveal substantial differences between the groups, though diarrhea was reported more in the two cediranib groups. By 12 months, that difference was highly significant, with more diarrhea reported in the maintenance cediranib group than in the other two groups (P < .001). Adjusting for that single outcome and reanalyzing the change in mean QOL scores after 1 year showed a significant improvement with maintenance over chemotherapy alone (+7.4, P = .03). This suggests, the authors noted, that improved QOL from the cancer control by cediranib can be achieved if diarrhea is better controlled.
“The unchanged QOL should be considered alongside the improved clinical outcomes by patients, clinicians, and funding authorities as they consider the case for cediranib as a new therapeutic treatment option for recurrent ovarian cancer,” the authors concluded.