The ICON7 study results suggest that improved progression-free survival with bevacizumab therapy for high-risk ovarian cancer may come at the cost of health-related quality of life (QoL).
The ICON (Gynecologic Cancer Intergroup International Collaboration on Ovarian Neoplasms)7 study reports data for women with high-risk stage I-IV epithelial ovarian cancer who were randomly assigned to receive chemotherapy with (n=764) or without (n=764) intravenous bevacizumab (7.5 mg/kg 30-90 min on day 1 of every 3-week cycle).
QoL was reported for 90% of both patient groups at baseline, and 66% of bevacizumab-treated patients and 51% of controls at week 54.
At week 54 of treatment, data for 502 women given bevacizumab plus carboplatin and paclitaxel chemotherapy showed significantly lower average global QoL scores than for the 388 women given standard chemotherapy alone (69.1 vs 76.1).
This 6.4-point difference in the European Organisation for Research and Treatment of Cancer QoL questionnaire-core 30 is a small clinical difference but statistically significant, report Dan Stark (University of Leeds, UK) and co-authors in The Lancet Oncology.
"Clinicians, women receiving ovarian cancer treatment, and funding authorities need to bear this decrement in global QoL in mind when considering bevacizumab as first-line treatment for ovarian cancer," the researchers emphasize.
Between baseline and week 18, QoL increased significantly by 7.2 points on average for the whole study population but a signifcant 5.1-point difference was noted between the groups. Furthermore, between baseline and week 54, just 56% of bevacizumab-treated women experienced a 10-point or greater increase in global QoL compared with 66% of standard chemotherapy patients , giving a significant odds ratio of 0.58.
"What the mechanism of a small decrement in QoL associated with bevacizumab might be remains unclear," the authors say.
The team found that bevacizumab had no impact on duration of ascites, abdominal wall wound healing, and did not prolong disruption of daily life. However, the researchers suggest that QoL may have been adversely affected by side effects such as rash, bleeding, or hormonal symptoms.
"Findings from exploratory analyses suggested that financial effects and impairment of women's return to their life roles might also be affected by continuation of treatment with bevacizumab compared with standard chemotherapy," they add.
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