In a study reported in The Lancet Oncology, Blagden et al found lower mean global quality-of-life scores on longitudinal analysis among women with newly diagnosed ovarian cancer who received weekly vs every-3-week paclitaxel in platinum-based regimens in the ICON8 trial.
The ICON8 trial showed no significant improvement in progression-free survival with weekly vs standard every-3-week chemotherapy.
“We found no evidence of a difference in global quality of life between treatment groups at 9 months; however, patients receiving weekly treatment reported lower mean quality of life across the 9-month period after [random assignment]. Taken together with the lack of progression-free survival benefit, these findings do not support routine use of weekly paclitaxel-containing regimens in the management of newly diagnosed ovarian cancer.”— Blagden et al
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Study Details
In the international Gynecologic Cancer Intergroup trial, 1,566 women were randomly assigned between June 2011 and November 2014 to receive one of three regimens:
- Group 1 (n = 522) received carboplatin at AUC 5 or 6 plus paclitaxel at 175 mg/m2 every 3 weeks
- Group 2 (n = 523) received carboplatin at AUC 5 or 6 every 3 weeks and weekly paclitaxel at 80 mg/m²
- Group 3 (n = 521) received weekly carboplatin at AUC 2 and weekly paclitaxel at 80 mg/m².
Patients could have upfront debulking surgery before starting chemotherapy (immediate primary surgery), delayed primary surgery after at least three cycles of neoadjuvant chemotherapy, or no planned surgery.
Health-related quality of life, a secondary endpoint of the trial, was assessed by the EORTC QLQ-C30 and QLQ-OV28 questionnaires at enrollment, before each chemotherapy cycle, every 6 weeks up to 9 months, every 3 months up to 2 years, and every 6 months up to 5 years. The primary outcome measures, assessed in the current report, were QLQ-C30 global health score at 9 months in cross-sectional analysis and mean QLQ-C30 global health score from random assignment through 9 months in longitudinal analysis. The cross-sectional comparisons used analysis of covariance adjusted for baseline score, whereas longitudinal analyses used all data collected from baseline to 9 months.
Key Findings
Baseline quality-of-life questionnaires were completed by 1,438 (92%) of 1,566 patients and 9-month questionnaires by 882 (69%) of 1,280 patients who remained in follow-up without disease progression.
Mean global health score improved between baseline and 9 months in each treatment group. Mean scores at baseline vs 9 months were 61.7 vs 70.5 in group 1, 60.4 vs 68.7 in group 2, and 60.3 vs 67.7 in group 3.
On cross-sectional analysis, differences between scores at 9 months adjusted for baseline scores were not significant for group 2 vs group 1 (difference in mean score = 2.3, 95% confidence interval [CI] = -0.4–4.9, P = .095) or for group 3 vs group 1 (difference in mean score = -0.8, 95% CI = -3.8–2.2, P = .61).
On longitudinal analysis, mean global health scores across the 9-month period were lower among patients receiving weekly paclitaxel vs those receiving every-3-week chemotherapy. For group 2 vs group 1, the mean difference was –1.8 (95% CI = −3.6 to −0.1, P = .043). For group 3 vs group 1, the mean difference was −2.9 (95% CI = −4.7 to −1.1, P = .0018).
The investigators concluded, “We found no evidence of a difference in global quality of life between treatment groups at 9 months; however, patients receiving weekly treatment reported lower mean quality of life across the 9-month period after [random assignment]. Taken together with the lack of progression-free survival benefit, these findings do not support routine use of weekly paclitaxel-containing regimens in the management of newly diagnosed ovarian cancer.”
Sarah P. Blagden, PhD, of the Department of Oncology, University of Oxford, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by Cancer Research UK, Medical Research Council, Health Research Board Ireland, Irish Cancer Society, and Cancer Australia. For full disclosures of the study authors, visit thelancet.com.
