By Lynda Williams, medwireNews Reporter
medwireNews: Two-year interim findings from the EUROPA trial indicate that radiotherapy after surgery for low-risk early breast cancer may be better for preserving health-related quality of life (HRQoL) for women aged 70 years and older than endocrine therapy.
“These findings highlight the need to weigh potential HRQOL impacts of endocrine therapy, especially in older patients, in whom quality of life is a priority”, say Icro Meattini, from the “M. Serio” University of Florence in Italy, and co-workers.
However, the team emphasizes that results for the trial’s co-primary endpoint of 5-year ipsilateral breast tumour recurrence (IBTR), as well as other long-term data after full participant accrual “are needed to draw definitive conclusions.”
For the interim analysis, 207 women (median age 75 years) with stage I, luminal A-like breast cancer who had undergone breast-conserving surgery and were randomly assigned to receive partial (85%) or whole (15%) breast external beam radiotherapy, consisting of 26–40 Gy given in 5–15 fractions (n=104), or 5–10 years of aromatase inhibitor (89%) or tamoxifen (11%) therapy (n=103) were assessed.
At baseline, the average score on the two-item global health status (GHS) scale of the 30-item EORTC Quality of Life Questionnaire (QLQ-C30) was 71.9 points for the radiation group and 75.5 points for the endocrine group.
The 86 radiotherapy patients who completed their 24-month GHS assessment had a significantly smaller decrease in their score than the 75 endocrine therapy patients, with an average change from baseline of –3.40 points and –9.79 points, respectively, after adjusting for health status and age.
On the QLQ-C30 functional scales, the endocrine group experienced a significant decline in physical functioning, the radiation group had a significant decline in role functioning, and both groups had significant declines in cognitive function, but there were no significant differences in the mean changes in scores between the arms.
Although both the radiation and endocrine groups experienced a significant and statistically comparable improvement in their EORTC QLQ-BR45 breast symptom scores over the study period, the endocrine arm had significantly greater worsening of systemic therapy side effects and skin mucosis symptoms than the radiation group.
“It is noteworthy that a higher proportion of patients in the endocrine therapy group did not complete the 24-month HRQOL assessment compared with the radiotherapy group”, Meattini et al comment.
They suggest that this may point to radiotherapy being better tolerated than endocrine therapy and observe that the reduced adherence to treatment and study visits “could lead to further underestimation of the true difference between groups in terms of GHS.”
However, the researchers also note that the “slightly higher” proportion of patients in the endocrine arm with comorbidities and taking concomitant medications at baseline might also have “influenced patient compliance.”
Safety analysis showed that 12% of patients given endocrine therapy discontinued treatment due to adverse events (AEs) and 22% switched their endocrine therapy.
Fewer patients in the radiation group than the endocrine group experienced treatment-related AEs (67% of 97 patients vs 85% of 76 patients). The most common grade 3 and 4 AEs were arthralgia (0 vs 7%), pelvic organ prolapse (0 vs 3%), and fatigue, hot flushes, myalgia, bone pain and fracture (all 0 vs 2%).
Fifteen percent of both the radiation and endocrine therapy groups had serious AEs and there were no fatal AEs. Four percent and 2% of the groups, respectively, died from non-breast-cancer-related causes.
Finally, there were no reports of IBTR, locoregional recurrence or distant metastases in the study, while contralateral breast cancer was reported in 2% of the radiation group and 1% of the endocrine therapy group.
The authors conclude: “Final results from the EUROPA trial, including long-term recurrence and survival data, will further clarify the roles of radiotherapy and endocrine therapy in this population.”
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Lancet Oncol 2024; doi:10.1016/S1470-2045(24)00661-2