Because of the findings from the PROSPECT (ANZ-1002) study, it’s imperative for clinicians to consider the potential for preserved health-related quality of life associated with omission of radiation therapy in treatment decision-making. Learn more about the design and key findings from this trial ahead of the presentation on this topic at the 2023 San Antonio Breast Cancer Symposium.
While breast cancer treatments have come a long way in recent years, there’s still much research that needs to be done to help improve patient outcomes and quality of life. And one such area of growing interest is treatment optimization in early breast cancer (EBC).
The current standard of care involves surgery to remove the tumor, followed by radiation therapy (RT) to reduce the chance of recurrence. However, some women may choose to omit RT due to various reasons, including concerns about long-term side effects.
And while the PROSPECT (ANZ-1002) study found that a combination of pre-operative MRI and pathological features could identify a group of patients with localized EBC in whom RT could be safely omitted, questions remained around the patient experience of de-escalation in addition to its implications for quality of life and fear of cancer recurrence (FCR).
That’s why an abstract featured at the 2023 San Antonio Breast Cancer Symposium presented results from a study that sought to answer these questions.
Study Design
A retrospective, mixed-methods, cross-sectional study was recently conducted using psychometrically validated measures, including the Fear of Cancer Recurrence Inventory Short-Form, Depression Anxiety Stress Scale, Breast Cancer Treatment Outcomes Scale, EORTC QLQ-C30 and its breast-specific module, the BR23, and the Decision Regret Scale.
Three groups of women with EBC were included:
- Group A: those in the PROSPECT clinical trial who underwent pre-surgical MRI and omitted RT
- Group B: those who underwent pre-surgical MRI and received RT
- Group C: those who received usual care (no MRI, but received RT)
A total of 400 women were included in the study, and there were no significant group differences in neuroticism, mental health, age, medical comorbidities, parity, or time since diagnosis.
Results
Women in Group A had significantly lower FCR than those in Group B or C. In fact, the number of women with normal FCR was significantly higher in Group A than in Groups B and C at 62 percent, 35 percent, and 40 percent, respectively. This indicates that RT may provide women with a sense of assurance.
Women in Group A also reported fewer breast and arm symptoms and better body image than Group B and Group C, highlighting the potential physical benefits of RT omission. And women in Group A performed better on cosmetic, functional, and breast-specific pain measures than in Groups B and C. This demonstrates the potential impact of RT on quality-of-life outcomes.
However, there were no differences in depression and anxiety between the groups, and so the researchers concluded that RT omission did not impact mental health outcomes.
Interestingly, women who omitted RT viewed this decision as appropriate treatment—not undertreatment—which indicates a need for shared decision-making and informed consent.
The study also found that pre-operative MRI and RT omission were highly acceptable, and decision regret was low. This finding suggests that providing women with adequate information about the risks and benefits of RT may help them make informed decisions.
Lastly, a secondary analysis was conducted to eliminate any potential impact of disease severity on the analysis, and after removing any patients with positive nodes, a Grade 3 tumor, and a tumor larger than 20mm, the results were found to be consistent with the primary analysis.
Conclusion
While the study provides helpful insights into the patient experience of treatment optimization in EBC, it's important to remember that these findings are just the beginning. It will be important for future research to explore these questions further and to consider the patient experience in other contexts, such as in metastatic breast cancer or in women with additional risk factors.
Reference
B. Mann, et al. Is de-escalation of treatment by omission of radiotherapy associated with fear of cancer recurrence and health-related quality of life in women with early breast cancer? An exploratory study. ATG Productions. 2023; PS02-03. Pages 26-27. 2023 SABCS Abstract Report-12-1-23 (atgproductions.net). Accessed December 5, 2023.