In the 5-year quality-of-life (QOL) analysis of the phase III SUPREMO trial published in The Lancet Oncology, Velikova et al found that women with intermediate-risk breast cancer who received postmastectomy chest wall radiotherapy experienced modestly worse local chest wall symptoms at 5 years, but no significant differences in overall QOL or most other patient-reported outcomes compared with those who did not receive radiotherapy. The substudy evaluated long-term patient-reported outcomes among UK participants enrolled in the international trial.
Study Details
SUPREMO, a randomized, controlled phase III trial, enrolled women aged 18 years or older with intermediate-risk breast cancer following mastectomy and axillary surgery. Eligible patients had pT1-2N1 disease, pT3N0 disease, or pT2N0 disease with histologic grade 3 disease, lymphovascular invasion, or both. Participants were randomly assigned 1:1 to receive chest wall radiotherapy (40–50 Gy delivered in 15–25 fractions) or no radiotherapy.
The QOL substudy included UK participants only. Of the 1,233 eligible patients, 989 (80%) consented, 947 (96%) of those completed baseline questionnaires, and 620 (75% of eligible participants) returned the planned 5-year questionnaires. Patient-reported outcomes were assessed before random assignment, and at 1, 2, 5, and 10 years. Prespecified primary QOL outcomes included global QOL, fatigue, physical functioning, chest wall symptoms, arm and shoulder symptoms, body image, anxiety, and depression.
Key Results
Patient-reported QOL improved over time in both treatment groups following recovery from surgery. Receipt of chest wall radiotherapy was associated with significantly worse chest wall symptoms than no receipt of radiotherapy (effect estimate = 1.99; 95% confidence interval [CI] = 0.36–3.62, P = .017), although symptoms improved progressively between years 1, 2, and 5. Chemotherapy was independently associated with less improvement in chest wall symptoms (effect estimate = 2.97, 95% CI = 0.24–5.71, P = .033), without evidence of interaction with radiotherapy.
No statistically significant differences between treatment groups were observed for overall QOL, physical functioning, fatigue, body image, arm and shoulder symptoms, pain, anxiety, or depression. In responder analyses, clinically meaningful worsening of chest wall symptoms at 5 years was reported by 13% of patients receiving chest wall radiotherapy compared with 9% of those assigned to no radiotherapy.
Subgroup analyses identified greater chest wall morbidity among patients who underwent sentinel lymph node biopsy followed by axillary lymph node clearance and received chest wall radiotherapy, compared with similar patients who did not receive radiotherapy (difference = –5.29, 95% CI = –8.53 to –2.05, P = .0015). Conversely, patients who underwent only a single axillary operation did not demonstrate increased chest wall symptoms with radiotherapy.
“The 5-year QOL findings showed worse chest wall toxicity and no effect on other QOL domains. The subgroup analyses suggested a potential negative effect of chemotherapy and axillary clearance after sentinel node biopsy,” the authors concluded.
Galina Velikova, FRCP, PhD, of Leeds Institute of Medical Research, University of Leeds, Leeds Cancer Centre, St James's University Hospital, Leeds, UK, is the corresponding author for the Lancet Oncology article.
DISCLOSURE: The study was supported by UK Medical Research Council, National Institute for Health and Care Research, European Organisation for Research and Treatment of Cancer, and others. For full disclosures of the study authors, visit thelancet.com.
