- Adjuvant whole-breast irradiation (WBI) with tumor bed boost vs no boost in the BIG 3-07/TROG 07.01 randomized controlled trial (RCT) of patients with nonlow-risk ductal carcinoma in situ (DCIS) is associated with adverse effects on cosmesis and arm and shoulder function up to 2 years later.
Why this matters
- This is the largest international RCT of its kind to study QoL.
- Phase 3, RCT (N=1208) with:
- 4 arms of boost vs no boost after conventional WBI (50 Gy in 25 fractions over 5 weeks) vs hypofractionated WBI (42.5 Gy in 16 fractions over 5 weeks).
- Boost vs no boost after conventional WBI.
- Boost vs no boost after hypofractionated WBI.
- Health-related QoL (HRQoL) outcomes were studied over the course of 2 years with 4 questionnaires.
- Funding: Dutch Cancer Society; others.
- Tumor bed boost vs no boost was associated with worse cosmetic outcomes on the Breast Cancer Treatment Outcome Scale (global P=.00014; Hochberg-adjusted P=.0016) and adverse arm and shoulder function across all times (global P=.0033; Hochberg-adjusted P=.045).
- Arm and shoulder function improved over time.
- No differences in HRQoL between conventional vs hypofractionated WBI.
- Some outcomes had too few patients for analysis.