Table 2.
Trial | Sample Size | Inclusion Criteria | RT Technique | Fractionation | Boost | Outcomes | Median Follow-Up | Results |
---|---|---|---|---|---|---|---|---|
OCOG [42,44] | 1234 | pT1-2 post lumpectomy | 2D (including cobalt) and 3D | 42.5 Gy in 16 fx 50 Gy in 25 fx |
No | LRIC; DR, BC, LRT. |
5.9 years | 5 yr LRIC: 97.2% (Short Arm), 96.8% (Long Arm), Abs Difference: 0.4% (95% CI: −1.5% to 2.4%) 3 yr BC: 76.8% (Short Arm), 77.0% (Long Arm), Abs Difference: −0.6% (95% CI: −6.5% to 5.5%) |
START A [41] and B [43] | START-A 2236 START-B 2215 |
pT1-3a pN0-1 M0) requiring radiotherapy after primary BCS or mastectomy, with clear tumor margins ≥1 mm |
2D (including cobalt) and 3D | START-A: f 50 Gy in 25 fx over 5 weeks with 41.6 Gy or 39 Gy in 13 fx START-B: 50 Gy in 25 fx with 40 Gy in 15 fx |
Yes in 42.6% with 10Gy | LR and LRT | 9.3 years for START-A, and 9.9 years for START-B. | START-A: 10 yr LR: 6.3% (41.6 Gy), 7.4% (50 Gy, HR 0.91, p = 0.65), 8.8% (39 Gy, HR 1.18, p = 0.41) START-B: 10 yr LR: 4.3% (40 Gy), 5.5% (50 Gy, HR 0.77, p = 0.21) |
DBCG HYPO [52] | 1854 | >40 years of age after BCS for node-negative breast cancer or DCIS (13%) | 3D | 50 Gy in 25 fx 40 Gy in 15 fx |
Yes, 23.1% received 10 Gy as boost | BI and LR | 7.26 years | 3 yr BI: 11.8% (50 Gy), 9.0% (40 Gy), risk difference: −2.7% (p = 0.07) 9 yr LRR: 3.3% (50 Gy), 3.0% (40 Gy) 9 yr OS: 93.4% (both 50 Gy and 40 Gy) |
Peking Union Medical College, Beijing, China [46] | 820 | Post-mastectomy pT3-4 N+ (at least 4 nodes) | 2D | 50 Gy in 25 fx 43.5 Gy in 15 fx Including chest wall and nodal irradiation |
No | 5-year LRR | 5 years | 5-year LRR: 8.3% (hypofractionated) vs. 8.1% (conventional), HR 1.10, 90% CI 0.72 to 1.69, p < 0.0001 |
Legend: LRIC: local recurrence of invasive cancer; LRR: locoregional recurrence; DFS: disease-free survival; DR: distant recurrence; BC: breast cosmesis; LRT: late radiation toxicity; BI: breast induration; LR: local-regional tumour relapse; OS: overall survival; BCS: breast cancer-specific survival; BCS: BCS surgery; fx: fractions.