Table 1. Summary of the regional lymph nodes irradiation studies.
Whelan et al.[5], 2015 | Poortmans et al.[6], 2015 | Hennequin et al.[8], 2013 | Stemmer et al.[7], 2003 | Thorsen et al.[9], 2016 | |
---|---|---|---|---|---|
Study Types | Randomized | Randomized | Randomized | Prospective Nonrandomized | Prospective Nonrandomized |
Enrolling Year | 2000–2007 | 1996–2004 | 1991–1997 | 1994–1998 | 2003–2007 |
Eligible Criteria | ALN+/ High-risk ALN- | ALN+/ Central or medial tumor | ALN+/ Central or medial tumor | Stage II-IIIA | ALN+ Left-side IMNI Right-side no IMNI |
No. of pts | 1,832 | 4,004 | 1,334 | 100 | 3,089 |
Median age (year) | 54 | 54 | 57 | 45 | 56 |
Breast Surgery | 100% Lumpectomy | 76.1% Lumpectomy 23.9% Mastectomy | 100% Mastectomy | 54% Lumpectomy 46% Mastectomy | 65% Mastectomy 35% Lumpectomy |
Systemic Treatment | CT (91%); HT (76%) | CT (25%); HT (30%); CT+HT (30%) | CT (61%); HT (52%) | CT (100%); HT (42%) | CT (19%); CT+HT (47%) |
ALN Status | |||||
N0 | 9.7% | 44.4% | 24.8% | 0% | 0% |
N1–3+ | 85.0% | 43.1% | 44.1% | 0% | 58.9% |
N ≥ 4+ | 5.3% | 12.5% | 31.1% | 100% | 41.1% |
Target Range | Breast ± RLN | Breast/chest wall ± RLN | Chest wall + SCV LN ± IMN | Breast/chest wall + SCV LN ± IMN | Breast/chest wall + SCV LN ± IMN |
Intercostal Spaces of IMNI | 1–3 | 1–5 (LIQ) 1–3 (other) | 1–5 | 1–5 | 1–4 |
Dose of Breast/Chest wall | 50 Gy/25 fx | 50 Gy/25 fx | Base on the center | 50.4 Gy/28 fx | 48 Gy/24 fx |
Dose of IMNI | 45 Gy/25 fx | 50 Gy/25 fx | 45 Gy/25 fx | 50.4 Gy/28 fx | 48 Gy/24 fx |
Median FU | 9.5 | 10.9 | 11.3 | 6.4 | 8.9 |
OS % Improved | 1%, P = 0.38 | 1.6%, P = 0.06 | 3.3%, P = 0.8 | 14%, P = 0.8 | 3.7%, P = 0.005 |
Other Outcomes Improved | DFS 5%, P= 0.01; BCM 1%, P= 0.11 | DFS 3%, P= 0.04; DMFS 3%,P = 0.02 | DFS 3.3%, P = 0.35 | DFS 21%, P = 0.02 | BCM 2.5%, P = 0.03; DRR 2.3%, P = 0.07 |
Abbreviations: ALN Axillary lymph node; IMNI Internal mammary lymph node irradiation; CT chemotherapy; HT hormonal therapy; RLN Regional lymph node; SCV LN supraclavicular lymph node; IMN Internal mammary lymph node; LIQ lower inner quadrant; fx fractions; FU Following-up; OS overall survival; DFS disease free survival; BCM breast cancer mortality; DMFS distant recurrence free survival; DR distant recurrence rate