Table 10.
Randomized controlled trials investigating thin resection margins for invasive melanoma.
| Group | Number of patients | Melanoma thickness | Excision margins | Follow up | Survival | Recurrence | Excluded | Comments | |
|---|---|---|---|---|---|---|---|---|---|
| Veronesi et al., NEJM, 1988120 Veronesi et al., Arch Surg, 1991119 |
WHO melanoma program trial 10 | 612 | ≤2 mm | 1 vs 3 cm | 90 months | 8-year DFS 81.6% vs 84.4% 8-year OS 89.6% vs 90.3% |
14% vs 13% Local 1.3% vs 0% Lymphatic 6.9% vs 7.8% Distant 5.6% vs 4.6% |
Facial, fingers, toes | No local recurrence when thickness <1 mm |
| Ringborg et al., Cancer, 1996113 Cohn-Cedermark et al., Cancer, 2000112 |
1st Swedish melanoma group trial | 989 | 0.8–2 mm | 2 vs 5 cm | 11 years | 10-year DFS 81% v. 83% 10-OS 79% vs 76% |
21% vs 19% Local 0.6% vs 1% Lymphatic 15% vs 12% Distant 15% vs 14% |
Head & neck, hands, feet, vulva | |
| Khayat et al., Cancer, 2003114 | French cooperative group trial | 337 | <2.1 mm | 2 vs 5 cm | 16 years | 10-year DFS 85% vs 83% 10-year OS 87% vs. 86% |
Median time to recurrence 43 vs. 37.6 months 13.6% vs 20% recurrence Local 0.6% vs 2.4%, Lymphatic 8.1% vs 6.7% Distant 2.5% vs 6.1% |
Toe, nail, finger, acral-lentiginous | LND not performed |
| Balch et al., Ann Surg, 1993116 Balch et al., Ann Surg Oncol, 2001115 |
Intergroup melanoma surgical trial | 468 | 1–4 mm | 2 vs 4 cm | 72 months | 5-year OS 79.5% vs 83.7% 10-year OS 70% vs 77% |
Local 2.1% vs 2.6% Distant 10.9% vs 8.5% |
Primary closure in 89% vs 54% (p<.001) | |
| Gillgren et al., Lancet, 2011365 Utjés et al., Lancet, 2019366 |
2nd Swedish melanoma group trial (Scandinavian Baltic trial) | 936 | >2 mm | 2 vs 4 cm | 19.6 years | Melanoma specific mortality 41% vs 43.5% Overall mortality 65% vs 67% |
41.7% vs 42.5% Local 4.3% vs 1.9 Regional 4.1% vs 3.2% Lymphatic 21.5% vs 24.2% Distal 8.2% vs 11.5% |
hands, feet, head & neck, anogenital region | 9% underwent SLNB |
| Thomas et al., NEJM, 2004118 Hayes et al., Lancet Oncol, 2016117 |
UK Melanoma Study Group, the British Association of Plastic Surgeons and the Scottish Cancer Therapy Network | 900 | >2 mm | 1 vs 3 cm | 8.8 years | Melanoma specific mortality 42.8% vs 36.9% (p=0.041). Overall mortality 55.8% vs 53.9% (p=0.14) |
Local 3.3% vs 2.9% Locoregional 37% vs 31.8% (p=0.05) Distal 8.4% vs 6.7% |
General anesthesia in 32.1% vs 66.4% of patients |
DFS, disease-free survival; OS, overall survival; WHO, World Health Organization; LND, lymph node dissection; SLNB, sentinel lymph node biopsy.