Intergroup Melanoma Surgical Trial: 2 cm versus 4 cm excision margins for 1 to 4 mm melanomas
Needs reviewN = 740
- Population
- Patients with melanomas 1 to 4 mm thick: 468 randomised (trunk or proximal extremity) plus 272 non-randomised (head, neck or distal extremities), per the 2001 abstract.
- Design
- Prospective multi-institutional surgical trial begun in 1983 in primary melanomas 1 to 4 mm thick: patients with trunk or proximal-extremity melanomas were randomised to 2 cm or 4 cm radial excision margins; a second cohort (head, neck, distal extremities) received 2 cm margins without randomisation. The 1993 report gives a median follow-up of 6 years; the 2001 report gives a median of 10 years.
- Arms
- 2 cm margin (experimental): 2 cm radial excision margin
- 4 cm margin (control): 4 cm radial excision margin
- People
- Balch CM, senior author Barnhill R, Intergroup Melanoma Surgical Trial
Δ Local recurrence at excision site−0.9 pointsΔ 60-month OS−4.2 pointsΔ Skin grafting required−35 pointsΔ 120-month OS−7 pointsΔ Local recurrence at excision site−0.5 points
Show the numbers
| Endpoint | Analysis | 2 cm margin | 4 cm margin | Effect |
|---|---|---|---|---|
| Local recurrence at excision siteRandomised patients with 1 to 4 mm melanomas on the trunk or proximal extremities (the abstract states 486) | primarymedian follow-up 6 yearsBalch 1993 | 0.8% | 1.7% | The abstract reports the difference as not significant; no exact p-value given. The first-report abstract states 486 randomised patients whereas the 2001 abstract states 468; neither could be reconciled from the abstracts. |
| OSRandomised patients with 1 to 4 mm melanomas on the trunk or proximal extremities (the abstract states 486) | primarymedian follow-up 6 yearsBalch 1993 | 79.5% at 5 y | 83.7% at 5 y | The abstract reports 'overall 5-year survival rate'; the difference is described as not significant (p NS). |
| Skin grafting requiredRandomised patients with 1 to 4 mm melanomas on the trunk or proximal extremities (the abstract states 486) | primaryBalch 1993 | 11% | 46% | P< 0.001Hospital stay was also shorter with 2 cm margins (5.2 vs 7.0 days, p = 0.0001), per the same abstract. |
| OSRandomised cohort comparing 2 cm and 4 cm margins (the abstract states 468 patients) | long term-updatemedian follow-up 10 yearsBalch 2001 | 70% at 10 y | 77% at 10 y | The abstract reports '10-year survival rates' without defining the endpoint, and describes the difference as not significant (no p-value given). Median follow-up is stated as 10 years. |
| Local recurrence at excision siteRandomised cohort comparing 2 cm and 4 cm margins (the abstract states 468 patients) | long term-updateBalch 2001 | 0.4% | 0.9% | Local recurrence as a first relapse. Counting local recurrence at any time, the abstract gives 2.1% (2 cm) vs 2.6% (4 cm). The abstract describes the incidences as the same for both margins. |
| Endpoint | Analysis | 2 cm margin | 4 cm margin | Effect |
|---|---|---|---|---|
| Local recurrence at excision siteRandomised patients with 1 to 4 mm melanomas on the trunk or proximal extremities (the abstract states 486) | primarymedian follow-up 6 yearsBalch 1993 | 0.8% | 1.7% | The abstract reports the difference as not significant; no exact p-value given. The first-report abstract states 486 randomised patients whereas the 2001 abstract states 468; neither could be reconciled from the abstracts. |
| OSRandomised patients with 1 to 4 mm melanomas on the trunk or proximal extremities (the abstract states 486) | primarymedian follow-up 6 yearsBalch 1993 | 79.5% at 5 y | 83.7% at 5 y | The abstract reports 'overall 5-year survival rate'; the difference is described as not significant (p NS). |
| Skin grafting requiredRandomised patients with 1 to 4 mm melanomas on the trunk or proximal extremities (the abstract states 486) | primaryBalch 1993 | 11% | 46% | P< 0.001Hospital stay was also shorter with 2 cm margins (5.2 vs 7.0 days, p = 0.0001), per the same abstract. |
| OSRandomised cohort comparing 2 cm and 4 cm margins (the abstract states 468 patients) | long term-updatemedian follow-up 10 yearsBalch 2001 | 70% at 10 y | 77% at 10 y | The abstract reports '10-year survival rates' without defining the endpoint, and describes the difference as not significant (no p-value given). Median follow-up is stated as 10 years. |
| Local recurrence at excision siteRandomised cohort comparing 2 cm and 4 cm margins (the abstract states 468 patients) | long term-updateBalch 2001 | 0.4% | 0.9% | Local recurrence as a first relapse. Counting local recurrence at any time, the abstract gives 2.1% (2 cm) vs 2.6% (4 cm). The abstract describes the incidences as the same for both margins. |
Appears in
Sources
Balch CM, Urist MM, Karakousis CP, Smith TJ, Temple WJ, Drzewiecki K, et al. Efficacy of 2-cm surgical margins for intermediate-thickness melanomas (1 to 4 mm). Results of a multi-institutional randomized surgical trial. Ann Surg. 1993;218(3):262-7; discussion 267-9.
Balch CM, Soong SJ, Smith T, Ross MI, Urist MM, Karakousis CP, et al. Long-term results of a prospective surgical trial comparing 2 cm vs. 4 cm excision margins for 740 patients with 1-4 mm melanomas. Ann Surg Oncol. 2001;8(2):101-8.