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Long term results of a randomized study by the Swedish Melanoma Study Group on 2‐cm versus 5‐cm resection margins for patients with cutaneous melanoma with a tumor thickness of 0.8–2.0 mm
Author(s) -
CohnCedermark Gabriella,
Rutqvist Lars Erik,
Andersson Ronny,
Breivald Mats,
Ingvar Christian,
Johansson Hemming,
Jönsson PerEbbe,
Krysander Lennart,
Lindholm Christer,
Ringborg Ulrik
Publication year - 2000
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(20001001)89:7<1495::aid-cncr12>3.0.co;2-d
Subject(s) - medicine , confidence interval , melanoma , surgery , hazard ratio , randomized controlled trial , prospective cohort study , resection margin , trunk , proportional hazards model , relative risk , resection , cancer research , ecology , biology
BACKGROUND Large, prospective, randomized trials with long term follow‐up are required to obtain an unbiased evaluation of the significance of resection margins in patients with cutaneous melanoma. METHODS The Swedish Melanoma Study Group performed a prospective, randomized, multicenter study of patients with primary melanoma located on trunk or extremities and with a tumor thickness > 0.8 mm and ≤ 2 mm. Patients were allocated randomly to a 2‐cm excision margin or a 5‐cm excision margin. In total, 989 patients were recruited during the period 1982–1991. The median follow‐up was 11 years (range, 7–17 years) for estimation of survival and 8 years (range, 0–17 years) for evaluation of recurrent disease. RESULTS The crude rate of local recurrence, defined as a recurrence in the scar or transplant, was < 1% (8 of 989 patients). Twenty percent of the patients (194 of 989 patients) experienced any disease recurrence, and 15% (146 of 989 patients) died of melanoma. There were no statistically significant differences between the two treatment arms. In a multivariate Cox analysis with patients allocated to wide excision as the reference group, the estimated relative hazards for overall survival and recurrence free survival among those allocated to a 2‐cm resection margin were 0.96 (95% confidence interval, 0.75–1.24), and 1.02 (95% confidence interval, 0.80–1.30), respectively. CONCLUSIONS In this long term follow‐up study, local recurrences were found to be rare among patients with tumors > 0.8 mm thick and ≤ 2.0 mm thick. No difference in recurrence rate or survival between the two treatment groups was found. Patients in this category can be treated with a resection margin of 2 cm as safely as with a resection margin of 5 cm. Cancer 2000;89:1495–501. © 2000 American Cancer Society.