Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm)

Charles M. Balch, Seng Jaw Soong, Merrick I. Ross, Marshall M. Urist, Constantine P. Karakousis, Walley J. Temple, Martin C. Mihm, Raymond L. Barnhill, William R. Jewell, Harry J. Wanebo, Rene Harrison

Research output: Contribution to journalArticle

Abstract

Background: Ten- to 15-year survival results were analyzed from a prospective multi-institutional randomized surgical trial that involved 740 stages I and II melanoma patients with intermediate thickness melanomas (1.0 to 4.0 mm) and compared elective (immediate) lymph node dissection (ELND) with clinical observation of the lymph nodes as well as prognostic factors that independently predict outcomes. Methods: Eligible patients were stratified according to tumor thickness, anatomical site, and ulceration, and then prerandomized to either ELND or nodal observation. By using Cox stepwise multivariate regression analysis, the independent predictors of outcome were tumor thickness (P <.001), the presence of tumor ulceration (P <.001), trunk site (P = .003), and patient age more than 60 years (P = .01). Results: Overall 10-year survival was not significantly different for patients who received ELND or nodal observation (77% vs. 73%; P =. 12). Among the prospectively stratified subgroups of patients, 10-year survival rates favored those patients with ELND, with a 30% reduction in mortality rate for the 543 patients with nonulcerated melanomas (84% vs. 77%; P = .03), a 30% reduction in mortality rate for the 446 patients with tumor thickness of 1.0 to 2.0 mm (86% vs. 80%; P = .03), and a 27% reduction in mortality rate for 385 patients with limb melanomas (84% vs. 78%; P = .05). Of these subgroups, the presence or absence of ulceration should be the key factor for making treatment recommendations with regard to ELND for patients with intermediate thickness melanomas. Conclusions: These long-term survival rates from patients treated at 77 institutions demonstrate that ulceration and tumor thickness are dominant predictive factors that should be used in the staging of stages I and II melanomas, and confer a survival advantage for these subgroups of prospectively defined melanoma patients.

Original languageEnglish (US)
Pages (from-to)87-97
Number of pages11
JournalAnnals of Surgical Oncology
Volume7
Issue number2
StatePublished - Mar 2000
Externally publishedYes

Fingerprint

Melanoma
Lymph Node Excision
Observation
Neoplasms
Survival
Mortality
Survival Rate
Multivariate Analysis
Extremities
Lymph Nodes
Regression Analysis

Keywords

  • Cox regression
  • Melanoma
  • Neoplasm staging
  • Regional lymphadenectomy
  • Risk factors

ASJC Scopus subject areas

  • Surgery
  • Oncology

Cite this

Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm). / Balch, Charles M.; Soong, Seng Jaw; Ross, Merrick I.; Urist, Marshall M.; Karakousis, Constantine P.; Temple, Walley J.; Mihm, Martin C.; Barnhill, Raymond L.; Jewell, William R.; Wanebo, Harry J.; Harrison, Rene.

In: Annals of Surgical Oncology, Vol. 7, No. 2, 03.2000, p. 87-97.

Research output: Contribution to journalArticle

Balch, CM, Soong, SJ, Ross, MI, Urist, MM, Karakousis, CP, Temple, WJ, Mihm, MC, Barnhill, RL, Jewell, WR, Wanebo, HJ & Harrison, R 2000, 'Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm)', Annals of Surgical Oncology, vol. 7, no. 2, pp. 87-97.
Balch, Charles M. ; Soong, Seng Jaw ; Ross, Merrick I. ; Urist, Marshall M. ; Karakousis, Constantine P. ; Temple, Walley J. ; Mihm, Martin C. ; Barnhill, Raymond L. ; Jewell, William R. ; Wanebo, Harry J. ; Harrison, Rene. / Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm). In: Annals of Surgical Oncology. 2000 ; Vol. 7, No. 2. pp. 87-97.
@article{2517681b21814ac09a4afb945b0f8520,
title = "Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm)",
abstract = "Background: Ten- to 15-year survival results were analyzed from a prospective multi-institutional randomized surgical trial that involved 740 stages I and II melanoma patients with intermediate thickness melanomas (1.0 to 4.0 mm) and compared elective (immediate) lymph node dissection (ELND) with clinical observation of the lymph nodes as well as prognostic factors that independently predict outcomes. Methods: Eligible patients were stratified according to tumor thickness, anatomical site, and ulceration, and then prerandomized to either ELND or nodal observation. By using Cox stepwise multivariate regression analysis, the independent predictors of outcome were tumor thickness (P <.001), the presence of tumor ulceration (P <.001), trunk site (P = .003), and patient age more than 60 years (P = .01). Results: Overall 10-year survival was not significantly different for patients who received ELND or nodal observation (77{\%} vs. 73{\%}; P =. 12). Among the prospectively stratified subgroups of patients, 10-year survival rates favored those patients with ELND, with a 30{\%} reduction in mortality rate for the 543 patients with nonulcerated melanomas (84{\%} vs. 77{\%}; P = .03), a 30{\%} reduction in mortality rate for the 446 patients with tumor thickness of 1.0 to 2.0 mm (86{\%} vs. 80{\%}; P = .03), and a 27{\%} reduction in mortality rate for 385 patients with limb melanomas (84{\%} vs. 78{\%}; P = .05). Of these subgroups, the presence or absence of ulceration should be the key factor for making treatment recommendations with regard to ELND for patients with intermediate thickness melanomas. Conclusions: These long-term survival rates from patients treated at 77 institutions demonstrate that ulceration and tumor thickness are dominant predictive factors that should be used in the staging of stages I and II melanomas, and confer a survival advantage for these subgroups of prospectively defined melanoma patients.",
keywords = "Cox regression, Melanoma, Neoplasm staging, Regional lymphadenectomy, Risk factors",
author = "Balch, {Charles M.} and Soong, {Seng Jaw} and Ross, {Merrick I.} and Urist, {Marshall M.} and Karakousis, {Constantine P.} and Temple, {Walley J.} and Mihm, {Martin C.} and Barnhill, {Raymond L.} and Jewell, {William R.} and Wanebo, {Harry J.} and Rene Harrison",
year = "2000",
month = "3",
language = "English (US)",
volume = "7",
pages = "87--97",
journal = "Annals of Surgical Oncology",
issn = "1068-9265",
publisher = "Springer New York",
number = "2",

}

TY - JOUR

T1 - Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm)

AU - Balch, Charles M.

AU - Soong, Seng Jaw

AU - Ross, Merrick I.

AU - Urist, Marshall M.

AU - Karakousis, Constantine P.

AU - Temple, Walley J.

AU - Mihm, Martin C.

AU - Barnhill, Raymond L.

AU - Jewell, William R.

AU - Wanebo, Harry J.

AU - Harrison, Rene

PY - 2000/3

Y1 - 2000/3

N2 - Background: Ten- to 15-year survival results were analyzed from a prospective multi-institutional randomized surgical trial that involved 740 stages I and II melanoma patients with intermediate thickness melanomas (1.0 to 4.0 mm) and compared elective (immediate) lymph node dissection (ELND) with clinical observation of the lymph nodes as well as prognostic factors that independently predict outcomes. Methods: Eligible patients were stratified according to tumor thickness, anatomical site, and ulceration, and then prerandomized to either ELND or nodal observation. By using Cox stepwise multivariate regression analysis, the independent predictors of outcome were tumor thickness (P <.001), the presence of tumor ulceration (P <.001), trunk site (P = .003), and patient age more than 60 years (P = .01). Results: Overall 10-year survival was not significantly different for patients who received ELND or nodal observation (77% vs. 73%; P =. 12). Among the prospectively stratified subgroups of patients, 10-year survival rates favored those patients with ELND, with a 30% reduction in mortality rate for the 543 patients with nonulcerated melanomas (84% vs. 77%; P = .03), a 30% reduction in mortality rate for the 446 patients with tumor thickness of 1.0 to 2.0 mm (86% vs. 80%; P = .03), and a 27% reduction in mortality rate for 385 patients with limb melanomas (84% vs. 78%; P = .05). Of these subgroups, the presence or absence of ulceration should be the key factor for making treatment recommendations with regard to ELND for patients with intermediate thickness melanomas. Conclusions: These long-term survival rates from patients treated at 77 institutions demonstrate that ulceration and tumor thickness are dominant predictive factors that should be used in the staging of stages I and II melanomas, and confer a survival advantage for these subgroups of prospectively defined melanoma patients.

AB - Background: Ten- to 15-year survival results were analyzed from a prospective multi-institutional randomized surgical trial that involved 740 stages I and II melanoma patients with intermediate thickness melanomas (1.0 to 4.0 mm) and compared elective (immediate) lymph node dissection (ELND) with clinical observation of the lymph nodes as well as prognostic factors that independently predict outcomes. Methods: Eligible patients were stratified according to tumor thickness, anatomical site, and ulceration, and then prerandomized to either ELND or nodal observation. By using Cox stepwise multivariate regression analysis, the independent predictors of outcome were tumor thickness (P <.001), the presence of tumor ulceration (P <.001), trunk site (P = .003), and patient age more than 60 years (P = .01). Results: Overall 10-year survival was not significantly different for patients who received ELND or nodal observation (77% vs. 73%; P =. 12). Among the prospectively stratified subgroups of patients, 10-year survival rates favored those patients with ELND, with a 30% reduction in mortality rate for the 543 patients with nonulcerated melanomas (84% vs. 77%; P = .03), a 30% reduction in mortality rate for the 446 patients with tumor thickness of 1.0 to 2.0 mm (86% vs. 80%; P = .03), and a 27% reduction in mortality rate for 385 patients with limb melanomas (84% vs. 78%; P = .05). Of these subgroups, the presence or absence of ulceration should be the key factor for making treatment recommendations with regard to ELND for patients with intermediate thickness melanomas. Conclusions: These long-term survival rates from patients treated at 77 institutions demonstrate that ulceration and tumor thickness are dominant predictive factors that should be used in the staging of stages I and II melanomas, and confer a survival advantage for these subgroups of prospectively defined melanoma patients.

KW - Cox regression

KW - Melanoma

KW - Neoplasm staging

KW - Regional lymphadenectomy

KW - Risk factors

UR - http://www.scopus.com/inward/record.url?scp=0034077059&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0034077059&partnerID=8YFLogxK

M3 - Article

C2 - 10761786

AN - SCOPUS:0034077059

VL - 7

SP - 87

EP - 97

JO - Annals of Surgical Oncology

JF - Annals of Surgical Oncology

SN - 1068-9265

IS - 2

ER -