Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma

被引：1050

作者：

Faries, M. B. ^{[1
]}

Thompson, J. F. ^{[5
,6
]}

Cochran, A. J. ^{[2
]}

Andtbacka, R. H. ^{[10
]}

Mozzillo, N. ^{[12
]}

Zager, J. S. ^{[15
]}

Jahkola, T. ^{[16
]}

Bowles, T. L. ^{[11
]}

Testori, A. ^{[13
]}

Beitsch, P. D. ^{[17
]}

Hoekstra, H. J. ^{[18
]}

Moncrieff, M. ^{[20
]}

Ingvar, C. ^{[22
]}

Wouters, M. W. J. M. ^{[19
]}

Sabel, M. S. ^{[23
]}

Levine, E. A. ^{[24
]}

Agnese, D. ^{[26
]}

Henderson, M. ^{[7
]}

Dummer, R. ^{[27
]}

Rossi, C. R. ^{[14
]}

Neves, R. I. ^{[29
]}

Trocha, S. D. ^{[33
]}

Wright, F. ^{[34
]}

Byrd, D. R. ^{[36
]}

Matter, M. ^{[28
]}

Hsueh, E. ^{[37
]}

MacKenzie-Ross, A. ^{[21
]}

Johnson, D. B. ^{[38
]}

Terheyden, P. ^{[40
]}

Berger, A. C. ^{[30
]}

Huston, T. L. ^{[43
]}

Wayne, J. D. ^{[46
]}

Smithers, B. M. ^{[8
]}

Neuman, H. B. ^{[48
]}

Schneebaum, S. ^{[49
]}

Gershenwald, J. E. ^{[50
]}

Ariyan, C. E. ^{[44
]}

Desai, D. C. ^{[32
]}

Jacobs, L. ^{[51
]}

McMasters, K. M. ^{[52
]}

Gesierich, A. ^{[41
]}

Hersey, P. ^{[9
]}

Bines, S. D. ^{[47
]}

Kane, J. M. ^{[45
]}

Barth, R. J. ^{[53
]}

McKinnon, G. ^{[35
]}

Farma, J. M. ^{[31
]}

Schultz, E. ^{[42
]}

Vidal-Sicart, S. ^{[54
]}

Hoefer, R. A. ^{[55
]}

机构：

[1] St Johns Hlth Ctr, John Wayne Canc Inst, Santa Monica, CA 90404 USA

[2] Univ Calif Los Angeles, Dept Pathol, Los Angeles, CA 90024 USA

[3] Univ Calif Los Angeles, Dept Biomath, Los Angeles, CA USA

[4] Univ Calif Los Angeles, Dept Med, Los Angeles, CA 90024 USA

[5] Melanoma Inst Australia, Sydney, NSW, Australia

[6] Univ Sydney, Sydney, NSW, Australia

[7] Peter MacCallum Canc Ctr, Melbourne, Vic, Australia

[8] Princess Alexandra Hosp, Brisbane, Qld, Australia

[9] Newcastle Melanoma Unit, Waratah, NSW, Australia

[10] Huntsman Canc Inst, Salt Lake City, UT USA

[11] Intermt Med Ctr, Intermt Healthcare Canc Serv, Murray, UT USA

[12] Ist Nazl Tumori Napoli, Naples, Italy

[13] Ist Europeo Oncol, Milan, Italy

[14] Univ Padua, Ist Oncol Veneto, Padua, Italy

[15] H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA

[16] Helsinki Univ Hosp, Helsinki, Finland

[17] Dallas Surg Grp, Dallas, TX USA

[18] Univ Groningen, Univ Med Ctr Groningen, Groningen, Netherlands

[19] Netherlands Canc Inst, Amsterdam, Netherlands

[20] Norfolk & Norwich Univ Hosp, Norwich, Norfolk, England

[21] Guys & St Thomas NHS Fdn Trust, London, England

[22] Univ Lund Hosp, Swedish Melanoma Study Grp, Lund, Sweden

[23] Univ Michigan, Ann Arbor, MI USA

[24] Wake Forest Univ, Winston Salem, NC 27109 USA

[25] Duke Univ, Durham, NC USA

[26] Ohio State Univ, Columbus, OH 43210 USA

[27] Univ Zurich, Zurich, Switzerland

[28] CHU Vaudois, Lausanne, Switzerland

[29] Penn State Hershey Canc Inst, Hershey, PA USA

[30] Thomas Jefferson Univ, Philadelphia, PA 19107 USA

[31] Fox Chase Canc Ctr, 7701 Burholme Ave, Philadelphia, PA 19111 USA

[32] St Lukes Univ, Hlth Network, Bethlehem, PA USA

[33] Greenville Hlth Syst Canc Ctr, Greenville, SC USA

[34] Sunnybrook Res Inst, Toronto, ON, Canada

[35] Tom Baker Canc Clin, Calgary, AB, Canada

[36] Univ Washington, Seattle, WA 98195 USA

[37] St Louis Univ, St Louis, MO 63103 USA

[38] Vanderbilt Univ, Nashville, TN USA

[39] Univ Tennessee, Knoxville, TN USA

[40] Univ Hosp Schleswig Holstein, Campus Lubeck, Lubeck, Germany

[41] Univ Hosp Wurzburg, Wurzburg, Germany

[42] City Hosp Nurnberg, Nurnberg, Germany

[43] SUNY Stony Brook, Hosp Med Ctr, Stony Brook, NY 11794 USA

[44] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA

[45] Roswell Pk Canc Inst, Buffalo, NY 14263 USA

[46] Northwestern Univ, Feinberg Sch Med, Chicago, IL 60611 USA

[47] Rush Univ, Med Ctr, Chicago, IL 60612 USA

[48] Univ Wisconsin, Madison, WI 53706 USA

[49] Tel Aviv Sourasky Med Ctr, Tel Aviv, Israel

[50] MD Anderson Med Ctr, Houston, TX USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2017年 / 376卷 / 23期

关键词：

LYMPH-NODES; BIOPSY; MULTICENTER; TRIAL; LYMPHADENECTOMY; MORBIDITY; IMPACT;

D O I：

10.1056/NEJMoa1613210

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

BACKGROUND Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness melanomas (1.2 to 3.5 mm). The value of completion lymph-node dissection for patients with sentinel-node metastases is not clear. METHODS In an international trial, we randomly assigned patients with sentinel-node metastases detected by means of standard pathological assessment or a multimarker molecular assay to immediate completion lymph-node dissection (dissection group) or nodal observation with ultrasonography (observation group). The primary end point was melanoma-specific survival. Secondary end points included disease-free survival and the cumulative rate of nonsentinel-node metastasis. RESULTS Immediate completion lymph-node dissection was not associated with increased melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat analysis or among 1755 patients in the per-protocol analysis. In the per-protocol analysis, the mean (+/-SE) 3-year rate of melanoma-specific survival was similar in the dissection group and the observation group (86+/-1.3% and 86+/-1.2%, respectively; P = 0.42 by the log-rank test) at a median follow-up of 43 months. The rate of disease-free survival was slightly higher in the dissection group than in the observation group (68+/-1.7% and 63+/-1.7%, respectively; P = 0.05 by the log-rank test) at 3 years, based on an increased rate of disease control in the regional nodes at 3 years (92+/-1.0% vs. 77+/-1.5%; P<0.001 by the log-rank test); these results must be interpreted with caution. Nonsentinel-node metastases, identified in 11.5% of the patients in the dissection group, were a strong, independent prognostic factor for recurrence (hazard ratio, 1.78; P = 0.005). Lymphedema was observed in 24.1% of the patients in the dissection group and in 6.3% of those in the observation group. CONCLUSIONS Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma-specific survival among patients with melanoma and sentinel-node metastases.

引用

页码：2211 / 2222

页数：12

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