Therapeutic Value of Sentinel Lymph Node Biopsy in Patients With Melanoma: A Randomized Clinical Trial.

Autor:	Crystal JS; Department of Surgery, University of Miami, Miami, Florida., Thompson JF; Melanoma Institute Australia, The University of Sydney, Sydney, Australia., Hyngstrom J; Department of Surgery, University of Utah, Salt Lake City., Caracò C; Istituto Nazionale Tumori IRCCS Fondazione 'G. Pascale,' Napoli, Italy., Zager JS; Departments of Cutaneous Oncology and Sarcoma, H. Lee Moffitt Cancer Center, Tampa, Florida., Jahkola T; Department of Plastic and Reconstructive Surgery, University of Helsinki, Helsinki University Hospital, Helsinki, Finland., Bowles TL; Department of Surgical Oncology, Intermountain Medical Center, Salt Lake City, Utah., Pennacchioli E; Division of Melanoma, Soft Tissue Sarcomas and Rare Tumors, European Institute of Oncology, Milano, Italy., Beitsch PD; Dallas Surgical Group, Dallas, Texas., Hoekstra HJ; Department of Surgery, University Hospital Groningen, Groningen, the Netherlands., Moncrieff M; Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, United Kingdom., Ingvar C; Department of Surgery, Lund University, Lund, Sweden., van Akkooi A; Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands., Sabel MS; Department of Surgery, University of Michigan, Ann Arbor., Levine EA; Department of Surgical Oncology, Wake Forest University, Winston-Salem, North Carolina., Agnese D; Department of Surgery, Ohio State University, Columbus., Henderson M; Department of Surgery, University of Melbourne, Peter MacCallum Cancer Centre, Melbourne, Australia., Dummer R; Department of Dermatology, University Hospital Zurich, Zurich, Switzerland., Neves RI; Department of Surgery, Pennsylvania State University Milton S. Hershey Medical Center, Hershey.; Now at Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida., Rossi CR; Melanoma and Sarcomas Unit, Veneto Institute of Oncology, Padua, Italy., Kane JM 3rd; Department of Surgical Oncology, Roswell Park Cancer Institute, Buffalo, New York., Trocha S; Department of Surgical Oncology, Prisma Health, Columbia, South Carolina., Wright F; Department of Surgical Oncology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Byrd DR; Department of Surgery, University of Washington, Seattle., Matter M; Department of Surgery, Lausanne University Hospital, Lausanne, Switzerland., Hsueh EC; Department of Surgery, Saint Louis University School of Medicine, Saint Louis, Missouri., MacKenzie-Ross A; Department of Plastic Surgery, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom., Kelley M; Department of Surgery, Vanderbilt University, Nashville, Tennessee., Terheyden P; Department of Dermatology, University of Lubeck, Lubeck, Germany., Huston TL; Department of Surgery, Stony Brook University, Stony Brook, New York., Wayne JD; Department of Surgery, Northwestern University, Chicago, Illinois., Neuman H; Department of Surgery, University of Wisconsin at Madison., Smithers BM; Department of Surgery, University of Queensland, Brisbane, Australia., Ariyan CE; Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York., Desai D; Department of Surgery, Saint Luke's University Hospital, Bethlehem, Pennsylvania., Gershenwald JE; Department of Surgical Oncology, MD Anderson Cancer Center, Houston, Texas., Schneebaum S; Department of Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel., Gesierich A; Department of Dermatology, University Hospital Wurzburg, Wurzburg, Germany., Jacobs LK; Department of Surgery, Johns Hopkins University, Baltimore, Maryland., Lewis JM; Department of Surgery, University of Tennessee Medical Center, Knoxville., McMasters KM; Department of Surgery, University of Louisville, Louisville, Tennessee., O'Donoghue C; Department of Surgery, Rush University, Chicago, Illinois., van der Westhuizen A; Department of Medical Oncology, Calvary Mater Hospital, Waratah, Australia., Sardi A; Department of Surgical Oncology, Mercy Medical Center, Baltimore, Maryland., Barth R; Department of Surgery, Dartmouth-Hitchcock Medical Center, Hanover, New Hampshire., Barone R; Surgical Oncology, Sharp Hospital, San Diego, California., McKinnon JG; Department of Surgery, University of Calgary, Calgary, Alberta, Canada., Slingluff CL; Department of Surgery, University of Virginia, Charlottesville., Farma JM; Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Schultz E; Department of Dermatology, Nuremberg General Hospital, Paracelsus Medical Center, Nuremberg, Germany., Scheri RP; Department of Surgery, Duke University, Durham, North Carolina., Vidal-Sicart S; Nuclear Medicine Department, Hospital Clinic Barcelona, Barcelona, Spain., Molina M; Department of Surgery, Lakeland Regional Health, Lakeland, Florida., Testori AAE; Department of Dermatology, Image Regenerative Clinic, Milano, Italy., Foshag LJ; Department of Surgical Oncology, John Wayne Cancer Institute, Santa Monica, California., Van Kreuningen L; Manager of Research Operations, Saint John's Cancer Institute, Santa Monica, California., Wang HJ; Department of Medicine Statistics Core, David Geffen School of Medicine at UCLA, University of California, Los Angeles., Sim MS; Department of Medicine, David Geffen School of Medicine at UCLA, University of California, Los Angeles., Scolyer RA; Melanoma Institute Australia, Department of Medicine, University of Sydney, Sydney, Australia., Elashoff DE; Department of Medicine Statistics Core, David Geffen School of Medicine at UCLA, University of California, Los Angeles., Cochran AJ; Department of Anatomic Pathology, David Geffen School of Medicine at UCLA, University of California, Los Angeles., Faries MB; The Angeles Clinic and Research Institute, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
Jazyk:	angličtina
Zdroj:	JAMA surgery [JAMA Surg] 2022 Sep 01; Vol. 157 (9), pp. 835-842.
DOI:	10.1001/jamasurg.2022.2055
Abstrakt:	Importance: Sentinel lymph node (SLN) biopsy is a standard staging procedure for cutaneous melanoma. Regional disease control is a clinically important therapeutic goal of surgical intervention, including nodal surgery. Objective: To determine how frequently SLN biopsy without completion lymph node dissection (CLND) results in long-term regional nodal disease control in patients with SLN metastases. Design, Setting, and Participants: The second Multicenter Selective Lymphadenectomy Trial (MSLT-II), a prospective multicenter randomized clinical trial, randomized participants with SLN metastases to either CLND or nodal observation. The current analysis examines observation patients with regard to regional nodal recurrence. Trial patients were aged 18 to 75 years with melanoma metastatic to SLN(s). Data were collected from December 2004 to April 2019, and data were analyzed from July 2020 to January 2022. Interventions: Nodal observation with ultrasonography rather than CLND. Main Outcomes and Measures: In-basin nodal recurrence. Results: Of 823 included patients, 479 (58.2%) were male, and the mean (SD) age was 52.8 (13.8) years. Among 855 observed basins, at 10 years, 80.2% (actuarial; 95% CI, 77-83) of basins were free of nodal recurrence. By univariable analysis, freedom from regional nodal recurrence was associated with age younger than 50 years (hazard ratio [HR], 0.49; 95% CI, 0.34-0.70; P < .001), nonulcerated melanoma (HR, 0.36; 95% CI, 0.36-0.49; P < .001), thinner primary melanoma (less than 1.5 mm; HR, 0.46; 95% CI, 0.27-0.78; P = .004), axillary basin (HR, 0.61; 95% CI, 0.44-0.86; P = .005), fewer positive SLNs (1 vs 3 or more; HR, 0.32; 95% CI, 0.14-0.75; P = .008), and SLN tumor burden (measured by diameter less than 1 mm [HR, 0.39; 95% CI, 0.26-0.60; P = .001] or less than 5% area [HR, 0.36; 95% CI, 0.24-0.54; P < .001]). By multivariable analysis, younger age (HR, 0.57; 95% CI, 0.39-0.84; P = .004), thinner primary melanoma (HR, 0.40; 95% CI, 0.22-0.70; P = .002), axillary basin (HR, 0.55; 95% CI, 0.31-0.96; P = .03), SLN metastasis diameter less than 1 mm (HR, 0.52; 95% CI, 0.33-0.81; P = .007), and area less than 5% (HR, 0.58; 95% CI, 0.38-0.88; P = .01) were associated with basin control. When looking at the identified risk factors of age (50 years or older), ulceration, Breslow thickness greater than 3.5 mm, nonaxillary basin, and tumor burden of maximum diameter of 1 mm or greater and/or metastasis area of 5% or greater and excluding missing value cases, basin disease-free rates at 5 years were 96% (95% CI, 88-100) for patients with 0 risk factors, 89% (95% CI, 82-96) for 1 risk factor, 86% (95% CI, 80-93) for 2 risk factors, 80% (95% CI, 71-89) for 3 risk factors, 61% (95% CI, 48-74) for 4 risk factors, and 54% (95% CI, 36-72) for 5 or 6 risk factors. Conclusions and Relevance: This randomized clinical trial was the largest prospective evaluation of long-term regional basin control in patients with melanoma who had nodal observation after removal of a positive SLN. SLN biopsy without CLND cleared disease in the affected nodal basin in most patients, even those with multiple risk factors for in-basin recurrence. In addition to its well-validated value in staging, SLN biopsy may also be regarded as therapeutic in some patients. Trial Registration: ClinicalTrials.gov Identifier: NCT00297895.
Databáze:	MEDLINE
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