Final Trial Report of Sentinel-Node Biopsy versus Nodal Observation in Melanoma
| Autor: | Bernard Mark Smithers, Daniel F. Roses, Alistair J. Cochran, Mark B. Faries, William G. Kraybill, Constantine P. Karakousis, Omgo E. Nieweg, E. Paul, Mohammed Kashani-Sabet, Nicola Mozzillo, Robert Elashoff, J. G. McKinnon, C. A. Puleo, He-Jing Wang, Harald J. Hoekstra, John F. Thompson, Brendon J. Coventry, Donald L. Morton |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Skin Neoplasms medicine.medical_treatment Observation Article Metastasis MALIGNANT-MELANOMA EARLY-STAGE MELANOMA PROGNOSTIC-FACTORS Multicenter trial Biopsy medicine MANAGEMENT Humans Survival rate Melanoma DISSECTION Aged MULTICENTER TRIAL LYMPH-NODES medicine.diagnostic_test business.industry Sentinel Lymph Node Biopsy Hazard ratio REGIONAL NODES General Medicine Sentinel node Middle Aged medicine.disease RANDOMIZED-TRIAL LYMPHADENECTOMY Surgery Survival Rate Lymphatic Metastasis Lymph Node Excision Lymphadenectomy Female Radiology business |
| Zdroj: | New England Journal of Medicine, 370(7), 599-609. MASSACHUSETTS MEDICAL SOC |
| ISSN: | 0028-4793 |
| Popis: | Sentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase 3 trial.We evaluated outcomes in 2001 patients with primary cutaneous melanomas randomly assigned to undergo wide excision and nodal observation, with lymphadenectomy for nodal relapse (observation group), or wide excision and sentinel-node biopsy, with immediate lymphadenectomy for nodal metastases detected on biopsy (biopsy group). Results No significant treatment-related difference in the 10-year melanoma-specific survival rate was seen in the overall study population (20.8% with and 79.2% without nodal metastases). Mean (± SE) 10-year disease-free survival rates were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3 ± 1.8% vs. 64.7 ± 2.3%; hazard ratio for recurrence or metastasis, 0.76; P=0.01), and those with thick melanomas, defined as3.50 mm (50.7 ± 4.0% vs. 40.5 ± 4.7%; hazard ratio, 0.70; P=0.03). Among patients with intermediate-thickness melanomas, the 10-year melanoma-specific survival rate was 62.1 ± 4.8% among those with metastasis versus 85.1 ± 1.5% for those without metastasis (hazard ratio for death from melanoma, 3.09; P0.001); among patients with thick melanomas, the respective rates were 48.0 ± 7.0% and 64.6 ± 4.9% (hazard ratio, 1.75; P=0.03). Biopsy-based management improved the 10-year rate of distant disease-free survival (hazard ratio for distant metastasis, 0.62; P=0.02) and the 10-year rate of melanoma-specific survival (hazard ratio for death from melanoma, 0.56; P=0.006) for patients with intermediate-thickness melanomas and nodal metastases. Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group, and a significant treatment benefit persisted.Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy. Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease-free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas. (Funded by the National Cancer Institute, National Institutes of Health, and the Australia and New Zealand Melanoma Trials Group; ClinicalTrials.gov number, NCT00275496.). |
| Databáze: | OpenAIRE |
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