Melanoma, Version 2.2013

Coit, Daniel G.; Andtbacka, Robert H.I.; Anker, Christopher J.; Bichakjian, Christopher K.; Carson, William E.; Daud, Adil; DiMaio, Dominick J.; Fleming, Martin D.; Guild, Valerie; Halpern, Allan C.; Hodi, F. Stephen; Kelley, Mark C.; Khushalani, Nikhil I.; Kudchadkar, Ragini R.; Lange, Julie R.; Lind, Anne C.; Martini, Mary C.; Olszanski, Anthony J.; Pruitt, Scott K.; Ross, Merrick I.; Swetter, Susan M.; Tanabe, Kenneth K.; Thompson, John A.; Trisal, Vijay; Urist, Marshall M.; McMillian, Nicole R.; Ho, Maria M.

doi:10.6004/jnccn.2013.0055

Cited by 131 publications

(46 citation statements)

References 48 publications

(50 reference statements)

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“…The current National Cancer Comprehensive (NCCN) guidelines recommend that patients with a positive sentinel lymph node undergo completion lymphadenectomy (CLND) or be enrolled into a clinical trial (9). However, a number of retrospective studies have shown that there may be limited survival or clinical benefits for those who are observed after a positive SNB compared to those who undergo immediate CLND after positive SNB (10-13).…”

Section: Introductionmentioning

confidence: 99%

Impact of Completion Lymph Node Dissection on Patients with Positive Sentinel Lymph Node Biopsy in Melanoma

Lee

Lau

Huynh

et al. 2016

Journal of the American College of Surgeons

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Background The need for complete lymph node dissection (CLND) in patients with positive sentinel lymph node biopsy (SNB) is an important unanswered clinical question. Study Design Patients diagnosed with positive SNB at a melanoma referral center from 1991 to 2013 were studied. Outcomes of patients who underwent CLND were compared to those who did not undergo immediate CLND (observation group, OBS). Results There were 471 patients who had positive SNB; 375 (79.6%) in the CLND group and 96 (20.4%) in the OBS group. The groups were similar except that the CLND group was younger and had more sentinel nodes removed. Five-year nodal recurrence free survival was significantly better in the CLND group compared to the OBS group (93.1% vs 84.4%, p= 0.005). However, the 5- (66.4% vs 55.2%) and 10- year (59.5% vs 45.0%) distant metastasis free survival was not significantly different (p= 0.061). The CLND group's melanoma specific survival (MSS) was superior to the OBS group; 5 year MSS was (73.7 vs 65.5%) and10 year MSS- (66.8 vs 48.3%, p=0.015). On multivariate analysis, CLND was associated with improved MSS (HR 0.60, 95% CI 0.40-0.89, p= 0.011) and lower nodal recurrence (HR 0.46, 95% CI 0.24-0.86, p=0.016). Increased Breslow thickness, older age, ulceration, and trunk melanoma were all associated with worse outcomes. On subgroup analysis, following factors were associated with better outcomes from CLND- male gender, non-ulcerated primary, intermediate thickness, Clark level IV or lower extremity tumors. Conclusions Treatment of positive SNB with CLND was associated with improved MSS and nodal recurrence rate. Follow up beyond 5 years was needed to see a significant difference in MSS.

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Section: Introductionmentioning

confidence: 99%

Impact of Completion Lymph Node Dissection on Patients with Positive Sentinel Lymph Node Biopsy in Melanoma

Lee

Lau

Huynh

et al. 2016

Journal of the American College of Surgeons

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“…(J Mol Diagn 2016, 18: 299e315; http:// dx.doi.org/10.1016/j.jmoldx. 2015.11.006) In modern oncologic practice, patients with advanced-stage non-small cell lung cancer (NSCLC), 1,2 melanoma, 3,4 and colorectal adenocarcinoma 5,6 are often treated with targeted therapies as standard of care or after enrollment in clinical trials. Molecular mutation analysis is the preferred testing modality to guide therapeutic decision making and/or eligibility for biological studies.…”

mentioning

confidence: 99%

Clinical Validation and Implementation of a Targeted Next-Generation Sequencing Assay to Detect Somatic Variants in Non-Small Cell Lung, Melanoma, and Gastrointestinal Malignancies

Fisher

Zhang

Wang

et al. 2016

The Journal of Molecular Diagnostics

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We tested and clinically validated a targeted next-generation sequencing (NGS) mutation panel using 80 formalin-fixed, paraffin-embedded (FFPE) tumor samples. Forty non-small cell lung carcinoma (NSCLC), 30 melanoma, and 30 gastrointestinal (12 colonic, 10 gastric, and 8 pancreatic adenocarcinoma) FFPE samples were selected from laboratory archives. After appropriate specimen and nucleic acid quality control, 80 NGS libraries were prepared using the Illumina TruSight tumor (TST) kit and sequenced on the Illumina MiSeq. Sequence alignment, variant calling, and sequencing quality control were performed using vendor software and laboratory-developed analysis workflows. TST generated !500Â coverage for 98.4% of the 13,952 targeted bases. Reproducible and accurate variant calling was achieved at !5% variant allele frequency with 8 to 12 multiplexed samples per MiSeq flow cell. TST detected 112 variants overall, and confirmed all known single-nucleotide variants (n Z 27), deletions (n Z 5), insertions (n Z 3), and multinucleotide variants (n Z 3). TST detected at least one variant in 85.0% (68/80), and two or more variants in 36.2% (29/80), of samples. TP53 was the most frequently mutated gene in NSCLC (13 variants; 13/32 samples), gastrointestinal malignancies (15 variants; 13/25 samples), and overall (30 variants; 28/ 80 samples). BRAF mutations were most common in melanoma (nine variants; 9/23 samples). Clinically relevant NGS data can be obtained from routine clinical FFPE solid tumor specimens using TST, benchtop instruments, and vendor-supplied bioinformatics pipelines. (J Mol Diagn 2016, 18: 299e315; http:// dx

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“…(33) The development and validation of a blood-based prognostic biomarker would offer the potential to improve the NCCN guidelines and direct radiographic imaging. Our data show that while blood BRAF V600E levels reduce following surgery, post-operative blood-based analysis may be useful in diagnosing BRAF V600E status.…”

Section: Discussionmentioning

confidence: 99%

Clinical Utility of a Blood-Based BRAFV600E Mutation Assay in Melanoma

Panka

Buchbinder

Giobbie‐Hurder

et al. 2014

Molecular Cancer Therapeutics

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BRAF inhibitors (BRAFi) have led to clinical benefit in patients with melanoma. The development of a blood-based assay to detect and quantify BRAF levels in these patients has diagnostic, prognostic, and predictive capabilities that could guide treatment decisions. Blood BRAFV600E detection and quantification was performed on samples from 128 patients with Stage II (19), III (67), and IV (42) melanoma. Tissue BRAF analysis was performed in all patients with Stage IV disease and in selected patients with Stage II and III disease. Clinical outcomes were correlated to initial BRAF levels as well as BRAF level dynamics. Serial analysis was performed on 17 Stage IV melanoma patients treated with BRAFi and compared to tumor measurements by RECIST. The assay was highly sensitive (96%) and specific (95%) in the Stage IV setting, using a blood level of 4.8 pg as “positive”. BRAF levels typically decreased following BRAFi. A subset of these patients (5) had an increase in BRAF V600E values 42-112 days prior to clinical or radiographic disease progression (PD). From 86 patients with resected, stage II or III melanoma, 39 had evidence of disease relapse (45.3%). Furthermore, BRAF mutation in the blood after surgical resection in these patients was not associated with a difference in relapse risk, though tissue BRAF status was only available for a subset of patients. In summary we have developed a highly sensitive and specific, blood-based assay to detect BRAFV600 mutation in patients with melanoma.

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Melanoma, Version 2.2013

Cited by 131 publications

References 48 publications

Impact of Completion Lymph Node Dissection on Patients with Positive Sentinel Lymph Node Biopsy in Melanoma

Impact of Completion Lymph Node Dissection on Patients with Positive Sentinel Lymph Node Biopsy in Melanoma

Clinical Validation and Implementation of a Targeted Next-Generation Sequencing Assay to Detect Somatic Variants in Non-Small Cell Lung, Melanoma, and Gastrointestinal Malignancies

Clinical Utility of a Blood-Based BRAFV600E Mutation Assay in Melanoma

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