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Melanoma: HELP
Articles by Mark B. Faries
Based on 70 articles published since 2008
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Between 2008 and 2019, Mark Faries wrote the following 70 articles about Melanoma.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline Sentinel Lymph Node Biopsy and Management of Regional Lymph Nodes in Melanoma: American Society of Clinical Oncology and Society of Surgical Oncology Clinical Practice Guideline Update. 2018

Wong, Sandra L / Faries, Mark B / Kennedy, Erin B / Agarwala, Sanjiv S / Akhurst, Timothy J / Ariyan, Charlotte / Balch, Charles M / Berman, Barry S / Cochran, Alistair / Delman, Keith A / Gorman, Mark / Kirkwood, John M / Moncrieff, Marc D / Zager, Jonathan S / Lyman, Gary H. ·Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA. · The Angeles Clinic and Research Institute, Santa Monica, CA, USA. · American Society of Clinical Oncology, Alexandria, VA, USA. guidelines@asco.org. · St Luke's Cancer Center, Easton, PA, USA. · Peter MacCallum Cancer Centre, Melbourne, VIC, Australia. · Memorial Sloan Kettering Cancer Center, New York, NY, USA. · MD Anderson Cancer Center, Houston, TX, USA. · Broward Health, Fort Lauderdale, FL, USA. · Los Angeles Center for Health Services, University of California, Los Angeles, CA, USA. · Emory University, Atlanta, GA, USA. · , Silver Spring, MD, USA. · University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA. · Norfolk and Norwich University Hospital, Norwich, UK. · H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA. · Fred Hutchinson Cancer Research Center, Seattle, WA, USA. ·Ann Surg Oncol · Pubmed #29236202.

ABSTRACT: PURPOSE: To update the American Society of Clinical Oncology (ASCO)-Society of Surgical Oncology (SSO) guideline for sentinel lymph node (SLN) biopsy in melanoma. METHODS: An ASCO-SSO panel was formed, and a systematic review of the literature was conducted regarding SLN biopsy and completion lymph node dissection (CLND) after a positive sentinel node in patients with melanoma. RESULTS: Nine new observational studies, two systematic reviews and an updated randomized controlled trial (RCT) of SLN biopsy, as well as two randomized controlled trials of CLND after positive SLN biopsy, were included. RECOMMENDATIONS: Routine SLN biopsy is not recommended for patients with thin melanomas that are T1a (non-ulcerated lesions < 0.8 mm in Breslow thickness). SLN biopsy may be considered for thin melanomas that are T1b (0.8 to 1.0 mm Breslow thickness or <0.8 mm Breslow thickness with ulceration) after a thorough discussion with the patient of the potential benefits and risk of harms associated with the procedure. SLN biopsy is recommended for patients with intermediate-thickness melanomas (T2 or T3; Breslow thickness of >1.0 to 4.0 mm). SLN biopsy may be recommended for patients with thick melanomas (T4; > 4.0 mm in Breslow thickness), after a discussion of the potential benefits and risks of harm. In the case of a positive SLN biopsy, CLND or careful observation are options for patients with low-risk micrometastatic disease, with due consideration of clinicopathological factors. For higher risk patients, careful observation may be considered only after a thorough discussion with patients about the potential risks and benefits of foregoing CLND. Important qualifying statements outlining relevant clinicopathological factors, and details of the reference patient populations are included within the guideline.

2 Editorial Completing the Dissection in Melanoma: Increasing Decision Precision. 2018

Faries, Mark B. ·The Angeles Clinic and Research Institute, Cedars Sinai Medical Center, Los Angeles, CA, USA. mfaries@theangelesclinic.org. ·Ann Surg Oncol · Pubmed #29302819.

ABSTRACT: -- No abstract --

3 Editorial Sentinel lymph node biopsy for melanoma: a plea to let the data be heard. 2014

Thompson, John F / Faries, Mark B / Cochran, Alistair J. ·Melanoma Institute Australia and the University of Sydney, Sydney, NSW, Australia, john.thompson@melanoma.org.au. ·Ann Surg Oncol · Pubmed #25103536.

ABSTRACT: -- No abstract --

4 Editorial Survival and the sentinel lymph node in melanoma. 2010

Faries, Mark. · ·Ann Surg Oncol · Pubmed #19885700.

ABSTRACT: -- No abstract --

5 Review Lymph node metastasis in melanoma: a debate on the significance of nodal metastases, conditional survival analysis and clinical trials. 2018

Faries, Mark B / Han, Dale / Reintgen, Michael / Kerivan, Lauren / Reintgen, Douglas / Caracò, Corrado. ·The Angeles Clinic and Research Institute, 11800 Wilshire Blvd, Suite 300, Los Angeles, CA, USA. mfaries@theangelesclinic.org. · Cedars Sinai Medical Center, 11818 Wilshire Blvd, Suite 200, Los Angeles, CA, 90025, USA. mfaries@theangelesclinic.org. · Section of Surgical Oncology, Department of Surgery, Yale University School of Medicine, New Haven, CT, USA. · Morsani School of Medicine, University of South Florida, Tampa, FL, USA. · Istituto Nazionale Tumori "Fondazione Pascale", Naples, Italy. ·Clin Exp Metastasis · Pubmed #29777421.

ABSTRACT: While there is no doubt that regional lymph node metastases are an enormously important factor in melanoma staging and treatment, the biology behind this significance and its precise implications for treatment planning have been a leading controversy in melanoma and other solid tumors for over a century. Recent clinical data, including data from prospective randomized clinical trials have refined our understanding of the process of nodal metastases and the advantages and disadvantages of different clinical management strategies. This review presents two points of view in this debate and discusses the results of new data analyses as well as pivotal clinical trials informing the discussion.

6 Review Intralesional Immunotherapy for Metastatic Melanoma: The Oldest and Newest Treatment in Oncology. 2016

Faries, Mark B. ·John Wayne Cancer Institute, 2200 Santa Monica Blvd, Santa Monica, CA 90404. ·Crit Rev Oncog · Pubmed #27481003.

ABSTRACT: The last few years have yielded exciting developments in immunotherapy for cancer. The promise of cancer immunotherapy has been well known for many years, but had generally produced limited or inconsistent benefit to patients. Intralesional therapies, which are in fact one of the oldest forms of immunotherapy, are also demonstrating benefits in the modern age. This review discusses the origins of intralesional immunotherapy and its underlying rationale. It also discusses the reemergence of this mode of therapy into the modern era, which is where Donald L. Morton, subject of this edition of the journal, plays a major role. The review also discusses current areas of investigation. Given the intuitive advantages of this strategy and the demonstrated, expanding areas of clinical responses, it is likely that intralesional immunotherapy will remain a useful component of cancer treatment into the future.

7 Review Metastasectomy for stage IV melanoma. 2015

Deutsch, Gary B / Kirchoff, Daniel D / Faries, Mark B. ·Melanoma Research Program, John Wayne Cancer Institute, Providence St. John's Hospital, 2200 Santa Monica Boulevard, Santa Monica, CA 90404, USA. · Melanoma Research Program, John Wayne Cancer Institute, Providence St. John's Hospital, 2200 Santa Monica Boulevard, Santa Monica, CA 90404, USA. Electronic address: mark.faries@jwci.org. ·Surg Oncol Clin N Am · Pubmed #25769712.

ABSTRACT: Metastatic melanoma has an unpredictable natural history but a predictably high mortality. Despite recent advances in systemic therapy, many patients do not respond, or develop resistance to drug therapy. Surgery has consistently shown good outcomes in appropriately selected patients. It is likely to be even more successful in the era of more effective medical treatment. Surgery should remain a strongly considered option for metastatic melanoma.

8 Review Melanoma vaccines: mixed past, promising future. 2014

Ozao-Choy, Junko / Lee, Delphine J / Faries, Mark B. ·John Wayne Cancer Institute, 2200 Santa Monica Boulevard, Santa Monica, CA 90404, USA. · John Wayne Cancer Institute, 2200 Santa Monica Boulevard, Santa Monica, CA 90404, USA. Electronic address: mark.faries@jwci.org. ·Surg Clin North Am · Pubmed #25245965.

ABSTRACT: Cancer vaccines were one of the earliest forms of immunotherapy to be investigated. Past attempts to vaccinate against cancer, including melanoma, have mixed results, showing the complexity of what was believed to be a simple concept. However, several recent successes and the combination of improved knowledge of tumor immunology and the advent of new immunomodulators make vaccination a promising strategy for the future.

9 Review Anorectal malignant melanoma: extensive 45-year review and proposal for a novel staging classification. 2013

Falch, Claudius / Stojadinovic, Alexander / Hann-von-Weyhern, Claus / Protic, Mladjan / Nissan, Aviram / Faries, Mark B / Daumer, Martin / Bilchik, Anton J / Itzhak, Avital / Brücher, Björn L D M. ·Department of Surgery, University of Tübingen, Tübingen, Germany. ·J Am Coll Surg · Pubmed #23697834.

ABSTRACT: -- No abstract --

10 Review Treatment of melanoma metastases in a limb by isolated limb perfusion and isolated limb infusion. 2011

Testori, Alessandro / Verhoef, Cornelis / Kroon, Hidde M / Pennacchioli, E / Faries, Mark B / Eggermont, Alexander M M / Thompson, John F. ·Melanoma and Sarcoma Division, European Institute of Oncology, Milan, Italy. alessandro.testori@ieo.it. ·J Surg Oncol · Pubmed #21858835.

ABSTRACT: In-transit melanoma metastases are often confined to a limb. In this circumstance, treatment by isolated limb perfusion or isolated limb infusion can be a remarkably effective regional treatment option.

11 Review Local and intralesional therapy of in-transit melanoma metastases. 2011

Testori, Alessandro / Faries, Mark B / Thompson, John F / Pennacchioli, E / Deroose, Jan P / van Geel, Albertus N / Verhoef, Cornelis / Verrecchia, Francesco / Soteldo, Javier. ·Melanoma and Sarcoma Division, European Institute of Oncology, Milan, Italy. alessandro.testori@ieo.it ·J Surg Oncol · Pubmed #21858834.

ABSTRACT: Regional relapse of melanoma may occur as satellite or in-transit metastases proximal to the primary tumor in the direction of the lymph flow. The management of in-transit metastases is challenging because the efficacy of treatment is largely dictated by the biological behavior of the patient's melanoma. This review examines local treatment modalities.

12 Review Sentinel node biopsy in melanoma: technical considerations of the procedure as performed at the John Wayne Cancer Institute. 2010

Bagaria, Sanjay P / Faries, Mark B / Morton, Donald L. ·John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, California 90404, USA. ·J Surg Oncol · Pubmed #20512942.

ABSTRACT: Since its first description in 1990, sentinel node (SN) biopsy has become the standard for accurate staging of a melanoma-draining regional lymphatic basin. This minimally invasive, multidisciplinary technique can detect occult metastases by selective sampling and focused pathologic analysis of the first nodes on the afferent lymphatic pathway from a primary cutaneous melanoma. An understanding of preoperative lymphoscintigraphy, intraoperative lymphatic mapping, and the definition of SN are critical for surgical expertise with SN biopsy.

13 Clinical Trial Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. 2017

Faries, Mark B / Mozzillo, Nicola / Kashani-Sabet, Mohammed / Thompson, John F / Kelley, Mark C / DeConti, Ronald C / Lee, Jeffrey E / Huth, James F / Wagner, Jeffrey / Dalgleish, Angus / Pertschuk, Daniel / Nardo, Christopher / Stern, Stacey / Elashoff, Robert / Gammon, Guy / Morton, Donald L / Anonymous10680923. ·John Wayne Cancer Institute, Santa Monica, CA, USA. mfaries@theangelesclinic.org. · Istituto Nazionale dei Tumori de Napoli, Naples, Italy. · Mt. Zion Medical Center, University of California, San Francisco, San Francisco, CA, USA. · Royal Prince Alfred Hospital, Sydney, Australia. · Vanderbilt University, Nashville, TN, USA. · H. Lee Moffitt Cancer Center, Tampa, FL, USA. · MD Anderson Cancer Center, Houston, TX, USA. · Southwestern Medical Center at Dallas, University of Texas, Dallas, TX, USA. · Wagner & Associates, Indianapolis, IN, USA. · St. George's Hospital Medical School, London, Great Britain. · CancerVax Corp, Carlsbad, CA, USA. · John Wayne Cancer Institute, Santa Monica, CA, USA. · UCLA Life Sciences, Biomathematics, Los Angeles, CA, USA. ·Ann Surg Oncol · Pubmed #29019177.

ABSTRACT: BACKGROUND: This phase III study was undertaken to evaluate the efficacy of an allogeneic whole-cell vaccine (Canvaxin™) plus bacillus Calmette-Guerin (BCG) after complete resection of stage IV melanoma. METHODS: After complete resection of ≤5 distant metastases, patients were randomly assigned to BCG+Canvaxin (BCG/Cv) or BCG+placebo (BCG/Pl). The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS), and immune response measured by skin test (ClinicalTrials.gov identifier: NCT00052156). RESULTS: Beginning in May 1998, 496 patients were randomized. In April 2005, the Data Safety Monitoring Board recommended stopping enrollment due to a low probability of efficacy. At that time, median OS and 5-year OS rate were 38.6 months and 44.9%, respectively, for BCG/Pl versus 31.4 months and 39.6% in the BCG/Cv group (hazard ratio (HR), 1.18; p = 0.250). Follow-up was extended at several trial sites through March 2010. Median OS and 5-year and 10-year survival was 39.1 months, 43.3 and 33.3%, respectively, for BCG/Pl versus 34.9 months, 42.5 and 36.4%, in the BCG/Cv group (HR 1.053; p = 0.696). Median DFS, 5- and 10-year DFS were 7.6 months, 23.8 and 21.7%, respectively, for BCG/Pl versus 8.5 months, 30.0%, and 30.0%, respectively, for the BCG/Cv group (HR 0.882; p = 0.260). Positive DTH skin testing correlated with increased survival. DISCUSSION: In this, the largest study of postsurgical adjuvant therapy for stage IV melanoma reported to date, BCG/Cv did not improve outcomes over BCG/placebo. Favorable long-term survival among study patients suggests that metastasectomy should be considered for selected patients with stage IV melanoma.

14 Clinical Trial Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma. 2017

Faries, Mark B / Thompson, John F / Cochran, Alistair J / Andtbacka, Robert H / Mozzillo, Nicola / Zager, Jonathan S / Jahkola, Tiina / Bowles, Tawnya L / Testori, Alessandro / Beitsch, Peter D / Hoekstra, Harald J / Moncrieff, Marc / Ingvar, Christian / Wouters, Michel W J M / Sabel, Michael S / Levine, Edward A / Agnese, Doreen / Henderson, Michael / Dummer, Reinhard / Rossi, Carlo R / Neves, Rogerio I / Trocha, Steven D / Wright, Frances / Byrd, David R / Matter, Maurice / Hsueh, Eddy / MacKenzie-Ross, Alastair / Johnson, Douglas B / Terheyden, Patrick / Berger, Adam C / Huston, Tara L / Wayne, Jeffrey D / Smithers, B Mark / Neuman, Heather B / Schneebaum, Schlomo / Gershenwald, Jeffrey E / Ariyan, Charlotte E / Desai, Darius C / Jacobs, Lisa / McMasters, Kelly M / Gesierich, Anja / Hersey, Peter / Bines, Steven D / Kane, John M / Barth, Richard J / McKinnon, Gregory / Farma, Jeffrey M / Schultz, Erwin / Vidal-Sicart, Sergi / Hoefer, Richard A / Lewis, James M / Scheri, Randall / Kelley, Mark C / Nieweg, Omgo E / Noyes, R Dirk / Hoon, Dave S B / Wang, He-Jing / Elashoff, David A / Elashoff, Robert M. ·From the John Wayne Cancer Institute at Saint John's Health Center, Santa Monica (M.B.F., D.S.B.H.), and the Departments of Pathology (A.J.C.), Biomathematics (H.-J.W., D.A.E., R.M.E.), and Medicine (D.A.E.), University of California, Los Angeles - both in California · Melanoma Institute Australia and the University of Sydney, Sydney (J.F.T., O.E.N.), Peter MacCallum Cancer Centre, Melbourne, VIC (M.H.), Princess Alexandra Hospital, Brisbane, QLD (B.M.S.), and Newcastle Melanoma Unit, Waratah, NSW (P.H.) - all in Australia · Huntsman Cancer Institute, Salt Lake City (R.H.A., R.D.N.), and Intermountain Healthcare Cancer Services-Intermountain Medical Center, Murray (T.L.B.) - both in Utah · Istituto Nazionale dei Tumori Napoli, Naples (N.M.), Istituto Europeo di Oncologia, Milan (A.T.), and Istituto Oncologico Veneto-University of Padua, Padua (C.R.R.) - all in Italy · H. Lee Moffitt Cancer Center, Tampa, FL (J.S.Z.) · Helsinki University Hospital, Helsinki (T.J.) · Dallas Surgical Group, Dallas (P.D.B.) · Universitair Medisch Centrum Groningen, Groningen (H.J.H.), and Netherlands Cancer Institute, Amsterdam (M.W.J.M.W.) - both in the Netherlands · Norfolk and Norwich University Hospital, Norwich (M. Moncrieff), and Guy's and St. Thomas' NHS Foundation Trust, London (A.M.-R.) - both in the United Kingdom · Swedish Melanoma Study Group-University Hospital Lund, Lund, Sweden (C.I.) · University of Michigan, Ann Arbor (M.S.S.) · Wake Forest University, Winston-Salem (E.A.L.), and Duke University, Durham (R.S.) - both in North Carolina · Ohio State University, Columbus (D.A.) · University of Zurich, Zurich (R.D.), and Centre Hospitalier Universitaire Vaudois, Lausanne (M. Matter) - both in Switzerland · Penn State Hershey Cancer Institute, Hershey (R.I.N.), Thomas Jefferson University (A.C.B.) and Fox Chase Cancer Center (J.M.F.), Philadelphia, and St. Luke's University Health Network, Bethlehem (D.C.D.) - all in Pennsylvania · Greenville Health System Cancer Center, Greenville, SC (S.D.T.) · Sunnybrook Research Institute, Toronto (F.W.), and Tom Baker Cancer Centre, Calgary, AB (G.M.) - both in Canada · University of Washington, Seattle (D.R.B.) · Saint Louis University, St. Louis (E.H.) · Vanderbilt University (D.B.J., M.C.K.), Nashville, and University of Tennessee, Knoxville (J.M.L.) - both in Tennessee · University Hospital Schleswig-Holstein-Campus Lübeck, Lübeck (P.T.), University Hospital of Würzburg, Würzburg (A.G.), and City Hospital of Nürnberg, Nuremberg (E.S.) - all in Germany · SUNY at Stony Brook Hospital Medical Center, Stony Brook (T.L.H.), Memorial Sloan Kettering Cancer Center, New York (C.E.A.), and Roswell Park Cancer Institute, Buffalo (J.M.K.) - all in New York · Northwestern University Feinberg School of Medicine (J.D.W.) and Rush University Medical Center (S.D.B.), Chicago · University of Wisconsin, Madison (H.B.N.) · Tel Aviv Sourasky Medical Center, Tel Aviv, Israel (S.S.) · M.D. Anderson Medical Center, Houston (J.E.G.) · Johns Hopkins University School of Medicine, Baltimore (L.J.) · University of Louisville, Louisville, KY (K.M.M.) · Dartmouth-Hitchcock Medical Center, Lebanon, NH (R.J.B.) · Hospital Clinic Barcelona, Barcelona (S.V.-S.) · and Sentara CarePlex Hospital, Hampton, VA (R.A.H.). ·N Engl J Med · Pubmed #28591523.

ABSTRACT: 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. (Funded by the National Cancer Institute and others; MSLT-II ClinicalTrials.gov number, NCT00297895 .).

15 Clinical Trial Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial. 2017

Jakub, James W / Terando, Alicia M / Sarnaik, Amod / Ariyan, Charlotte E / Faries, Mark B / Zani, Sabino / Neuman, Heather B / Wasif, Nabil / Farma, Jeffrey M / Averbook, Bruce J / Bilimoria, Karl Y / Grotz, Travis E / Allred, Jacob B Jake / Suman, Vera J / Brady, Mary Sue / Tyler, Douglas / Wayne, Jeffrey D / Nelson, Heidi. ·*Department of Surgery, Mayo Clinic, Rochester, MN †Department of Surgery, Ohio State University Medical Center, Columbus, OH ‡Department of Surgery, H. Lee Moffitt Cancer Center, Tampa, FL §Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY ¶Department of Surgical Oncology, John Wayne Cancer Institute, Santa Monica, CA ||Department of Surgery, Duke University School of Medicine, Durham, NC **Division of General Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI ††Department of Surgery, Mayo Clinic, Phoenix, AZ ‡‡Department of Surgery, Fox Chase Cancer Center, Philadelphia, PA §§Department of Surgery, MetroHealth Medical Center, Cleveland, OH ¶¶Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL ||||Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN ***Department of Surgery, University of Texas Medical Branch, Galveston, TX. ·Ann Surg · Pubmed #28009745.

ABSTRACT: BACKGROUND: Minimally invasive inguinal lymph node dissection (MILND) is a novel approach to inguinal lymphadenectomy. SAFE-MILND (NCT01500304) is a multicenter, phase I/II clinical trial evaluating the safety and feasibility of MILND for patients with melanoma in a group of surgeons newly adopting the procedure. METHODS: Twelve melanoma surgeons from 10 institutions without any previous MILND experience, enrolled patients into a prospective study after completing specialized training including didactic lectures, participating in a hands-on cadaveric laboratory, and being provided an instructional DVD of the procedure. Complications and adverse postoperative events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.0. RESULTS: Eighty-seven patients underwent a MILND. Seventy-seven cases (88.5%) were completed via a minimally invasive approach. The median total inguinal lymph nodes pathologically examined (SLN + MILND) was 12.0 (interquartile range 8.0, 14.0). Overall, 71% of patients suffered an adverse event (AE); the majority of these were grades 1 and 2, with 26% of patients experiencing a grade 3 AE. No grade 4 or 5 AEs were observed. CONCLUSIONS: After a structured training program, high-volume melanoma surgeons adopted a novel surgical technique with a lymph node retrieval rate that met or exceeded current oncologic guidelines and published benchmarks, and a favorable morbidity profile.

16 Clinical Trial Training High-Volume Melanoma Surgeons to Perform a Novel Minimally Invasive Inguinal Lymphadenectomy: Report of a Prospective Multi-Institutional Trial. 2016

Jakub, James W / Terando, Alicia M / Sarnaik, Amod / Ariyan, Charlotte E / Faries, Mark B / Zani, Sabino / Neuman, Heather B / Wasif, Nabil / Farma, Jeffrey M / Averbook, Bruce J / Bilimoria, Karl Y / Allred, Jacob B Jake / Suman, Vera J / Grotz, Travis E / Zendejas, Benjamin / Wayne, Jeffrey D / Tyler, Douglas S. ·Department of Surgery, Mayo Clinic, Rochester, MN. Electronic address: jakub.james@mayo.edu. · Department of Surgery, Ohio State University Medical Center, Columbus, OH. · Department of Surgery, H Lee Moffitt Cancer Center, Tampa, FL. · Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY. · Department of Surgical Oncology, John Wayne Cancer Institute, Santa Monica, CA. · Department of Surgery, Duke University School of Medicine, Durham, NC. · Division of General Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI. · Department of Surgery, Mayo Clinic, Phoenix, AZ. · Department of Surgery, Fox Chase Cancer Center, Philadelphia, PA. · Department of Surgery, MetroHealth Medical Center, Cleveland, OH. · Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL. · Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN. · Department of Surgery, Mayo Clinic, Rochester, MN. · Department of Surgery, University of Texas Medical Branch, Galveston, TX. ·J Am Coll Surg · Pubmed #26711792.

ABSTRACT: BACKGROUND: Minimally invasive inguinal lymphadenectomy (MILND) is a novel procedure with the potential to decrease surgical morbidity compared with the traditional open approach. The current study examined the feasibility of a combined didactic and hands-on training program to prepare high-volume melanoma surgeons to perform this procedure safely and proficiently. STUDY DESIGN: A select group of melanoma surgeons with no MILND experience were recruited. After completing a structured training program, surgeons enrolled patients with melanoma who required inguinal lymphadenectomy and performed the procedure in the minimally invasive fashion. A proficiency score composed of lymph node yield, operative time, and blood loss (or adverse events) was assigned for each case. After performing six cases, surgeons meeting a threshold score were considered proficient in the procedure. RESULTS: Twelve surgeons from 10 institutions enrolled 88 patients. The majority of surgeons were deemed proficient within 6 cases (83%). No differences in operative time or lymph node yield were noted during the course of the study. The rate of conversion was higher during an individual surgeon's early experience (9 of 49 [18%]), and only 1 procedure was converted in the 39 cases performed after a surgeon had performed 5 cases (late conversion rate, 3%; p = 0.038); however, this did not remain significant after controlling for surgeon. CONCLUSIONS: After a structured training program, experienced melanoma surgeons adopted a novel surgical technique with acceptable operative times, conversions, and lymph node yield. Eighty-four percent of the surgeons who completed at least 6 MILND procedures were considered proficient based on our predetermined definition.

17 Clinical Trial Results of a Randomized Controlled Multicenter Phase III Trial of Percutaneous Hepatic Perfusion Compared with Best Available Care for Patients with Melanoma Liver Metastases. 2016

Hughes, Marybeth S / Zager, Jonathan / Faries, Mark / Alexander, H Richard / Royal, Richard E / Wood, Bradford / Choi, Junsung / McCluskey, Kevin / Whitman, Eric / Agarwala, Sanjiv / Siskin, Gary / Nutting, Charles / Toomey, Mary Ann / Webb, Carole / Beresnev, Tatiana / Pingpank, James F. ·Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA. · H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA. · John Wayne Cancer Institute, Providence St. John's Health Center, Santa Monica, CA, USA. · Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA. · M.D. Anderson Cancer Center, University of Texas, Houston, TX, USA. · Center for Interventional Oncology, National Institutes of Health, Bethesda, MD, USA. · University of Pittsburgh Schools of the Health Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. · Carol G. Simon Cancer Center, Atlantic Health System, Morristown, NJ, USA. · St. Luke's Cancer Center, Bethlehem, PA, USA. · Albany Medical Neurosciences Institute, Albany, NY, USA. · RIA Endovascular, Greenwood Village, CO, USA. · University of Pittsburgh Schools of the Health Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. pingpankjf@upmc.edu. · Division of Hepatobiliary Surgery, Surgical Oncology Services, Hillman Cancer Center, UPMC, Pittsburgh, PA, USA. pingpankjf@upmc.edu. ·Ann Surg Oncol · Pubmed #26597368.

ABSTRACT: PURPOSE: There is no consensus for the treatment of melanoma metastatic to the liver. Percutaneous hepatic perfusion with melphalan (PHP-Mel) is a method of delivering regional chemotherapy selectively to the liver. In this study, we report the results of a multicenter, randomized controlled trial comparing PHP-Mel with best alternative care (BAC) for patients with ocular or cutaneous melanoma metastatic to the liver. PATIENTS AND METHODS: A total of 93 patients were randomized to PHP-Mel (n = 44) or BAC (n = 49). On the PHP-Mel arm, melphalan was delivered via the hepatic artery, and the hepatic effluent captured and filtered extracorporeally prior to return to the systemic circulation via a venovenous bypass circuit. PHP-Mel was repeatable every 4-8 weeks. The primary endpoint was hepatic progression-free survival (hPFS), and secondary endpoints included overall PFS (oPFS), overall survival (OS), hepatic objective response (hOR), and safety. RESULTS: hPFS was 7.0 months for PHP-Mel and 1.6 months for BAC (p < 0.0001), while oPFS was 5.4 months for PHP-Mel and 1.6 months for BAC (p < 0.0001). Median OS was not significantly different (PHP-Mel 10.6 months vs. BAC 10.0 months), likely due to crossover to PHP-Mel treatment (57.1 %) from the BAC arm, and the hOR was 36.4 % for PHP-Mel and 2.0 % for BAC (p < 0.001). The majority of adverse events were related to bone marrow suppression. Four deaths were attributed to PHP-Mel, three in the primary PHP-Mel group, and one post-crossover to PHP-Mel from BAC. CONCLUSION: This randomized, phase III study demonstrated the efficacy of the PHP-Mel procedure. hPFS, oPFS, and hOR were significantly improved with PHP-Mel. PHP with melphalan should provide a new treatment option for unresectable metastatic melanoma in the liver.

18 Clinical Trial Final trial report of sentinel-node biopsy versus nodal observation in melanoma. 2014

Morton, Donald L / Thompson, John F / Cochran, Alistair J / Mozzillo, Nicola / Nieweg, Omgo E / Roses, Daniel F / Hoekstra, Harold J / Karakousis, Constantine P / Puleo, Christopher A / Coventry, Brendon J / Kashani-Sabet, Mohammed / Smithers, B Mark / Paul, Eberhard / Kraybill, William G / McKinnon, J Gregory / Wang, He-Jing / Elashoff, Robert / Faries, Mark B / Anonymous4460784. ·The authors' affiliations are listed in the Appendix. ·N Engl J Med · Pubmed #24521106.

ABSTRACT: BACKGROUND: Sentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase 3 trial. METHODS: 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 as >3.50 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; P<0.001); 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. CONCLUSIONS: 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.).

19 Clinical Trial Combined analysis of phase III trials evaluating [⁹⁹mTc]tilmanocept and vital blue dye for identification of sentinel lymph nodes in clinically node-negative cutaneous melanoma. 2013

Sondak, Vernon K / King, Dennis W / Zager, Jonathan S / Schneebaum, Schlomo / Kim, Julian / Leong, Stanley P L / Faries, Mark B / Averbook, Bruce J / Martinez, Steve R / Puleo, Christopher A / Messina, Jane L / Christman, Lori / Wallace, Anne M. ·H. Lee Moffitt Cancer Center, Tampa, FL, USA. vernon.sondak@moffitt.org ·Ann Surg Oncol · Pubmed #23054107.

ABSTRACT: BACKGROUND: [(99m)Tc]Tilmanocept is a CD206 receptor-targeted radiopharmaceutical designed for sentinel lymph node (SLN) identification. Two nearly identical nonrandomized phase III trials compared [(99m)Tc]tilmanocept to vital blue dye. METHODS: Patients received [(99m)Tc]tilmanocept and blue dye. SLNs identified intraoperatively as radioactive and/or blue were excised and histologically examined. The primary end point, concordance, was the proportion of blue nodes detected by [(99m)Tc]tilmanocept; 90 % concordance was the prespecified minimum concordance level. Reverse concordance, the proportion of radioactive nodes detected by blue dye, was also calculated. The prospective statistical plan combined the data from both trials. RESULTS: Fifteen centers contributed 154 melanoma patients who were injected with both agents and were intraoperatively evaluated. Intraoperatively, 232 of 235 blue nodes were detected by [(99m)Tc]tilmanocept, for 98.7 % concordance (p < 0.001). [(99m)Tc]Tilmanocept detected 364 nodes, for 63.7 % reverse concordance (232 of 364 nodes). [(99m)Tc]Tilmanocept detected at least one node in more patients (n = 150) than blue dye (n = 138, p = 0.002). In 135 of 138 patients with at least one blue node, all blue nodes were radioactive. Melanoma was identified in the SLNs of 22.1 % of patients; all 45 melanoma-positive SLNs were detected by [(99m)Tc]tilmanocept, whereas blue dye detected only 36 (80 %) of 45 (p = 0.004). No positive SLNs were detected exclusively by blue dye. Four of 34 node-positive patients were identified only by [(99m)Tc]tilmanocept, so 4 (2.6 %) of 154 patients were correctly staged only by [(99m)Tc]tilmanocept. No serious adverse events were attributed to [(99m)Tc]tilmanocept. CONCLUSIONS: [(99m)Tc]Tilmanocept met the prespecified concordance primary end point, identifying 98.7 % of blue nodes. It identified more SLNs in more patients, and identified more melanoma-containing nodes than blue dye.

20 Clinical Trial Association between circulating tumor cells and prognosis in patients with stage III melanoma with sentinel lymph node metastasis in a phase III international multicenter trial. 2012

Hoshimoto, Sojun / Shingai, Tatsushi / Morton, Donald L / Kuo, Christine / Faries, Mark B / Chong, Kelly / Elashoff, David / Wang, He-Jing / Elashoff, Robert M / Hoon, Dave S B. ·John Wayne Cancer Institute at Saint John's Health Center, 2200 Santa Monica Blvd, Santa Monica, CA 90404, USA. ·J Clin Oncol · Pubmed #23008288.

ABSTRACT: PURPOSE: The outcomes of patients with melanoma who have sentinel lymph node (SLN) metastases can be highly variable, which has precluded establishment of consensus regarding treatment of the group. The detection of high-risk patients from this clinical setting may be helpful for determination of both prognosis and management. We report the utility of multimarker reverse-transcriptase quantitative polymerase chain reaction (RT-qPCR) detection of circulating tumor cells (CTCs) in patients with melanoma diagnosed with SLN metastases in a phase III, international, multicenter clinical trial. PATIENTS AND METHODS: Blood specimens were collected from patients with melanoma (n = 331) who were clinically disease-free after complete lymphadenectomy (CLND) before entering onto a randomized adjuvant melanoma vaccine plus bacillus Calmette-Guérin (BCG) versus BCG placebo trial from 30 melanoma centers (United States and international). Blood was assessed using a verified multimarker RT-qPCR assay (MART-1, MAGE-A3, and GalNAc-T) of melanoma-associated proteins. Cox regression analyses were used to evaluate the prognostic significance of CTC status for disease recurrence and melanoma-specific survival (MSS). RESULTS: Individual CTC biomarker detection ranged from 13.4% to 17.5%. There was no association of CTC status (zero to one positive biomarkers v two or more positive biomarkers) with known clinical or pathologic prognostic variables. However, two or more positive biomarkers was significantly associated with worse distant metastasis disease-free survival (hazard ratio [HR] = 2.13, P = .009) and reduced recurrence-free survival (HR = 1.70, P = .046) and MSS (HR = 1.88, P = .043) in a multivariable analysis. CONCLUSION: CTC biomarker status is a prognostic factor for recurrence-free survival, distant metastasis disease-free survival, and MSS after CLND in patients with SLN metastasis. This multimarker RT-qPCR analysis may therefore be useful in discriminating patients who may benefit from aggressive adjuvant therapy or stratifying patients for adjuvant clinical trials.

21 Clinical Trial Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. 2012

Hoshimoto, Sojun / Faries, Mark B / Morton, Donald L / Shingai, Tatsushi / Kuo, Christine / Wang, He-Jing / Elashoff, Robert / Mozzillo, Nicola / Kelley, Mark C / Thompson, John F / Lee, Jeffrey E / Hoon, Dave S B. ·Department of Molecular Oncology, John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, CA 90404, USA. ·Ann Surg · Pubmed #22202581.

ABSTRACT: OBJECTIVE: To verify circulating tumor cell (CTC) prognostic utility in stage IV resected melanoma patients in a prospective international phase III clinical trial. BACKGROUND: Our studies of melanoma patients in phase II clinical trials demonstrated prognostic significance for CTCs in patients with AJCC stage IV melanoma. CTCs were assessed to determine prognostic utility in follow-up of disease-free stage IV patients pre- and during treatment. METHODS: After complete metastasectomy, patients were prospectively enrolled in a randomized trial of adjuvant therapy with a whole-cell melanoma vaccine, Canvaxin, plus Bacille Calmette-Guerin (BCG) versus placebo plus BCG. Blood specimens obtained pretreatment (n = 244) and during treatment (n = 214) were evaluated by quantitative real-time reverse-transcriptase polymerase chain reaction (qPCR) for expression of MART-1, MAGE-A3, and PAX3 mRNA biomarkers. Univariate and multivariate Cox analyses examined CTC biomarker expression with respect to clinicopathological variables. RESULTS: CTC biomarker(s) (≥ 1) was detected in 54% of patients pretreatment and in 86% of patients over the first 3 months. With a median follow-up of 21.9 months, 71% of patients recurred and 48% expired. CTC levels were not associated with known prognostic factors or treatment arm. In multivariate analysis, pretreatment CTC (> 0 vs. 0 biomarker) status was significantly associated with disease-free survival (DFS; HR 1.64, P = 0.002) and overall survival (OS; HR 1.53, P = 0.028). Serial CTC (>0 vs. 0 biomarker) status was also significantly associated with DFS (HR 1.91, P = 0.02) and OS (HR 2.57, P = 0.012). CONCLUSION: CTC assessment can provide prognostic discrimination before and during adjuvant treatment for resected stage IV melanoma patients.

22 Clinical Trial A phase 2 study of (99m)Tc-tilmanocept in the detection of sentinel lymph nodes in melanoma and breast cancer. 2011

Leong, Stanley P L / Kim, Julian / Ross, Merrick / Faries, Mark / Scoggins, Charles R / Metz, Wendy L Rich / Cope, Frederick O / Orahood, Richard C. ·California Pacific Medical Center and Sutter Pacific Medical Foundation and Research Institute, University of California, San Francisco, CA, USA. leongsx@cpmcri.org ·Ann Surg Oncol · Pubmed #21331809.

ABSTRACT: BACKGROUND: Several (99m)Tc-labeled agents that are not approved by the U.S. Food and Drug Administration are used for lymphatic mapping. A new low-molecular-weight mannose receptor-based, reticuloendothelial cell-directed, (99m)Tc-labeled lymphatic imaging agent, (99m)Tc-tilmanocept, was used for lymphatic mapping of sentinel lymph nodes (SLNs) from patients with primary breast cancer or melanoma malignancies. This novel molecular species provides the basis for potentially enhanced SLN mapping reliability. METHODS: In a prospectively planned, open-label phase 2 clinical study, (99m)Tc-tilmanocept was injected into breast cancer and cutaneous melanoma patients before intraoperative lymphatic mapping. Injection technique, preoperative lymphoscintigraphy (LS), and intraoperative lymphatic mapping with a handheld gamma detection probe were performed by investigators per standard practice. RESULTS: Seventy-eight patients underwent (99m)Tc-tilmanocept injection and were evaluated (47 melanoma, 31 breast cancer). For those whom LS was performed (55 patients, 70.5%), a (99m)Tc-tilmanocept hot spot was identified in 94.5% of LS patients before surgery. Intraoperatively, (99m)Tc-tilmanocept identified at least one regional SLN in 75 (96.2%) of 78 patients: 46 (97.9%) of 47 in melanoma and 29 (93.5%) of 31 in breast cancer cases. Tissue specificity of (99m)Tc-tilmanocept for lymph nodes was 100%, displaying 95.1% mapping sensitivity by localizing in 173 of 182 nodes removed during surgery. The overall proportion of (99m)Tc-tilmanocept-identified nodes that contained metastatic disease was 13.7%. Five procedure-related serious adverse events occurred, none related to (99m)Tc-tilmanocept. CONCLUSIONS: Our results demonstrate the safety and efficacy of (99m)Tc-tilmanocept for use in intraoperative lymphatic mapping. The high intraoperative localization and lymph node specificity of (99m)Tc-tilmanocept and the identification of metastatic disease within the nodes suggest SLNs are effectively identified by this novel mannose receptor-targeted molecule.

23 Clinical Trial Effect of granulocyte/macrophage colony-stimulating factor on vaccination with an allogeneic whole-cell melanoma vaccine. 2009

Faries, Mark B / Hsueh, Eddy C / Ye, Xing / Hoban, Mary / Morton, Donald L. ·Sonya Valley Ghidossi Vaccine Laboratory of the Roy E. Coats Research Laboratories of the John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, CA 90404, USA. fariesm@jwci.org ·Clin Cancer Res · Pubmed #19903777.

ABSTRACT: PURPOSE: The availability of a variety of immune response modifiers creates an opportunity for improved efficacy of immunotherapy, but it also leads to uncertainty in how to combine agents and how to assess those combinations. We sought to assess the effect of the addition of granulocyte/macrophage colony-stimulating factor (GM-CSF) to vaccination with a melanoma vaccine. EXPERIMENTAL DESIGN: Ninety-seven patients with resected melanoma (stage II-IV) were enrolled, stratified by stage, and randomized to receive a cellular melanoma vaccine with or without GM-CSF. The primary endpoint was delayed-type hypersensitivity (DTH) response to melanoma cells. Antibody responses, peripheral leukocyte counts, and survival were also examined. RESULTS: The GM-CSF arm showed enhanced antibody responses with an increase in IgM titer against the TA90 antigen and increased TA90 immune complexes. This arm also had diminished antimelanoma cell delayed-type hypersensitivity response. Peripheral blood leukocyte profiles showed increases in eosinophils and basophils with decreased monocytes in the GM-CSF arm. These immune changes were accompanied by an increase in early melanoma deaths and a trend toward worse survival with GM-CSF. CONCLUSION: These data suggest that GM-CSF is not helpful as an immune adjuvant in this dose and schedule and raise concern that it may be harmful. Based on the discordant findings of an immune endpoint and clinical outcome, the use of such surrogate endpoints in selecting treatments for further evaluation must be done with a great deal of caution.

24 Article Microsatellitosis in Patients with Melanoma. 2019

Karakousis, Giorgos C / Gimotty, Phyllis A / Leong, Stanley P / Pockaj, Barbara A / White, Richard L / O'Donoghue, Cristina / Sinnamon, Andrew J / Bartlett, Edmund K / Dueck, Amylou C / Gould Rothberg, Bonnie E / Messina, Jane L / Vetto, John T / Sondak, Vernon K / Schneebaum, Schlomo / Kashani-Sabet, Mohammed / Han, Dale / Faries, Mark B / Zager, Jonathan S / Anonymous2571200. ·Hospital of the University of Pennsylvania, Philadelphia, PA, USA. giorgos.karakousis@uphs.upenn.edu. · Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, USA. · California Pacific Medical Center and Research Institute, San Francisco, CA, USA. · Mayo Clinic, Phoenix, AZ, USA. · Carolinas Medical Center, Charlotte, NC, USA. · Department of Surgery, Rush Medical College, Chicago, IL, USA. · Hospital of the University of Pennsylvania, Philadelphia, PA, USA. · Memorial Sloan Kettering Cancer Center, New York, NY, USA. · Yale University School of Medicine, New Haven, CT, USA. · Moffitt Cancer Center, Tampa, FL, USA. · Oregon Health and Science University, Portland, OR, USA. · Ichilov Hospital, Tel Aviv, Israel. · Angeles Clinic and Research Institute, Los Angeles, CA, USA. ·Ann Surg Oncol · Pubmed #30421045.

ABSTRACT: BACKGROUND: Microsatellitosis (mS) in melanoma has been considered a marker of unfavorable tumor biology, leading to the current American Joint Committee on Cancer staging of IIIB/C/D disease, despite few investigative studies of this entity limited by the small sample sizes and incomplete nodal microstaging. We sought to better characterize outcomes and prognostic factors in a multi-institutional cohort of patients with mS and nodal microstaging. METHODS: The Sentinel Lymph Node Working Group cohort included 414 mS patients who underwent sentinel lymph node (SLN) biopsy. Cox regression analysis was used to evaluate the prognostic significance of established clinicopathologic characteristics. Melanoma-specific survival (MSS) of patients with mS was compared with 3002 similarly staged patients from the Surveillance, Epidemiology, and End Results (SEER) Program registry. RESULTS: The median age of the mS cohort was 64.9 years; 39.6% were female. Median thickness was 3 mm, 40.6% of cases were ulcerated, and the SLN positivity rate was 46.7%. Increasing thickness, male sex, and SLN positivity were significantly associated with poorer MSS. Stage IIIB/C/D 5-year MSS rates were 86.3% (95% confidence interval [CI] 79.4-93.3%), 54.1% (95% CI 45.4-59.7%), and 44.2% (95% CI 25.4-63.0%), respectively. MSS survival for the stage IIIB mS cohort was significantly better than a similarly staged SEER cohort (5-year MSS of 70.1%, 95% CI 66.0-74.2%), while no significant difference was observed for the stage IIIC or D cohorts. CONCLUSIONS: SLN metastases are common and are a significant prognostic factor in patients with mS. Survival in stage IIIB patients with mS was considerably more favorable than their stage would otherwise suggest, which has important implications for decisions regarding adjuvant therapy for patients with mS.

25 Article Authentication of M14 melanoma cell line proves misidentification of MDA-MB-435 breast cancer cell line. 2018

Korch, Christopher / Hall, Erin M / Dirks, Wilhelm G / Ewing, Margaret / Faries, Mark / Varella-Garcia, Marileila / Robinson, Steven / Storts, Douglas / Turner, Jacqueline A / Wang, Ying / Burnett, Edward C / Healy, Lyn / Kniss, Douglas / Neve, Richard M / Nims, Raymond W / Reid, Yvonne A / Robinson, William A / Capes-Davis, Amanda. ·International Cell Line Authentication Committee (ICLAC). · Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora CO. · Genetica Cell Line Testing - a LabCorp brand, Burlington, NC. · Leibniz-Institute DSMZ - Deutsche Sammlung von Mikroorganismen und Zellkulturen, Braunschweig, Germany. · Promega Corporation, Madison, WI. · John Wayne Cancer Institute, Santa Monica, CA. · Culture Collections Public Health England, Porton Down, United Kingdom. · Biological Research Facility, The Francis Crick Institute, London, United Kingdom. · Departments of Obstetrics and Gynecology and Biomedical Engineering, The Ohio State University, Columbus, OH. · Gilead Sciences Inc, Foster City, CA. · RMC Pharmaceutical Solutions, Inc., Longmont, CO. · American Type Culture Collection (ATCC), Manassas, VA. · CellBank Australia, Children's Medical Research Institute, The University of Sydney, Westmead, NSW, Australia. ·Int J Cancer · Pubmed #28940260.

ABSTRACT: A variety of analytical approaches have indicated that melanoma cell line UCLA-SO-M14 (M14) and breast carcinoma cell line MDA-MB-435 originate from a common donor. This indicates that at some point in the past, one of these cell lines became misidentified, meaning that it ceased to correspond to the reported donor and instead became falsely identified (through cross-contamination or other means) as a cell line from a different donor. Initial studies concluded that MDA-MB-435 was the misidentified cell line and M14 was the authentic cell line, although contradictory evidence has been published, resulting in further confusion. To address this question, we obtained early samples of the melanoma cell line (M14), a lymphoblastoid cell line from the same donor (ML14), and donor serum preserved at the originator's institution. M14 samples were cryopreserved in December 1975, before MDA-MB-435 cells were established in culture. Through a series of molecular characterizations, including short tandem repeat (STR) profiling and cytogenetic analysis, we demonstrated that later samples of M14 and MDA-MB-435 correspond to samples of M14 frozen in 1975, to the lymphoblastoid cell line ML14, and to the melanoma donor's STR profile, sex and blood type. This work demonstrates conclusively that M14 is the authentic cell line and MDA-MB-435 is misidentified. With clear provenance information and authentication testing of early samples, it is possible to resolve debates regarding the origins of problematic cell lines that are widely used in cancer research.

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