Journal ArticleDOI
Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial
Ulrike Leiter,Rudolf Stadler,Cornelia Mauch,Werner Hohenberger,Norbert H. Brockmeyer,Carola Berking,Cord Sunderkötter,Martin Kaatz,Klaus-Werner Schulte,Percy Lehmann,Thomas Vogt,Jens Ulrich,Rudolf A. Herbst,Wolfgang Gehring,Jan-Christoph Simon,Ulrike Keim,Peter Martus,Claus Garbe +17 more
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Results showed no difference in survival in patients treated with complete lymph node dissection compared with observation only, and complete lymph nodes dissection should not be recommended in patients with melanoma with lymph node micrometastases of at least a diameter of 1 mm or smaller.Abstract:
Summary Background Complete lymph node dissection is recommended in patients with positive sentinel lymph node biopsy results. To date, the effect of complete lymph node dissection on prognosis is controversial. In the DeCOG-SLT trial, we assessed whether complete lymph node dissection resulted in increased survival compared with observation. Methods In this multicentre, randomised, phase 3 trial, we enrolled patients with cutaneous melanoma of the torso, arms, or legs from 41 German skin cancer centres. Patients with positive sentinel lymph node biopsy results were eligible. Patients were randomly assigned (1:1) to undergo complete lymph node dissection or observation with permuted blocks of variable size and stratified by primary tumour thickness, ulceration of primary tumour, and intended adjuvant interferon therapy. Treatment assignment was not masked. The primary endpoint was distant metastasis-free survival and analysed by intention to treat. All patients in the intention-to-treat population of the complete lymph node dissection group were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT02434107. Follow-up is ongoing, but the trial no longer recruiting patients. Findings Between Jan 1, 2006, and Dec 1, 2014, 5547 patients were screened with sentinel lymph node biopsy and 1269 (23%) patients were positive for micrometastasis. Of these, 483 (39%) agreed to randomisation into the clinical trial; due to difficulties enrolling and a low event rate the trial closed early on Dec 1, 2014. 241 patients were randomly assigned to the observation group and 242 to the complete lymph node dissection group. Ten patients did not meet the inclusion criteria, so 233 patients were analysed in the observation group and 240 patients were analysed in the complete lymph node dissection group, as the intention-to-treat population. 311 (66%) patients (158 in the observation group and 153 in the dissection group) had sentinel lymph node metastases of 1 mm or less. Median follow-up was 35 months (IQR 20–54). Distant metastasis-free survival at 3 years was 77·0% (90% CI 71·9–82·1; 55 events) in the observation group and 74·9% (69·5–80·3; 54 events) in the complete lymph node dissection group. In the complete lymph node dissection group, grade 3 and 4 events occurred in 15 patients (6%) and 19 patients (8%) patients, respectively. Adverse events included lymph oedema (grade 3 in seven patients, grade 4 in 13 patients), lymph fistula (grade 3 in one patient, grade 4 in two patients), seroma (grade 3 in three patients, no grade 4), infection (grade 3 in three patients, no grade 4), and delayed wound healing (grade 3 in one patient, grade 4 in four patients); no serious adverse events were reported. Interpretation Although we did not achieve the required number of events, leading to the trial being underpowered, our results showed no difference in survival in patients treated with complete lymph node dissection compared with observation only. Consequently, complete lymph node dissection should not be recommended in patients with melanoma with lymph node micrometastases of at least a diameter of 1 mm or smaller. Funding German Cancer Aid.read more
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Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma
Alexander M.M. Eggermont,Christian U. Blank,Mario Mandalà,Georgina V. Long,Victoria Atkinson,Stéphane Dalle,Andrew Haydon,Mikhail Lichinitser,Adnan Khattak,Adnan Khattak,Matteo S. Carlino,Shahneen Sandhu,James Larkin,James Larkin,Susana Puig,Paolo A. Ascierto,Piotr Rutkowski,Dirk Schadendorf,Rutger H. T. Koornstra,Leonel Hernandez-Aya,Michele Maio,Alfonsus J. M. van den Eertwegh,Jean-Jacques Grob,Ralf Gutzmer,Rahima Jamal,Rahima Jamal,Paul Lorigan,Nageatte Ibrahim,Sandrine Marreaud,Alexander C.J. van Akkooi,Stefan Suciu,Caroline Robert +31 more
TL;DR: As adjuvant therapy for high‐risk stage III melanoma, 200 mg of pembrolizumab administered every 3 weeks for up to 1 year resulted in significantly longer recurrence‐free survival than placebo, with no new toxic effects identified.
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Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma
Mark B. Faries,John F. Thompson,Alistair J. Cochran,Robert H.I. Andtbacka,Nicola Mozzillo,Jonathan S. Zager,Tiina Jahkola,Tawnya L. Bowles,Alessandro Testori,Peter D. Beitsch,Harald J. Hoekstra,Marc Moncrieff,Christian Ingvar,Michel W.J.M. Wouters,Michael S. Sabel,Edward A. Levine,Doreen M. Agnese,Michael A. Henderson,Reinhard Dummer,Carlo Riccardo Rossi,Rogerio I. Neves,Steven D. Trocha,Frances C. Wright,David R. Byrd,Maurice Matter,Eddy Hsueh,Alastair MacKenzie-Ross,Douglas B. Johnson,Patrick Terheyden,Adam C. Berger,Tara L. Huston,Jeffrey D. Wayne,B. Mark Smithers,Heather B. Neuman,Schlomo Schneebaum,Jeffrey E. Gershenwald,Charlotte E. Ariyan,Darius C. Desai,Lisa K. Jacobs,Kelly M. McMasters,Anja Gesierich,Peter Hersey,Steven D. Bines,John M. Kane,Richard J. Barth,Gregory McKinnon,Jeffrey M. Farma,Erwin S. Schultz,Sergi Vidal-Sicart,Richard A. Hoefer,James M. Lewis,Randall P. Scheri,Mark C. Kelley,Omgo E. Nieweg,R. Dirk Noyes,Dave S.B. Hoon,He-Jing Wang,David Elashoff,Robert Elashoff +58 more
TL;DR: 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.
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Lymph protects metastasizing melanoma cells from ferroptosis
Jessalyn M. Ubellacker,Alpaslan Tasdogan,Vijayashree Ramesh,Bo Shen,Evann C. Mitchell,Misty S. Martin-Sandoval,Zhimin Gu,Michael L. McCormick,Alison B. Durham,Douglas R. Spitz,Zhiyu Zhao,Thomas P. Mathews,Sean J. Morrison +12 more
TL;DR: Melanoma cells in lymph experience less oxidative stress and less ferroptosis in lymph than in blood, owing to higher levels of oleic acid in lymph, and thus exposure to the lymphatic environment increases subsequent metastasis through blood.
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Melanoma Staging: American Joint Committee on Cancer (AJCC) 8th Edition and Beyond
TL;DR: This poster presents a probabilistic procedure that can be used to evaluate the immune response of the immune system to treat leukaemia and other types of cancer.
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Cutaneous melanoma, version 2.2019
Daniel G. Coit,John A. Thompson,Mark R. Albertini,Christopher A. Barker,William E. Carson,Carlo M. Contreras,Gregory A. Daniels,Dominick J. DiMaio,Ryan C. Fields,Martin D. Fleming,Morganna Freeman,Anjela Galan,Brian R. Gastman,Valerie Guild,Douglas B. Johnson,Richard W. Joseph,Julie R. Lange,Sameer K. Nath,Anthony J. Olszanski,Patrick A. Ott,Aparna Priyanath Gupta,Merrick I. Ross,April K.S. Salama,Joseph J. Skitzki,Jeffrey A. Sosman,Susan M. Swetter,Kenneth K. Tanabe,Evan Wuthrick,Nicole R. McMillian,Anita M. Engh +29 more
TL;DR: The data and rationale supporting extensive changes to the recommendations for systemic therapy as adjuvant treatment of resected disease and as treatment of unresectable or distant metastatic disease are summarized.
References
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Final Version of the American Joint Committee on Cancer Staging System for Cutaneous Melanoma
Charles M. Balch,Antonio C. Buzaid,Seng Jaw Soong,Michael B. Atkins,Natale Cascinelli,Daniel G. Coit,Irvin D. Fleming,Jeffrey E. Gershenwald,Alan Houghton,John M. Kirkwood,Kelly M. McMasters,Martin F. Mihm,Donald L. Morton,Douglas S. Reintgen,M. I. Ross,Arthur J. Sober,John A. Thompson,John F. Thompson +17 more
TL;DR: This revision of the staging system for cutaneous melanoma will become official with publication of the sixth edition of the AJCC Cancer Staging Manual in the year 2002.
Journal ArticleDOI
Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: A randomized clinical trial
Armando E. Giuliano,Kelly K. Hunt,Karla V. Ballman,Peter D. Beitsch,Pat Whitworth,Peter W. Blumencranz,A. Marilyn Leitch,Sukamal Saha,Linda M. McCall,Monica Morrow +9 more
TL;DR: Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND alone compared with ALND did not result in inferior survival, and overall survival was the primary end point, with a noninferiority margin of a 1-sided hazard ratio of less than 1.3 indicating thatSLND alone is noninherited.
Journal ArticleDOI
Sentinel-node biopsy or nodal observation in melanoma
Donald L. Morton,John F. Thompson,Alistair J. Cochran,Nicola Mozzillo,Robert Elashoff,Richard Essner,Omgo E. Nieweg,Daniel F. Roses,Harald J Hoekstra,Constantine P. Karakousis,Douglas S. Reintgen,Brendon J. Coventry,Edwin C. Glass,He-Jing Wang +13 more
TL;DR: The staging of intermediate-thickness primary melanomas according to the results of sentinel-node biopsy provides important prognostic information and identifies patients with nodal metastases whose survival can be prolonged by immediate lymphadenectomy.
Journal ArticleDOI
Final Trial Report of Sentinel-Node Biopsy versus Nodal Observation in Melanoma
Donald L. Morton,John F. Thompson,Alistair J. Cochran,Nicola Mozzillo,Omgo E. Nieweg,Daniel F. Roses,Harald J. Hoekstra,Constantine P. Karakousis,C. A. Puleo,Brendon J. Coventry,Mohammed Kashani-Sabet,Bernard Mark Smithers,E. Paul,William G. Kraybill,J. G. McKinnon,He-Jing Wang,Robert Elashoff,Mark B. Faries +17 more
TL;DR: 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, and prolongs disease-free survival and melanoma-specific survival.
Journal ArticleDOI
Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23–01): a phase 3 randomised controlled trial
Viviana Galimberti,Bernard F. Cole,Bernard F. Cole,Stefano Zurrida,Giuseppe Viale,Giuseppe Viale,Alberto Luini,Paolo Veronesi,Paolo Veronesi,Paola Baratella,Camelia Chifu,Manuela Sargenti,Mattia Intra,Oreste Gentilini,Mauro G. Mastropasqua,Giovanni Mazzarol,Samuele Massarut,Jean Rémi Garbay,Janez Zgajnar,Hanne Galatius,Angelo Recalcati,David Littlejohn,Monika Bamert,Marco Colleoni,Karen N. Price,Meredith M. Regan,Aron Goldhirsch,Alan S. Coates,Richard D. Gelber,Umberto Veronesi +29 more
TL;DR: Axillary dissection could be avoided in patients with early breast cancer and limited sentinel-node involvement, thus eliminating complications of axillary surgery with no adverse effect on survival.
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