Efficacy of adjuvant therapy in patients with stage IIIA cutaneous melanoma

被引：0

作者：

Grover, P. ^{[1
,2
,3
]}

Lo, S. N. ^{[1
]}

Li, I. ^{[1
]}

Kuijpers, A. M. J. ^{[4
]}

Kreidieh, F. ^{[5
]}

Williamson, A. ^{[6
]}

Amaral, T. ^{[7
]}

Dimitriou, F. ^{[8
]}

Placzke, J. ^{[9
]}

Olino, K. ^{[10
]}

Vitale, M. G. ^{[11
]}

Saiag, P. ^{[12
]}

Gutzmer, R. ^{[13
]}

Allayous, C. ^{[14
]}

Bagge, R. Olofsson ^{[15
]}

Mattsson, J. ^{[16
]}

Asher, N. ^{[17
]}

Carter, T. J. ^{[18
]}

Meniawy, T. M. ^{[3
]}

Lawless, A. R. ^{[19
]}

Czapla, J. A. ^{[19
]}

Warburton, L. ^{[2
,20
]}

Gaudy-Marqueste, C. ^{[21
]}

Grob, J. J. ^{[21
]}

Collins, R. G. ^{[22
]}

Zhang, E. ^{[23
]}

Kessels, J. I. ^{[24
]}

Neyns, B. ^{[24
]}

Mehmi, I. ^{[25
]}

Hamid, O. ^{[25
]}

Julve, M. ^{[26
]}

Furness, A. J. S. ^{[26
]}

Margolin, K. A. ^{[27
]}

Lev-Ari, S. ^{[28
]}

Ressler, J. M. ^{[29
]}

Haque, W. ^{[30
]}

Khattak, M. A. ^{[2
]}

Wicky, A. ^{[31
]}

Roberts-Thomson, R. ^{[32
]}

Arance, A. ^{[33
,34
]}

Warrier, G. ^{[35
,36
]}

Schollenberger, M. D. ^{[35
,36
]}

Parent, P. ^{[37
]}

Chatziioannou, E. ^{[7
]}

Lipson, E. J. ^{[35
,36
]}

Michielin, O. ^{[38
]}

Weber, J. S. ^{[30
]}

Hoeller, C. ^{[29
]}

Larkin, J. ^{[26
]}

Atkins, M. B. ^{[28
]}

机构：

[1] Univ Sydney, Melanoma Inst Australia, Sydney, Australia

[2] Fiona Stanley Hosp, Dept Med Oncol, Perth, Australia

[3] Sir Charles Gairdner Hosp, Dept Med Oncol, Perth, Australia

[4] Netherlands Canc Inst, Dept Surg Oncol, Amsterdam, Netherlands

[5] Univ Texas MD Anderson Canc Ctr, Dept Melanoma Med Oncol, Div Canc Med, Houston, TX USA

[6] Christie NHS Fdn Trust, Manchester, England

[7] Eberhard Karls Univ Tubingen, Dept Dermatol, Ctr Dermatooncol, Tubingen, Germany

[8] Univ Hosp Zurich, Dept Dermatol, Fac Med, Zurich, Switzerland

[9] Maria Sklodowska Curie Natl Res Inst Oncol, Warsaw, Poland

[10] Yale Univ, New Haven Hosp, Smilow Canc Ctr, Sch Med, New Haven, CT USA

[11] Ist Nazl Tumori IRCCS Fdn G Pascale, Melanoma Canc Immunotherapy & Dev Therapeut Unit, Naples, Italy

[12] Univ Versailles St Quentin Yvelines, Univ Dept Dermatol, APHP, Boulogne, France

[13] Ruhr Univ Bochum, Johannes Wesling Med Ctr, Dept Dermatol, Minden, Germany

[14] St Louis Hosp, AP HP, Dermatooncol, Canc Inst,APHP Nord Paris Cite, Paris, France

[15] Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Surg, Gothenburg, Sweden

[16] Sahlgrens Univ Hosp, Dept Surg, Gothenburg, Sweden

[17] Sheba Med Ctr, Ella Lemelbaum Inst Immunooncol, Tel Hashomer, Israel

[18] Mt Vernon Canc Ctr, Northwood, England

[19] Harvard Med Sch, Massachusetts Gen Hosp, Canc Ctr, Boston, MA USA

[20] Edith Cowan Univ, Sch Med & Hlth Sci, Perth, Australia

[21] Aix Marseille Univ, Hop Timone, APHM, Serv dermatol & cancerol cutanee, Marseille, France

[22] Vanderbilt Univ, Sch Med, Nashville, TN USA

[23] Westmead Hosp, Dept Surg, Sydney, Australia

[24] Univ Ziekenhuis Brussel, Dept Med Oncol, Brussels, Belgium

[25] Angeles Clin & Res Inst, Los Angeles, CA USA

[26] Royal Marsden NHS Fdn Trust, Renal Skin & Cell Therapy, London, England

[27] Providence St Johns Canc Inst, Dept Med Oncol, Santa Monica, CA USA

[28] Georgetown Lombardi Comprehens Canc Ctr, Washington, DC USA

[29] Med Univ Vienna, Dept Dermatol, Vienna, Austria

[30] NYU, Laura & Isaac Perlmutter Canc Ctr, Langone Med Ctr, New York, NY USA

[31] Lausanne Univ Hosp, Oncol, Lausanne, Switzerland

[32] Queen Elizabeth Hosp, Med Oncol Dept, Adelaide, Australia

[33] Hosp Clin Barcelona, Barcelona, Spain

[34] IDIBAPS, Barcelona, Spain

[35] Johns Hopkins, Bloomberg Kimmel Inst Canc Immunotherapy, Baltimore, MD USA

[36] Johns Hopkins Univ SOM, Sidney Kimmel Comprehens Canc Ctr, Dept Oncol, Baltimore, MD USA

[37] Monash Univ, Box Hill Hosp, Eastern Hlth Clin Sch, Melbourne, Australia

[38] Geneva Univ Hosp, Dept Oncol, Geneva, Switzerland

[39] Providence St Johns Hlth Ctr, St Johns Canc Inst, Dept Surg, Santa Monica, CA USA

[40] Vanderbilt Univ, Med Ctr, Dept Med, Nashville, TN USA

[41] Vanderbilt Ingram Canc Ctr, Nashville, TN USA

[42] Sheba Med Ctr Tel HaShomer, Ramat Gan, Israel

[43] Univ Paris Cite, St Louis Hosp, AP HP Dermatooncol, Canc Inst,APHP Nord Paris Cite,INSERM,U976, Paris, France

[44] Univ Manchester, Div Canc Sci, Manchester, England

[45] Univ Texas MD Anderson Canc Ctr, Dept Genom Med, Houston, TX USA

[46] Netherlands Canc Inst, Div Med Oncol, Amsterdam, Netherlands

[47] Univ Sydney, Westmead & Blacktown Hosp, Melanoma Inst Australia, Sydney, Australia

[48] Univ Sydney, Mater & Royal North Shore Hosp, Melanoma Inst Australia, Sydney, Australia

来源：

ANNALS OF ONCOLOGY | 2025年 / 36卷 / 07期

基金：

澳大利亚国家健康与医学研究理事会;

关键词：

stage IIIA; melanoma; immunotherapy; distant metastasis-free survival; observation; GUIDELINES; DISSECTION; IPILIMUMAB; NIVOLUMAB;

D O I：

10.1016/j.annonc.2025.03.021

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Patients with resected American Joint Committee on Cancer eighth edition (AJCC v8) stage IIIA melanoma have been underrepresented in clinical trials of adjuvant drug therapy. The benefit of adjuvant targeted therapy and immunotherapy in this population is unclear. Patients and methods: In this multicentre, retrospective study, patients with stage IIIA melanoma (AJCC v8) who received adjuvant pembrolizumab or nivolumab [anti-programmed cell death protein 1 (PD-1)], BRAF/MEK-targeted therapy dabrafenib + trametinib (TT) or no adjuvant treatment [observation (OBS)] were included. Recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and toxicity rates were examined. Results: A total of 628 patients from 34 centres across Australia, Europe and the United States were identified-256 in anti-PD-1, 80 in TT and 292 in OBS. The median follow-up was 2.6 years (interquartile range 1.6-3.4 years). The presence of some key poor prognostic variables was significantly higher in anti-PD-1 compared with OBS. The 2-year RFS was 79.3% [95% confidence interval (CI) 74.1% to 84.8%] for anti-PD-1, 98.6% (95% CI 96.0% to 100%) for TT and 84.3% (95% CI 79.9% to 89.0%) for OBS. The 2-year DMFS was 88.4% (95% CI 84.3% to 92.8%) in anti-PD-1, 100% in TT and 91.1% (95% CI 87.7% to 94.7%) in OBS. Higher Breslow thickness and higher mitotic rate were associated with higher risk of recurrence in anti-PD-1 and OBS (P < 0.05). Rates of >= grade 3 toxicities were 10.9% with anti-PD-1 and 17.5% with TT; discontinuation due to toxicity occurred in 13.3% and 21.2%, respectively. Rates of unresolved toxicity at last follow-up were 26.9% in the anti-PD-1 group and 12.5% in the TT group. Conclusions: Stage IIIA melanoma has a modest risk of recurrence. Adjuvant anti-PD-1 did not significantly improve RFS or DMFS compared with OBS alone. Adjuvant TT appears promising over anti-PD-1 or OBS. Outcomes after adjuvant therapy in this population needs further study in larger datasets with longer follow-up or prospective randomised trials.

引用

页码：807 / 818

页数：12

共 26 条

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共 26 条

[1] Sequencing of Ipilimumab Plus Nivolumab and Encorafenib Plus Binimetinib for Untreated BRAF-Mutated Metastatic Melanoma (SECOMBIT): A Randomized, Three-Arm, Open-Label Phase II Trial [J].

Ascierto, Paolo A. A. ;

Mandala, Mario ;

Ferrucci, Pier Francesso ;

Guidoboni, Massimo ;

Rutkowski, Piotr ;

Ferraresi, Virginia ;

Arance, Ana ;

Guida, Michele ;

Maiello, Evaristo ;

Gogas, Helen ;

Richtig, Erika ;

Fierro, Maria Teresa ;

Lebbe, Celeste ;

Helgadottir, Hildur ;

Queirolo, Paola ;

Spagnolo, Francesco ;

Tucci, Marco ;

Del Vecchio, Michele ;

Gonzales Cao, Maria ;

Minisini, Alessandro Marco ;

De Placido, Sabino ;

Sanmamed, Miguel F. F. ;

Mallardo, Domenico ;

Curvietto, Marcello ;

Melero, Ignacio ;

Palmieri, Giuseppe ;

Grimaldi, Antonio M. ;

Giannarelli, Diana ;

Dummer, Reinhard ;

Sileni, Vanna Chiarion .

JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 (02) :212-+

[2] Combination Dabrafenib and Trametinib Versus Combination Nivolumab and Ipilimumab for Patients With Advanced BRAF-Mutant Melanoma: The DREAMseq Trial-ECOG-ACRIN EA6134 [J].

Atkins, Michael B. ;

Lee, Sandra J. ;

Chmielowski, Bartosz ;

Tarhini, Ahmad A. ;

Cohen, Gary I. ;

Truong, Thach-Giao ;

Moon, Helen H. ;

Davar, Diwakar ;

O'Rourke, Mark ;

Stephenson, Joseph J. ;

Curti, Brendan D. ;

Urba, Walter J. ;

Brell, Joanna M. ;

Funchain, Pauline ;

Kendra, Kari L. ;

Ikeguchi, Alexandra P. ;

Jaslowski, Anthony ;

Bane, Charles L. ;

Taylor, Mark A. ;

Bajaj, Madhuri ;

Conry, Robert M. ;

Ellis, Robert J. ;

Logan, Theodore F. ;

Laudi, Noel ;

Sosman, Jeffrey A. ;

Crockett, David G. ;

Pecora, Andrew L. ;

Okazaki, Ian J. ;

Reganti, Sowjanya ;

Chandra, Sunandana ;

Guild, Samantha ;

Chen, Helen X. ;

Streicher, Howard Z. ;

Wolchok, Jedd D. ;

Ribas, Antoni ;

Kirkwood, John M. .

JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 (02) :186-+

[3] Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma [J].

Dummer, Reinhard ;

Hauschild, Axel ;

Santinami, Mario ;

Atkinson, Victoria ;

Mandala, Mario ;

Kirkwood, John M. ;

Sileni, Vanna Chiarion ;

Larkin, James ;

Nyakas, Marta ;

Dutriaux, Caroline ;

Haydon, Andrew ;

Robert, Caroline ;

Mortier, Laurent ;

Schachter, Jacob ;

Lesimple, Thierry ;

Plummer, Ruth ;

Dasgupta, Kohinoor ;

Gasal, Eduard ;

Tan, Monique ;

Long, Georgina V. ;

Schadendorf, Dirk .

NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (12) :1139-1148

[4] Seven-year analysis of adjuvant pembrolizumab versus placebo in stage III melanoma in the EORTC1325 / KEYNOTE-054 trial [J].

Eggermont, Alexander M. M. ;

Kicinski, Michal ;

Blank, Christian U. ;

Mandala, Mario ;

V. Long, Georgina ;

Atkinson, Victoria ;

Dalle, Stephane ;

Haydon, Andrew ;

Meshcheryakov, Andrey ;

Khattak, Adnan ;

Carlino, Matteo S. ;

Sandhu, Shahneen ;

Larkin, James ;

Puig, Susana ;

Ascierto, Paolo A. ;

Rutkowski, Piotr ;

Schadendorf, Dirk ;

Boers-Sonderen, Marye ;

Di Giacomo, Anna Maria ;

van den Eertwegh, Alfonsus J. M. ;

Grob, Jean-Jacques ;

Gutzmer, Ralf ;

Jamal, Rahima ;

van Akkooi, Alexander C. J. ;

Lorigan, Paul ;

Grebennik, Dmitri ;

Kreplere, Clemens ;

Marreaud, Sandrine ;

Suciu, Stefan ;

Robert, Caroline .

EUROPEAN JOURNAL OF CANCER, 2024, 211

[5] Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial [J].

Eggermont, Alexander M. M. ;

Blank, Christian U. ;

Mandala, Mario ;

Long, Georgina V. ;

Atkinson, Victoria G. ;

Dalle, Stephane ;

Haydon, Andrew M. ;

Meshcheryakov, Andrey ;

Khattak, Adnan ;

Carlino, Matteo S. ;

Sandhu, Shahneen ;

Larkin, James ;

Puig, Susana ;

Ascierto, Paolo A. ;

Rutkowski, Piotr ;

Schadendorf, Dirk ;

Koornstra, Rutger ;

Hernandez-Aya, Leonel ;

Di Giacomo, Anna Maria ;

van den Eertwegh, Alfonsus J. M. ;

Grob, Jean-Jacques ;

Gutzmer, Ralf ;

Jamal, Rahima ;

Lorigan, Paul C. ;

van Akkooi, Alexander C. J. ;

Krepler, Clemens ;

Ibrahim, Nageatte ;

Marreaud, Sandrine ;

Kicinski, Michal ;

Suciu, Stefan ;

Robert, Caroline .

JOURNAL OF CLINICAL ONCOLOGY, 2020, 38 (33)

[6] Prognostic and predictive value of AJCC-8 staging in the phase III EORTC1325/KEYNOTE-054 trial of pembrolizumab vs placebo in resected high-risk stage III melanoma [J].

Eggermont, Alexander M. M. ;

Blank, Christian U. ;

Mandala, Mario ;

Long, Georgina, V ;

Atkinson, Victoria G. ;

Dalle, Stephane ;

Haydon, Andrew ;

Lichinitser, Mikhail ;

Khattak, Adnan ;

Carlino, Matteo S. ;

Sandhu, Shahneen ;

Larkin, James ;

Puig, Susana ;

Ascierto, Paolo A. ;

Rutkowski, Piotr ;

Schadendorf, Dirk ;

Koornstra, Rutger ;

Hernandez-Aya, Leonel ;

Di Giacomo, Anna Maria ;

van den Eertwegh, Alfonsus J. M. ;

Grob, Jean-Jacques ;

Gutzmer, Ralf ;

Jamal, Rahima ;

Lorigan, Paul C. ;

Lupinacci, Robert ;

Krepler, Clemens ;

Ibrahim, Nageatte ;

Kicinski, Michal ;

Marreaud, Sandrine ;

van Akkooi, Alexander C. ;

Suciu, Stefan ;

Robert, Caroline .

EUROPEAN JOURNAL OF CANCER, 2019, 116 :148-157

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Eggermont, Alexander M. M. ;

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