Adjuvant treatment for melanoma in clinical practice - Trial versus reality

被引：21

作者：

de Meza, Melissa M. ^{[1
,2
,3
]}

Ismail, Rawa K. ^{[3
,4
]}

Rauwerdink, Daan ^{[5
]}

van Not, Olivier J. ^{[3
,6
]}

van Breeschoten, Jesper ^{[3
,7
]}

Blokx, Willeke A. M. ^{[8
]}

de Boer, Anthonius ^{[4
,9
]}

van Dartel, Maaike ^{[9
]}

Hilarius, Doranne L. ^{[10
]}

Ellebaek, Eva ^{[11
]}

Bonenkamp, Han J. ^{[12
]}

Blank, Christian U. ^{[13
]}

Aarts, Maureen J. B. ^{[14
]}

van Akkooi, Alexander C. J. ^{[4
]}

van den Berkmortel, Franchette W. P. J. ^{[15
]}

Boers-Sonderen, Marye J. ^{[16
]}

de Groot, Jan Willem B. ^{[17
]}

Haanen, John B. ^{[13
]}

Hospers, Geke A. P. ^{[18
]}

Kapiteijn, Ellen W. ^{[19
]}

Piersma, Djura ^{[20
]}

van Rijn, Roos S. ^{[21
]}

van der Veldt, Astrid A. M. ^{[22
,23
]}

Vreugdenhil, Art ^{[24
]}

Westgeest, Hans M. ^{[25
]}

van den Eertwegh, Alfons J. M. ^{[7
]}

Suijkerbuijk, Karijn P. M. ^{[6
]}

Wouters, Michel W. J. M. ^{[1
,2
,3
]}

机构：

[1] Leiden Univ, Dept Biomed Data Sci, Med Ctr, Albinusdreef 2, NL-2333 ZA Leiden, Netherlands

[2] Netherlands Canc Inst, Dept Surg Oncol, Plesmanlaan 121, NL-1066 CX Amsterdam, Netherlands

[3] Dutch Inst Clin Auditing, Sci Bur, Rijnsburgerweg 10, NL-2333 AA Leiden, Netherlands

[4] Utrecht Inst Pharmaceut Sci, Div Pharmacoepidemiol & Clin Pharmacol, Heidelberglaan 8, NL-3584 CS Utrecht, Netherlands

[5] Leiden Univ, Dept Surg, Med Ctr, Albinusdreef 2, NL-2333 ZA Leiden, Netherlands

[6] Univ Med Ctr Utrecht, Dept Med Oncol, Heidelberglaan 100, NL-3584 CX Utrecht, Netherlands

[7] Vrije Univ Amsterdam Med Ctr, Dept Med Oncol, Amsterdam UMC, Canc Ctr Amsterdam, De Boelelaan 1118, NL-1081 HZ Amsterdam, Netherlands

[8] Univ Med Ctr Utrecht, Dept Pathol, Heidelberglaan 100, NL-3584 CX Utrecht, Netherlands

[9] Med Evaluat Board, Graadt van Roggenweg 500, NL-3531 AH Utrecht, Netherlands

[10] Rode Kruis Ziekenhuis, Dept Pharm, Vondellaan 13, NL-1942 LE Beverwijk, Netherlands

[11] Copenhagen Univ Hosp, Natl Ctr Canc Immune Therapy, Dept Oncol, Borgmester Ib Juuls Vej 1, DK-2730 Herlev, Denmark

[12] Radboud Univ Nijmegen Med Ctr, Dept Surg, Geert Grootepl Zuid 10, NL-6525 GA Nijmegen, Netherlands

[13] Netherlands Canc Inst, Dept Med Oncol & Immunol, Plesmanlaan 121, NL-1066 CX Amsterdam, Netherlands

[14] Maastricht Univ, Dept Med Oncol, Med Ctr, P Debyelaan 25, NL-6229 HX Maastricht, Netherlands

[15] Zuyderland Med Ctr Sittard, Dept Med Oncol, Dr H Van der Hoffpl 1, NL-6162 BG Sittard Geleen, Netherlands

[16] Radboud Univ Nijmegen Med Ctr, Dept Med Oncol, Geert Grootepl Zuid 10, NL-6525 GA Nijmegen, Netherlands

[17] Isala Oncol Ctr, Dokter van Heesweg 2, NL-8025 AB Zwolle, Netherlands

[18] Univ Groningen, Univ Med Ctr Groningen, Dept Med Oncol, Hanzepl 1, NL-9713 GZ Groningen, Netherlands

[19] Leiden Univ, Dept Med Oncol, Med Ctr, Albinusdreef 2, NL-2333 ZA Leiden, Netherlands

[20] Med Spectrum Twente, Dept Internal Med, Koningspl 1, NL-7512 KZ Enschede, Netherlands

[21] Med Ctr Leeuwarden, Dept Internal Med, Henri Dunantweg 2, NL-8934 AD Leeuwarden, Netherlands

[22] Erasmus MC, Dept Med Oncol, S Gravendijkwal 230, NL-3015 CE Rotterdam, Netherlands

[23] Erasmus MC, Dept Radiol & Nucl Med, S Gravendijkwal 230, NL-3015 CE Rotterdam, Netherlands

[24] Maxima Med Ctr, Dept Internal Med, De Run 4600, NL-5504 DB Eindhoven, Netherlands

[25] Amphia Hosp, Dept Internal Med, Molengracht 21, NL-4818 CK Breda, Netherlands

来源：

EUROPEAN JOURNAL OF CANCER | 2021年 / 158卷

关键词：

Melanoma; Immune checkpoint inhibitors; Immunotherapy; Nivolumab; Pembrolizumab; Survival rate; Skin neoplasms; Data management; Registries; Quality of health care; METASTATIC MELANOMA; STAGE-III; IPILIMUMAB; NIVOLUMAB;

D O I：

10.1016/j.ejca.2021.08.044

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Little is known about outcomes of adjuvant-treated melanoma patients beyond the clinical trial setting. Since 2019, adjuvant-treated melanoma patients have been registered in the DMTR, a population-based registry to monitor the quality and safety of melanoma care in the Netherlands. This study aims to describe treatment patterns, relapse, and toxicity rates of adjuvant-treated melanoma patients beyond the clinical trial setting. Methods: Analyses were performed on adjuvant-treated melanoma patients included in the DMTR. Descriptive statistics were used to analyse patient-, and treatment characteristics. A baseline registration completeness analysis was performed, and an analysis on trial eligibility in clinical practice patients. Recurrence-free survival (RFS) at 12-months was estimated with the Kaplan-Meier method. Results: A total of 641 patients were treated with adjuvant anti-PD-1 therapy. RFS at 12-months was 70.6% (95% CI, 66.9-74.6) with a median follow-up of 12.8 months. Sex, stage of disease and Breslow thickness were associated with a higher hazard for RFS. Eighteen per cent of the anti-PD-1-treated patients developed grade >= 3 toxicity. Sixty-one per cent of patients prematurely discontinued anti-PD-1 therapy. Conclusion: Adjuvant anti-PD-1 treatment of resected stage III/IV melanoma in daily practice showed slightly higher toxicity rates and more frequent premature discontinuation but similar RFS rates compared to trials. (C) 2021 The Authors. Published by Elsevier Ltd.

引用

页码：234 / 245

页数：12

共 34 条

[1] [Anonymous], 2014, ColorBrewer Palettes
[2] Arnold Jeffrey B, 2024, CRAN
[3] Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial
Ascierto, Paolo A.
Del Vecchio, Michele
Mandala, Mario
Gogas, Helen
Arance, Ana M.
Dalle, Stephane
Cowey, C. Lance
Schenker, Michael
Grob, Jean-Jacques
Chiarion-Sileni, Vanna
Marquez-Rodas, Ivan
Butler, Marcus O.
Maio, Michele
Middleton, Mark R.
de la Cruz-Merino, Luis
Arenberger, Petr
Atkinson, Victoria
Hill, Andrew
Fecher, Leslie A.
Millward, Michael
Khushalani, Nikhil, I
Queirolo, Paola
Lobo, Maurice
de Pril, Veerle
Loffredo, John
Larkin, James
Weber, Jeffrey
[J]. LANCET ONCOLOGY, 2020, 21 (11) : 1465 - 1477
[4] Final Version of 2009 AJCC Melanoma Staging and Classification
Balch, Charles M.
Gershenwald, Jeffrey E.
Soong, Seng-jaw
Thompson, John F.
Atkins, Michael B.
Byrd, David R.
Buzaid, Antonio C.
Cochran, Alistair J.
Coit, Daniel G.
Ding, Shouluan
Eggermont, Alexander M.
Flaherty, Keith T.
Gimotty, Phyllis A.
Kirkwood, John M.
McMasters, Kelly M.
Mihm, Martin C., Jr.
Morton, Donald L.
Ross, Merrick I.
Sober, Arthur J.
Sondak, Vernon K.
[J]. JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (36) : 6199 - 6206
[5] The Dutch Institute for Clinical Auditing Achieving Codman's Dream on a Nationwide Basis
Beck, Naomi
van Bommel, Annelotte C.
Eddes, Eric H.
van Leersum, Nicoline J.
Tollenaar, Rob A.
Wouters, Michel W.
[J]. ANNALS OF SURGERY, 2020, 271 (04) : 627 - 631
[6] BOM C, 2018, MED ONCOL, P53
[7] BOM C, 2018, MED ONCOL, P47
[8] 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
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
[J]. EUROPEAN JOURNAL OF CANCER, 2019, 116 : 148 - 157
[9] Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma
Eggermont, Alexander M. M.
Blank, Christian U.
Mandala, Mario
Long, Georgina, V
Atkinson, Victoria
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
Maio, Michele
van den Eertwegh, Alfonsus J. M.
Grob, Jean-Jacques
Gutzmer, Ralf
Jamal, Rahima
Lorigan, Paul
Ibrahim, Nageatte
Marreaud, Sandrine
van Akkooi, Alexander C. J.
Suciu, Stefan
Robert, Caroline
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 2018, 378 (19) : 1789 - 1801
[10] The Danish metastatic melanoma database (DAMMED): A nation-wide platform for quality assurance and research in real-world data on medical therapy in Danish melanoma patients
Ellebaek, Eva
Svane, Inge Marie
Schmidt, Henrik
Haslund, Charlotte Aaquist
Donia, Marco
Hoejberg, Lise
Ruhlmann, Christina
Guldbrandt, Louise Mahncke
Kohler, Ulrich Heide
Bastholt, Lars
[J]. CANCER EPIDEMIOLOGY, 2021, 73

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