Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial

Bottomley, Andrew; Coens, Corneel; Mierzynska, Justyna; Blank, Christian U.; Mandalà, Mario; Long, Georgina V.; Atkinson, Victoria; Dalle, Stéphane; Haydon, Andrew; Meshcheryakov, Andrey; Khattak, Adnan; Carlino, Matteo S.; Sandhu, Shahneen; Puig, Susana; Ascierto, Paolo A.; Larkin, James; Lorigan, Paul; Rutkowski, Piotr; Schadendorf, Dirk; Koornstra, Rutger H.T.; Hernandez‐Aya, Leonel F.; Giacomo, Anna Maria Di; Eertwegh, A.J.M. van den; Grob, Jean‐Jacques; Gutzmer, Ralf; Jamal, Rahima; Akkooi, A.C.J. van; Krepler, Clemens; Ibrahim, Nageatte; Marréaud, Sandrine; Kiciński, Michal; Suciu, Stefan; Robert, Caroline; Eggermont, Alexander; Lesimple, Thierry; Maio, Michele; Linette, Gerald P.; Mortier, Laurent; Svane, Inge Marie; Schachter, Jacob; Brown, Michael P.; Hersey, Peter; Barrow, Catherine; Kudchadkar, Ragini R.; Dutriaux, Caroline; Song, Xinni; Quaglino, Pietro; Queirolo, Paola; Meier, Friedegund; Stroyakovskiy, Daniil; Guillot, B.; Romero, Pablo Luis Ortiz; Bastholt, Lars; Garbe, Claus; Grange, Florent; Mohr, Peter; Algazi, Alain P.; Bechter, Oliver; Hernberg, Micaela; Loquai, Carmen; Meiß, Frank; Sileni, V. Chiarion; Bar‐Sela, Gil; Fitzharris, B.; Saïag, Philippe; Arnault, Jean‐Philippe; Simon, Jan‐Christoph; Stephens, Rosalie; Baurain, Jean‐François; Lebbe, Célèste; Combemale, P.; Dummer, Reinhard; Hauschild, Axel; Parente, Phillip; Yamazaki, Naoya; Milhem, Mohammed; Leccia, M.-T.; Geoffrois, L.; Kretschmer, Lutz; Dunwoodie, Elaine; Walker, John; Lotem, Michal; Hendler, Daniel; Maćkiewicz, Andrzej; Sekulović, Lidija Kandolf; Dzienis, Marcin; Hospers, Geke A.P.; Siano, Marco; Hassel, Jessica C.; Corrie, Pippa; Passos, Maria-Jose; Levin, Max; Höeller, Christoph; Machet, L.; Hallmeyer, Sigrun; Waterston, Ashita; Descamps, V.; Kiecker, Felix; Aarts, Maureen J.B.; Schmidt, Henrik; Raimundo, Ana; Nyakas, Marta; Lacour, Jean‐Philippe; Berking, Carola; Ferrucci, Pier Francesco; Jameson, Michael B.; Kim, Kevin; Yokota, Kenji; Kerger, Joseph; Aubin, F.; Groenewegen, Gerard; Kapiteijn, H.W.; Boehncke, Wolf‐Henning; Utikal, Jochen; Casasola, Richard; Marshall, Ernest; Ferraresi, Virginia; Richtig, Erika; Matković, Suzana; Inozume, Takashi; Crook, Timothy; McNeil, Catriona M.; Kiyohara, Yoshio; Avril, Marie-Françoise; Hein, Rüdiger; Terheyden, Patrick; Nathan, Paul; Aoi, Jun; Skyttä, Tanja; Jouary, Thomas; Takenouchi, Tatsuya; Straume, Oddbjørn; Martins, César; Mukhametshina, Guzel

doi:10.1016/s1470-2045(21)00081-4

Cited by 46 publications

(22 citation statements)

References 29 publications

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“…Pembrolizumab is an anti-PD-1 molecule currently approved for the management of patients with metastatic or unresectable melanoma and for the adjuvant treatment of patients with melanoma and with lymph node involvement at a dosage of 200 mg every three week (Q3W) or 400 mg Q6W [ 10 ]. Several clinical trials have shown its efficacy and safety in the treatment of metastatic or unresectable melanoma and as adjuvant therapy [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ]. The effectiveness of pembrolizumab was firstly reported in a randomized (1:1:1), open-label, multicenter, controlled trial (KEYNOTE-006) [ 10 , 15 , 16 , 17 ].…”

Section: Resultsmentioning

confidence: 99%

“…A multicenter, randomized (1:1), double-blind, placebo-controlled trial (KEYNOTE-054) investigated the efficacy of pembrolizumab as adjuvant treatment of resected melanoma (stage IIIA-IIIB-IIIC) [ 10 , 19 , 20 , 21 ]. Recurrence-free survival (RFS), defined as the time between the randomization date and the date of first recurrence or death, was evaluated as the main effectiveness outcome.…”

Section: Resultsmentioning

confidence: 99%

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The Treatment of Advanced Melanoma: Therapeutic Update

Villani

Potestio

Fabbrocini

et al. 2022

IJMS

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Cutaneous melanoma is the main cause of death for skin cancer. The majority of patients with a diagnosis of melanoma have localized disease, which can be successfully treated with surgical treatment. However, the surgical approach is not curative for advanced melanoma (AM). Indeed, the management of AM is still challenging, since melanoma is the solid tumor with the highest number of mutations and cancer cells have the capacity to evade the immune system. In the past, the treatment of AM relied on chemotherapeutic agents, without showing efficacy data. Recent knowledge on melanoma pathogenesis as well as the introduction of immunotherapies, targeted therapies vaccines, small molecules, and combination therapies has revolutionized AM management, showing promising results in terms of effectiveness and safety. The aim of this review is to assess and to discuss the role of emerging therapies for AM management in order to obtain a complete overview of the currently available treatment options and future perspectives.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

The Treatment of Advanced Melanoma: Therapeutic Update

Villani

Potestio

Fabbrocini

et al. 2022

IJMS

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“…Much of what we have learned about AYAs to date has been extrapolated from research on childhood and older adult cancer patient populations in disease-but not age-specific cohorts, e.g., breast cancer and Hodgkin's [16,[34][35][36]. However, there is still a dearth of literature on (long-term) adverse health outcomes in AYAs treated for other early-onset adult cancers, such as colorectal cancer, and AYA cancers, such as melanoma [37][38][39][40][41]. We summarize the most important literature according to the biopsychosocial model, which provides a comprehensive framework for the physical, psychological, and social issues caused by cancer (treatment) and the interactions between different issues.…”

Section: What Do We Know About Long-term and Late Effects Among Aya Cancer Survivors?mentioning

confidence: 99%

Adolescent and Young Adult (AYA) Cancer Survivorship Practices: An Overview

Janssen

Graaf

Meer

et al. 2021

Cancers

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Worldwide, more than 1.2 million adolescents and young adults (AYAs; those aged 15–39 years) are diagnosed with cancer each year. Although considerable variability exists according to cancer site and stage of disease, the 5-year relative survival at the time of diagnosis has been estimated at >80% for all AYA patients with cancer combined. Extensive survivorship research in recent decades has focused on patients diagnosed with cancer as children (<15 years) and older adults (>39 years), yet few studies to date have reported outcomes specifically for patients diagnosed as AYAs. With increasing incidence and improving survival for many tumor types, leading to the majority of AYA patients with cancer becoming long-term survivors, there is a critical need for research efforts to inform the survivorship care of this growing population. This article describes the population of AYA cancer survivors according to their epidemiology and late and long-term effects, the challenges and models of AYA survivorship care, as well as future opportunities for research and healthcare.

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“…Two of the included studies were qualitative in study design, [31,32] while the others had quantitative outcomes. The latter included four RCTs [24][25][26][27] and three cross-sectional descriptive studies. [28][29][30] In four of the included studies, [28,29,31,32] the re-entry phase was not differentiated from early survivorship.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Finally, nine studies were included for analysis. [24][25][26][27][28][29][30][31][32] The results of the critical appraisal can be found in Appendix 3 (http://links.lww.com/OR9/A38). According to the Mixed Methods Appraisal Tool, the qualitative studies met all five core quality criteria.…”

Section: Study Characteristicsmentioning

confidence: 99%