Adjuvant vemurafenib in resected, BRAFV600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial

Goodman, Grant R.; Simmons, Brian; Ye, Chenglin; Yan, Yibing; Cinat, Gabriela; Fein, Luis; Brown, Michael P.; Guminski, Alexander; Haydon, Andrew; Khattak, Adnan; McNeil, Catriona M.; Parente, Phillip; Power, Jeremy; Roberts‐Thomson, Rachel; Sandhu, Shahneen; Underhill, Craig; Varma, Suresh; Berger, Thomas G.; Awada, Ahmad; Blockx, Nathalie; Buyse, Véronique; Mebis, Jeroen; Franke, Fábio; Azevedo, Sérgio Jobim; Lazaretti, Nicolas; Jamal, Rahima; Mihalcioiu, Catalin; Petrella, Teresa M.; Savage, Kerry J.; Song, Xinni; Wong, Ralph; Dabelić, Nina; Pleština, Stjepko; Vojnović, Željko; Arenberger, Petr; Kocák, Ivo; Krajsová, Ivana; Kubala, E; Melichar, Bohuslav; Vantuchová, Yvetta; Putnik, Kadri; Dréno, Brigitte; Dutriaux, Caroline; Grob, Jean‐Jacques; Joly, P.; Lacour, Jean‐Philippe; Meyer, Nicolas; Mortier, Laurent; Thomas, Luc; Fluck, Michael; Gambichler, Thilo; Hassel, Jessica C.; Hauschild, Axel; Schadendorf, Dirk; Donnellan, Paul; McCaffrey, John; Power, Derek G.; Ariad, Samuel; Bar-Sela, Gil; Hendler, Daniel; Ron, Ilan G.; Schachter, Jacob; Ascierto, Paolo A.; Berruti, Alfredo; Bianchi, Luca; Chiarion-Sileni, Vanna; Cognetti, Francesco; Danielli, Riccardo; Giacomo, Anna Maria Di; Gianni, Luca; Goldhirsch, Aron; Guida, Michele; Maio, Michele; Mandalà, Mario; Marchetti, Paolo; Queirolo, Paola; Santoro, Armando; Kapiteijn, Ellen; Maćkiewicz, Andrzej; Rutkowski, Piotr; Ferreira, P.; Демидов, Лев В.; Gafton, G I; Makarova, Yulia; Andrić, Zoran; Babović, Nada; Jovanović, Đorđe; Kandolf-Sekulovic, Lidija; Cohen, G.; Dreosti, Lydia; Vorobiof, Daniel; García, María Teresa Curiel; Beveridge, Roberto Díaz; Tarruella, M. Majem; Rodas, Iván Márquez; Rodriguez, Jose-M Puliats; Domı́nguez, A.; Maroti, Marianne; Papworth, Karin; Michielin, Olivier; Bondarenko, Igor; Brown, Ewan; Corrie, Pippa; Harries, Mark; Herbert, Christopher; Kumar, Satish; Martín-Clavijo, Agustín; Middleton, Mark R.; Patel, Poulam M.; Talbot, Toby; Agarwala, Sanjiv S.; Chapman, Paul B.; Conry, Robert M.; Doolittle, Gary C.; Gangadhar, Tara C.; Hallmeyer, Sigrun; Hamid, Omid; Hernandez‐Aya, Leonel F.; Johnson, Douglas B.; Kass, Frederic; Kolevska, Tatjana; Lewis, Karl D.; Lunin, Scott D.; Salama, April K.S.; Šikić, Branimir I.; Somer, Bradley G.; Spigel, David R.; Whitman, Eric D.

doi:10.1016/s1470-2045(18)30106-2

Cited by 182 publications

(154 citation statements)

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“…National guidelines do not currently recommend intensive surveillance and adjuvant therapy for stage I-IIA disease [139]. Additional strategies for prognostication in this early-stage CM cohort, particularly those with biological propensity to metastasise and who might benefit from modern survival-prolonging adjuvant therapies [140][141][142], would clearly be beneficial. However it seems clear that while there is tremendous enthusiasm to integrate molecular biomarkers into clinical practice, no such markers or signatures fulfil the necessary criteria for inclusion into the AJCC melanoma staging or as a component of any validated clinical tool [136].…”

Section: Resultsmentioning

confidence: 99%

Melanoma subtypes: genomic profiles, prognostic molecular markers and therapeutic possibilities

Rabbie

Ferguson

Molina‐Aguilar

et al. 2019

The Journal of Pathology

172

205

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Melanoma is characterised by its ability to metastasise at early stages of tumour development. Current clinico‐pathologic staging based on the American Joint Committee on Cancer criteria is used to guide surveillance and management in early‐stage disease, but its ability to predict clinical outcome has limitations. Herein we review the genomics of melanoma subtypes including cutaneous, acral, uveal and mucosal, with a focus on the prognostic and predictive significance of key molecular aberrations. © 2018 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of Pathological Society of Great Britain and Ireland.

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Section: Resultsmentioning

confidence: 99%

Melanoma subtypes: genomic profiles, prognostic molecular markers and therapeutic possibilities

Rabbie

Ferguson

Molina‐Aguilar

et al. 2019

The Journal of Pathology

172

205

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“…The BRIM8 study analysed vemurafenib monotherapy versus a placebo in stage IIC and stage III (AJCC seventh edition [43]) melanoma after complete surgical resection. The study did not meet its primary end point of DFS [71]. Therefore, BRAF inhibitor (BRAFi) monotherapy cannot be recommended as adjuvant treatment for melanoma.…”

Section: Special Articlementioning

confidence: 96%

Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Michielin¹,

et al. 2019

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“…The BRIM8 trial was the only randomized, doubleblind, placebo-controlled trial comparing BRAF inhibitor monotherapy (with vemurafenib) with placebo in 498 patients with stage IIC to IIIC melanoma [5].…”

Section: Adjuvant Targeted Therapymentioning

confidence: 99%

Adjuvant and neoadjuvant treatment of melanoma

Koelblinger

2020

memo

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For years, interferon alpha was the sole option in the adjuvant treatment of patients with completely resected melanoma with lymph node metastases and a high risk of disease recurrence, albeit being associated with a relatively low efficacy combined with significant toxicities. After the advent of immunotherapy and targeted therapy in locally advanced or metastatic melanoma at the beginning of the last decade, these therapeutic approaches have meanwhile also shown superior efficacy compared to previously used treatments or observation in the context of adjuvant therapy. Hence, adjuvant targeted or anti-PD1-antibody-based immunotherapy was incorporated into routine clinical practice to reduce the risk of tumor recurrence in affected patients in early 2018. Moreover, modern melanoma therapies are increasingly being investigated in a neoadjuvant setting in analogy to other solid malignancies. Considering the promising results reported so far, neoadjuvant immunotherapy might potentially become the treatment of choice in high-risk melanoma patients with macrometastatic disease in the near future.

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Adjuvant vemurafenib in resected, BRAFV600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial

Cited by 182 publications

References 20 publications

Melanoma subtypes: genomic profiles, prognostic molecular markers and therapeutic possibilities

Melanoma subtypes: genomic profiles, prognostic molecular markers and therapeutic possibilities

Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Adjuvant and neoadjuvant treatment of melanoma

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