Neoadjuvant systemic therapy in melanoma: recommendations of the International Neoadjuvant Melanoma Consortium

Rodabe N Amaria; Alexander M Menzies; Elizabeth M Burton; Richard A Scolyer; Michael T Tetzlaff; Robert Antdbacka; Charlotte Ariyan; Roland Bassett; Brett Carter; Adil Daud; Mark Faries; Leslie A Fecher; Keith T Flaherty; Jeffrey E Gershenwald; Omid Hamid; Angela Hong; John M Kirkwood; Serigne Lo; Kim Margolin; Jane Messina; Michael A Postow; Helen Rizos; Merrick I Ross; Elisa A Rozeman; Robyn P M Saw; Vernon Sondak; Ryan J Sullivan; Janis M Taube; John F Thompson; Bart A van de Wiel; Alexander M Eggermont; Michael A Davies; International Neoadjuvant Melanoma Consortium members; Paolo A Ascierto; Andrew J Spillane; Alexander C J van Akkooi; Jennifer A Wargo; Christian U Blank; Hussein A Tawbi; Georgina V Long

doi:10.1016/S1470-2045(19)30332-8

Neoadjuvant systemic therapy in melanoma: recommendations of the International Neoadjuvant Melanoma Consortium

Lancet Oncol. 2019 Jul;20(7):e378-e389. doi: 10.1016/S1470-2045(19)30332-8.

Authors

Rodabe N Amaria¹, Alexander M Menzies², Elizabeth M Burton³, Richard A Scolyer⁴, Michael T Tetzlaff⁵, Robert Antdbacka⁶, Charlotte Ariyan⁷, Roland Bassett⁸, Brett Carter⁹, Adil Daud¹⁰, Mark Faries¹¹, Leslie A Fecher¹², Keith T Flaherty¹³, Jeffrey E Gershenwald³, Omid Hamid¹¹, Angela Hong⁴, John M Kirkwood¹⁴, Serigne Lo¹⁵, Kim Margolin¹⁶, Jane Messina¹⁷, Michael A Postow¹⁸, Helen Rizos¹⁹, Merrick I Ross³, Elisa A Rozeman²⁰, Robyn P M Saw²¹, Vernon Sondak¹⁷, Ryan J Sullivan¹³, Janis M Taube²², John F Thompson²¹, Bart A van de Wiel²³, Alexander M Eggermont²³, Michael A Davies¹; International Neoadjuvant Melanoma Consortium members; Paolo A Ascierto²⁴, Andrew J Spillane²⁵, Alexander C J van Akkooi²⁶, Jennifer A Wargo³, Christian U Blank²⁰, Hussein A Tawbi¹, Georgina V Long²⁷

Collaborators

International Neoadjuvant Melanoma Consortium members:
Miles C Andrews, Donald A Berry, Matthew S Block, Genevieve M Boland, Kathryn B Bollin, Matteo S Carlino, Richard D Carvajal, Jonathan Cohen, Diwakar Davar, Keith A Delman, Reinhard Dummer, Michael D Farwell, David E Fisher, Alberto Fusi, Isabella C Glitza, Tanja D de Gruijl, David E Gyorki, Axel Hauschild, Tina J Hieken, James Larkin, David H Lawson, Celeste Lebbe, Jeffrey E Lee, Michael C Lowe, Jason J Luke, Grant A McArthur, David F McDermott, Jennifer L McQuade, Tara C Mitchell, Teresa M Petrella, Peter A Prieto, Igor Puzanov, Caroline Robert, April K Salama, Shaneen Sandhu, Dirk Schadendorf, Alexander N Shoushtari, Jeffrey A Sosman, Susan M Swetter, Ken K Tanabe, Samra Turajlic, Douglas S Tyler, Scott E Woodman, Frances C Wright, Jonathan S Zager

Affiliations

¹ Department of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
² Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Department of Medical Oncology, Royal North Shore Hospital, Sydney, NSW, Australia; Department of Medical Oncology, Mater Hospital Sydney, Sydney, NSW, Australia.
³ Department of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁴ Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal Prince Alfred Hospital, Sydney, Australia.
⁵ Department of Pathology and Translational and Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁶ Birdie Pharmaceuticals, Iselin, NJ, USA.
⁷ Department of Surgery, Memorial Sloan Kettering Cancer Center, New York City, NY, USA.
⁸ Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁹ Department of Diagnostic Imaging, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁰ University of California San Francisco, San Francisco, CA, USA.
¹¹ The Angeles Clinic and Research Institute, Cedars Sinai Medical Center, Los Angeles, CA, USA.
¹² University of Michigan, Ann Arbor, MI, USA.
¹³ Massachusetts General Hospital Cancer Center, Boston, MA, USA.
¹⁴ University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA.
¹⁵ Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia.
¹⁶ City of Hope, Duarte, CA, USA.
¹⁷ Moffitt Cancer Center, Tampa, FL, USA.
¹⁸ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City, NY, USA; Department of Medicine, Weill Cornell Medical College, New York City, NY, USA.
¹⁹ Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Macquarie University, Sydney, Australia.
²⁰ Department of Medical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.
²¹ Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Department of Melanoma Surgery, Mater Hospital Sydney, Sydney, NSW, Australia; Royal Prince Alfred Hospital, Sydney, Australia.
²² Johns Hopkins Hospital, Baltimore, MD, USA.
²³ Department of Pathology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.
²⁴ Experimental Medical Oncology for Melanoma, Cancer Immunotherapy and Development Therapeutics-Istituto Nazionale Tumouri IRCCS Fondazione Pascale, Napoli, Italy.
²⁵ Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Department of Surgical Oncology, Royal North Shore Hospital, Sydney, NSW, Australia; Department of Melanoma Surgery, Mater Hospital Sydney, Sydney, NSW, Australia.
²⁶ Department of Surgical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.
²⁷ Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Department of Medical Oncology, Royal North Shore Hospital, Sydney, NSW, Australia; Department of Medical Oncology, Mater Hospital Sydney, Sydney, NSW, Australia. Electronic address: georgina.long@sydney.edu.au.

PMID: 31267972
DOI: 10.1016/S1470-2045(19)30332-8

Abstract

Advances in the treatment of metastatic melanoma have improved responses and survival. However, many patients continue to experience resistance or toxicity to treatment, highlighting a crucial need to identify biomarkers and understand mechanisms of response and toxicity. Neoadjuvant therapy for regional metastases might improve operability and clinical outcomes over upfront surgery and adjuvant therapy, and has become an established role for drug development and biomarker discovery in other cancers (including locally advanced breast cancer, head and neck squamous cell carcinomas, gastroesophageal cancer, and anal cancer). Patients with clinically detectable stage III melanoma are ideal candidates for neoadjuvant therapy, because they represent a high-risk patient population with poor outcomes when treated with upfront surgery alone. Neoadjuvant therapy is now an active area of research for melanoma with numerous completed and ongoing trials (since 2014) with disparate designs, endpoints, and analyses under investigation. We have, therefore, established the International Neoadjuvant Melanoma Consortium with experts in medical oncology, surgical oncology, pathology, radiation oncology, radiology, and translational research to develop recommendations for investigating neoadjuvant therapy in melanoma to align future trial designs and correlative analyses. Alignment and consistency of neoadjuvant trials will facilitate optimal data organisation for future regulatory review and strengthen translational research across the melanoma disease continuum.

Publication types

Practice Guideline
Review

MeSH terms

Clinical Trials as Topic
Humans
Melanoma / secondary
Melanoma / therapy*
Neoadjuvant Therapy*
Patient Selection