Melanoma, KIT-mutated

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	Ryan Nguyen, DO University of Illinois at Chicago Chicago, IL, USA LinkedIn		Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA, USA LinkedIn

Note: these are regimens tested in biomarker-specific populations, please see the main melanoma page for other regimens.

1 regimens on this page 2 variants on this page

Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

NCCN

• NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Melanoma: Cutaneous.

Advanced or metastatic disease, TKI-naive

Imatinib monotherapy

Regimen variant #1, pre-planned escalation

Study	Dates of enrollment	Evidence
Hodi et al. 2013 (BUS255)	2006-2011	Phase 2

Note: upon progression, the dose of imatinib was escalated; see below.

Biomarker eligibility criteria

• Gene: KIT
• Alteration: amplification and mutation
• Acceptable methods of measurement: PCR or HPLC

Targeted therapy

• Imatinib (Gleevec) 400 mg PO once per day

Continued indefinitely (see note)

Regimen variant #2

Study	Dates of enrollment	Evidence
Carvajal et al. 2011 (MSKCC 07-014)	2007-2010	Phase 2

Patients had melanomas arising from mucosal, acral, and chronically sun-damaged skin with KIT mutations or amplifications.

Biomarker eligibility criteria

• Gene: KIT
• Alteration: amplification or mutation

Targeted therapy

• Imatinib (Gleevec) 400 mg PO once or twice per day

Continued indefinitely

References

1. MSKCC 07-014: Carvajal RD, Antonescu CR, Wolchok JD, Chapman PB, Roman RA, Teitcher J, Panageas KS, Busam KJ, Chmielowski B, Lutzky J, Pavlick AC, Fusco A, Cane L, Takebe N, Vemula S, Bouvier N, Bastian BC, Schwartz GK. KIT as a therapeutic target in metastatic melanoma. JAMA. 2011 Jun 8;305(22):2327-34. link to original article contains dosing details in abstract link to PMC article PubMed NCT00470470

Advanced or metastatic disease, TKI-exposed

Imatinib monotherapy

Regimen variant #1, pre-planned escalation

Study	Dates of enrollment	Evidence
Hodi et al. 2013 (BUS255)	2006-2011	Phase 2

Biomarker eligibility criteria

• Gene: KIT
• Alteration: amplification and mutation
• Acceptable methods of measurement: PCR or HPLC

Prior treatment criteria

• Imatinib 400 mg/day, with progression

Targeted therapy

• Imatinib (Gleevec) 400 mg PO twice per day

Continued indefinitely

References

1. BUS255: Hodi FS, Corless CL, Giobbie-Hurder A, Fletcher JA, Zhu M, Marino-Enriquez A, Friedlander P, Gonzalez R, Weber JS, Gajewski TF, O'Day SJ, Kim KB, Lawrence D, Flaherty KT, Luke JJ, Collichio FA, Ernstoff MS, Heinrich MC, Beadling C, Zukotynski KA, Yap JT, Van den Abbeele AD, Demetri GD, Fisher DE. Imatinib for Melanomas Harboring Mutationally Activated or Amplified KIT Arising on Mucosal, Acral, and Chronically Sun-Damaged Skin. J Clin Oncol. 2013 Sep 10;31(26):3182-90. Epub 2013 Jun 17. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00424515