Difference between revisions of "Malignant solid neoplasm, ERBB3-mutated"
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''Note: the cycle length is not described in the manuscript; the authors have clarified that the cycles are 28 days in length. This trial should not be confused with the one by the same name in multiple myeloma.'' | ''Note: the cycle length is not described in the manuscript; the authors have clarified that the cycles are 28 days in length. This trial should not be confused with the one by the same name in multiple myeloma.'' | ||
− | ==== | + | ====Biomarker eligibility criteria==== |
− | * | + | *Gene: HER3 |
+ | *Alteration: various [[Biomarkers#Substitution|substitutions]] | ||
+ | *Acceptable methods of measurement: next-generation sequencing assay or RT-PCR, Sanger, pyrosequencing, or mass spectrometry-based sequencing methods | ||
+ | |||
+ | ====Preceding treatment==== | ||
+ | * No prior treatment with HER kinase inhibitors | ||
+ | |||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Neratinib (Nerlynx)]] 240 mg PO once per day | *[[Neratinib (Nerlynx)]] 240 mg PO once per day |
Revision as of 23:58, 8 January 2020
1 regimens on this page
1 variants on this page
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Note: this is a new type of page for HemOnc.org, as most other regimen pages are tissue-specific. We will collect published information from basket trials on these pages, as well as regimens that are FDA approved.
All lines of therapy
Neratinib monotherapy
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Regimen
Study | Evidence |
---|---|
Hyman et al. 2018 (SUMMITHER) | Non-randomized basket trial, <20 pts in this subgroup |
Note: the cycle length is not described in the manuscript; the authors have clarified that the cycles are 28 days in length. This trial should not be confused with the one by the same name in multiple myeloma.
Biomarker eligibility criteria
- Gene: HER3
- Alteration: various substitutions
- Acceptable methods of measurement: next-generation sequencing assay or RT-PCR, Sanger, pyrosequencing, or mass spectrometry-based sequencing methods
Preceding treatment
- No prior treatment with HER kinase inhibitors
Chemotherapy
- Neratinib (Nerlynx) 240 mg PO once per day
Supportive medications
- Loperamide (Imodium) (dose not specified) mandatory during cycle 1
28-day cycles
References
- SUMMIT: Hyman DM, Piha-Paul SA, Won H, Rodon J, Saura C, Shapiro GI, Juric D, Quinn DI, Moreno V, Doger B, Mayer IA, Boni V, Calvo E, Loi S, Lockhart AC, Erinjeri JP, Scaltriti M, Ulaner GA, Patel J, Tang J, Beer H, Selcuklu SD, Hanrahan AJ, Bouvier N, Melcer M, Murali R, Schram AM, Smyth LM, Jhaveri K, Li BT, Drilon A, Harding JJ, Iyer G, Taylor BS, Berger MF, Cutler RE Jr, Xu F, Butturini A, Eli LD, Mann G, Farrell C, Lalani AS, Bryce RP, Arteaga CL, Meric-Bernstam F, Baselga J, Solit DB. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature. 2018 Feb 8;554(7691):189-194. Epub 2018 Jan 31. link to original article contains verified protocol link to PMC article PubMed