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1 regimens on this page 1 variants on this page

All lines of therapy

Neratinib monotherapy

Regimen

Study	Evidence
Hyman et al. 2018 (SUMMIT_HER)	Non-randomized basket trial, fewer than 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

Prior treatment criteria

No prior treatment with HER kinase inhibitors

Targeted therapy

Neratinib (Nerlynx) 240 mg PO once per day on days 1 to 28

Supportive therapy

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 dosing details in manuscript link to PMC article PubMed NCT01953926

@@ Line 12: / Line 12: @@
 =All lines of therapy=
 ==Neratinib monotherapy {{#subobject:3c1a9c|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen {{#subobject:d9f619|Variant=1}}===
 {| class="wikitable" style="width: 40%; text-align:center;"
@@ Line 19: / Line 19: @@
 |-
 |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808581/ Hyman et al. 2018 (SUMMIT<sub>HER</sub>)]
-|style="background-color:#ffffbe"|Non-randomized basket trial, <20 pts in this subgroup
+|style="background-color:#ffffbe"|Non-randomized basket trial, fewer than 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.''
+<div class="toccolours" style="background-color:#fdcdac">
 ====Biomarker eligibility criteria====
 *Gene: HER3
@@ Line 28: / Line 29: @@
 *Acceptable methods of measurement: next-generation sequencing assay or RT-PCR, Sanger, pyrosequencing, or mass spectrometry-based sequencing methods
-====Preceding treatment====
+====Prior treatment criteria====
 * No prior treatment with HER kinase inhibitors
+</div>
+<div class="toccolours" style="background-color:#b3e2cd">
+====Targeted therapy====
+*[[Neratinib (Nerlynx)]] 240 mg PO once per day on days 1 to 28
-====Targeted therapy====
+====Supportive therapy====
-*[[Neratinib (Nerlynx)]] 240 mg PO once per day
-====Supportive medications====
 *[[Loperamide (Imodium)]] (dose not specified) mandatory during cycle 1
 '''28-day cycles'''
+</div></div>
 ===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. [https://www.nature.com/articles/nature25475 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808581/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29420467 PubMed]
+# '''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. [https://www.nature.com/articles/nature25475 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808581/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29420467/ PubMed] [https://clinicaltrials.gov/study/NCT01953926 NCT01953926]
-[[Category:ERBB3 (HER3) regimens]]
+[[Category:Malignant solid neoplasm, ERBB3-mutated regimens]]
 [[Category:Biomarker-specific pages]]
 [[Category:Malignant solid neoplasm]]
-[[Category:Site-agnostic regimens]]

Difference between revisions of "Malignant solid neoplasm, ERBB3-mutated"