Difference between revisions of "Malignant solid neoplasm, ERBB2-mutated"
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=All lines of therapy= | =All lines of therapy= | ||
==Neratinib monotherapy {{#subobject:3c1a9c|Regimen=1}}== | ==Neratinib monotherapy {{#subobject:3c1a9c|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:d9f619|Variant=1}}=== | ===Regimen {{#subobject:d9f619|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
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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.'' | ||
| + | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*Gene: HER2 | *Gene: HER2 | ||
*Alteration: various [[Biomarkers#Substitution|substitutions]], [[Biomarkers#Insertion|insertions]], [[Biomarkers#Frameshift|frameshifts]], or [[Biomarkers#Structural variant|structural variants]] | *Alteration: various [[Biomarkers#Substitution|substitutions]], [[Biomarkers#Insertion|insertions]], [[Biomarkers#Frameshift|frameshifts]], or [[Biomarkers#Structural variant|structural variants]] | ||
*Acceptable methods of measurement: next-generation sequencing assay or RT-PCR, Sanger, pyrosequencing, or mass spectrometry-based sequencing methods | *Acceptable methods of measurement: next-generation sequencing assay or RT-PCR, Sanger, pyrosequencing, or mass spectrometry-based sequencing methods | ||
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====Prior treatment criteria==== | ====Prior treatment criteria==== | ||
* No prior treatment with HER kinase inhibitors | * No prior treatment with HER kinase inhibitors | ||
| − | + | </div> | |
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Neratinib (Nerlynx)]] 240 mg PO once per day | *[[Neratinib (Nerlynx)]] 240 mg PO once per day | ||
====Supportive therapy==== | ====Supportive therapy==== | ||
*[[Loperamide (Imodium)]] (dose not specified) mandatory during cycle 1 | *[[Loperamide (Imodium)]] (dose not specified) mandatory during cycle 1 | ||
| − | |||
'''28-day cycles''' | '''28-day cycles''' | ||
| − | + | </div></div> | |
===References=== | ===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] | ||
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==Pertuzumab & Trastuzumab {{#subobject:e0d17a|Regimen=1}}== | ==Pertuzumab & Trastuzumab {{#subobject:e0d17a|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:392a4b|Variant=1}}=== | ===Regimen {{#subobject:392a4b|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
| Line 54: | Line 52: | ||
|- | |- | ||
|} | |} | ||
| + | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*Gene: HER2 | *Gene: HER2 | ||
*Alteration: [[Biomarkers#Amplification|amplification]] or [[Biomarkers#Activating|activation]] (including exon 20 [[Biomarkers#Insertion|insertions]], [[Biomarkers#Deletion|deletions]] around amino acids 755 to 759, and nonsynonymous amino acid [[Biomarkers#Substitution|substitutions]]) | *Alteration: [[Biomarkers#Amplification|amplification]] or [[Biomarkers#Activating|activation]] (including exon 20 [[Biomarkers#Insertion|insertions]], [[Biomarkers#Deletion|deletions]] around amino acids 755 to 759, and nonsynonymous amino acid [[Biomarkers#Substitution|substitutions]]) | ||
*Acceptable methods of measurement: molecular profiling performed on tissue obtained at the most recent tumor biopsy | *Acceptable methods of measurement: molecular profiling performed on tissue obtained at the most recent tumor biopsy | ||
| + | </div> | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Pertuzumab (Perjeta)]] as follows: | *[[Pertuzumab (Perjeta)]] as follows: | ||
| Line 65: | Line 66: | ||
**Cycle 1: 8 mg/kg IV once on day 1 | **Cycle 1: 8 mg/kg IV once on day 1 | ||
**Cycle 2 onwards: 6 mg/kg IV once on day 1 | **Cycle 2 onwards: 6 mg/kg IV once on day 1 | ||
| − | |||
'''21-day cycles''' | '''21-day cycles''' | ||
| − | + | </div></div> | |
===References=== | ===References=== | ||
# '''MyPathway:''' Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. [https://doi.org/10.1200/JCO.2017.75.3780 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29320312 PubMed] NCT02091141 | # '''MyPathway:''' Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. [https://doi.org/10.1200/JCO.2017.75.3780 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29320312 PubMed] NCT02091141 | ||
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==Trastuzumab emtansine monotherapy {{#subobject:0a0a41|Regimen=1}}== | ==Trastuzumab emtansine monotherapy {{#subobject:0a0a41|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:9b61eb|Variant=1}}=== | ===Regimen {{#subobject:9b61eb|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
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|} | |} | ||
''Note: only partial results have been published to date.'' | ''Note: only partial results have been published to date.'' | ||
| − | + | <div class="toccolours" style="background-color:#fdcdac"> | |
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*Gene: HER2 | *Gene: HER2 | ||
*Alteration: various exon 20 [[Biomarkers#Insertion|insertions]], single-base pair [[Biomarkers#Substitution|substitutions]], or other likely [[Biomarkers#Activation|activating]] mutations | *Alteration: various exon 20 [[Biomarkers#Insertion|insertions]], single-base pair [[Biomarkers#Substitution|substitutions]], or other likely [[Biomarkers#Activation|activating]] mutations | ||
*Acceptable methods of measurement: next-generation sequencing | *Acceptable methods of measurement: next-generation sequencing | ||
| + | </div> | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Antibody-drug conjugate therapy==== | ====Antibody-drug conjugate therapy==== | ||
*[[Trastuzumab emtansine (Kadcyla)]] 3.6 mg/kg IV once on day 1 | *[[Trastuzumab emtansine (Kadcyla)]] 3.6 mg/kg IV once on day 1 | ||
| − | |||
'''21-day cycles''' | '''21-day cycles''' | ||
| − | + | </div></div> | |
===References=== | ===References=== | ||
# '''MSK 15-335:''' Li BT, Shen R, Buonocore D, Olah ZT, Ni A, Ginsberg MS, Ulaner GA, Offin M, Feldman D, Hembrough T, Cecchi F, Schwartz S, Pavlakis N, Clarke S, Won HH, Brzostowski EB, Riely GJ, Solit DB, Hyman DM, Drilon A, Rudin CM, Berger MF, Baselga J, Scaltriti M, Arcila ME, Kris MG. Ado-trastuzumab emtansine for patients with HER2-mutant lung cancers: results from a phase II basket trial. J Clin Oncol. 2018 Aug 20;36(24):2532-2537. Epub 2018 Jul 10. [https://doi.org/10.1200/JCO.2018.77.9777 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29989854 PubMed] | # '''MSK 15-335:''' Li BT, Shen R, Buonocore D, Olah ZT, Ni A, Ginsberg MS, Ulaner GA, Offin M, Feldman D, Hembrough T, Cecchi F, Schwartz S, Pavlakis N, Clarke S, Won HH, Brzostowski EB, Riely GJ, Solit DB, Hyman DM, Drilon A, Rudin CM, Berger MF, Baselga J, Scaltriti M, Arcila ME, Kris MG. Ado-trastuzumab emtansine for patients with HER2-mutant lung cancers: results from a phase II basket trial. J Clin Oncol. 2018 Aug 20;36(24):2532-2537. Epub 2018 Jul 10. [https://doi.org/10.1200/JCO.2018.77.9777 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29989854 PubMed] | ||
Revision as of 13:16, 23 January 2023
4 regimens on this page
4 variants on this page
|
All lines of therapy
Neratinib monotherapy
Regimen
| Study | Evidence |
|---|---|
| Hyman et al. 2018 (SUMMITHER) | Non-randomized basket trial |
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: HER2
- Alteration: various substitutions, insertions, frameshifts, or structural variants
- 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
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
Pertuzumab & Trastuzumab
Regimen
| Study | Years of enrollment | Evidence |
|---|---|---|
| Hainsworth et al. 2018 (MyPathway) | 2014-2016 | Phase 2a |
Biomarker eligibility criteria
- Gene: HER2
- Alteration: amplification or activation (including exon 20 insertions, deletions around amino acids 755 to 759, and nonsynonymous amino acid substitutions)
- Acceptable methods of measurement: molecular profiling performed on tissue obtained at the most recent tumor biopsy
Targeted therapy
- Pertuzumab (Perjeta) as follows:
- Cycle 1: 840 mg IV once on day 1
- Cycle 2 onwards: 240 mg IV once on day 1
- Trastuzumab (Herceptin) as follows:
- Cycle 1: 8 mg/kg IV once on day 1
- Cycle 2 onwards: 6 mg/kg IV once on day 1
21-day cycles
References
- MyPathway: Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. link to original article contains dosing details in manuscript PubMed NCT02091141
Trastuzumab emtansine monotherapy
Regimen
| Study | Evidence |
|---|---|
| Li et al. 2018 (MSK 15-335) | Phase 2 basket trial, <20 pts reported to date |
Note: only partial results have been published to date.
Biomarker eligibility criteria
- Gene: HER2
- Alteration: various exon 20 insertions, single-base pair substitutions, or other likely activating mutations
- Acceptable methods of measurement: next-generation sequencing
Antibody-drug conjugate therapy
- Trastuzumab emtansine (Kadcyla) 3.6 mg/kg IV once on day 1
21-day cycles
References
- MSK 15-335: Li BT, Shen R, Buonocore D, Olah ZT, Ni A, Ginsberg MS, Ulaner GA, Offin M, Feldman D, Hembrough T, Cecchi F, Schwartz S, Pavlakis N, Clarke S, Won HH, Brzostowski EB, Riely GJ, Solit DB, Hyman DM, Drilon A, Rudin CM, Berger MF, Baselga J, Scaltriti M, Arcila ME, Kris MG. Ado-trastuzumab emtansine for patients with HER2-mutant lung cancers: results from a phase II basket trial. J Clin Oncol. 2018 Aug 20;36(24):2532-2537. Epub 2018 Jul 10. link to original article contains dosing details in manuscript PubMed