Difference between revisions of "Malignant solid neoplasm, ERBB2-mutated"
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Revision as of 17:38, 25 November 2019
4 regimens on this page
4 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
Ado-trastuzumab emtansine monotherapy
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Regimen
| Study | Evidence |
|---|---|
| Li et al. 2018 (MSK 15-335) | Phase II basket trial, <20 pts reported to date |
Note: only partial results have been published to date.
Chemotherapy
- Ado-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 verified protocol PubMed
Neratinib monotherapy
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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.
Eligibility criteria
- HER2 or HER3 mutations
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
Pertuzumab & Trastuzumab
Regimen
| Study | Evidence |
|---|---|
| Hainsworth et al. 2018 (MyPathway) | Phase IIa |
Eligibility criteria
- HER2 amplification or activating mutations
Chemotherapy
- 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 verified protocol PubMed