Revision as of 12:11, 22 July 2020

Page editor		Section editor
	Ryan Nguyen, DO University of Illinois at Chicago Chicago, IL LinkedIn		Neeta K. Venepalli, MD, MBA University of Illinois at Chicago Chicago, IL

Note: the page has regimens specific to BRAF-mutated colon cancer.

See the main colon cancer page for general regimens.

4 regimens on this page 5 variants on this page

Guidelines

ESMO

2016: Van Cutsem et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. PubMed

Older

2013: Labianca et al. Early Colon Cancer: ESMO Clinical Practice Guidelines PubMed
2013: Balmaña et al. Familial risk-colorectal cancer: ESMO Clinical Practice Guidelines. PubMed

Japanese Society for Cancer of the Colon and Rectum

2016: Watanabe et al. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer PubMed

NCCN

NCCN Guidelines - Colon Cancer

SIOG

2014: Papamichael et al. Treatment of colorectal cancer in older patients: International Society of Geriatric Oncology (SIOG) consensus recommendations 2013

Advanced or metastatic disease, second or third-line therapy

Binimetinib, Encorafenib, Cetuximab

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Regimen

Study	Evidence	Comparator	Comparative Efficacy
Kopetz et al. 2019 (BEACON)	Phase III (E-RT-switch-ooc)	1. Irinotecan & Cetuximab 2. FOLFIRI & Cetuximab	Superior OS

Biomarker eligibility criteria

BRAF V600E

Chemotherapy

Binimetinib (Mektovi) 45 mg PO twice per day
Encorafenib (Braftovi) 300 mg PO once per day
Cetuximab (Erbitux) as follows:
- Cycle 1: 400 mg/m² IV over 120 minutes once on day 1, then 250 mg/m² IV over 60 minutes once per day on days 8, 15, 22
- Cycle 2 onwards: 250 mg/m² IV over 60 minutes once per day on days 1, 8, 15, 22

28-day cycles

References

BEACON: Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. Epub 2019 Sep 30. link to original article contains verified protocol PubMed

Encorafenib & Cetuximab

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Regimen

FDA-recommended dose

Study	Evidence	Comparator	Comparative Efficacy
Kopetz et al. 2019 (BEACON)	Phase III (E-RT-switch-ooc)	1. Irinotecan & Cetuximab 2. FOLFIRI & Cetuximab	Superior OS

Biomarker eligibility criteria

BRAF V600E

Chemotherapy

Encorafenib (Braftovi) 300 mg PO once per day
Cetuximab (Erbitux) as follows:
- Cycle 1: 400 mg/m² IV over 120 minutes once on day 1, then 250 mg/m² IV over 60 minutes once per day on days 8, 15, 22
- Cycle 2 onwards: 250 mg/m² IV over 60 minutes once per day on days 1, 8, 15, 22

28-day cycles

References

BEACON: Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. Epub 2019 Sep 30. link to original article contains verified protocol PubMed

Irinotecan, Vemurafenib, Cetuximab

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Regimen

Study	Evidence	Comparator	Comparative Efficacy
Kopetz et al. 2017 (SWOG 1406)	Randomized Phase II (E-esc)	Irinotecan & Cetuximab	Superior PFS

Biomarker eligibility criteria

BRAF V600

Chemotherapy

Irinotecan (Camptosar) 180 mg/m² IV once on day 1
Vemurafenib (Zelboraf) 960 mg PO twice per day
Cetuximab (Erbitux) 500 mg/m² IV once on day 1

14-day cycles

References

Abstract: Kopetz S, McDonough S, Morris V, Lenz HJ, Magliocco A, Atreya C, Diaz L, Allegra C, Lieu C, Wang S, Eckhardt SG, Semrad T, Kaberle K, Guthrie K, Hochster H. Randomized phase II study of irinotecan and cetuximab with or without vemurafenib in BRAF-mutant metastatic colorectal cancer (SWOG1406). Journal of Clinical Oncology 35, no. 4_suppl (February 01, 2017) 520-520. Published online March 21, 2017. link to abstract

Dabrafenib, Trametinib, Panitumumab

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Regimen

Study	Evidence	Efficacy
Atreya et al. 2017 (Study 116833)	Phase I/II	ORR: 26%

Biomarker eligibility criteria

BRAF V600E

Chemotherapy

Dabrafenib (Tafinlar) 150 mg PO twice per day
Trametinib (Mekinist) 2 mg PO once per day
Panitumumab (Vectibix) 6 mg/kg IV once on day 1

14-day cycles

References

Abstract: Chloe EA, Van Cutsem E, Bendell JC, Andre T, Schellens JHM, Gordon MS, McRee AJ, O'Dwyer PJ, Muro K, Tabernero J, Van Geel R, Sidhu R, Greger JG, Rangwala FA, Motwani M, Wu Y, Orford KW, and Corcoran RB. Journal of Clinical Oncology 2015 33:15_suppl, 103-103. Published online January 31, 2017. link to abstract

@@ Line 78: / Line 78: @@
 #'''BEACON:''' Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. Epub 2019 Sep 30. [https://www.nejm.org/doi/full/10.1056/NEJMoa1908075 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/31566309 PubMed]
+==Encorafenib & Cetuximab {{#subobject:ea894c|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[#top|back to top]]
+|}
+===Regimen {{#subobject:9134b2|Variant=1}}===
+{| class="wikitable" style="color:white; background-color:#404040"
+|<small>'''FDA-recommended dose'''</small>
+|-
+|}
+{| class="wikitable" style="width: 100%; text-align:center;"
+! style="width: 25%" |Study
+! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
+! style="width: 25%" |Comparator
+! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+|-
+|[https://www.nejm.org/doi/full/10.1056/NEJMoa1908075 Kopetz et al. 2019 (BEACON)]
+| style="background-color:#1a9851" |Phase III (E-RT-switch-ooc)
+|1. Irinotecan & Cetuximab <br> 2. FOLFIRI & Cetuximab
+| style="background-color:#1a9851" |Superior OS
+|-
+|}
+'''Biomarker eligibility criteria'''
+BRAF V600E
+====Chemotherapy====
+*[[Encorafenib (Braftovi)]] 300 mg PO once per day
+*[[Cetuximab (Erbitux)]] as follows:
+**Cycle 1: 400 mg/m<sup>2</sup> IV over 120 minutes once on day 1, then 250 mg/m<sup>2</sup> IV over 60 minutes once per day on days 8, 15, 22
+**Cycle 2 onwards: 250 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15, 22
+'''28-day cycles'''
+===References===
+#'''BEACON:''' Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. Epub 2019 Sep 30. [https://www.nejm.org/doi/full/10.1056/NEJMoa1908075 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/31566309 PubMed]
 ==Irinotecan, Vemurafenib, Cetuximab {{#subobject:aab14c|Regimen=1}}==

Difference between revisions of "Colorectal cancer, BRAF-mutated"

Revision as of 12:11, 22 July 2020

Contents

Guidelines

ESMO

Older

Japanese Society for Cancer of the Colon and Rectum

NCCN

SIOG

Advanced or metastatic disease, second or third-line therapy

Binimetinib, Encorafenib, Cetuximab

Regimen

Chemotherapy

References

Encorafenib & Cetuximab

Regimen

Chemotherapy

References

Irinotecan, Vemurafenib, Cetuximab

Regimen

Chemotherapy

References

Dabrafenib, Trametinib, Panitumumab

Regimen

Chemotherapy

References

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