Difference between revisions of "Colorectal cancer, BRAF-mutated"
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<big>Note: the page has regimens specific to BRAF-mutated colon cancer. | <big>Note: the page has regimens specific to BRAF-mutated colon cancer. | ||
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*See the [[Colon_cancer|'''main colon cancer page''']] for general regimens.</big> | *See the [[Colon_cancer|'''main colon cancer page''']] for general regimens.</big> | ||
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{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
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=Guidelines= | =Guidelines= | ||
==[http://www.esmo.org/ ESMO]== | ==[http://www.esmo.org/ ESMO]== | ||
| + | |||
*'''2016:''' Van Cutsem et al. [https://www.esmo.org/Guidelines/Gastrointestinal-Cancers/Management-of-Patients-with-Metastatic-Colorectal-Cancer ESMO consensus guidelines for the management of patients with metastatic colorectal cancer.] [https://www.ncbi.nlm.nih.gov/pubmed/27380959 PubMed] | *'''2016:''' Van Cutsem et al. [https://www.esmo.org/Guidelines/Gastrointestinal-Cancers/Management-of-Patients-with-Metastatic-Colorectal-Cancer ESMO consensus guidelines for the management of patients with metastatic colorectal cancer.] [https://www.ncbi.nlm.nih.gov/pubmed/27380959 PubMed] | ||
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===Older=== | ===Older=== | ||
| + | |||
*'''2013:''' Labianca et al. [http://annonc.oxfordjournals.org/content/24/suppl_6/vi64.full.pdf+html Early Colon Cancer: ESMO Clinical Practice Guidelines] [https://www.ncbi.nlm.nih.gov/pubmed/24078664 PubMed] | *'''2013:''' Labianca et al. [http://annonc.oxfordjournals.org/content/24/suppl_6/vi64.full.pdf+html Early Colon Cancer: ESMO Clinical Practice Guidelines] [https://www.ncbi.nlm.nih.gov/pubmed/24078664 PubMed] | ||
*'''2013:''' Balmaña et al. [http://annonc.oxfordjournals.org/content/24/suppl_6/vi73.full.pdf+html Familial risk-colorectal cancer: ESMO Clinical Practice Guidelines.] [https://www.ncbi.nlm.nih.gov/pubmed/23813931 PubMed] | *'''2013:''' Balmaña et al. [http://annonc.oxfordjournals.org/content/24/suppl_6/vi73.full.pdf+html Familial risk-colorectal cancer: ESMO Clinical Practice Guidelines.] [https://www.ncbi.nlm.nih.gov/pubmed/23813931 PubMed] | ||
==[http://www.jsccr.jp/en/index.html Japanese Society for Cancer of the Colon and Rectum]== | ==[http://www.jsccr.jp/en/index.html Japanese Society for Cancer of the Colon and Rectum]== | ||
| + | |||
*'''2016:''' Watanabe et al. [https://link.springer.com/article/10.1007%2Fs10147-017-1101-6 Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer] [https://www.ncbi.nlm.nih.gov/pubmed/28349281 PubMed] | *'''2016:''' Watanabe et al. [https://link.springer.com/article/10.1007%2Fs10147-017-1101-6 Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer] [https://www.ncbi.nlm.nih.gov/pubmed/28349281 PubMed] | ||
==[https://www.nccn.org/ NCCN]== | ==[https://www.nccn.org/ NCCN]== | ||
| + | |||
*[https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf NCCN Guidelines - Colon Cancer] | *[https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf NCCN Guidelines - Colon Cancer] | ||
==[http://www.siog.org/ SIOG]== | ==[http://www.siog.org/ SIOG]== | ||
| + | |||
*'''2014:''' Papamichael et al. [https://academic.oup.com/annonc/article/26/3/463/222917 Treatment of colorectal cancer in older patients: International Society of Geriatric Oncology (SIOG) consensus recommendations 2013] | *'''2014:''' Papamichael et al. [https://academic.oup.com/annonc/article/26/3/463/222917 Treatment of colorectal cancer in older patients: International Society of Geriatric Oncology (SIOG) consensus recommendations 2013] | ||
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===Regimen {{#subobject:9134b2|Variant=1}}=== | ===Regimen {{#subobject:9134b2|Variant=1}}=== | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
| − | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 25%"|Comparator | + | ! style="width: 25%" |Comparator |
| − | !style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
|- | |- | ||
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1908075 Kopetz et al. 2019 (BEACON)] | |[https://www.nejm.org/doi/full/10.1056/NEJMoa1908075 Kopetz et al. 2019 (BEACON)] | ||
| − | |style="background-color:#1a9851"|Phase III (E-switch-ooc) | + | | style="background-color:#1a9851" |Phase III (E-switch-ooc) |
|1. Irinotecan & Cetuximab <br> 2. FOLFIRI & Cetuximab | |1. Irinotecan & Cetuximab <br> 2. FOLFIRI & Cetuximab | ||
| style="background-color:#1a9851" |Superior OS | | style="background-color:#1a9851" |Superior OS | ||
|- | |- | ||
|} | |} | ||
| + | '''Biomarker eligibility criteria''' | ||
| + | |||
| + | BRAF V600E | ||
| + | |||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Binimetinib (Mektovi)]] 45 mg PO twice per day | *[[Binimetinib (Mektovi)]] 45 mg PO twice per day | ||
*[[Encorafenib (Braftovi)]] 300 mg PO once per day | *[[Encorafenib (Braftovi)]] 300 mg PO once per day | ||
| Line 63: | Line 76: | ||
===References=== | ===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://www.ncbi.nlm.nih.gov/pubmed/31566309 PubMed] | + | |
| + | #'''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://www.ncbi.nlm.nih.gov/pubmed/31566309 PubMed] | ||
==Irinotecan, Vemurafenib, Cetuximab {{#subobject:aab14c|Regimen=1}}== | ==Irinotecan, Vemurafenib, Cetuximab {{#subobject:aab14c|Regimen=1}}== | ||
| Line 72: | Line 86: | ||
===Regimen {{#subobject:98buya|Variant=1}}=== | ===Regimen {{#subobject:98buya|Variant=1}}=== | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
| − | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 25%"|Comparator | + | ! style="width: 25%" |Comparator |
| − | !style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
|- | |- | ||
|[https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.4_suppl.520 Kopetz et al. 2017 (SWOG 1406)] | |[https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.4_suppl.520 Kopetz et al. 2017 (SWOG 1406)] | ||
| − | |style="background-color:#1a9851"|Randomized Phase II (E-esc) | + | | style="background-color:#1a9851" |Randomized Phase II (E-esc) |
| − | | Irinotecan & Cetuximab | + | |Irinotecan & Cetuximab |
| style="background-color:#1a9851" |Superior PFS | | style="background-color:#1a9851" |Superior PFS | ||
|- | |- | ||
|} | |} | ||
| + | '''Biomarker eligibility criteria''' | ||
| + | |||
| + | BRAF V600 | ||
| + | |||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Irinotecan (Camptosar)]] 180 mg/m<sup>2</sup> IV once on day 1 | *[[Irinotecan (Camptosar)]] 180 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vemurafenib (Zelboraf)]] 960 mg PO twice per day | *[[Vemurafenib (Zelboraf)]] 960 mg PO twice per day | ||
| Line 91: | Line 110: | ||
===References=== | ===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. [https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.4_suppl.520 link to abstract] | + | |
| + | #'''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. [https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.4_suppl.520 link to abstract] | ||
==Dabrafenib, Trametinib, Panitumumab{{#subobject:abca4c|Regimen=1}}== | ==Dabrafenib, Trametinib, Panitumumab{{#subobject:abca4c|Regimen=1}}== | ||
| Line 100: | Line 120: | ||
===Regimen {{#subobject:98bhza|Variant=1}}=== | ===Regimen {{#subobject:98bhza|Variant=1}}=== | ||
{| class="wikitable" style="width: 75%; text-align:center;" | {| class="wikitable" style="width: 75%; text-align:center;" | ||
| − | !style="width: 33%"|Study | + | ! style="width: 33%" |Study |
| − | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|[https://ascopubs.org/doi/abs/10.1200/jco.2015.33.15_suppl.103 Atreya et al. 2017 (Study 116833)] | |[https://ascopubs.org/doi/abs/10.1200/jco.2015.33.15_suppl.103 Atreya et al. 2017 (Study 116833)] | ||
| − | |style="background-color:#91cf61"|Phase I/II | + | | style="background-color:#91cf61" |Phase I/II |
| − | |style="background-color:#6e016b; color:white| ORR: 26% | + | | style="background-color:#6e016b; color:white" |ORR: 26% |
|- | |- | ||
|} | |} | ||
| + | '''Biomarker eligibility criteria''' | ||
| + | |||
| + | BRAF V600E | ||
| + | |||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day | *[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day | ||
*[[Trametinib (Mekinist)]] 2 mg PO once per day | *[[Trametinib (Mekinist)]] 2 mg PO once per day | ||
| Line 117: | Line 142: | ||
===References=== | ===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. [https://ascopubs.org/doi/abs/10.1200/jco.2015.33.15_suppl.103 link to abstract] | + | |
| + | #'''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. [https://ascopubs.org/doi/abs/10.1200/jco.2015.33.15_suppl.103 link to abstract] | ||
[[Category:Colon cancer regimens]] | [[Category:Colon cancer regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Colorectal cancers]] | [[Category:Colorectal cancers]] | ||
Revision as of 23:11, 8 January 2020
| Page editor | Section editor | ||
|---|---|---|---|
 |
Ryan Nguyen, DO University of Illinois at Chicago Chicago, IL |
 |
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
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
| back to top |
Regimen
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Kopetz et al. 2019 (BEACON) | Phase III (E-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
Irinotecan, Vemurafenib, Cetuximab
| back to top |
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
| back to top |
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