Difference between revisions of "Colorectal cancer, BRAF-mutated"
Jump to navigation
Jump to search
Ryannguyen (talk | contribs) |
m |
||
| Line 50: | Line 50: | ||
===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: | + | !style="width: 20%"|Study |
| − | ! style="width: | + | !style="width: 20%"|Years of enrollment |
| − | ! style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| − | ! style="width: | + | !style="width: 20%"|Comparator |
| + | !style="width: 20%"|[[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)] | ||
| + | |2017-2019 | ||
| style="background-color:#1a9851" |Phase III (E-RT-switch-ooc) | | style="background-color:#1a9851" |Phase III (E-RT-switch-ooc) | ||
|1. Irinotecan & Cetuximab <br> 2. FOLFIRI & Cetuximab | |1. Irinotecan & Cetuximab <br> 2. FOLFIRI & Cetuximab | ||
| Line 61: | Line 63: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Biomarker eligibility criteria==== | |
| + | *BRAF V600E | ||
| − | + | ====Targeted therapy==== | |
| − | |||
| − | ==== | ||
*[[Binimetinib (Mektovi)]] 45 mg PO twice per day | *[[Binimetinib (Mektovi)]] 45 mg PO twice per day | ||
| Line 77: | Line 78: | ||
===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://pubmed.ncbi.nlm.nih.gov/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://pubmed.ncbi.nlm.nih.gov/31566309 PubMed] NCT02928224 |
==Encorafenib & Cetuximab {{#subobject:ea894c|Regimen=1}}== | ==Encorafenib & Cetuximab {{#subobject:ea894c|Regimen=1}}== | ||
| Line 90: | Line 91: | ||
|} | |} | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | ! style="width: | + | !style="width: 20%"|Study |
| − | ! style="width: | + | !style="width: 20%"|Years of enrollment |
| − | ! style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| − | ! style="width: | + | !style="width: 20%"|Comparator |
| + | !style="width: 20%"|[[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)] | ||
| + | |2017-2019 | ||
| style="background-color:#1a9851" |Phase III (E-RT-switch-ooc) | | style="background-color:#1a9851" |Phase III (E-RT-switch-ooc) | ||
|1. Irinotecan & Cetuximab <br> 2. FOLFIRI & Cetuximab | |1. Irinotecan & Cetuximab <br> 2. FOLFIRI & Cetuximab | ||
| Line 101: | Line 104: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Biomarker eligibility criteria==== | |
| − | + | *BRAF V600E | |
| − | |||
| − | |||
| − | ==== | ||
| + | ====Targeted therapy==== | ||
*[[Encorafenib (Braftovi)]] 300 mg PO once per day | *[[Encorafenib (Braftovi)]] 300 mg PO once per day | ||
*[[Cetuximab (Erbitux)]] as follows: | *[[Cetuximab (Erbitux)]] as follows: | ||
| Line 116: | Line 117: | ||
===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://pubmed.ncbi.nlm.nih.gov/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://pubmed.ncbi.nlm.nih.gov/31566309 PubMed] NCT02928224 |
| Line 137: | Line 138: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Biomarker eligibility criteria==== | |
| + | *BRAF V600 | ||
| − | + | ====Targeted therapy==== | |
| − | |||
| − | ==== | ||
*[[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 | ||
| Line 169: | Line 169: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Biomarker eligibility criteria==== | |
| − | + | *BRAF V600E | |
| − | BRAF V600E | ||
| − | ==== | + | ====Targeted therapy==== |
*[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day | *[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day | ||
Revision as of 15:26, 25 July 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 | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Kopetz et al. 2019 (BEACON) | 2017-2019 | Phase III (E-RT-switch-ooc) | 1. Irinotecan & Cetuximab 2. FOLFIRI & Cetuximab |
Superior OS |
Biomarker eligibility criteria
- BRAF V600E
Targeted therapy
- 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 NCT02928224
Encorafenib & Cetuximab
| back to top |
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Kopetz et al. 2019 (BEACON) | 2017-2019 | Phase III (E-RT-switch-ooc) | 1. Irinotecan & Cetuximab 2. FOLFIRI & Cetuximab |
Superior OS |
Biomarker eligibility criteria
- BRAF V600E
Targeted therapy
- 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 NCT02928224
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
Targeted therapy
- 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
Targeted therapy
- 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