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

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===References===
 
===References===
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#'''BEACON CRC:''' 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, Schmidt Tarpgaard L, 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://doi.org/10.1056/NEJMoa1908075 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31566309/ PubMed] NCT02928224
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#'''BEACON CRC:''' 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, Schmidt Tarpgaard L, 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://doi.org/10.1056/NEJMoa1908075 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31566309/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT02928224 Clinical Trial Registry]
 
##'''Update:''' Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. [https://doi.org/10.1200/jco.20.02088 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8078423/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33503393/ PubMed]
 
##'''Update:''' Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. [https://doi.org/10.1200/jco.20.02088 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8078423/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33503393/ PubMed]
 
##'''PRO analysis:''' Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. Epub 2022 May 30. [https://doi.org/10.1016/j.esmoop.2022.100477 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9271477/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35653981/ PubMed]
 
##'''PRO analysis:''' Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. Epub 2022 May 30. [https://doi.org/10.1016/j.esmoop.2022.100477 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9271477/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35653981/ PubMed]
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===References===
 
===References===
−
#'''BEACON CRC:''' 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, Schmidt Tarpgaard L, 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://doi.org/10.1056/NEJMoa1908075 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31566309/ PubMed] NCT02928224
+
#'''BEACON CRC:''' 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, Schmidt Tarpgaard L, 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://doi.org/10.1056/NEJMoa1908075 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31566309/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT02928224 Clinical Trial Registry]
 
##'''Update:''' Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. [https://doi.org/10.1200/jco.20.02088 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8078423/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33503393/ PubMed]
 
##'''Update:''' Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. [https://doi.org/10.1200/jco.20.02088 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8078423/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33503393/ PubMed]
 
##'''PRO analysis:''' Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. Epub 2022 May 30. [https://doi.org/10.1016/j.esmoop.2022.100477 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9271477/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35653981/ PubMed]
 
##'''PRO analysis:''' Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. Epub 2022 May 30. [https://doi.org/10.1016/j.esmoop.2022.100477 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9271477/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35653981/ PubMed]
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#'''BREAKWATER:''' NCT04607421
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#'''BREAKWATER:''' [https://clinicaltrials.gov/ct2/show/NCT04607421 Clinical Trial Registry]
  
 
==Irinotecan, Vemurafenib, Cetuximab {{#subobject:aab14c|Regimen=1}}==
 
==Irinotecan, Vemurafenib, Cetuximab {{#subobject:aab14c|Regimen=1}}==
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===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://doi.org/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://doi.org/10.1200/JCO.2017.35.4_suppl.520 link to abstract] -->
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#'''SWOG S1406:''' Kopetz S, Guthrie KA, Morris VK, Lenz HJ, Magliocco AM, Maru D, Yan Y, Lanman R, Manyam G, Hong DS, Sorokin A, Atreya CE, Diaz LA, Allegra C, Raghav KP, Wang SE, Lieu CH, McDonough SL, Philip PA, Hochster HS. Randomized Trial of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF-Mutant Metastatic Colorectal Cancer (SWOG S1406). J Clin Oncol. 2021 Feb 1;39(4):285-294. Epub 2020 Dec 23. [https://doi.org/10.1200/jco.20.01994 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8462593/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33356422/ PubMed] NCT02164916
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#'''SWOG S1406:''' Kopetz S, Guthrie KA, Morris VK, Lenz HJ, Magliocco AM, Maru D, Yan Y, Lanman R, Manyam G, Hong DS, Sorokin A, Atreya CE, Diaz LA, Allegra C, Raghav KP, Wang SE, Lieu CH, McDonough SL, Philip PA, Hochster HS. Randomized Trial of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF-Mutant Metastatic Colorectal Cancer (SWOG S1406). J Clin Oncol. 2021 Feb 1;39(4):285-294. Epub 2020 Dec 23. [https://doi.org/10.1200/jco.20.01994 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8462593/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33356422/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT02164916 Clinical Trial Registry]
 
==Dabrafenib, Trametinib, Panitumumab{{#subobject:abca4c|Regimen=1}}==
 
==Dabrafenib, Trametinib, Panitumumab{{#subobject:abca4c|Regimen=1}}==
 
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! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
|-
 
|-
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|[https://clinicaltrials.gov/ct2/show/NCT01750918 Awaiting publication (Study 116833)]
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|[https://clinicaltrials.gov/ct2/show/[https://clinicaltrials.gov/ct2/show/NCT01750918 Clinical Trial Registry] Awaiting publication (Study 116833)]
 
| style="background-color:#91cf61" |Phase 1/2
 
| style="background-color:#91cf61" |Phase 1/2
 
| style="background-color:#6e016b; color:white" |ORR: 26%
 
| style="background-color:#6e016b; color:white" |ORR: 26%
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===References===
 
===References===
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#'''Study 116833:''' NCT01750918
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#'''Study 116833:''' [https://clinicaltrials.gov/ct2/show/NCT01750918 Clinical Trial Registry]
 
[[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 15:36, 31 May 2023

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

4 regimens on this page
5 variants on this page


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

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Kopetz et al. 2019 (BEACON CRC) 2017-2019 Phase 3 (E-RT-switch-ooc) 1. Irinotecan & Cetuximab
2. FOLFIRI & Cetuximab 		Superior OS
Median OS: 9.3 vs 5.9 mo
(HR 0.60, 95% CI 0.47-0.75)

Biomarker eligibility criteria

  • BRAF p.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

  1. BEACON CRC: 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, Schmidt Tarpgaard L, 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 dosing details in manuscript PubMed Clinical Trial Registry
    1. Update: Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. link to original article link to PMC article PubMed
    2. PRO analysis: Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. Epub 2022 May 30. link to original article link to PMC article PubMed

Encorafenib & Cetuximab

Regimen

FDA-recommended dose
Study Dates of enrollment Evidence Comparator Comparative Efficacy
Kopetz et al. 2019 (BEACON CRC)
ESMO-MCBS (4)
2017-2019 Phase 3 (E-RT-switch-ooc) 1. Irinotecan & Cetuximab
2. FOLFIRI & Cetuximab 		Superior OS
Median OS: 9.3 vs 5.9 mo
(HR 0.60, 95% CI 0.47-0.75)

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

  1. BEACON CRC: 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, Schmidt Tarpgaard L, 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 dosing details in manuscript PubMed Clinical Trial Registry
    1. Update: Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. link to original article link to PMC article PubMed
    2. PRO analysis: Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. Epub 2022 May 30. link to original article link to PMC article PubMed
  2. BREAKWATER: Clinical Trial Registry

Irinotecan, Vemurafenib, Cetuximab

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Kopetz et al. 2020 (SWOG 1406) 2014-NR Randomized Phase 2 (E-esc) Irinotecan & Cetuximab Superior PFS

Biomarker eligibility criteria

  • BRAF V600E, absence of NRAS and KRAS mutations

Chemotherapy

Targeted therapy

14-day cycles

References

  1. SWOG S1406: Kopetz S, Guthrie KA, Morris VK, Lenz HJ, Magliocco AM, Maru D, Yan Y, Lanman R, Manyam G, Hong DS, Sorokin A, Atreya CE, Diaz LA, Allegra C, Raghav KP, Wang SE, Lieu CH, McDonough SL, Philip PA, Hochster HS. Randomized Trial of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF-Mutant Metastatic Colorectal Cancer (SWOG S1406). J Clin Oncol. 2021 Feb 1;39(4):285-294. Epub 2020 Dec 23. link to original article contains dosing details in manuscript link to PMC article PubMed Clinical Trial Registry

Dabrafenib, Trametinib, Panitumumab

Regimen

Study Evidence Efficacy
[https://clinicaltrials.gov/ct2/show/NCT01750918 Clinical Trial Registry Awaiting publication (Study 116833)] Phase 1/2 ORR: 26%

Note: efficacy and dosing details are from a 2017 ASCO abstract.

Biomarker eligibility criteria

  • BRAF V600E

Targeted therapy

14-day cycles

References

  1. Study 116833: Clinical Trial Registry
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