Difference between revisions of "Colorectal cancer, BRAF-mutated"
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|2017-2019 | |2017-2019 | ||
| style="background-color:#1a9851" |Phase 3 (E-RT-switch-ooc) | | style="background-color:#1a9851" |Phase 3 (E-RT-switch-ooc) | ||
| − | |1. [[#Irinotecan_.26_Cetuximab_88|Irinotecan & Cetuximab]] <br> 2. [[#FOLFIRI_.26_Cetuximab_88|FOLFIRI & Cetuximab]] | + | |1. [[#Irinotecan_.26_Cetuximab_88|Irinotecan & Cetuximab]] <br>2. [[#FOLFIRI_.26_Cetuximab_88|FOLFIRI & Cetuximab]] |
| style="background-color:#1a9851" |Superior OS<br>Median OS: 9.3 vs 5.9 mo<br>(HR 0.60, 95% CI 0.47-0.75) | | style="background-color:#1a9851" |Superior OS<br>Median OS: 9.3 vs 5.9 mo<br>(HR 0.60, 95% CI 0.47-0.75) | ||
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|2017-2019 | |2017-2019 | ||
| style="background-color:#1a9851" |Phase 3 (E-RT-switch-ooc) | | style="background-color:#1a9851" |Phase 3 (E-RT-switch-ooc) | ||
| − | |1. [[#Irinotecan_.26_Cetuximab_88|Irinotecan & Cetuximab]] <br> 2. [[#FOLFIRI_.26_Cetuximab_88|FOLFIRI & Cetuximab]] | + | |1. [[#Irinotecan_.26_Cetuximab_88|Irinotecan & Cetuximab]] <br>2. [[#FOLFIRI_.26_Cetuximab_88|FOLFIRI & Cetuximab]] |
| style="background-color:#1a9851" |Superior OS<br>Median OS: 9.3 vs 5.9 mo<br>(HR 0.60, 95% CI 0.47-0.75) | | style="background-color:#1a9851" |Superior OS<br>Median OS: 9.3 vs 5.9 mo<br>(HR 0.60, 95% CI 0.47-0.75) | ||
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Revision as of 12:54, 22 October 2022
Section editor transclusions Note: the page has regimens specific to BRAF-mutated colon cancer.
- See the main colorectal 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
Regimen
| Study | Years 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
- 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 NCT02928224
- 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 PubMed
Encorafenib & Cetuximab
Regimen
| FDA-recommended dose |
| Study | Years 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 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 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 NCT02928224
- 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 PubMed
- BREAKWATER: NCT04607421
Irinotecan, Vemurafenib, Cetuximab
Regimen
| Study | Years 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
- Irinotecan (Camptosar) 180 mg/m2 IV once on day 1
Targeted therapy
- Vemurafenib (Zelboraf) 960 mg PO twice per day
- Cetuximab (Erbitux) 500 mg/m2 IV once on day 1
14-day cycles
References
- 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 PubMed NCT02164916
Dabrafenib, Trametinib, Panitumumab
Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Atreya et al. 2017 (Study 116833) | Phase 1/2 | 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