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| − | [[File:Kisspng-emoji-computer-icons-police-car-siren-5d13c924b69c66.632658731561577764748.jpg]]
| + | ==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}== |
| − | | + | CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab |
| − | ==FOLFIRI & Cetuximab {{#subobject:11cf7b|Regimen=1}}== | |
| − | FOLFIRI & Cetuximab: '''<u>FOL</u>'''inic acid (Leucovorin), '''<u>F</u>'''luorouracil, '''<u>IRI</u>'''notecan, Cetuximab
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| | <div class="toccolours" style="background-color:#eeeeee"> | | <div class="toccolours" style="background-color:#eeeeee"> |
| − | ===Regimen {{#subobject:921ac6|Variant=1}}=== | + | ===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}=== |
| − | {| class="wikitable" style="color:white; background-color:#404040"
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
| − | |<small>'''FDA-recommended dose'''</small>
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| − | |-
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| − | |}
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| − | {| class="wikitable sortable" style="width: 100%; text-align:center;" | |
| | !style="width: 20%"|Study | | !style="width: 20%"|Study |
| | !style="width: 20%"|Dates of enrollment | | !style="width: 20%"|Dates of enrollment |
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| | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
| | |- | | |- |
| − | |[https://doi.org/10.1056/NEJMoa0805019 Van Cutsem et al. 2009 (CRYSTAL)] | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)] |
| − | | + | {| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3" |
| − | |2004-07 to 2005-11 | + | |[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]] |
| | + | |- |
| | + | |Click to learn more! |
| | + | |- |
| | + | |} |
| | + | |2017-2019 |
| | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) | | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) |
| − | |[[#FOLFIRI_2|FOLFIRI]] | + | |1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]] |
| − | | style="background-color:#1a9850" |Superior OS<sup>1</sup> (secondary endpoint)<br>Median OS: 23.5 vs 19.5 mo<br>(HR 0.81, 95% CI 0.69-0.94) | + | | style="background-color:#1a9850" |Superior EFS (co-primary endpoint)<br>Median EFS: 31.6 vs 20.8 mo<br>(HR 0.63, 97.38% CI 0.43-0.91)<br><br>Superior pCR rate (co-primary endpoint)<br>pCR rate: 24% vs 2.2%<br>(OR 13.94, 99% CI 3.49-55.75) |
| − | |-
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| − | |[https://doi.org/10.1016/S1470-2045(14)70330-4 Heinemann et al. 2014 (FIRE-3)]
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| − | |2007-2012
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| − | | style="background-color:#1a9851" |Phase 3 (E-switch-ooc)
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| − | |[[#FOLFIRI_.26_Bevacizumab|FOLFIRI & Bevacizumab]]
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| − | | style="background-color:#ffffbf" |Did not meet primary endpoint of ORR
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| | |- | | |- |
| | |} | | |} |
| − | | + | ''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.'' |
| − | ''<sup>1</sup>Reported efficacy for CRYSTAL is based on the 2012 pooled update and is only for KRAS wild-type tumors.'' | |
| | <div class="toccolours" style="background-color:#fdcdac"> | | <div class="toccolours" style="background-color:#fdcdac"> |
| | ====Biomarker eligibility criteria==== | | ====Biomarker eligibility criteria==== |
| − | *CRYSTAL: none | + | *CheckMate 816: No sensitizing EGFR or ALK mutations |
| − | *FIRE-3: Wild-type KRAS, Wild-type NRAS
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| − | </div>
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| − | <div class="toccolours" style="background-color:#b3e2cd">
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| − | ====Chemotherapy====
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| − | *[[Leucovorin (Folinic acid)]] 400 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given second, 1 hour after completion of cetuximab, with irinotecan'''
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| − | *[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup> IV bolus once on day 1, then 2400 mg/m<sup>2</sup> IV continuous infusion over 46 hours, '''given third''' (total dose per cycle: 2800 mg/m<sup>2</sup>)
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| − | *[[Irinotecan (Camptosar)]] 180 mg/m<sup>2</sup> IV over 30 to 90 minutes once on day 1, '''given second, 1 hour after completion of cetuximab, with leucovorin'''
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| − | ====Targeted therapy====
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| − | *[[Cetuximab (Erbitux)]] as follows, '''given first and completed at least 1 hour before FOLFIRI begins''':
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| − | **Cycle 1: 400 mg/m<sup>2</sup> IV over 2 hours once on day 1, then 250 mg/m<sup>2</sup> IV over 60 minutes once on day 8
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| − | **Cycle 2 onwards: 250 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 & 8
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| − | '''14-day cycles'''
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| | </div></div> | | </div></div> |
| − | ===References===
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| − | #'''boo'''
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| − | #'''CRYSTAL:''' Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. [https://doi.org/10.1056/NEJMoa0805019 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/19339720/ PubMed] [https://clinicaltrials.gov/study/NCT00154102 NCT00154102]
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| − | ##'''Update:''' Van Cutsem E, Köhne CH, Láng I, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Tejpar S, Schlichting M, Zubel A, Celik I, Rougier P, Ciardiello F. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol. 2011 May 20;29(15):2011-9. Epub 2011 Apr 18. [https://doi.org/10.1200/jco.2010.33.5091 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21502544/ PubMed]
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| − | ##'''Pooled update:''' Bokemeyer C, Van Cutsem E, Rougier P, Ciardiello F, Heeger S, Schlichting M, Celik I, Köhne CH. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: Pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer. 2012 Jul;48(10):1466-75. Epub 2012 Mar 23. [https://doi.org/10.1016/j.ejca.2012.02.057 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22446022/ PubMed]
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| − | ##'''Biomarker analysis:''' Van Cutsem E, Lenz HJ, Köhne CH, Heinemann V, Tejpar S, Melezínek I, Beier F, Stroh C, Rougier P, van Krieken JH, Ciardiello F. Fluorouracil, leucovorin, and irinotecan plus cetuximab treatment and RAS mutations in colorectal cancer. J Clin Oncol. 2015 Mar 1;33(7):692-700. Epub 2015 Jan 20. [https://doi.org/10.1200/JCO.2014.59.4812 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25605843/ PubMed]
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| − | #'''FIRE-3:''' Heinemann V, von Weikersthal LF, Decker T, Kiani A, Vehling-Kaiser U, Al-Batran SE, Heintges T, Lerchenmüller C, Kahl C, Seipelt G, Kullmann F, Stauch M, Scheithauer W, Hielscher J, Scholz M, Müller S, Link H, Niederle N, Rost A, Höffkes HG, Moehler M, Lindig RU, Modest DP, Rossius L, Kirchner T, Jung A, Stintzing S. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Sep;15(10):1065-75. Epub 2014 Jul 31. [https://doi.org/10.1016/S1470-2045(14)70330-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25088940/ PubMed] [https://clinicaltrials.gov/study/NCT00433927 NCT00433927]
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