Difference between revisions of "Editing test page"

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===Regimen variant #1, accelerated hyperfractionated RT {{#subobject:1fecad|Variant=1}}===
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==Carboplatin & RT {{#subobject:ea866d|Regimen=1}}==
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{| class="wikitable" style="width: 40%; text-align:center;"
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Carboplatin & RT: Carboplatin & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
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!style="width: 25%"|Study
 
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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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|-
 
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|[http://link.springer.com/article/10.1007/s10637-008-9128-1 Carter et al. 2008]
 
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|style="background-color:#91cf61"|Phase 2
 
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|-
 
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|}
 
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<div class="toccolours" style="background-color:#b3e2cd">
 
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====Chemotherapy====
 
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*[[Carboplatin (Paraplatin)]] as follows:
 
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**Dose: AUC 1
 
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**Route: IV
 
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**Frequency: once per day
 
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**Schedule: days 1, 8, 15, 22, 29, 36
 
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*[[Paclitaxel (Taxol)]] 40 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22, 29, 36
 
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====Radiotherapy====
 
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*Concurrent [[External_beam_radiotherapy|radiation therapy]], 1.2 Gy twice per day fractions (total dose: 69.6 Gy)
 
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*Concurrent [[External_beam_radiotherapy|radiation therapy]] as follows:
 
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**Modality: Electrons
 
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**Dose: 1.2 Gy
 
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**Frequency: twice per day
 
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**Total fractions: 25
 
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**Total dose: 69.6 Gy
 
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'''6-week course'''
 
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</div></div><br>
 
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
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===Regimen variant #1, weekly carboplatin {{#subobject:e0ewe0|Variant=1}}===
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==FOLFIRI & Cetuximab {{#subobject:11cf7b|Regimen=1}}==
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{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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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">
 
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===Regimen {{#subobject:921ac6|Variant=1}}===
 
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{| class="wikitable" style="color:white; background-color:#404040"
 
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|<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]]
 
|-
 
|-
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|[https://doi.org/10.1056/NEJMoa0805019 Van Cutsem et al. 2009 (CRYSTAL)]
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|[https://doi.org/10.1016/s1470-2045(23)00479-5 Monk et al. 2023 (CALLA)]
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|2019-02-15 to 2020-12-10
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|2004-07 to 2005-11
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|style="background-color:#1a9851"|Phase 3 (C)
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| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
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|[[#Carboplatin.2C_UFT.2C_RT_999|Carboplatin, UFT, RT]]
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|[[#FOLFIRI_2|FOLFIRI]]
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| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
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| 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)
 
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|-
 
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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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''<sup>1</sup>Reported efficacy for CRYSTAL is based on the 2012 pooled update and is only for KRAS wild-type tumors.''
 
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<div class="toccolours" style="background-color:#fdcdac">
 
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====Biomarker eligibility criteria====
 
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*CRYSTAL: none
 
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*FIRE-3: Wild-type KRAS, Wild-type NRAS
 
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</div>
 
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====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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*[[Carboplatin (Paraplatin)]] AUC 2 IV once per day on days 1, 8, 15, 22, 29
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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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====Radiotherapy====
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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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*Concurrent [[External_beam_radiotherapy|radiation therapy]], 1.8 Gy per fraction on days 1 to 5, 8 to 12, 15 to 19, 22 to 26, 29 to 33 (45 Gy total in 25 fractions)
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====Targeted therapy====
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'''5-week course'''
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*[[Cetuximab (Erbitux)]] as follows, '''given first and completed at least 1 hour before FOLFIRI begins''':
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</div>
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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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<div class="toccolours" style="background-color:#cbd5e8">
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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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====Subsequent treatment====
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'''14-day cycles'''
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*Brachytherapy
 
</div></div>
 
</div></div>
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===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]
 

Revision as of 13:26, 4 December 2023

Carboplatin & RT

Carboplatin & RT: Carboplatin & Radiation Therapy

Regimen variant #1, weekly carboplatin

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Monk et al. 2023 (CALLA) 2019-02-15 to 2020-12-10 Phase 3 (C) Carboplatin, UFT, RT Did not meet primary endpoint of PFS

Chemotherapy

Radiotherapy

  • Concurrent radiation therapy, 1.8 Gy per fraction on days 1 to 5, 8 to 12, 15 to 19, 22 to 26, 29 to 33 (45 Gy total in 25 fractions)

5-week course

Subsequent treatment

  • Brachytherapy
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