Difference between revisions of "Staging page"

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[[#top|Back to Top]]
 
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{{#lst:Section editor transclusions|gi}}
 
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{| class="wikitable" style="float:right; margin-right: 5px;"
 
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|-
 
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|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
 
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
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|}
 
  
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{{TOC limit|limit=3}}
 
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=Guidelines=
 
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==[http://www.esmo.org/ ESMO]==
 
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*'''2021:''' Rao et al. [https://doi.org/10.1016/j.annonc.2021.06.015 Anal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up]
 
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===Older===
 
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*'''2014:''' Glynne-Jones et al. [https://doi.org/10.1016/j.ejso.2014.07.030 Anal cancer: ESMO-ESSO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up]
 
−
 
−
==[https://www.nccn.org/ NCCN]==
 
−
*[https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf NCCN Guidelines - Anal Carcinoma]
 
−
 
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=Definitive chemoradiotherapy for locally advanced disease=
 
−
==Capecitabine, Mitomycin, RT {{#subobject:6a7b17 |Regimen=1}}==
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:9368b2|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://doi.org/10.1016/S0360-3016(07)04703-7 Glynne-Jones et al. 2008 (EXTRA)]
 
−
|2004-2006
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 825 mg/m<sup>2</sup> PO twice per day on radiation days
 
−
*[[Mitomycin (Mutamycin)]] 12 mg/m<sup>2</sup> IV once on day 1
 
−
====Radiotherapy====
 
−
*Concurrent [[External_beam_radiotherapy|radiation therapy]]: 1.8 Gy per day x 28 fractions (total dose: 50.4 Gy)
 
−
 
−
'''6-week course'''
 
−
</div></div>
 
−
===References===
 
−
# '''EXTRA:''' Glynne-Jones R, Meadows H, Wan S, Gollins S, Leslie M, Levine E, McDonald AC, Myint S, Samuel L, Sebag-Montefiore D; National Cancer Research Institute Anal Sub Group; NCRI Colorectal Clinical Oncology Group. EXTRA--a multicenter phase II study of chemoradiation using a 5 day per week oral regimen of capecitabine and intravenous mitomycin C in anal cancer. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):119-26. Epub 2008 May 9. [https://doi.org/10.1016/S0360-3016(07)04703-7 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/18472366 PubMed]
 
−
 
−
==Cisplatin & Fluorouracil (CF) & RT {{#subobject:6c5a17 |Regimen=1}}==
 
−
 
−
CF & RT: '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil, '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:6d1962 |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1200/jco.1996.14.12.3121 Doci et al. 1996]
 
−
|1991-1995
 
−
| style="background-color:#91cf61" |Phase 2
 
−
| style="background-color:#d3d3d3" |
 
−
| style="background-color:#d3d3d3" |
 
−
|-
 
−
|[http://jama.ama-assn.org/content/299/16/1914.full Ajani et al. 2008 (RTOG 98-11)]
 
−
|1998-2005
 
−
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
 
−
|[[Anal_cancer#Fluorouracil.2C_Mitomycin.2C_RT|Fluorouracil, Mitomycin, RT]]
 
−
|style="background-color:#fc8d59"|Seems to have inferior OS<sup>1</sup>
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.2011.35.4837 Peiffert et al. 2012 (ACCORD 03)]
 
−
|1999-2005
 
−
| style="background-color:#91cf61" |Non-randomized portion of phase 3 RCT
 
−
| style="background-color:#d3d3d3" |
 
−
| style="background-color:#d3d3d3" |
 
−
|-
 
−
|[https://doi.org/10.1016/S1470-2045(13)70086-X James et al. 2013 (ACT II)]
 
−
|2001-2008
 
−
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
 
−
|[[Anal_cancer#Fluorouracil.2C_Mitomycin.2C_RT|Fluorouracil, Mitomycin, RT]]
 
−
|style="background-color:#ffffbf"|Did not meet primary endpoint of CR rate at 26 weeks
 
−
|-
 
−
|}
 
−
''<sup>1</sup>Reported efficacy for RTOG 98-11 is based on the 2012 update.''<br>
 
−
''Included for reference purposes only.''
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]]
 
−
*[[Fluorouracil (5-FU)]]
 
−
====Radiotherapy====
 
−
*[[External beam radiotherapy]]
 
−
 
−
</div></div>
 
−
===References===
 
−
#Doci R, Zucali R, La Monica G, Meroni E, Kenda R, Eboli M, Lozza L. Primary chemoradiation therapy with fluorouracil and cisplatin for cancer of the anus: results in 35 consecutive patients. J Clin Oncol. 1996 Dec;14(12):3121-5. [https://doi.org/10.1200/jco.1996.14.12.3121 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8955657/ PubMed]
 
−
# '''RTOG 98-11:''' Ajani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett C. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA. 2008 Apr 23;299(16):1914-21. [http://jama.ama-assn.org/content/299/16/1914.full link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18430910 PubMed] NCT00003596
 
−
## '''Update:''' Gunderson LL, Winter KA, Ajani JA, Pedersen JE, Moughan J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett CG. Long-term update of US GI intergroup RTOG 98-11 phase III trial for anal carcinoma: survival, relapse, and colostomy failure with concurrent chemoradiation involving fluorouracil/mitomycin versus fluorouracil/cisplatin. J Clin Oncol. 2012 Dec 10;30(35):4344-51. Epub 2012 Nov 13. [https://doi.org/10.1200/JCO.2012.43.8085 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3515768/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23150707 PubMed]
 
−
# '''ACCORD 03:''' Peiffert D, Tournier-Rangeard L, Gérard JP, Lemanski C, François E, Giovannini M, Cvitkovic F, Mirabel X, Bouché O, Luporsi E, Conroy T, Montoto-Grillot C, Mornex F, Lusinchi A, Hannoun-Lévi JM, Seitz JF, Adenis A, Hennequin C, Denis B, Ducreux M. Induction chemotherapy and dose intensification of the radiation boost in locally advanced anal canal carcinoma: final analysis of the randomized UNICANCER ACCORD 03 trial. J Clin Oncol. 2012 Jun 1;30(16):1941-8. Epub 2012 Apr 23. Erratum in: J Clin Oncol. 2012 Nov 1;30(31):3903. [https://doi.org/10.1200/JCO.2011.35.4837 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22529257 PubMed] NCT00003652
 
−
# '''ACT II:''' James RD, Glynne-Jones R, Meadows HM, Cunningham D, Myint AS, Saunders MP, Maughan T, McDonald A, Essapen S, Leslie M, Falk S, Wilson C, Gollins S, Begum R, Ledermann J, Kadalayil L, Sebag-Montefiore D. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2×2 factorial trial. Lancet Oncol. 2013 May;14(6):516-24. Epub 2013 Apr 9. [https://doi.org/10.1016/S1470-2045(13)70086-X link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23578724 PubMed] NCT00025090
 
−
 
−
==Fluorouracil, Mitomycin, RT {{#subobject:744af9|Regimen=1}}==
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #1, 3750/12/45 {{#subobject:6hdc9c |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1016/S0140-6736(96)03409-5 Northover et al. 1996 (ACT I)]
 
−
|1987-1994
 
−
|style="background-color:#1a9851"|Phase 3 (E-esc)
 
−
|[[Anal_cancer#Radiation_therapy|Radiation]]
 
−
|style="background-color:#1a9850"|Superior local failure rate
 
−
|-
 
−
|}
 
−
''Because there were a few different schedules used in UKCCCR Anal Cancer Trial Working Party 1996 and the update (Northover et al. 2010), there is some variability in potential schedules.''
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 750 mg/m<sup>2</sup>/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 3750 mg/m<sup>2</sup>)
 
−
*[[Mitomycin (Mutamycin)]] 12 mg/m<sup>2</sup> (maximum dose of 20 mg) IV bolus once on day 1
 
−
====Radiotherapy====
 
−
*Concurrent [[External_beam_radiotherapy|radiation therapy]]: 1.8 or 2.25 Gy fractions x 20 or 25 fractions (total dose: 45 Gy), given over 4 to 5 weeks; see Northover et al. 2010 for details, including information about boost radiation therapy
 
−
 
−
'''28-day cycle for 2 cycles'''
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #2, 3750/15/45 {{#subobject:cf4334 |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.1997.15.5.2040 Bartelink et al. 1997 (EORTC 22861)]
 
−
|1987-1994
 
−
|style="background-color:#1a9851"|Phase 3 (E-esc)
 
−
|[[Anal_cancer#Radiation_therapy|Radiation]]
 
−
|style="background-color:#1a9850"|Superior local failure rate
 
−
|-
 
−
|}
 
−
''Note: mitomycin is only given with cycle 1.''
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 750 mg/m<sup>2</sup>/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 3750 mg/m<sup>2</sup>)
 
−
*[[Mitomycin (Mutamycin)]] as follows:
 
−
**Cycle 1: 15 mg/m<sup>2</sup> IV bolus once on day 1
 
−
====Radiotherapy====
 
−
*Concurrent [[External_beam_radiotherapy|radiation therapy]]: 1.8 Gy x 25 fractions (total dose: 45 Gy)
 
−
 
−
'''28-day cycle for 2 cycles'''
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #3, 4000/10/45 {{#subobject:8659c6 |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.1996.14.9.2527 Flam et al. 1996 (ECOG E1289)]
 
−
|1988-1991
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Stub#5-FU_.26_RT|5-FU & RT]]
 
−
| style="background-color:#1a9850" |Superior DFS
 
−
|-
 
−
|[http://jama.ama-assn.org/content/299/16/1914.full Ajani et al. 2008 (RTOG 98-11)]
 
−
|1998-2005
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]]
 
−
|style="background-color:#91cf60"|Seems to have superior OS<sup>1</sup>
 
−
|-
 
−
|}
 
−
''<sup>1</sup>Reported efficacy for RTOG 98-11 is based on the 2012 update.''
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 1000 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 4000 mg/m<sup>2</sup>)
 
−
*[[Mitomycin (Mutamycin)]] 10 mg/m<sup>2</sup> (maximum dose of 20 mg) IV bolus once on day 1
 
−
====Radiotherapy====
 
−
*Concurrent [[External_beam_radiotherapy|radiation therapy]]; at a minimum: 1.8 Gy per day x 25 fractions (total dose: 45 Gy), given over 5 weeks; see articles for additional details
 
−
 
−
'''28-day cycle for 2 cycles'''
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #4, 4000/12/45 {{#subobject:63839c |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1016/S0140-6736(96)03409-5 Northover et al. 1996 (ACT I)]
 
−
|1987-1994
 
−
|style="background-color:#1a9851"|Phase 3 (E-esc)
 
−
|[[Anal_cancer#Radiation_therapy|Radiation]]
 
−
|style="background-color:#1a9850"|Superior local failure rate
 
−
|-
 
−
|}
 
−
''Because there were a few different schedules used in UKCCCR Anal Cancer Trial Working Party 1996 and the update (Northover et al. 2010), there is some variability in potential schedules.''
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 1000 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1, '''initiated at least 2 hours before the first radiation fraction''' (total dose per cycle: 4000 mg/m<sup>2</sup>)
 
−
*[[Mitomycin (Mutamycin)]] 12 mg/m<sup>2</sup> (maximum dose of 20 mg) IV bolus once on day 1
 
−
====Radiotherapy====
 
−
*Concurrent [[External_beam_radiotherapy|radiation therapy]]: 1.8 or 2.25 Gy fractions x 20 or 25 fractions (total dose: 45 Gy), given over 4 to 5 weeks; see Northover et al. 2010 for details, including information about boost radiation therapy
 
−
 
−
'''28-day cycle for 2 cycles'''
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #5, 4000/12/50.4 {{#subobject:6382ac |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1016/S1470-2045(13)70086-X James et al. 2013 (ACT II)]
 
−
|2001-2008
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|Cisplatin, Fluorouracil, RT]]
 
−
|style="background-color:#ffffbf"|Did not meet primary endpoint of CR rate at 26 weeks
 
−
|-
 
−
|}
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 1000 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 4000 mg/m<sup>2</sup>)
 
−
*[[Mitomycin (Mutamycin)]] 12 mg/m<sup>2</sup> (maximum dose of 20 mg) IV bolus once on day 1
 
−
====Radiotherapy====
 
−
*Concurrent [[External_beam_radiotherapy|radiation therapy]]: 1.8 Gy per day x 28 fractions (total dose: 50.4 Gy), given over 5.5 weeks; see paper for details
 
−
 
−
'''28-day cycle for 2 cycles'''
 
−
</div>
 
−
<div class="toccolours" style="background-color:#cbd5e7">
 
−
====Subsequent treatment====
 
−
*[[#Cisplatin_.26_Fluorouracil_.28CF.29_88|CF]] maintenance versus [[#Observation_88|no further treatment]]
 
−
 
−
</div></div>
 
−
===References===
 
−
# '''ECOG E1289:''' Flam M, John M, Pajak TF, Petrelli N, Myerson R, Doggett S, Quivey J, Rotman M, Kerman H, Coia L, Murray K; RTOG; ECOG. Role of mitomycin in combination with fluorouracil and radiotherapy, and of salvage chemoradiation in the definitive nonsurgical treatment of epidermoid carcinoma of the anal canal: results of a phase III randomized intergroup study. J Clin Oncol. 1996 Sep;14(9):2527-39. [https://doi.org/10.1200/JCO.1996.14.9.2527 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/8823332 PubMed]
 
−
# '''ACT I:''' Northover JMA, Arnott SJ, Cunningham D, Gallagher J, Gray R, Hardcastle J, Houghton J, James RD, Lennon TA, Meadows HM, Mossman J, Morgan DAL, Plowman PN, Slevin M; UKCCCR Anal Cancer Trial Working Party; UK Co-ordinating Committee on Cancer Research. Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. Lancet. 1996 Oct 19;348(9034):1049-54. [https://doi.org/10.1016/S0140-6736(96)03409-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/8874455 PubMed]
 
−
## '''Update:''' Northover J, Glynne-Jones R, Sebag-Montefiore D, James R, Meadows H, Wan S, Jitlal M, Ledermann J. Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I). Br J Cancer. 2010 Mar 30;102(7):1123-8. Epub 2010 Mar 16. [https://doi.org/10.1038/sj.bjc.6605605 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2853094/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20354531 PubMed] content property of [http://hemonc.org HemOnc.org]
 
−
# '''EORTC 22861:''' Bartelink H, Roelofsen F, Eschwege F, Rougier P, Bosset JF, Gonzalez DG, Peiffert D, van Glabbeke M, Pierart M; European Organisation for Research and Treatment of Cancer Radiotherapy Group; EORTC Gastrointestinal Cooperative Group. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organisation for Research and Treatment of Cancer Radiotherapy and Gastrointestinal Cooperative Groups. J Clin Oncol. 1997 May;15(5):2040-9. [https://doi.org/10.1200/JCO.1997.15.5.2040 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/9164216 PubMed]
 
−
# '''RTOG 98-11:''' Ajani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett C. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA. 2008 Apr 23;299(16):1914-21. [http://jama.ama-assn.org/content/299/16/1914.full link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18430910 PubMed] NCT00003596
 
−
## '''Update:''' Gunderson LL, Winter KA, Ajani JA, Pedersen JE, Moughan J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett CG. Long-term update of US GI intergroup RTOG 98-11 phase III trial for anal carcinoma: survival, relapse, and colostomy failure with concurrent chemoradiation involving fluorouracil/mitomycin versus fluorouracil/cisplatin. J Clin Oncol. 2012 Dec 10;30(35):4344-51. Epub 2012 Nov 13. [https://doi.org/10.1200/JCO.2012.43.8085 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3515768/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23150707 PubMed]
 
−
# '''ACT II:''' James RD, Glynne-Jones R, Meadows HM, Cunningham D, Myint AS, Saunders MP, Maughan T, McDonald A, Essapen S, Leslie M, Falk S, Wilson C, Gollins S, Begum R, Ledermann J, Kadalayil L, Sebag-Montefiore D. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2×2 factorial trial. Lancet Oncol. 2013 May;14(6):516-24. Epub 2013 Apr 9. [https://doi.org/10.1016/S1470-2045(13)70086-X link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23578724 PubMed] NCT00025090
 
−
 
−
==Radiation therapy {{#subobject:f4d6d6|Regimen=1}}==
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:57260e |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1016/S0140-6736(96)03409-5 Northover et al. 1996 (ACT I)]
 
−
|1987-1994
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Fluorouracil.2C_Mitomycin.2C_RT|Fluorouracil, Mitomycin, RT]]
 
−
|style="background-color:#d73027"|Inferior local failure rate
 
−
|-
 
−
|}
 
−
''Inferior to combined modality therapy; included for reference purposes only.''
 
−
====Radiotherapy====
 
−
*[[External beam radiotherapy]]
 
−
 
−
</div></div>
 
−
===References===
 
−
# '''ACT I:''' Northover JMA, Arnott SJ, Cunningham D, Gallagher J, Gray R, Hardcastle J, Houghton J, James RD, Lennon TA, Meadows HM, Mossman J, Morgan DAL, Plowman PN, Slevin M; UKCCCR Anal Cancer Trial Working Party; UK Co-ordinating Committee on Cancer Research. Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. Lancet. 1996 Oct 19;348(9034):1049-54. [https://doi.org/10.1016/S0140-6736(96)03409-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/8874455 PubMed]
 
−
## '''Update:''' Northover J, Glynne-Jones R, Sebag-Montefiore D, James R, Meadows H, Wan S, Jitlal M, Ledermann J. Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I). Br J Cancer. 2010 Mar 30;102(7):1123-8. Epub 2010 Mar 16. [https://doi.org/10.1038/sj.bjc.6605605 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2853094/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20354531 PubMed] content property of [http://hemonc.org HemOnc.org]
 
−
 
−
=Metastatic disease, first-line therapy=
 
−
==Cisplatin & Fluorouracil (CF) {{#subobject:f83c8e|Regimen=1}}==
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #1, 100/5000 every 4 weeks {{#subobject:88896f |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[http://www.jle.com/en/revues/medecine/bdc/e-docs/00/01/12/15/resume.phtml Faivre et al. 1999]
 
−
|NR in abstract
 
−
|style="background-color:#ffffbe"|Pilot, <20 patients reported
 
−
|-
 
−
|}
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV once on day 2
 
−
*[[Fluorouracil (5-FU)]] 1000 mg/m<sup>2</sup>/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 5000 mg/m<sup>2</sup>)
 
−
 
−
'''28-day cycles'''
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #2, 60/4000 every 3 weeks {{#subobject:77796f |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7406334/ Rao et al. 2020 (InterAACT)]
 
−
|2013-2017
 
−
| style="background-color:#1a9851" |Randomized Phase 2 (C)
 
−
|[[#Carboplatin_.26_Paclitaxel_.28CP.29|Carboplatin & Paclitaxel]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of ORR
 
−
|-
 
−
|}
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Fluorouracil (5-FU)]] 1000 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 4000 mg/m<sup>2</sup>)
 
−
 
−
'''21-day cycles'''
 
−
 
−
</div></div>
 
−
===References===
 
−
# Faivre C, Rougier P, Ducreux M, Mitry E, Lusinchi A, Lasser P, Elias D, Eschwege F. [5-fluorouracile and cisplatinum combination chemotherapy for metastatic squamous-cell anal cancer]. Bull Cancer. 1999 Oct;86(10):861-5. [http://www.jle.com/en/revues/medecine/bdc/e-docs/00/01/12/15/resume.phtml link to original article & English summary] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/10572237 PubMed]
 
−
<!-- # '''Abstract:''' Sclafani F et al. [InterAACT: An international multicenter open label randomized phase II advanced anal cancer trial comparing cisplatin (CDDP) plus 5-fluorouracil (5-FU) versus carboplatin (CBDCA) plus weekly paclitaxel (PTX) in patients with inoperable locally recurrent (ILR) or metastatic disease]. Journal of Clinical Oncology. 2015 33:3_suppl, TPS792-TPS792. [https://doi.org/10.1200/jco.2015.33.3_suppl.tps792 link to abstract] '''contains dosing details in abstract''' -->
 
−
#'''InterAAct:''' Rao S, Sclafani F, Eng C, Adams RA, Guren MG, Sebag-Montefiore D, Benson A, Bryant A, Peckitt C, Segelov E, Roy A, Seymour MT, Welch J, Saunders MP, Muirhead R, O'Dwyer P, Bridgewater J, Bhide S, Glynne-Jones R, Arnold D, Cunningham D. International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct. J Clin Oncol. 2020 Aug 1;38(22):2510-2518. Epub 2020 Jun 12. [https://doi.org/10.1200/jco.19.03266 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7406334/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32530769/ PubMed] NCT02051868
 
−
 
−
==Carboplatin & Paclitaxel (CP) {{#subobject:1a2b3c|Regimen=1}}==
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:88896f |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7406334/ Rao et al. 2020 (InterAACT)]
 
−
|2013-2017
 
−
| style="background-color:#1a9851" |Randomized Phase 2 (E-switch-ic)
 
−
|[[#Cisplatin_.26_Fluorouracil_.28CF.29|CF]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of ORR
 
−
|-
 
−
|}
 
−
====Chemotherapy====
 
−
*[[Carboplatin (Paraplatin)]] AUC 5 IV once on day 1
 
−
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 
−
 
−
'''28-day cycles'''
 
−
 
−
</div></div>
 
−
===References===
 
−
<!-- # '''Abstract:''' Sclafani F et al. [InterAACT: An international multicenter open label randomized phase II advanced anal cancer trial comparing cisplatin (CDDP) plus 5-fluorouracil (5-FU) versus carboplatin (CBDCA) plus weekly paclitaxel (PTX) in patients with inoperable locally recurrent (ILR) or metastatic disease]. Journal of Clinical Oncology. 2015 33:3_suppl, TPS792-TPS792. [https://doi.org/10.1200/jco.2015.33.3_suppl.tps792 link to abstract] '''contains dosing details in abstract''' -->
 
−
#'''InterAAct:''' Rao S, Sclafani F, Eng C, Adams RA, Guren MG, Sebag-Montefiore D, Benson A, Bryant A, Peckitt C, Segelov E, Roy A, Seymour MT, Welch J, Saunders MP, Muirhead R, O'Dwyer P, Bridgewater J, Bhide S, Glynne-Jones R, Arnold D, Cunningham D. International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct. J Clin Oncol. 2020 Aug 1;38(22):2510-2518. Epub 2020 Jun 12. [https://doi.org/10.1200/jco.19.03266 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7406334/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32530769/ PubMed] NCT02051868
 
−
#'''ECOG-ACRIN EA2176:''' NCT04444921
 
−
 
−
==mDCF {{#subobject:70e20f|Regimen=1}}==
 
−
 
−
mDCF: '''<u>m</u>'''odified '''<u>D</u>'''ocetaxel, '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:323b13|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://doi.org/10.1016/S1470-2045(18)30321-8 Kim et al. 2018 (Epitopes-HPV02)]
 
−
|2014-2016
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
====Chemotherapy====
 
−
*[[Docetaxel (Taxotere)]] 40 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Cisplatin (Platinol)]] 40 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Fluorouracil (5-FU)]] 1200 mg/m<sup>2</sup>/day IV continuous infusion over 48 hours, started on day 1 (total dose per cycle: 2400 mg/m<sup>2</sup>)
 
−
 
−
'''14-day cycle for 8 cycles'''
 
−
 
−
</div></div>
 
−
===References===
 
−
# '''Epitopes-HPV02:''' Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. Epub 2018 Jul 2. [https://doi.org/10.1016/S1470-2045(18)30321-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30042063 PubMed] NCT02402842
 
−
 
−
=Metastatic disease, subsequent lines of therapy=
 
−
==Nivolumab monotherapy {{#subobject:09c0df|Regimen=1}}==
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:f2c946|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5809128/ Morris et al. 2017 (NCI9673)]
 
−
|2015
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
====Immunotherapy====
 
−
*[[Nivolumab (Opdivo)]] 3 mg/kg IV once on day 1
 
−
 
−
'''14-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
# '''NCI9673:''' Morris VK, Salem ME, Nimeiri H, Iqbal S, Singh P, Ciombor K, Polite B, Deming D, Chan E, Wade JL, Xiao L, Bekaii-Saab T, Vence L, Blando J, Mahvash A, Foo WC, Ohaji C, Pasia M, Bland G, Ohinata A, Rogers J, Mehdizadeh A, Banks K, Lanman R, Wolff RA, Streicher H, Allison J, Sharma P, Eng C. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Apr;18(4):446-453. Epub 2017 Feb 18. [https://doi.org/10.1016/S1470-2045(17)30104-3 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5809128/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28223062 PubMed] NCT02314169
 
−
 
−
==Pembrolizumab monotherapy {{#subobject:82c0df|Regimen=1}}==
 
−
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:f2c123|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406758/ Ott et al. 2017a (KEYNOTE-028)]
 
−
|2014
 
−
| style="background-color:#91cf61" |Phase 1b, >20 pts in this subgroup
 
−
|-
 
−
|}
 
−
====Immunotherapy====
 
−
*[[Pembrolizumab (Keytruda)]] 10 mg/kg IV once on day 1
 
−
 
−
'''14-day cycle for up to 52 cycles (2 years)'''
 
−
 
−
</div></div>
 
−
===References===
 
−
# '''KEYNOTE-028:''' Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EMJ, Cohen RB, Gomez-Roca C, Ejadi S, Stein M, Chan E, Simonelli M, Morosky A, Saraf S, Emancipator K, Koshiji M, Bennouna J. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017 May 1;28(5):1036-1041. [https://doi.org/10.1093/annonc/mdx029 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406758/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/28453692 PubMed] NCT02054806
 
−
 
−
[[Category:Anal cancer regimens]]
 
−
[[Category:Disease-specific pages]]
 
−
[[Category:Gastrointestinal cancers]]
 

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