Anal cancer

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Last updated on 2024-07-23:9 regimens on this page
14 variants on this page
 
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==ASCO==
*2024: Morris et al. Systemic Therapy for Stage I-III Anal Squamous Cell Carcinoma: ASCO Guideline EuroPMC
==ESMO==
*2021: Rao et al. Anal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up EuroPMC
**2014: Glynne-Jones et al. Anal cancer: ESMO-ESSO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up EuroPMC
**2010: Glynne-Jones et al. Anal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up EuroPMC
**2009: Glynne-Jones et al. Anal cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up EuroPMC
==French Intergroup==
*2017: Moureau-Zabotto et al. Anal cancer: French Intergroup Clinical Practice Guidelines for diagnosis, treatment and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, SNFCP) EuroPMC
==NCCN==
*NCCN Guidelines - Anal Carcinoma
**2023: Benson et al. Anal Carcinoma, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology. EuroPMC
**2018: Benson et al. Anal Carcinoma, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology link to PMC article EuroPMC
**2012: Benson et al. Anal Carcinoma, Version 2.2012: featured updates to the NCCN guidelines. EuroPMC
**2010: Engstrom et al. NCCN clinical practice guidelines in oncology. Anal carcinoma. EuroPMC
**2005: Engstrom et al. Anal canal cancer clinical practice guidelines in oncology. EuroPMC
**2003: Engstrom et al. Anal canal cancer. Clinical practice guidelines in oncology EuroPMC
=Definitive chemoradiotherapy for locally advanced disease=
==Capecitabine, Mitomycin, RT==
===Regimen===
Study 	Dates of enrollment	Evidence
Glynne-Jones et al. 2008 (EXTRA)	2004-2006 	Phase 2
====Chemotherapy====
*Capecitabine (Xeloda) 825 mg/m2 PO twice per day on days 1 to 5, 8 to 12, 15 to 19, 22 to 26, 29 to 33, 35 to 37
*Mitomycin (Mutamycin) 12 mg/m2 IV once on day 1
====Radiotherapy====
*Concurrent radiation therapy 180 cGy per day on days 1 to 5, 8 to 12, 15 to 19, 22 to 26, 29 to 33, 35 to 37 (28 fractions; total dose: 5040 cGy)
6-week course
===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. link to original article dosing details in abstract have been reviewed by our editors EuroPMC
==Cisplatin & Fluorouracil (CF) & RT==
CF & RT: Cisplatin, Fluorouracil, Radiation Therapy
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Doci et al. 1996 	1991-1995 	Phase 2 	 	
Ajani et al. 2008 (RTOG 98-11) 	1998-2005 	Phase 3 (E-switch-ic) 	Fluorouracil, Mitomycin, RT	Seems to have shorter OS1 (secondary endpoint)
Peiffert et al. 2012 (ACCORD 03)	1999-2005 	Non-randomized part of phase 3 RCT	 	
James et al. 2013 (ACT II) 	2001-2008 	Phase 3 (E-switch-ic) 	Fluorouracil, Mitomycin, RT	Did not meet primary endpoint of CR rate at 26 weeks
1Reported efficacy for RTOG 98-11 is based on the 2012 update.
Included for reference purposes only.
====Chemotherapy====
*Cisplatin (Platinol) 60 mg/m2 (maximum dose of 120 mg) IV once per day on days 1 & 29
*Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours, started on days 1 & 29 (total dose: 8000 mg/m2)
====Radiotherapy====
*External beam radiotherapy 5040 cGy delivered in 28 daily fractions over 5.5 weeks
8-week course
===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. link to original article EuroPMC
# 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. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC 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. link to original article link to PMC article EuroPMC
# 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. link to original article EuroPMC NCT00003652
##HRQoL analysis: Tournier-Rangeard L, Mercier M, Peiffert D, Gerard JP, Romestaing P, Lemanski C, Mirabel X, Pommier P, Denis B. Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03). Radiother Oncol. 2008 Jun;87(3):391-7. Epub 2008 Jan 11. link to original article EuroPMC
# 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, 2x2 factorial trial. Lancet Oncol. 2013 May;14(6):516-24. Epub 2013 Apr 9. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00025090
==Fluorouracil, Mitomycin, RT==
===Regimen variant #1, 3750/12/45===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Northover et al. 1996 (ACT I)	1987-1994 	Phase 3 (E-esc)	Radiation 	Higher 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/m2/day IV continuous infusion over 120 hours, started on days 1 & 29 (total dose: 7500 mg/m2)
*Mitomycin (Mutamycin) 12 mg/m2 (maximum dose of 20 mg) IV bolus once per day on days 1 & 29
====Radiotherapy====
*Concurrent radiation therapy 1.8 or 225 cGy fractions x 20 or 25 fractions (total dose: 4500 cGy), given over 4 to 5 weeks; see Northover et al. 2010 for details, including information about boost radiation therapy
8-week course
 
===Regimen variant #2, 3750/15/45===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Bartelink et al. 1997 (EORTC 22861)	1987-1994 	Phase 3 (E-esc)	Radiation 	Higher local failure rate
Note: mitomycin is only given with cycle 1.
====Chemotherapy====
*Fluorouracil (5-FU) 750 mg/m2/day IV continuous infusion over 120 hours, started on days 1 & 29 (total dose: 7500 mg/m2)
*Mitomycin (Mutamycin) 15 mg/m2 IV bolus once on day 1
====Radiotherapy====
*Concurrent radiation therapy 180 cGy per day on days 1 to 5, 8 to 12, 15 to 19, 22 to 26, 29 to 33 (25 fractions; total dose: 4500 cGy)
5-week course
 
===Regimen variant #3, 4000/10/45===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Flam et al. 1996 (ECOG E1289) 	1988-1991 	Phase 3 (C)	5-FU & RT 	Longer DFS
Ajani et al. 2008 (RTOG 98-11)	1998-2005 	Phase 3 (C)	CF & RT 	Seems to have longer OS1
1Reported efficacy for RTOG 98-11 is based on the 2012 update.
====Chemotherapy====
*Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours, started on days 1 & 29 (total dose: 8000 mg/m2)
*Mitomycin (Mutamycin) 10 mg/m2 (maximum dose of 20 mg) IV bolus once per day on days 1 & 29
====Radiotherapy====
*Concurrent radiation therapy at a minimum, 180 cGy per day x 25 fractions (total dose: 4500 cGy), given over 5 weeks; see articles for additional details
5-week course
 
===Regimen variant #4, 4000/12/45===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Northover et al. 1996 (ACT I)	1987-1994 	Phase 3 (E-esc)	Radiation 	Higher 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/m2/day IV continuous infusion over 96 hours, started on days 1 & 29, initiated at least 2 hours before the first radiation fraction (total dose: 8000 mg/m2)
*Mitomycin (Mutamycin) 12 mg/m2 (maximum dose of 20 mg) IV bolus once per day on days 1 & 29
====Radiotherapy====
*Concurrent radiation therapy 1.8 or 225 cGy fractions x 20 or 25 fractions (total dose: 4500 cGy), given over 4 to 5 weeks; see Northover et al. 2010 for details, including information about boost radiation therapy
8-week course
 
===Regimen variant #5, 4000/12/50.4===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
James et al. 2013 (ACT II)	2001-2008 	Phase 3 (C)	Cisplatin, Fluorouracil, RT	Did not meet primary endpoint of CR rate at 26 weeks
====Chemotherapy====
*Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours, started on days 1 & 29 (total dose: 8000 mg/m2)
*Mitomycin (Mutamycin) 12 mg/m2 (maximum dose of 20 mg) IV bolus once on day 1
====Radiotherapy====
*Concurrent radiation therapy 180 cGy per day on days 1 to 5, 8 to 12, 15 to 19, 22 to 26, 29 to 33, 35 to 37 (28 fractions; total dose: 5040 cGy); see paper for details
6-week course
====Subsequent treatment====
*CF maintenance versus no further treatment
===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. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
# 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. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
## 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. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC content property of 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. link to original article dosing details in abstract have been reviewed by our editors EuroPMC
# 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. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC 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. link to original article link to PMC article EuroPMC
# 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, 2x2 factorial trial. Lancet Oncol. 2013 May;14(6):516-24. Epub 2013 Apr 9. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00025090
==Radiation therapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Northover et al. 1996 (ACT I)	1987-1994 	Phase 3 (C)	Fluorouracil, Mitomycin, RT	Lower local failure rate
Inferior to combined modality therapy; included for reference purposes only.
====Radiotherapy====
*External beam radiotherapy
===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. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
## 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. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC content property of HemOnc.org
=Metastatic disease, first-line therapy=
==Cisplatin & Fluorouracil (CF)==
===Regimen variant #1, 100/5000 every 4 weeks===
Study 	Dates of enrollment 	Evidence
Faivre et al. 1999	Not reported in abstract	Pilot, fewer than 20 patients reported
Note: The full manuscript was not available for review.
====Chemotherapy====
*Cisplatin (Platinol) 100 mg/m2 IV once on day 2
*Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 5000 mg/m2)
28-day cycles
 
===Regimen variant #2, 60/4000 every 3 weeks===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Rao et al. 2020 (InterAACT)	2013-2017 	Randomized Phase 2 (C)	Carboplatin & Paclitaxel	Did not meet primary endpoint of ORR
====Chemotherapy====
*Cisplatin (Platinol) 60 mg/m2 IV once on day 1
*Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
21-day cycle for 8 cycles
===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. link to original article & English summary dosing details in abstract have been reviewed by our editors EuroPMC
#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. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02051868
==Carboplatin & Paclitaxel (CP)==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Rao et al. 2020 (InterAACT)	2013-2017 	Randomized Phase 2 (E-switch-ic)	CF 	Did not meet primary endpoint of ORR
====Chemotherapy====
*Carboplatin (Paraplatin) AUC 5 IV once on day 1
*Paclitaxel (Taxol) 80 mg/m2 IV once per day on days 1, 8, 15
28-day cycle for 6 cycles
===References===
#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. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02051868
#ECOG-ACRIN EA2176: NCT04444921
==mDCF==
mDCF: modified Docetaxel, Cisplatin, Fluorouracil
===Regimen===
Study 	Dates of enrollment	Evidence
Kim et al. 2018 (Epitopes-HPV02)	2014-2016 	Phase 2
====Chemotherapy====
*Docetaxel (Taxotere) 40 mg/m2 IV once on day 1
*Cisplatin (Platinol) 40 mg/m2 IV once on day 1
*Fluorouracil (5-FU) 1200 mg/m2/day IV continuous infusion over 48 hours, started on day 1 (total dose per cycle: 2400 mg/m2)
14-day cycle for 8 cycles
===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. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02402842
=Metastatic disease, subsequent lines of therapy=
==Nivolumab monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence
Morris et al. 2017 (NCI9673)	2015-05-14 to 2015-11-11	Phase 2
====Immunotherapy====
*Nivolumab (Opdivo) 3 mg/kg IV once on day 1
14-day cycles
===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. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02314169
==Pembrolizumab monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Efficacy
Ott et al. 2017a (KEYNOTE-028anal)	2014-04 to 2014-09 	Phase 1b, >20 pts in this subgroup	ORR: 17%, 95% CI 5-37
====Immunotherapy====
*Pembrolizumab (Keytruda) 10 mg/kg IV once on day 1
14-day cycle for up to 52 cycles (2 years)
===References===
# KEYNOTE-028anal: 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. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02054806
Category:Anal cancer regimens
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Category:Gastrointestinal cancers