Anal cancer

Page editor		Section editor
	Ari Seifter, MD University of Illinois at Chicago Chicago, IL		Neeta K. Venepalli, MD, MBA University of Illinois at Chicago Chicago, IL

9 regimens on this page 13 variants on this page

Guidelines

ESMO

• Anal cancer: ESMO-ESSO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed

NCCN

• NCCN Guidelines - Anal Carcinoma

Definitive chemoradiotherapy for locally advanced disease

Capecitabine, Mitomycin, RT

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Regimen

Study	Evidence
Glynne-Jones et al. 2008	Phase II

Chemoradiotherapy

• Capecitabine (Xeloda) 825 mg/m² PO twice per day on radiation days
• Mitomycin (Mutamycin) 12 mg/m² IV once on day 1
• Concurrent radiation therapy: 1.8 Gy per day x 28 fractions (total dose: 50.4 Gy)

6-week course

References

1. 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 and 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 contains protocol PubMed

Cisplatin, Fluorouracil, RT

Fluorouracil, cisplatin, radiation therapy for anal cancer

Fluorouracil, Mitomycin, RT

Fluorouracil, mitomycin, radiation therapy for anal cancer

Radiation therapy

Radiation therapy for anal cancer

Metastatic disease, first-line therapy

Cisplatin & Fluorouracil

Fluorouracil & cisplatin for anal cancer

mDCF

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mDCF: modified Docetaxel, Cisplatin, Fluorouracil

Regimen

Study	Evidence
Kim et al. 2018 (Epitopes-HPV02)	Phase II

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

1. 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 PubMed

Metastatic disease, subsequent lines of therapy

Nivolumab monotherapy

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Regimen

Study	Evidence
Morris et al. 2017 (NCI9673)	Phase II

Immunotherapy

• Nivolumab (Opdivo) 3 mg/kg IV once on day 1

14-day cycles

References

1. 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 PubMed

Pembrolizumab monotherapy

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Regimen

Study	Evidence
Ott et al. 2017 (KEYNOTE-028)	Phase Ib, >20 pts in this subgroup

Immunotherapy

• Pembrolizumab (Keytruda) 10 mg/kg IV once on day 1

14-day cycle for up to 2 years

References

1. 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. link to original article link to PMC article contains protocol PubMed