Anal cancer

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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

Chemotherapy & radiation therapy

Fluorouracil, mitomycin, radiation therapy

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Regimen #1

Study	Evidence	Comparator	Efficacy
James et al. 2013 (ACT II)	Phase III	Fluorouracil, Cisplatin, radiation	Seems not superior

Chemotherapy

• Fluorouracil (5-FU) 1000 mg/m²/day IV continuous infusion on days 1 to 4, 29 to 32
• Mitomycin (Mutamycin) 12 mg/m² (maximum dose per cycle: 20 mg) IV bolus once on day 1
• Concurrent radiation therapy: 1.8 Gy per day x 28 fractions (total dose: 50.4 Gy), given over 5.5 weeks; see paper for details

5.5-week course

Patients were then randomized to maintenance cisplatin & fluorouracil vs. observation.

Regimen #2

Study	Evidence	Comparator	Efficacy
UKCCCR Anal Cancer Trial Working Party 1996 (ACT I)	Phase III	Radiation	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/m²/day IV continuous infusion over 4 days (total dose for the week's treatment: 4000 mg/m²) during the first and last weeks of radiation therapy, started at least 2 hours before the first radiation fraction
  • Alternate dosing & schedule (per physician discretion): Fluorouracil (5-FU) 750 mg/m²/day IV continuous infusion over 5 days (total dose for the week's treatment: 3750 mg/m²) during the first and last weeks of radiation therapy
• Mitomycin (Mutamycin) 12 mg/m² (maximum dose per cycle: 20 mg) IV bolus once on day 1
• Concurrent 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

4 or 5-week course

Regimen #3

Study	Evidence	Comparator	Efficacy
Ajani et al. 2008 (RTOG 98-11)	Phase III	Fluorouracil, Cisplatin, radiation	Seems not superior

Chemotherapy

• Fluorouracil (5-FU) 1000 mg/m²/day IV continuous infusion on days 1 to 4, 29 to 32
• Mitomycin (Mutamycin) 10 mg/m² (maximum dose per cycle: 20 mg) IV bolus once per day on days 1 & 29
• Concurrent radiation therapy; at a minimum: 1.8 Gy per day x 25 fractions (total dose: 45 Gy), given over 5 weeks; see article for additional details

5-week course

References

1. UKCCCR Anal Cancer Trial Working Party. UK Co-ordinating Committee on Cancer Research. Lancet. 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 contains verified protocol PubMed
   1. 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 contains verified protocol PubMed content property of HemOnc.org
2. 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 contains verified protocol PubMed
3. 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. link to original article contains verified protocol PubMed

Radiation therapy

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Regimen

Study	Evidence	Comparator	Efficacy
UKCCCR Anal Cancer Trial Working Party 1996 (ACT I)	Phase III	Fluorouracil, Mitomycin, radiation	Inferior local failure rate

Inferior to combined modality therapy; included for reference purposes only.

References

1. UKCCCR Anal Cancer Trial Working Party. UK Co-ordinating Committee on Cancer Research. Lancet. Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. 1996 Oct 19;348(9034):1049-54. link to original article contains verified protocol PubMed
   1. 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 contains verified protocol PubMed

Chemotherapy

Fluorouracil & Cisplatin

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Regimen

Study	Evidence
Faivre et al. 1999	Pilot, <20 patients reported

Chemotherapy

• Fluorouracil (5-FU) 1000 mg/m²/day IV continuous infusion on days 1 to 5
• Cisplatin (Platinol) 100 mg/m² IV once on day 2

28-day cycles

References

1. 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]. [Article in French] Bull Cancer. 1999 Oct;86(10):861-5. link to original article & English summary contains protocol PubMed