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Nigro protocol

Nigro protocol
SpecialtyOncology

The Nigro protocol is the preoperative use of chemotherapy with 5-fluorouracil and mitomycin and medical radiation for squamous cell carcinomas of the anal canal.[1][2]

Treatment

Success of the preoperative regimen changed the paradigm of anal cancer treatment from surgical to non-surgical and was the advent of definitive chemoradiation (omitting surgery) being accepted as a standard-of-care for anal squamous cell carcinomas. Larger doses of radiation are used in modern chemoradiotherapy protocols versus the original Nigro protocol radiotherapy dose.

In the Nigro protocol, the patient receives 30 Gy (3000 rads) of radiation over a three-week period, as well as continuous administration of fluorouracil for the first four days and on days 20–31, with bolus mitomycin on day 1.[3] It is named after Norman Nigro (1912–2009),[4] who developed it in the mid-1970s.[5] In cases of patients who still have residual disease after receiving the protocol, they should undergo salvage APR (abdomino-perineal resection); adequate time should be allowed for regression. The immediate complete response rate was in the 75% range in Nigro's original reports. Response to treatment can be evaluated every 6-8 weeks for many months if disease is regressing or clinically stable. Any sign of progressive disease should prompt reassessment of disease with biopsy and subsequent surgery with the aforementioned APR.[6]

A 2024 systematic review of the literature found that chemoradiation with 5-FU and mitomycin C, as used in the Nigro Protocol, improves outcomes like colostomy-free survival in anal cancer patients compared to alternatives like cisplatin. However, it can lead to more severe side effects, especially blood-related toxicity.[7]

References

  1. ^ Al Hallak, M.Najeeb; George Hage-Nassar; Anas Mouchli (2010). "Primary Submucosal Squamous Cell Carcinoma of the Rectum Diagnosed by Endoscopic Ultrasound: Case Report and Literature Review". Case Reports in Gastroenterology. 4 (2): 243–249. doi:10.1159/000319013. ISSN 1662-0631. PMC 2929423. PMID 20805951.
  2. ^ Nigro ND, Vaitkevicius VK, Buroker T, Bradley GT, Considine B (1981). "Combined therapy for cancer of the anal canal". Dis. Colon Rectum. 24 (2): 73–5. doi:10.1007/bf02604287. PMID 7215078. S2CID 32047935.
  3. ^ Ehrenpreis, Eli (2003). Anal and Rectal Diseases Explained. Remedica. pp. 113. ISBN 9781901346671.
  4. ^ "In Memoriam: Norman D. Nigro, M.D., 1912–2009" (PDF). ASCRS News. The American Society of Colon and Rectal Surgeons. Winter 2010. pp. 8–9. Archived from the original (PDF) on 10 May 2017. Retrieved 13 August 2016.
  5. ^ Blumetti, Jennifer; Bastawrous, Amir (27 May 2009). "Epidermoid Cancers of the Anal Canal: Current Treatment". Clinics in Colon and Rectal Surgery. 22 (2): 077–083. doi:10.1055/s-0029-1223838. PMC 2780240. PMID 20436831.
  6. ^ Nirula, Raminder (2006). High-yield Surgery. Lippincott Williams & Wilkins. p. 64. ISBN 9780781776561.
  7. ^ Troester, Alexander; Parikh, Romil; Southwell, Bronwyn; Ester, Elizabeth; Sultan, Shahnaz; Greeno, Edward; Arsoniadis, Elliot; Church, Timothy R; Wilt, Timothy; Butler, Mary; Goffredo, Paolo (2024-08-20). "Treatment of stage I-III squamous cell anal cancer: a comparative effectiveness systematic review". JNCI: Journal of the National Cancer Institute. doi:10.1093/jnci/djae195. ISSN 0027-8874. PMC 11807441.
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