What is the administration protocol for 5-Fluorouracil (5-FU)/Mitomycin (mitomycini) combined with radiation therapy (RT) for stage 3 anal cancer?

From the Guidelines

For stage 3 anal cancer, the standard treatment is concurrent chemoradiation therapy using 5-fluorouracil (5-FU) and mitomycin C combined with radiation therapy, with a recommended dose of mitomycin C at 10 mg/m² (max 20 mg) once per day on day 1 and day 29, or 12 mg/m² (max 20 mg) once on day 1 only, and 5-FU at 1,000 mg/m² (continuous infusion) once per day on days 1-4 (week 1) and 29-32 (week 5) 1. The treatment regimen involves:

• 5-FU administered as a continuous intravenous infusion at 1,000 mg/m²/day on days 1-4 and days 29-32
• Mitomycin C given as an intravenous bolus at 10 mg/m² on days 1 and 29, or 12 mg/m² on day 1 only
• Radiation therapy delivered concurrently, typically at a total dose of 50-54 Gy to the primary tumor and involved lymph nodes, with 45 Gy to areas at risk for microscopic disease
• Daily fractions of 1.8-2 Gy, five days per week, over approximately 5-6 weeks Patients require close monitoring during treatment for side effects including myelosuppression, mucositis, dermatitis, and diarrhea. Supportive care with hydration, antiemetics, and skin care is essential. Some key points to consider:
• The use of mitomycin C and 5-FU is recommended as the radiosensitizing component of chemoradiation for anal cancer, with a strong recommendation based on moderate evidence quality 1
• Cisplatin with 5-FU is an additional chemotherapy combination that may be recommended as the radiosensitizing component of chemoradiation, with a strong recommendation based on moderate evidence quality 1
• Routine induction chemotherapy prior to CRT is not recommended for patients with localized anal cancer, with a strong recommendation based on moderate evidence quality 1
• Additional chemotherapy following CRT is not recommended for patients with localized anal cancer, with a strong recommendation based on moderate evidence quality 1

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Treatment Overview

• The treatment for anal cancer stage 3 typically involves a combination of chemotherapy and radiation therapy (RT) 2, 3, 4, 5.
• The chemotherapy regimen often includes 5-fluorouracil (5-FU) and mitomycin C (MMC), with or without cisplatin (CDDP) 2, 3, 4, 5.

Chemotherapy Regimen

• The 5-FU/MMC regimen is a common combination used in conjunction with RT for anal cancer treatment 2, 3, 5.
• The regimen typically consists of 5-FU administered as a 24-hour intravenous (IV) infusion, and MMC administered as a single IV dose 4.
• Cisplatin may be added to the regimen, either as a replacement for MMC or in addition to it 3, 4, 5.

Radiation Therapy

• RT is typically administered concurrently with chemotherapy, with a total dose of 55-59.4 Gy delivered over 4-6 weeks 2, 4, 5.
• The radiation field includes the anal region, perineum, middle and lower pelvis, and inguinal and external iliac nodes 4.

Treatment Outcomes

• The combination of 5-FU/MMC and RT has been shown to be effective in treating anal cancer, with complete response rates ranging from 70-94% 2, 3, 4, 5.
• The addition of cisplatin to the regimen may improve treatment outcomes, with one study showing a complete response rate of 70.6% 3.
• Long-term follow-up has confirmed the good results of chemoradiotherapy with 5-FU/MMC and RT, with 5-year overall survival rates ranging from 52-86% 2, 5.