Capecitabine/Mitomycin versus 5-Fluorouracil/Mitomycin in Combination with Simultaneous Integrated Boost...

Area of Science:

• Oncology
• Radiation Oncology
• Medical Oncology

Background:

• The EXTRA trial established capecitabine, mitomycin, and radiation therapy (RT) as an alternative to 5-FU for localized squamous cell carcinoma of the anal canal (SCCAC).
• Limited data exist on the comparative efficacy of capecitabine versus 5-FU in chemoradiation therapy (CRT) using simultaneous integrated boost (SIB) radiation therapy (SIB-IMRT) for SCCAC.

Purpose of the Study:

• To compare the efficacy and toxicity of capecitabine-based versus 5-FU-based CRT with SIB-RapidArc in patients with localized SCCAC.
• To evaluate progression-free survival (PFS) and acute toxicities as primary endpoints.

Main Methods:

• A prospective monocentric cohort study included 147 patients with localized SCCAC (T2-4 N, M0 or T, N1-3 M0).
• Group 1 (n=91) received SIB-RapidArc RT with mitomycin C and 5-FU daily for 7 weeks.
• Group 2 (n=56) received SIB-RapidArc RT with capecitabine daily for 7 weeks.

Main Results:

• With a median follow-up of 53.5 months, 3-year PFS rates were 80% (Group 1) and 75% (Group 2) (p=0.32).
• 3-year colostomy-free survival rates were 92% (Group 1) and 85% (Group 2) (p=0.11).
• Grade 3+ acute toxicities occurred in 35.5% (Group 1) and 21.4% (Group 2) (p=0.10), with a trend towards fewer toxicities with capecitabine.

Conclusions:

• Capecitabine/mitomycin with SIB RapidArc RT demonstrates comparable efficacy to 5-FU-based chemotherapy for anal cancer.
• The capecitabine regimen is well-tolerated, showing a trend towards reduced acute toxicity.
• SIB RapidArc RT offers a consistent treatment approach for SCCAC, facilitating comparative treatment analyses.