Simultaneous Integrated Boost–Intensity Modulated Radiation Therapy With Concomitant Capecitabine and Mitomycin C for Locally Advanced Anal Carcinoma: A Phase 1 Study

摘要: Purpose Newer radiation techniques, and the application of continuous 5-FU exposure during therapy using oral capecitabine may improve treatment anal cancer. This phase 1, dose-finding study assessed feasibility efficacy simultaneous integrated boost–intensity modulated (SIB-IMRT) with concomitant mitomycin C in locally advanced cancer, including pharmacokinetic pharmacogenetic analyses. Methods Materials Patients carcinoma were treated SIB-IMRT 33 daily fractions 1.8 Gy to primary tumor macroscopically involved lymph nodes 1.5 electively bilateral iliac inguinal node areas. received a sequential boost dose 3 × on macroscopic residual if this was still present week 5 treatment. Mitomycin 10 mg/m 2 (maximum 15 mg) administered intravenously day 1, given orally dose-escalated fashion (500-825 b.i.d.) irradiation days, until dose-limiting toxicity emerged ≥2 maximally 6 patients. An additional 8 patients at maximum tolerated (MTD). Results A total 18 included. The MTD determined be 825 b.i.d. predominant acute grade ≥3 toxicities included dermatitis (50%), fatigue (22%), pain (6%). Fifteen (83% [95%-CI: 66%-101%]) achieved complete response, (17%) partial response. With median follow-up 28 months, none responders, responders had relapsed. Conclusions single days resulted an acceptable safety profile, proved tolerable effective regimen for