Published in:
01-09-2011 | Original Article
Preoperative radiotherapy with capecitabine and mitomycin C in locally advanced rectal carcinoma
Published in: Cancer Chemotherapy and Pharmacology | Issue 3/2011
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Purpose
To evaluate the efficacy and safety of preoperative radiotherapy with capecitabine and mitomycin C in patients with locally advanced rectal cancer.
Methods
A prospective, open-label, non-randomized, phase II study was performed on 49 patients with locally advanced rectal cancer. Preoperative radiotherapy was conducted on linear accelerators (15 or 18 MV) with a tumor dose of 45 Gy in 25 fractions over 5 weeks, combined with mitomycin C 7 mg/m2 on days 1 and 29 and oral capecitabine 825 mg/m2 twice daily on days 1–35. Surgery was performed 5–6 weeks after the end of chemoradiation. The primary study endpoint was histopathological complete regression rate (pCR; Dworak grade 4).
Results
Disease stage at diagnosis was T3 in 34 patients (69%) and T4 in 15 patients (31%). Positive lymph nodes were diagnosed in 28 patients (57%). Toxicity (all grades) was documented in 35 patients (71%). Grade 3 toxicities were radiation dermatitis (25%), diarrhea (2%), neutropenia (2%), and granulocytopenia (2%). No patient experienced grade 4 toxicity. A pCR was seen in 8 (16%, 95% CI 9–29%) patients, a major response was noted in 24 (49%) patients and a minor response in 14 (29%) patients. R0 resection was performed in 46 patients (93.9%) and R1 in 3 patients (6.1%). Histopathological tumor downstaging was documented in 26 patients (53%). One-year disease-free survival was 93.3% and 1-year survival was 97.7%.
Conclusion
Preoperative chemoradiation with capecitabine and mitomycin C appeared to be effective with low toxicity in patients with locally advanced rectal cancer.