Ballonoff A et al. - In a study to evaluate the feasibility, safety, and pathologic response rate of preoperative capecitabine and accelerated synchronous integrated boost (SIB) intensity-modulated radiotherapy (IMRT) in pts with locally advanced rectal cancer, it was shown that preoperative chemoradiation with capecitabine and SIB-IMRT is well tolerated and results in an encouraging pCR rate for these pts Methods
Consenting operable pts with stage II or III adenocarcinoma of the rectum received capecitabine (825 mg/m2 PO BID, 5 days/wk x 5 weeks) and SIB-IMRT delivering 55 Gy (2.2 Gy/fraction) to the gross tumor while simultaneously delivering 45 Gy (1.8 Gy/fraction) to the regional lymph nodes and areas at risk for harboring microscopic disease
Total mesorectal excision followed 6 weeks later
A single pathologist analyzed the resected tumor's TNM stage and Mandard regression/response scores
The primary end point was pathologic complete response (pCR) rate
Results
10 subjects were enrolled, 2 of which were ineligible; the remaining 8 pts were evaluable
All 8 completed chemoradiation with strict compliance to the protocol schedule and then went on to surgical resection
At a median follow-up of 26 months, all pts were alive without evidence of recurrent disease
The crude pCR rate was 38% with 50% achieving down-staging
Of 3 pts who had tumors within 5 cm of the anal verge, 2 underwent sphincter-sparing procedures
Grade 4 diarrhea occurred in 1 of 8 pts; the remaining toxicities were grade 1 or 2
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