Preoperative radiation with concurrent chemotherapy for resectable rectal cancer: effect of dose escalation on pathologic complete response, local recurrence-free survival, disease-free survival, and overall survival.

摘要: Purpose: Three Phase II studies of preoperative radiotherapy and concurrent 5FU chemotherapy were undertaken. The primary endpoints acute toxicity pathologic complete response rate (pCR). Secondary local recurrence-free survival (LRFS), disease-free (DFS), overall (OS). Methods Materials: A total 134 patients with adenocarcinoma the rectum (clinical T3/T4 or N1/N2) treated. initial cohort received 40 Gy in 20 fractions, second 46 23 third 50 25 fractions. (225 mg/m 2 /day) was given continuously throughout radiotherapy. 121 underwent surgical resection. Results: Treatment well tolerated. Grade 3/4 observed 13%, 4%, 14% Gy, cohorts, respectively ( p = 0.20). pCR documented 15%, 23%, 33% patients, 0.07). 2-year actuarial LRFS 72%, 90%, 89% 0.02); DFS 62%, 84%, 78% OS 94%, 92%, 0.03). Conclusions: All treatment schedules There a trend toward increased higher doses. statistically significant increase LRFS, DFS, seen radiation doses greater, but there no difference between Gy.