Phase II study of neoadjuvant treatment of @entity5 with XXXX , raltitrexed and radiotherapy.

@entity1 @entity901 @entity137 @entity138 @entity5 @entity1398 @entity420
UNASSIGNED: 3746 Background and objective: Preoperative chemoradiation can improve the outcome of surgery in @entity5 . The aim of this phase II study was to evaluate the efficacy and @entity137 of a preoperative radiochemotherapy combination including @entity901 , raltitrexed and radiotherapy in locoregionally advanced @entity5 . METHODS: Between January 2002 and July 2003, 43 consecutive @entity1 (22 @entity1 , 21 @entity1 ; median age 61 years, range 34-74) with stage II and III rectal @entity420 have been enrolled. All @entity1 underwent endorectal ultrasonography (uT2N1= 2, uT3N0= 14, uT3N1= 23, uT4N0= 1, uT4N1= 3), and CT scan for staging purposes. Radiotherapy was delivered with a three-field technique to a dose of 50Gy over 5 weeks with a concomitant boost approach. Chemotherapy was initiated concurrently with @entity138 and consisted of three courses of raltitrexed 3 mg/m2 followed by @entity901 130 mg/m2 every 21 days. Surgery was planned six to eight weeks after @entity138 . Three additional cycles of chemotherapy were given after surgery. RESULTS: 33 @entity1 can be evaluated for response and 43 for @entity137 . 25 @entity1 were downstaged (76%), there were 6 pathological complete responses (18%) and sphincter sparing surgery was accomplished in 22 @entity1 (67%). Grade 3 diarrea developed in two @entity1 , and grade 4 in one @entity1 (7%). Grade 3 @entity1398 was observed in three @entity1 (7%), including one @entity1398 . Other adverse events were mild, including grade 2 hepatotoxicity (transaminases) in 5 @entity1 (11%). CONCLUSION: The regimen is feasible, has a low @entity137 profile and can be administered in a three weeks basis. This treatment achieves significant @entity5 downstaging with a remarkable rate of conservative surgeries and complete pathological responses. No significant financial relationships to disclose.
