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document
Pathological response and safety of two neoadjuvant strategies with bevacizumab in MRI-defined locally advanced T3 resectable rectal cancer : a randomized , noncomparative phase II study . BACKGROUND In T3 rectal cancer ( RC ) , preoperative chemoradiotherapy [ 5-fluorouracil ( 5-FU-RT ) ] reduces local recurrences , but does not affect overall survival . New therapeutic options are still necessary to improve clinical outcomes . PATIENTS AND METHODS This randomized , noncomparative , open-label , multicenter , two arms , phase II study was conducted in MRI-defined locally advanced T3 resectable RC . In arm A , patients received 12-week bevacizumab plus 5-FU , leucovorin and oxaliplatin ( Folfox-4 ) followed with bevacizumab-5-FU-RT before total mesorectal excision ( TME ) . In arm B , patients received only bevacizumab-5-FU-RT before TME . Primary end point was pathological complete response ( pCR ) rate . RESULTS Forty-six patients were randomized in arm A and 45 patients in arm B . In arm A , the rate of pCR was 23.8 % [ 95 % confidence interval ( CI ) 12.1 % to 39.5 % ] statistically superior to the defined standard rate of 10 % , P = 0.015 . In arm B , the rate of pCR of 11.4 % ( 95 % CI 3.8 % to 24.6 % ) was not different from 10 % , P = 0.906 . No death occurred during the study period , from the start until 8 weeks following surgery . Postoperative fistulas were reported for 16 patients ( 7 in arm A and 9 in arm B ) . CONCLUSION Even if the addition of bevacizumab induced manageable toxicities including an increased risk of postoperative fistula and no treatment-related death , arm B did not achieve the expected pCR rate in the population of patients included . Induction bevacizumab-Folfox-4 followed by bevacizumab-5-FU-RT is promising . It is however necessary to continue investigations in the management of locally advanced RC . CLINICAL TRIALSGOV IDENTIFIER NCT 00865189 .
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
chemoradiotherapy [ 5-fluorouracil ( 5-FU-RT ) ]
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Intervention_Pharmacological
bevacizumab plus 5-FU , leucovorin and oxaliplatin ( Folfox-4 ) followed with bevacizumab-5-FU-RT before total mesorectal excision ( TME )
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Intervention_Pharmacological
bevacizumab-5-FU-RT before TME .
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Intervention_Pharmacological
bevacizumab-Folfox-4
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Intervention_Pharmacological
bevacizumab-5-FU-RT