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document
A phase II study of cetuximab , capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer . BACKGROUND Neoadjuvant chemoradiotherapy ( CRT ) reduces local tumor recurrence in locally advanced rectal cancer ( LARC ) . This phase II study assessed neoadjuvant cetuximab with capecitabine-based CRT in LARC . METHODS Patients with stage II/III LARC received capecitabine 1250 mg/m ( 2 ) twice daily for 2 weeks followed by intravenous cetuximab 400 mg/m ( 2 ) at week 3 , then weekly intravenous 250 mg/m ( 2 ) cetuximab plus CRT including capecitabine 825 mg/m ( 2 ) twice daily ( including weekends during radiotherapy ) with radiotherapy of 45 Gy ( 25 x 1.8 Gy ) , 5 days a week for 5 weeks . Total mesorectal excision was scheduled 4-6 weeks following completion of CRT . The primary endpoint was pathological complete response ( pCR ) . RESULTS Thirty-seven patients were eligible for safety and efficacy . TMN staging at baseline was : T4N2 , 11 % ; T3N2 , 40 % ; T2N2 , 3 % ; T3N1 , 35 % ; T2N1 , 3 % and T3N0 8 % . The most common adverse events included , grade 1/2 acneiform skin rash ( 86 % ) , and grade 3 radiodermatitis , ( 16 % ) , diarrhea ( 11 % ) and hypersensitivity ( 5 % ) . pCR was achieved in 3 patients ( 8 % ) . Overall- , T- and N-downstaging rates were 73 % , 57 % and 81 % respectively . Total sphincter preservation rate was 76 % , and 53 % in 17 patients whose tumors were located within 5 cm from the anal verge . Non-fatal perioperative complications occurred in 13 patients ( 35 % ) with delayed wound healing occurring in 6 patients ( 16 % ) . One death was recorded due to sepsis following colonic necrosis . CONCLUSION Neoadjuvant cetuximab with capecitabine-based CRT is tolerable in patients with resectable LARC . Whilst the pCR rate was similar to recent reports , a high pathological downstaging rate was achieved .
43693
Intervention_Pharmacological
cetuximab
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Intervention_Pharmacological
capecitabine
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Intervention_Pharmacological
radiotherapy
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Intervention_Physical
chemoradiotherapy ( CRT )
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Intervention_Pharmacological
capecitabine
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Intervention_Pharmacological
intravenous cetuximab
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Intervention_Pharmacological
cetuximab plus CRT
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Intervention_Pharmacological
capecitabine
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Intervention_Physical
radiotherapy
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Intervention_Pharmacological
cetuximab with capecitabine-based CRT
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Outcome_Other
pathological complete response ( pCR )
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Outcome_Other
safety and efficacy
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Outcome_Physical
TMN
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Outcome_Adverse-effects
grade 1/2 acneiform skin rash
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Outcome_Adverse-effects
grade 3 radiodermatitis
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Outcome_Adverse-effects
diarrhea
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Outcome_Adverse-effects
hypersensitivity
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Outcome_Other
pCR
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Outcome_Other
T- and N-downstaging rates
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Outcome_Other
Total sphincter preservation rate
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Outcome_Adverse-effects
Non-fatal perioperative complications
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Outcome_Adverse-effects
delayed wound healing
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Participant_Condition
locally advanced resectable rectal cancer
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Participant_Condition
stage II/III LARC
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Participant_Sample-size
Thirty-seven
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Participant_Sample-size
17
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Participant_Sample-size
13
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Participant_Sample-size
6
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Participant_Condition
resectable LARC