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document
Multicenter randomized phase 2 clinical trial of a recombinant human endostatin adenovirus in patients with advanced head and neck carcinoma . A randomized , open-label , phase 2 , multicenter clinical trial was conducted to evaluate the efficacy and safety of the addition of a recombinant human endostatin adenovirus ( E10A ) to cisplatin and paclitaxel in patients with advanced head and neck squamous cell carcinoma or nasopharyngeal carcinoma . Patients with locally advanced or metastatic head and neck squamous cell carcinoma or nasopharyngeal carcinoma not suitable for operation or radiotherapy were randomly assigned to receive E10A plus chemotherapy every 3 weeks for a maximum of six cycles or to receive chemotherapy only . One hundred and thirty-six eligible patients were randomly assigned . The addition of E10A did not significantly improve the objective response rate ( 29.9 versus 39.7 % , P = 0.154 ) . However , patients who received endostatin had longer progression-free survival ( 7.03 versus 3.60 months , P = 0.006 ; hazard ratio : 0.55 ) . The combination of E10A with chemotherapy benefited prior chemotherapy-treated patients and those who received three to four treatment cycles ( 6.50 versus 3.43 months , P = 0.003 ; 8.27 versus 4.27 months , P = 0.018 ; respectively ) . The overall disease control rate significantly increased from 80.6 % in the control group to 92.6 % in the test group ( P = 0.034 ) . Except for fever , no adverse events were associated with the E10A treatment . In summary , E10A plus chemotherapy is a safe and effective therapeutic approach in patients with advanced head and neck squamous cell carcinoma or nasopharyngeal carcinoma .
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Intervention_Pharmacological
recombinant human endostatin adenovirus
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Intervention_Pharmacological
recombinant human endostatin adenovirus ( E10A ) to cisplatin and paclitaxel
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Intervention_Pharmacological
E10A plus chemotherapy
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Intervention_Control
chemotherapy only
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Outcome_Other
efficacy and safety
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Outcome_Physical
objective response rate
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Outcome_Mortality
progression-free survival
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Outcome_Physical
overall disease control rate
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Outcome_Physical
fever
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Outcome_Adverse-effects
adverse events
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Outcome_Other
safe and effective therapeutic approach
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Participant_Condition
patients with advanced head and neck carcinoma .
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Participant_Condition
patients with advanced head and neck squamous cell carcinoma or nasopharyngeal carcinoma . Patients with locally advanced or metastatic head and neck squamous cell carcinoma or nasopharyngeal carcinoma not suitable for operation or radiotherapy
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Participant_Sample-size
One hundred and thirty-six
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Participant_Condition
patients with advanced head and neck squamous cell carcinoma or nasopharyngeal carcinoma .