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document
Effect of recombinant adenovirus-p53 combined with radiotherapy on long-term prognosis of advanced nasopharyngeal carcinoma . PURPOSE To centrally assess the safety , efficacy , and 6-year follow-up of recombinant adenovirus-p53 ( rAd-p53 ) combined with radiotherapy ( RT ) for patients with nasopharyngeal carcinoma ( NPC ) . PATIENTS AND METHODS A randomized controlled clinical study on rAd-p53 combined with RT in 42 patients with NPC was compared with a control group of 40 patients with NPC treated with RT alone . In the group receiving rAd-p53 combined with RT , rAd-p53 was intratumorally injected once a week for 8 weeks . Concurrent RT ( 70 Gy in 35 fractions ) was given to the nasopharyngeal tumor and neck lymph node . Patients and tumors were monitored for adverse events and responses . RESULTS rAd-p53-specific p53 mRNA was detected in postinjection of rAd-p53 biopsies from 16 ( 94.1 % ) of 17 patients . Upregulation of p21/WAF1 and Bax and downregulation of vascular endothelial growth factor were observed in postinjection tumor biopsy . Complete response rate in the group receiving rAd-p53 combined with RT was observed at 2.73 times that of the group receiving RT alone ( 66.7 % v 24.4 % ) . Six-year follow-up data showed that rAd-p53 significantly increased the 5-year locoregional tumor control rate by 25.3 % for patients with NPC treated with irradiation ( P = .002 ) . The 5-year overall survival rate and 5-year disease-free survival rate of the group receiving rAd-p53 combined with RT were 7.5 % ( P = .34 ) and 11.7 % ( P = .21 ) higher than those of the group receiving RT alone . No dose-limiting toxicity or adverse events appeared , except for transient fever after rAd-p53 administration . CONCLUSION In patients with NPC , rAd-p53 was safe and biologically active . Our results indicated that rAd-p53 improves radiotherapeutic tumor control and survival rate in patients with NPC .
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Intervention_Pharmacological
recombinant adenovirus-p53 combined with radiotherapy
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Intervention_Pharmacological
recombinant adenovirus-p53 ( rAd-p53 ) combined with radiotherapy ( RT )
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Intervention_Pharmacological
rAd-p53 combined with RT
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Intervention_Pharmacological
RT alone .
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Intervention_Pharmacological
rAd-p53 combined with RT , rAd-p53
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Intervention_Physical
rAd-p53 combined with RT
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Intervention_Physical
RT alone
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Intervention_Pharmacological
rAd-p53
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Intervention_Pharmacological
rAd-p53 combined with RT
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Intervention_Physical
RT alone
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Intervention_Pharmacological
rAd-p53
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Intervention_Pharmacological
rAd-p53
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Intervention_Pharmacological
rAd-p53
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Outcome_Physical
long-term prognosis
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Outcome_Other
safety , efficacy , and 6-year follow-up
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Outcome_Adverse-effects
adverse events and responses .
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Outcome_Physical
rAd-p53-specific p53 mRNA
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Outcome_Physical
p21/WAF1 and Bax
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Outcome_Physical
vascular endothelial growth factor
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Outcome_Physical
Complete response rate
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Outcome_Physical
5-year locoregional tumor control rate
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Outcome_Mortality
5-year overall survival rate and 5-year disease-free survival rate
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Outcome_Adverse-effects
dose-limiting toxicity
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Outcome_Adverse-effects
transient fever
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Participant_Condition
advanced nasopharyngeal carcinoma
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Participant_Condition
nasopharyngeal carcinoma ( NPC ) .
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Participant_Sample-size
42 patients
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Participant_Condition
NPC
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Participant_Sample-size
40 patients
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Participant_Condition
NPC .