76302
document
The effects of delay in standard treatment due to induction chemotherapy in two randomized prospective studies . It is often suggested that tumors will respond to induction chemotherapy and result in improved survival for patients with squamous cell carcinoma of the head and neck . Two regimens of induction chemotherapy were studied in separate randomized , prospective trials over the last 6 years . Eighty-three patients with advanced disease were entered into the first study ( 43/chemotherapy ; 40/control ) , and 60 into the second ( 27/chemotherapy ; 33/control ) . Patient randomization was stratified by stage ( III/IV ) and site ( oral cavity , oropharynx , nasopharynx , hypopharynx , larynx , paranasal sinuses ) . The first study utilized bleomycin , Cytoxan , methotrexate and 5-fluorouracil in two cycles ( one cycle if no tumor response ) , followed by standard treatment which consisted of combined irradiation and surgery or , in some instances , primary irradiation alone . The second study utilized cisplatin and 5-fluorouracil in three cycles prior to standard treatment . An objective tumor response to chemotherapy was observed in 68 % in the first study and 85 % in the second . The patient survival in both studies ( at 24 months in the first ; at 19 in the second ) was better in the control than that in the experimental groups ( 43 % to 31 % ; 69 % to 46 % ) . In the second study , the average length of delay of standard treatment was longer than in the first study ( 95 days vs. 66 days ; P less than .02 ) . Results combining the P-values of both studies indicate that the relative risk of having persistent disease was 2.9 times greater for patients who received chemotherapy . While toxicity to chemotherapy was not a factor in survival , the number of patients who withdrew from the studies and those who did not comply with treatment were greater in the chemotherapy groups . Except for new drug regimens of exceptional promise , it is recommended that future studies be designed so that chemotherapy is given concurrent with , or following the completion of standard treatment .
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Intervention_Pharmacological
induction chemotherapy
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Intervention_Pharmacological
utilized bleomycin
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Intervention_Pharmacological
Cytoxan
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Intervention_Pharmacological
methotrexate
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Intervention_Pharmacological
5-fluorouracil
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Intervention_Pharmacological
consisted of combined irradiation and surgery or , in some instances , primary irradiation
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
5-fluorouracil
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Intervention_Control
prior to standard treatment
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Outcome_Mortality
survival
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Outcome_Other
objective tumor response
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Outcome_Mortality
patient survival
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Outcome_Other
average length of delay of standard treatment
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Outcome_Physical
toxicity to chemotherapy
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Participant_Condition
patients with squamous cell carcinoma of the head and neck .