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document
Induction chemotherapy in head and neck cancer : results of a phase III trial . Between December 1982 and October 1986 , 131 patients with stage II-III-IV squamous cell carcinoma of the oropharynx or oral cavity were randomized to induction chemotherapy , consisting of bleomycin ( 10 mg/m2/day in continuous infusion from day 1 to day 5 ) , methotrexate ( 120 mg/m2 on day 2 ) followed by folinic acid , 5-fluorouracil ( 5 FU ) ( 600 mg/m2 on day 2 ) , and cisplatin ( 120 mg/m2 on day 4 ) every 4 weeks for a total of three cycles followed by definitive locoregional treatment versus locoregional treatment alone . The modalities of definitive treatment ( radiotherapy +/- surgery ) were chosen prior to randomization . A total of 116 patients were evaluable . Of 55 patients in the chemotherapy arm , four ( 7 % ) had a complete response ( CR ) and 23 ( 42 % ) a partial response ( PR ) following the induction regimen . At the completion of locoregional treatment , 76 % ( 42 of 55 ) of patients in the experimental group were in CR compared to 89 % ( 54 of 61 ) in the control group . There was no difference in survival , cause-specific survival , and pattern of relapse between both groups . The median survival was 22 months in the chemotherapy group and 29 months in the control group . Responders to chemotherapy did not fare better than nonresponders . Chemotherapy-related toxicities were few and most of them related to cisplatin which was reduced to 100 mg/m2 for 35 patients . There were no treatment-related deaths and , in the experimental arm of the trial , no increased morbidity from locoregional treatment . This induction regimen does not offer any advantages over standard treatment .
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Intervention_Pharmacological
Induction chemotherapy
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Intervention_Pharmacological
induction chemotherapy , consisting of bleomycin ( 10 mg/m2/day in continuous infusion from day 1 to day 5 ) , methotrexate ( 120 mg/m2 on day 2 ) followed by folinic acid , 5-fluorouracil ( 5 FU ) ( 600 mg/m2 on day 2 ) , and cisplatin ( 120 mg/m2 on day 4 ) every 4 weeks
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Intervention_Control
locoregional treatment
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Intervention_Surgical
radiotherapy
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Intervention_Surgical
surgery
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Intervention_Physical
chemotherapy
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Outcome_Mortality
survival
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Outcome_Mortality
cause-specific survival
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Outcome_Physical
pattern of relapse
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Outcome_Mortality
median survival
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Outcome_Adverse-effects
Chemotherapy-related toxicities
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Outcome_Mortality
deaths
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Outcome_Adverse-effects
morbidity
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Participant_Condition
head and neck cancer
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Participant_Condition
stage II-III-IV squamous cell carcinoma of the oropharynx or oral cavity
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Participant_Sample-size
116 patients were evaluable