77063
document
A randomized , prospective trial of adjuvant chemotherapy in adults with soft tissue sarcomas of the head and neck , breast , and trunk . Since 1977 , 31 patients were entered in a randomized , prospective study testing the efficacy of adjuvant chemotherapy after aggressive local treatment of high-grade sarcomas of the head , neck , breast , and trunk ( excluding retroperitoneal sarcomas ) . All patients had complete resection of gross tumor and underwent postoperative radiotherapy ( 6000-6300 rads over 7-8 weeks ) . Seventeen patients received adjuvant chemotherapy consisting of doxorubicin ( less than or equal to 550 mg/m2 ) , cyclophosphamide ( less than or equal to 5500 mg/m2 ) , and methotrexate ( less than or equal to 1000 mg/kg ) . Three-year actuarial disease-free survival in the chemotherapy arm was 77 % , compared to 49 % in the no-chemotherapy arm ( P = 0.075 ) . Three-year overall actuarial survivals in the two treatment arms , however , were 68 % and 58 % , respectively ( P = 0.38 ) . Considering only patients with tumors of the trunk ( 22 patients ) , 3-year actuarial disease-free survival in the chemotherapy arm was 92 % , compared to 47 % in the no-chemotherapy arm ( P = 0.006 ) . Actuarial 3-year overall survival in the chemotherapy arm was 82 % , compared to 61 % in the no-chemotherapy arm ( P = 0.18 ) . An additional 26 patients were treated in an identical fashion , but were not part of the randomized trial because of contraindications to chemotherapy , refusal to enter the randomized trial , or because they were treated before 1977 in a trial in which all patients received chemotherapy . Considering the entire group of 57 patients , follow-up ranged from 10 to 86 months ( median , 35 months ) . Local control was achieved in 46 patients ( 81 % ) ; 3-year actuarial disease-free and overall survivals were 67 % and 77 % , respectively . A tendency toward improved disease-free survival was apparent among patients treated with chemotherapy ( P = 0.018 ) , but there was no statistically significant improvement in overall actuarial survival ( P = 0.46 ) . The subgroup of patients with sarcomas of the trunk ( 39 patients ) demonstrated the greatest benefit from chemotherapy , with regard to disease-free survival ( P less than or equal to 0.001 ) . The most significant toxicity associated with chemotherapy was doxorubicin-induced cardiomyopathy , which resulted in clinically apparent congestive heart failure in five patients . Thus , the use of chemotherapy when combined with aggressive local measures appears to improve disease-free survival , but additional patients and longer follow-up are necessary to determine if improved overall survival will result .
77064
Intervention_Pharmacological
adjuvant chemotherapy
77065
Intervention_Pharmacological
adjuvant chemotherapy
77066
Intervention_Surgical
resection of gross tumor
77067
Intervention_Physical
postoperative radiotherapy
77068
Intervention_Pharmacological
adjuvant chemotherapy consisting of doxorubicin ( less than or equal to 550 mg/m2 )
77069
Intervention_Pharmacological
cyclophosphamide ( less than or equal to 5500 mg/m2 )
77070
Intervention_Pharmacological
methotrexate ( less than or equal to 1000 mg/kg
77071
Intervention_Pharmacological
chemotherapy
77072
Intervention_Control
no-chemotherapy
77073
Intervention_Pharmacological
chemotherapy
77074
Intervention_Pharmacological
chemotherapy
77075
Intervention_Pharmacological
doxorubicin-induced
77076
Intervention_Pharmacological
chemotherapy
77077
Outcome_Mortality
actuarial disease-free survival
77078
Outcome_Mortality
overall actuarial survivals
77079
Outcome_Other
Local control
77080
Outcome_Mortality
actuarial disease-free and overall survivals
77081
Outcome_Mortality
disease-free survival
77082
Outcome_Mortality
overall actuarial survival
77083
Outcome_Mortality
disease-free survival
77084
Outcome_Physical
toxicity
77085
Outcome_Adverse-effects
doxorubicin-induced cardiomyopathy
77086
Outcome_Physical
congestive heart failure
77087
Outcome_Mortality
disease-free survival
77088
Outcome_Mortality
overall survival
77089
Participant_Age
adults
77090
Participant_Condition
with soft tissue sarcomas of the head and neck , breast , and trunk .
77091
Participant_Sample-size
57
77092
Participant_Sample-size
subgroup of patients with sarcomas of the trunk ( 39 patients )