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Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus . BACKGROUND The efficacy of conventional treatment with surgery and radiation for cancer of the esophagus is limited . The median survival is less than 10 months , and less than 10 percent of patients survive for 5 years . Recent studies have suggested that combined chemotherapy and radiation therapy may result in improved survival . METHODS This phase III prospective , randomized , and stratified trial was undertaken to evaluate the efficacy of four courses of combined fluorouracil ( 1000 mg per square meter of body-surface area daily for four days ) and cisplatin ( 75 mg per square meter on the first day ) plus 5000 cGy of radiation therapy , as compared with 6400 cGy of radiation therapy alone , in patients with squamous-cell carcinoma or adenocarcinoma of the thoracic esophagus . The trial was stopped after the accumulated results in 121 patients demonstrated a significant advantage for survival in the patients who received chemotherapy and radiation therapy . RESULTS The median survival was 8.9 months in the radiation-treated patients , as compared with 12.5 months in the patients treated with chemotherapy and radiation therapy . In the former group , the survival rates at 12 and 24 months were 33 percent and 10 percent , respectively , whereas they were 50 percent and 38 percent in the patients receiving combined therapy ( P less than 0.001 ) . Seven patients in the radiotherapy group and 25 in the combined-therapy group were alive at the time of the analysis . The patients who received combined treatment had fewer local ( P less than 0.02 ) and fewer distant ( P less than 0.01 ) recurrences . Severe and life-threatening side effects occurred in 44 percent and 20 percent , respectively , of the patients who received combined therapy , as compared with 25 percent and 3 percent of those treated with radiation alone . CONCLUSIONS Concurrent therapy with cisplatin and fluorouracil and radiation is superior to radiation therapy alone in patients with localized carcinoma of the esophagus , as measured by control of local tumors , distant metastases , and survival , but at the cost of increased side effects .
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Intervention_Physical
Combined chemotherapy and radiotherapy
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Intervention_Physical
radiotherapy alone
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Intervention_Physical
combined chemotherapy and radiation therapy
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Intervention_Pharmacological
fluorouracil ( 1000 mg per square meter of body-surface area daily for four days )
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Intervention_Pharmacological
cisplatin ( 75 mg per square meter on the first day )
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Intervention_Physical
5000 cGy of radiation therapy
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Intervention_Physical
6400 cGy of radiation therapy
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Intervention_Physical
chemotherapy and radiation therapy
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Intervention_Physical
chemotherapy and radiation therapy
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Intervention_Physical
combined therapy
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Intervention_Physical
radiotherapy
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Intervention_Physical
combined-therapy
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Intervention_Physical
Concurrent therapy with cisplatin and fluorouracil and radiation
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Intervention_Physical
radiation therapy
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Outcome_Mortality
median survival
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Outcome_Mortality
survival rates
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Outcome_Mortality
alive
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Outcome_Physical
local
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Outcome_Physical
distant
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Outcome_Physical
recurrences
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Outcome_Adverse-effects
Severe and life-threatening side effects