79040
document
A prospective randomized clinical trial of melphalan and cis-platinum versus hexamethylmelamine , adriamycin , and cyclophosphamide in advanced ovarian cancer . From May 1978 until November 1980 , 169 previously untreated patients with advanced epithelial ovarian cancer were entered into a prospective randomized clinical trial comparing the combination of hexamethylmelamine , Adriamycin , and cyclophosphamide ( HAC ) to a combination of melphalan and cis-platinum . Eleven patients were excluded from analysis and another 5 patients were excluded from response analysis . Of 153 patients evaluable for response , there were 47 , or 30.7 % , complete responders ( all determined surgically ) , 6 partial responders , and 100 nonresponders . The response rate for the HAC group was 31 % and for the melphalan-platinum group was 37.8 % . The overall response rate was 34.6 % . Residual tumor diameter ( less than or greater than 2 cm ) exerted a statistically significant effect on response -- 47.8 vs 24.4 % . Of the 47 complete responders , 7 , or 14.9 % , have relapsed , with the median duration of remission of 44+ months . Of the 158 patients evaluable for survival , 90 patients have died , with a median survival time of 27.9 months ( HAC = 26.4 months , melphalan-platinum = 29.6 months ) . Age , FIGO stage , histologic grade , and residual disease all exerted a significant effect on survival time . Second-line therapy in the treatment failures was of no benefit . Hematologic toxicity was greater in the melphalan-platinum group . Gastrointestinal toxicity was severe in both groups . Other toxicities were minor and infrequent .
79041
Intervention_Pharmacological
melphalan and cis-platinum
79042
Intervention_Pharmacological
hexamethylmelamine , adriamycin , and cyclophosphamide
79043
Intervention_Pharmacological
hexamethylmelamine , Adriamycin , and cyclophosphamide ( HAC )
79044
Intervention_Pharmacological
combination of melphalan and cis-platinum
79045
Intervention_Pharmacological
HAC
79046
Intervention_Pharmacological
melphalan-platinum
79047
Intervention_Pharmacological
HAC
79048
Intervention_Pharmacological
melphalan-platinum
79049
Intervention_Pharmacological
melphalan-platinum
79050
Outcome_Physical
complete responders
79051
Outcome_Physical
response rate
79052
Outcome_Mortality
survival
79053
Outcome_Mortality
median survival time
79054
Outcome_Adverse-effects
Hematologic toxicity
79055
Outcome_Adverse-effects
Gastrointestinal toxicity
79056
Outcome_Adverse-effects
Other toxicities
79057
Participant_Condition
advanced ovarian cancer
79058
Participant_Sample-size
169
79059
Participant_Condition
previously untreated
79060
Participant_Condition
advanced epithelial ovarian cancer
79061
Participant_Sample-size
Eleven
79062
Participant_Sample-size
153
79063
Participant_Sample-size
158