• 1 January 1984
    • journal article
    • research article
    • Vol. 68  (12) , 1433-1438
Abstract
Patients (33) with advanced-stage ovarian adenocarcinomas, with no prior chemotherapy, were treated with weekly cisplatin (DDP) for 4 courses followed by 5 monthly courses of 1 of 2 randomly assigned multidrug combinations. These combinations were high-dose methotrexate-leucovorin plus cyclophosphamide (MECY) or cyclophosphamide, hexamethylmelamine, doxorubicin and DDP (CHAD). Patients with no clinically measurable disease after 6 mo. of therapy were evaluated by laparoscopy. In the absence of disease progression at the time of the laparoscopy, the study design called for a repeat cycle of 4 weekly DDP courses and another 5 monthly courses of the assigned multidrug combination. All patients with no evidence of disease after 1 yr of treatment had a 2nd-look laparoscopy which, if negative, was followed by a 2nd-look laparotomy. This report includes all of the consecutively entered patients observed for a minimum of 1 yr or to death. DDP-MECY and DDP-CHAD were similarly active for overall response rates and complete response rates according to laparscopic criteria. DDP-MECY had a statistically significantly lower relapse rate (P < 0.02) and a statistically significantly higher negative 2nd-look laparotomy rate than did DDP-CHAD. Using all entered patients, with no exclusions from analysis, 8 of 17 patients (47%) treated with DDP-MECY had negative 2nd-looks after 1 yr of treatment. This compares with 1 of 16 (6%) negative 2nd-looks in patients treated with DDP-CHAD (P < 0.02). The high negative 2nd-look rate with DDP-MECY is exciting. Positive cytologic washings at the 6-mo., laparoscopic evaluation were highly predictive that residual disease would be found at the 1 yr 2nd-look surgery. Only 1 patient with positive peritoneal cytology after 6 mo. of treatment was found to have a negative 2nd-look after 1 yr of therapy.