[Chemo-(hormonal)-therapy of advanced ovarian neoplasms in FIGO stages III and IV. Prospective SAKK-study 20/71]

From 1971 to 1974 89 patients with advanced ovarian cancer (FIGO-stage III-IV), admitted to seven centers of the Swiss Group for Clinical Cancer Research (SAKK), were randomly allocated to three different treatment schedules: cyclophosphamide (CYT) alone or CYT in combination with either medroxyprogesterone acetate (GEST) or 5-fluorouracil (FU). Results in 71 evaluable patients (according to standardized group criterial) were as follows: 1. The overall remission rate was 48% (34 out of 71 patients) with no clear-cut statistical difference between the three treatment schedules but a firm trend towards higher remission rate with CYT + FU (58% as compared to 42% with CYT alone). 2. The scheduled "second-look" operations were performed in only 5 of 34 patients clinically judged to respond to therapy (PR), and does not allow objective surgical monitoring of therapeutic effects intraabdominally. 3. The median remission duration varied from 3 months (CYT alone) to 6 months (CYT + FU or CYT + GEST), again with only marginal statistical differences. 4. With regard to survival from initiation of chemotherapy, no treatment regimen was superior to another. The median survival ranged from 6.6 months (CYT) to 10.3 months (CYT + GEST). Patients responding to chemo-(hormone) therapy (CR + PR + NC) showed a significant prolongation of survival as compared to those with initial disease progression: median survival in "responders" was 11 months and in "non-responders" 2.9 months. A small group of 8-10% of all treated patients has survived in documented tumor remission for 4 years and more. 5. Toxicity was moderate and consisted mainly of mild temporary hematologic depression, tolerable nausea and transient alopecia, with equal distribution in the three treatment regimens. Hemorrhagic cystitis due to CYT was observed only in 3 cases. 6. Progress in remission induction and duration, as well as survival in advanced ovarian cancer, seems to depend on the inclusion of new effective agents (such as adriamycin, hexamethylmelamine and cisplatinum) and, most probably, on significantly more intensive treatment.