Study objective: To evaluate the efficacy of cisplatin-based combination chemotherapy in patients with advanced ovarian germ-cell tumors.
Design: Nonrandom prospective trial with endpoints of tumor response, results of repeat surgical exploration, progression-free interval, and survival.
Setting: Cooperative university-based cancer study comprising 27 participating institutions.
Patients: Ninety-seven patients were treated and all were evaluable. Of these, 8 had dysgerminoma and 89 had other cell types.
Interventions: Patients received 3 to 4 courses of cisplatin. vinblastine, and bleomycin (PVB). After chemotherapy, suitable patients had re-staging laparotomy. Maintenance vinblastine therapy was originally given but was discontinued for all patients in 1981. Patients with persistent or recurrent disease were treated with vincristine, dactinomycin, and cyclophosphamide (VAC) or etoposide plus cisplatin (EP).
Results: Of 35 patients with tumors other than dysgerminoma who had clinically measurable disease, 15 (43%; CI, 26% to 61%) had complete responses. Forty of fifty-six second-look laparotomies (71%; CI, 58% to 83%) revealed no tumor or mature teratoma. Forty-seven patients are still disease-free and 59 are alive. The survival rate is 71% (CI, 62% to 89%) and the disease-free rate is 51% (CI, 41% to 62%) at 2 years. Eight patients had durable remissions with second- or third-line therapy. Seven of eight patients with dysgerminoma are also disease-free.
Conclusions: Cisplatin-based chemotherapy is effective for patients with ovarian germ-cell tumors, is superior to previous regimens, and will cure a substantial number of patients.