A MULTICENTER RANDOMIZED PHASE-II TRIAL OF GRANULOCYTE-COLONY-STIMULATING FACTOR-SUPPORTED, PLATINUM-BASED CHEMOTHERAPY WITH FLEXIBLE MIDCYCLE CISPLATIN ADMINISTRATION IN PATIENTS WITH ADVANCED OVARIAN-CARCINOMA

BACKGROUND. The purpose of this study was to analyze whether the addit ion of granulocyte-colony stimulating factor (G-CSF) to platinum-based combination chemotherapy could increase platinum dose intensity and r esponse rates and decrease hematologic toxicity in patients with advan ced epithelial ovarian carcinoma. METHODS. Patients with untreated adv anced ovarian carcinoma (International Federation of Gynecology and Ob stetrics [FIGO] Stage IIC-IV) were treated after maximum debulking sur gery with cyclophosphamide, 750 mg/m(2), and carboplatin, 350 mg/m(2), on Day 1 plus cisplatin, 75 mg/m(2), on Day 14 when clinically indica ted (adequate bone marrow and renal function). Patients were randomize d to receive chemotherapy alone (Arm A) or chemotherapy supported with G-CSF (5 mu g/kg subcutaneously on Days 2-13; Arm B). RESULTS. Betwee n November 1993 and April 1995, 80 patients were included. Seventy-eig ht patients were evaluable for dose intensity calculations. Both group s were well matched with regard to age, Eastern Cooperative Oncology G roup performance status, histopathologic subtype, tumor grade, FIGO st age, and residual tumor after surgery. The dose intensities calculated in mg/m(2)/week for cycle phosphamide and carboplatin were similar in both groups; however, the dose intensity of cisplatin was higher in A rm B (5.7 mg/m(2) vs. 10.3 mg/m(2)). The occurrence of Common Toxicity Criteria Grade 3-4 neutropenia was less common in the G-CSF arm (55% vs. 7.7%). Response rates (52% vs. 68%) and pathologic complete respon ses (32% vs. 25%) were similar in both groups. CONCLUSIONS. The additi on of G-CSF to this platinum-based chemotherapy regimen in patients wi th advanced ovarian carcinoma resulted in a modest increment in platin um dose intensity and appeared to reduce the incidence of Grade 3-4 ne utropenia. Cancer 1998;83:719-25. (C) 1998 American Cancer Society.