PHASE-II STUDY OF DOSE-DENSE HIGH-DOSE CHEMOTHERAPY TREATMENT WITH PERIPHERAL-BLOOD PROGENITOR-CELL SUPPORT AS PRIMARY-TREATMENT FOR PATIENTS WITH ADVANCED OVARIAN-CANCER

Purpose: We performed a pilot phase II study to evaluate the potential for delivery of rapidly sequenced high-dose chemotherapy treatments r escued with autologous peripheral-blood progenitor cells (PBP) in pati ents with previously untreated, advanced ovarian cancer. Patients and Methods: A single cycle of mobilization was used, primed with cyclopho sphamide (CPA)/paclitaxel (Txl) and filgrastim (granulocyte colony-sti mulating factor [G-CSF]), followed by three cycles of high-dose carbop latin (CBDCA)/Txl and one cycle of high-dose melphalan (MEL), each res cued by PBP. We then analyzed the outcome for a total of 56 consecutiv e patients treated with high-dose chemotherapy as part of this program . Results: In the phase II pilot, 21 patients were enrolled. There wer e no treatment-related deaths through 98 high-dose treatments, althoug h 34 treatments were complicated by hospitalization, primarily for neu tropenic fever. Seventy-six percent of patients experienced grade 3 to 4 gastrointestinal toxicity and 62% experienced grade 2 to 3 neuropat hy. Five of 15 (33%) patients who underwent second-look surgery attain ed a pathologic complete response. In the overall analysis, 56 patient s were reviewed. Forty-four patients were assessable for response by s econd-look surgery or clinical progression. Fifteen of 44 patients ach ieved a pathologic complete response (34%). The pathologic complete re sponse rate in optimal disease patients was 12 of 22 (55%), while only three of 22 (13%) suboptimal stage III and IV patients achieved a pat hologic complete response. Conclusion: The Gynecologic Oncology Group has initiated a pilot phase II trial of this approach in patients with optimally debulked stage III ovarian cancer. There is no evidence to support the use of this or other aggressive regimens outside of a clin ical trial.