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| |  High-Dose Sequential Chemo Does Not Improve Outcomes in Poor-Prognosis Germ Cell Tumours: Presented at ASCO-GU By Fred Gebhart SAN FRANCISCO -- March 8, 2010 -- A phase 3 trial presented here at the 2010 Genitourinary Cancers Symposium (ASCO-GU) has found that high-dose sequential chemotherapy does not improve outcomes as a first-line treatment for advanced, poor-prognosis germ cell tumours. The trial was ended early at the first planned interim analysis due to lack of efficacy and incomplete accrual. Final data from the shortened study were presented during a poster presentation on March 6 by Roberto Salvioni, MD, Fondazione IRCCS Instituto Nazionale dei Tumori, Milan, Italy. The multicentre trial was based on promising results seen in phase 1 and phase 2 trials, which suggested that high-dose sequential chemotherapy might offer improved outcomes compared with conventional chemotherapy for patients with advanced poor-prognosis germ cell tumours. The small early trials pointed to a 2-year survival advantage of 15% to 20% for more intensive treatment. In 1996, researchers launched a phase 3 study comparing 2 regimens: 4 cycles of cisplatin, etoposide, and bleomycin (PEB) versus high-dose sequential treatment starting with 2 cycles of PEB followed by a high-dose cyclophosphamide, 2 cycles PEB plus high-dose etoposide phosphate, and high-dose carboplatin with autologous stem-cell transplantation. Postchemotherapy surgery was planned when possible. The primary endpoint was 2-year survival, using an accrual of 50 patients in each arm to detect a 20% improvement in patients in the high-dose sequential treatment arm. Between December 1996 and April 2007, only 89 patients were accrued: 46 randomised to PEB and 43 to high-dose sequential chemotherapy. Of the original group, 84 patients (94%) could be evaluated for response and outcome. The median follow-up period was 50 months. On an intent-to-treat basis, patients in the high-dose sequential arm had a somewhat higher rate of complete response (60% vs 46%) at the interim analysis. Patients in the high-dose sequential arm also had slightly lower rates of partial response (14% vs 20%) and incomplete response (23% vs 26%). There was no difference in overall survival at 2 years, 66.8% for patients in the PEB arm and 60.5% in the high-dose sequential arm (P = .42). There was also no difference in disease-free survival at 2 years, 58.5% for both arms (P = .94). There was little difference in disease progression -- 39% in the PEB arm and 44% in the high-dose sequential arm. Time to progression was similar -- 4 months in the PEB arm and 5 months in the high-dose sequential arm. Dr. Salvioni concluded that high-dose sequential chemotherapy offers no advantages as first-line treatment for patients with advanced germ cell tumours who have a poor prognosis. The conference is sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Therapeutic Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO). [Presentation title: High-Dose Sequential Chemotherapy (HDS) Versus Conventional-Dose Chemotherapy (CT) as First-Line Treatment for Advanced Poor Prognosis Germ Cell Tumors (GCT): A Multicenter Phase III Italian Trial. Abstract 260]
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