A phase-II trial of dose-dense chemotherapy in patients with disseminated thymoma: Report of a Japan Clinical Oncology Group trial (JCOG 9605)

Abstract

Background: To evaluate the safety and efficacy of dose-dense weekly chemotherapy in the treatment of advanced thymoma.Methods:Subjects comprised patients with histologically documented chemotherapy-nave thymoma with stage-IVa or IVb disease. Thymic carcinoma, carcinoid or lymphoma cases were excluded. Patients received 9 weeks of chemotherapy: cisplatin (25 mg m 2) on weeks 1-9; vincristine (1 mg m 2) on weeks 1, 2, 4, 6 and 8; and doxorubicin (40 mg m 2) and etoposide (80 mg m 2) on days 1-3 of weeks 1, 3, 5, 7 and 9. Chemotherapy courses were supported by granulocyte colony-stimulating factor. Post-protocol local therapy was allowed.Results:From July 1997 to March 2004, 30 patients were entered. Three were ineligible due to different histology. Chemotherapy- associated toxicity was mainly haematological and was well tolerated, with no deaths due to toxicity, and 87% of patients completed the planned 9-week regimen. Overall response rate was 59%, with 16 of the 27 eligible patients achieving partial response. Median progression-fee survival (PFS) was 0.79 years (95% confidence interval: 0.52-1.40 years), and PFS at 1 and 2 years was 37 and 15%, respectively. Overall survival rates at 2 and 5 years were 89 and 65%, respectively.Conclusion:In stage-IV thymoma patients, weekly dose-dense chemotherapy offers similar activity to conventional regimens. © 2009 Cancer Research UK All rights reserved.