A Phase II Study of the Combination of Topotecan, Ara-C, Cisplatin and Prednisolone (Toposhap) for Slavage of Primary Refractory and Relapsed Patients with Lymphoid Malignancies.

Introduction: Topotecan has activity in several hematological malignancies. We have previosuly described a phase I trial of the combination of Topotecan, Cisplatin, Ara-C and Prednisolone (TOPOSHAP) (

Patients and Methods: We treated 22 patients (19 to 73 years old) with primary refractory or relapsed Acute lymphoblastic leukemia (ALL), Non-Hodgkin’s Lymphoma (NHL) or Hodgkin’s disease (HD), with measurable disease, with the TOPOSHAP regimen in the aforementioned doses. Tumor reponse was evaluated after the second cycle of this regimen.

Results: Fifty four cycles of chemotherapy were given, ranging from 2 to 6 per patient. One patient died before completing the second cycle of chemotherapy. In the 19 evaluable patients we observed a response rate of 53% (5 CR and 6 PR). All patients had grade IV myelotoxicity and 8 required dose reduction. Seven patients had febrile neutropenia and 3 had mucositis, 2 had diarrhea and 1 had WHO grade 1 renal insuficiency.

Conclusion: We conclude that the TOPOSHAP regimen is an active regimen for the salvage of refractory or relapsed patients with hematological lymphoid malignancies.