A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma.
Patients suffering from lymphoma (a type of cancer of the white blood cells called
lymphocytes) have less chance of cure if they are refractory to initial chemotherapy or
relapse after receiving initial chemotherapy when compared to patients who are responsive to
and do not relapse following initial chemotherapy. The standard of care, therefore, for
these patients is to undergo some form of bone marrow transplant procedure. However, before
this can be considered most patients require chemotherapy to control the lymphoma and to
determine whether the lymphoma is still sensitive to alternative types of chemotherapy
(salvage chemotherapy). Currently used types of salvage chemotherapy require significant
periods of inpatient hospitalisation and are associated with significant haematological
toxicities (low blood counts with the associated risks of infection and bleeding and the
need for blood and platelet transfusions). Two new chemotherapy drugs, vinorelbine and
gemcitabine, have both shown encouraging efficacy against lymphoma when used alone for
patients with heavily pretreated lymphoma. Furthermore, they can be given in an outpatient
setting and are usually not associated with significant haematological toxicity. All the
patients participating in this study have been diagnosed with relapsed or refractory
lymphoma and have been offered treatment with vinorelbine and gemcitabine as an alternative
to inpatient salvage chemotherapy.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy and regimen related toxicity of the study treatment (vinorelbine and gemcitabine with filgrastim support).
Andrew Spencer, Assoc. Prof
Australia: Department of Health and Ageing Therapeutic Goods Administration