multicentre phase-II feasibility study evaluating gemcitabine/ vinorelbine / prednisolone combination chemotherapy in relapsed / refractory Hodgkin's lymphoma

ABSTRACT

To determine the efficacy and toxicity of Gemcitabine, Vinorelbine and Prednisolone [GVP] salvage chemotherapy in relapsed / refractory Hodgkin's Lymphoma [HL]. A phase-II non-randomized single arm study. This study was conducted at Combined Military Hospital and Medical College Lahore, Mayo Hospital, King Edward Medical University, Lahore, Allied Hospital, Punjab Medical College, Faisalabad and Combined Military Hospital, Rawalpindi, from January 2007 to December 2007. Fifty adult patients with relapsed/refractory HL, adequate marrow reserve, hepatorenal and pulmonary functions, with radiological measurable disease and Karnofsky performance status of 0 - 2 non-candidates for stem cell transplantation, were enrolled. Four 28 days cycles of GVP [Gemcitabine 1000 mg/m2, Vinorelbine 30 mg/m2 on day 1 and 8 intravenously with oral Prednisolone 100 mg/day on day 1 - 5] were given. Response evaluation done according to Cotswolds meeting recommendations and toxicity was evaluated with NCI-CTC [National Cancer Institute - Common Terminology Criteria for adverse events v 3.0]. Forty patients completing 4 cycles of GVP, 14 refractory/early relapse and 26 late relapsed [one year postprimary treatment with ABVD] were available for evaluation. The overall response [CRu+PR] rate was 77.5% with better response 85% in late relapsed patients. Haematological toxicity was most common and seen in 70% of cases. GVP is well-tolerated regimen with high response rate and needs to be tested in late relapsed H