An Outpatient Salvage Approach for Advanced Lymphoma Incorporating Stratification and Dose-Escalation

Aim:
To assess efficacy and toxicity of 2 and 3 drug salvage regimens.

Conclusions:
Researchers concluded that both VGF and F-GIV can be safely administered on an outpatient basis and show activity against advanced lymphoma

Official Title

Conditions

Study Type

Phase II

Study Design

Patients were stratified into: – Group 1 (G1 – good risk – first relapse following durable first remission – follicular NHL>12 months, all other NHL sub-types and HL>6 months); – Group 2 (G2 – poor risk – primary refractory, second or subsequent relapse, or non-durable first remission); – Group 3 (G3 – post transplant – relapse following any form of stem cell transplant therapy)A planned total of 90 patients were accrued This is a report on the first 88 patients (G1 = 26, G2 = 50, G3 = 12) with a median age of 57 years (range, 17-78). Diagnoses at entry were HL, n = 16 (nodular sclerosing = 13, mixed cellularity = 3) and NHL, n = 72 (diffuse large cell = 41, follicular = 16, others = 15)Treatment:2 chemotherapy regimens were evaluated- VGF (vinorelbine 25mg/m2 days 1 and 8, gemcitabine 1000mg/m2 days 1 and 8, pegfilgrastim 6mg SC day 9)- F-GIV (same as VGF but with ifosfamide 3000mg/m2 day 1 with mesna uroepithelial protection). G1 and G3 commenced therapy with VGF and G2 with F-GIV.Responsive patients (>50% reduction in all previous sites of disease and gallium and/or FDG-PET negativity where baseline positivity was demonstrated) received 2 further cycles of the same therapy.The remainder ‘escalated’ therapy with F-GIV (G1 and G3) or IVAC (G2)

Further Details

Results:Grades 3/4 neutropenia or thrombocytopenia occurring in 24% and 18% (VGF) and 62% and 49% (F-GIV) of patients, respectively. Significant non-haematological toxicities were uncommon. Febrile neutropenia, hospital admission, treatment delay or dose-reductions occurred with 4%, 19%, 4%, 1% and 17%, 34%, 9%, 9% of VGF and F-GIV cycles, respectivelyOverall response (CR + Cru + PR) on an intention-to-treat basis after 2 to 4 cycles of treatment is 54% (CR 29%) (77% and 42% for G1 and G2, respectively). Diffuse large cell NHL patients have demonstrated response rates of 67% and 17% for G1 and G2 patients, respectively.

Study Start

Eligibility & Criteria

Indication:Non-Hodgkin’s lymphoma (NHL) and Hodgkin’s lymphoma (HL) incorporating patient stratification and treatment escalation

Total Enrolment

90

Contact Details

Abstract 3336 ASH 2005Andrew Spencer et al