Economic evaluation of prophylactic granulocyte colony stimulating factor during chemotherapy in elderly patients with aggressive non-Hodgkin's lymphoma.

BACKGROUND AND OBJECTIVES: Treatment with CHOP chemotherapy in elderly patients with aggressive non-Hodgkin's lymphoma (NHL) is less effective and accompanied by more adverse effects than in younger patients. The prophylactic use of granulocyte colony-stimulating factor (G-CSF) might improve the results, but increases the costs of treatment. We analyzed the costs of therapy and follow-up of patients with NHL treated with CHOP with or without G-CSF prophylaxis. DESIGN AND METHODS: Four hundred and eleven patients were randomized for treatment with CHOP or CHOP+G-CSF. A detailed study of treatment costs from randomization until 3 years of follow-up or death was performed in a subset of 100 out of 389 eligible patients. Because costs during follow-up were independent of the use of G-CSF during treatment, costs of follow-up and second-line treatment were calculated irrespective of the treatment arm. RESULTS: Total hospital costs for first-line treatment were 12178 [95% CI 10297 - 14059] for CHOP alone and 18356 [95% CI 15807 - 20906] for CHOP + G-CSF. Costs during follow-up showed a wide difference (range 74 - 53925) depending on disease status and choice of treatment in the case of relapse or progression. INTERPRETATION AND CONCLUSIONS: The clinical study showed no difference between the treatment arms in response, overall survival or event-free survival, while the costs were significantly higher in the G-CSF arm. We conclude that the addition of prophylactic G-CSF to CHOP chemotherapy is not cost-effective in these patients.

Overall and event-free survival are not improved by the use of myeloablative therapy following intensified chemotherapy in previously untreated patients with multiple myeloma: a prospective randomized phase 3 study.

We compared the efficacy of intensified chemotherapy followed by myeloablative therapy and autologous stem cell rescue with intensified chemotherapy alone in patients newly diagnosed with multiple myeloma. There were 261 eligible patients younger than 66 years with stage II/III multiple myeloma who were randomized after remission induction therapy with vincristine, adriamycin, dexamethasone (VAD) to receive intensified chemotherapy, that is, melphalan 140 mg/m(2) administered intravenously in 2 doses of 70 mg/m(2) (intermediate-dose melphalan [IDM]) without stem cell rescue (n = 129) or the same regimen followed by myeloablative therapy consisting of cyclophosphamide, total body irradiation, and autologous stem cell reinfusion (n = 132). Interferon-alpha-2a was given as maintenance. Of the eligible patients, 79% received both cycles of IDM and 79% of allocated patients actually received myeloablative treatment. The response rate (complete remission [CR] plus partial remission [PR]) was 88% in the intensified chemotherapy group versus 95% in the myeloablative treatment group. CR was significantly higher after myeloablative therapy (13% versus 29%; P =.002). With a median follow-up of 33 months (range, 8-65 months), the event-free survival (EFS) was not different between the treatments (median 21 months versus 22 months; P =.28). Time to progression (TTP) was significantly longer after myeloablative treatment (25 months versus 31 months; P =.04). The overall survival (OS) was not different (50 months versus 47 months; P =.41). Intensified chemotherapy followed by myeloablative therapy as first-line treatment for multiple myeloma resulted in a higher CR and a longer TTP when compared with intensified chemotherapy alone. However, it did not result in a better EFS and OS.