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Oral Combination Chemotherapy (CT) in Conjunction with Filgrastim (G-CSF) in the Treatment of AIDS-related non-Hodgkin's Lymphoma (NHL): 86

Remick, S C; Bibighaus, M R; Rcddy, M; Haase, R F; Nazeer, T; Kumar, N; Anand, P K; Ramnes, C R; Pearee, T P; Mastrianni, D M

Journal of Acquired Immune Deficiency Syndromes & Human Retrovirology: 1 April 1997 - Volume 14 - Issue 4 - p A37
National AIDS Malignancy Conference

Case Western Reserve University & Albany Medical College.

Background: In 1993, we reported on the efficacy and toxicity profile of an oral combination CT regimen administered to 18 patients (pts) with AIDS-related NHI. We observed a 61% objective remission rate, nearly two-thirds of pts developed grade 3 and 4 leukopenia, and 28% of cycles were associated with febrile neutropenia. These results prompted us to shorten the duration of oral CT and to incorporate G-CSF into the regimen in hope of improving the therapeutic index.

Methods: Twenty pts with biopsy-proven AIDS-related NHL were treated with oral CT consisting of CCNU 100mg/m2 on day 1, C# 1 and 3, VP-16 200mg/m2 day 1-3, cyclophosphamide 100mg/m2 day 22-31, procarbazine 100mg/m2 day 22-31, and G-CSF 300µg (5µg/kg) SC day 5-21 and day 33-42 at 6-week intervals for a total of 3 cycles. This group of pts was compared by multivariate analysis of variance on 14 clinical parameters to our initial 18 pts treated with the same chemotherapy regimen without G-CSF and found to be statistically similar at both the multivariate level (p=.634) and each univanate F-test (p s> 113). Clinical follow-up for all 38 pts is from Nov. 1989 to Oct. 1996. The severity of myelosuppression including: leukopenia, thrombocytopenia, episodes of febrile neutropenia, number and days of hospitalization(s) for febrile neutropenia, and myclotosicity causing discontinuation of treatment were compared.

Results: The overall objective response rate using ECOG criteria was 70% (95?% confidence interval, 50% to 90%) with 6 CRs (30%) and 8 PRs (40%). The median survival duration was 7 months, with a range of 0.5 to 24 months. The 1-year, 18-month, and 2-year survival rates for ãll 38 pts are respectively 34%, 21% and 11%. At time of death, 49% of pts were free from progression of their lymphoma. One pt developed CNS relapse, for an overall CNS relapse rate of 5% for all 38 pts. There was no difference between the current group and the group treated without G-CSF in the following: incidence of grade 3 and 4 leukopenia, 51% versus (v) 64%(p=.211); episodes of febrile neutropenia, 17% v 28% (p=.216); average number of days of hospitalization for febrile neutropenia, 16.4 v 17.2 (p=.909); and discontinuation of protocol chemotherapy because of thrombocytopenia, 15% v 6% (p=.343). The two groups did significantly differ, favoring the G-CSF treated group of pts, on the following: incidence of grade 3 and 4 thrombocytopenia, 60% v 38% (p=.039), the number of hospitalizations for febrile neutropenia, 7 v 13 (p=.042), and discontinuation of protocol chemotherapy because of leukopenia, 0 v 6(p=.005).

Conclusions: Administration of the oral regimen has resulted in one-third of pts surviving one year, 11% two years, and half of pts surviving free from progression of their lymphoma. This regimen is efficacious and considerate of pt quality-of-life issues because of case of administration. The addition of G-CSF to the regimen decreases the frequency of hospitalization for febrile neutropenia. CNS prohylaxis for many pts can be avoided and it is less costly to administer.

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National AIDS Malignancy Conference

Bethesda, Maryland April 28-30, 1997

sponsored by the National Cancer Institute

© Lippincott-Raven Publishers.