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Annals of Oncology 7:1029-1036, 1996
© 1996 European Society for Medical Oncology

research-article

Phase I/II trial of filgrastim (r-metHuG-CSF), CEOP chemotherapy and antiretroviral therapy in HIV-related non-Hodgkin's lymphoma

M. Newell1,, D. Goldstein2, S. Milliken3, C. Lewis4, J. Hoy2, B. Thomson5 and D. Cooper1,3

1National Centre in HIV Epidemiology and Clinical Rcsearch, Faculty of Medicine, University of New South Wales Sydney
2Fairfield Hospital Melbourne
3HIV Medicine Unit, St. Vincent's Hospital Sydney
4Department of Medical Oncology, Prince Henry and Prince of Wales Hospitals Sydney
5AMGEN Australia Pry Ltd Melbourne, Australia

Correspondence to: Mark Newell, MD National Centre in HIV Epidemiology and Clinical Research University of New South Wales 2nd floor, 376 Victoria St. Darlinghurst, Sydney 2010 NSW Australia

BACKGROUND:: A phase I/II trial determined the maximum tolerated dose (MTD) of CEOP for AIDS-related non-Hodgkin's lymphoma (NHL) with concurrent filgrastim and antiretroviral therapy.

PATIENTS AND METHODS:: Fourteen AIDS-NHL patients, chemotherapy-naïve and ECOG performance status >2 received filgrastim 1.0 µg/kg s.c. daily for 3–7 days to assess neutrophil response, followed by CEOP with filgrastim support 10 µg/kg s.c. daily, day 2–14, continued if the absolute neutrophil count (ANC) <1.2 x 109/l. Two CEOP dose cohorts were used: cohort 1 (5 patients) - cyclophospharnide (C) 500 mg/m2, epirubicin (E) 37.5 mg/m2, vincristine (O) 2 mg and prednisolone (P) 75 mg/m2 daily on days 1–5; cohort 2 (9 patients) - C 750 mg/m2, E 50 mg/m2, same doses of O and P. Antiretroviral therapy was maintained (zidovudine-10, ddI-3, both-1).

RESULTS:: In cohort 1, 4/5 patients received at least 3 courses of CEOP with one complete response after five cycles and four progressions. Four have died (3–21 months after entry) with 1 alive at 40 months. Dose limiting toxicity (DLT - grade IV febrile neutropenia in cycle 1) occurred in 1 patient. In cohort 2, 5/9 completed ≥5 cycles with 6 complete responses, 1 partial response and 2 progressions, 6 deaths and 3 alive at i33 months. DLT (evaluable in 8 patients) occurred in two patients. Median survival for both cohorts was 17 months. Mean relative dose intensity was >85%.

CONCLUSIONS:: The dosages of CEOP in cohort 1 defined the MTD however the cohort 2 doses with filgrastim and antiretroviral therapy gave an encouraging response, acceptable toxicities and merit further study.

AIDS, antineoplastic agents, antiretroviral therapy, G-CSF, non-Hodgkin's lymphoma


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