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

M. Newell, D. Goldstein, S. Milliken, C. Lewis, J. Hoy, B. Thomson, D. Cooper

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Abstract

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-naive 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) - cyclophosphamide (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 > 33 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.

Original languageEnglish
Pages (from-to)1029-1036
Number of pages8
JournalAnnals of Oncology
Volume7
Issue number10
DOIs
Publication statusPublished - 1 Jan 1996

Keywords

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

Cite this

Newell, M. ; Goldstein, D. ; Milliken, S. ; Lewis, C. ; Hoy, J. ; Thomson, B. ; Cooper, D. / Phase I/II trial of filgrastim (r-metHuG-CSF), CEOP chemotherapy and antiretroviral therapy in HIV-related non-Hodgkin's lymphoma. In: Annals of Oncology. 1996 ; Vol. 7, No. 10. pp. 1029-1036.
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title = "Phase I/II trial of filgrastim (r-metHuG-CSF), CEOP chemotherapy and antiretroviral therapy in HIV-related non-Hodgkin's lymphoma",
abstract = "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-naive 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) - cyclophosphamide (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 > 33 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.",
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Phase I/II trial of filgrastim (r-metHuG-CSF), CEOP chemotherapy and antiretroviral therapy in HIV-related non-Hodgkin's lymphoma. / Newell, M.; Goldstein, D.; Milliken, S.; Lewis, C.; Hoy, J.; Thomson, B.; Cooper, D.

In: Annals of Oncology, Vol. 7, No. 10, 01.01.1996, p. 1029-1036.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Phase I/II trial of filgrastim (r-metHuG-CSF), CEOP chemotherapy and antiretroviral therapy in HIV-related non-Hodgkin's lymphoma

AU - Newell, M.

AU - Goldstein, D.

AU - Milliken, S.

AU - Lewis, C.

AU - Hoy, J.

AU - Thomson, B.

AU - Cooper, D.

PY - 1996/1/1

Y1 - 1996/1/1

N2 - 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-naive 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) - cyclophosphamide (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 > 33 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.

AB - 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-naive 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) - cyclophosphamide (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 > 33 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.

KW - AIDS

KW - antineoplastic agents

KW - antiretroviral therapy

KW - G-CSF

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U2 - 10.1093/oxfordjournals.annonc.a010495

DO - 10.1093/oxfordjournals.annonc.a010495

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JO - Annals of Oncology

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