High Dose Cyclophosphamide Plus Recombinant Human Granulocyte-colony Stimulating Factor (rhG-CSF) in the Treatment of Follicular, Low Grade Non-Hodgkin's Lymphoma: CALGB 9150.

Autor: Lichtman, Stuart M., Petroni, Gina, Schilsky, Richard L., Johnson, Jeffrey L., Perri, Robert T., Niedzwiecki, Donna, Sklar, Jeffrey, Barcos, Maurice, Peterson, Bruce A.
Předmět:
Zdroj: Leukemia & Lymphoma; Oct2001, Vol. 42 Issue 6, p1255-1264, 10p
Abstrakt: The main objectives of this study were to determine the feasibility of administering high doses of cyclophosphamide plus recombinant human granulocyte-colony stimulating factor (rhG-CSF) every 14-21 days to patients with follicular small cleaved cell lymphoma. For each patient, the treatment was not considered feasible if fewer than four cycles of cyclophosphamide chemotherapy could be administered on schedule (i.e. at least every 29 days) or (1) hospitalization of the patient for longer than three days was necessary for neutropenic fever (38°C) or bacteriologically documented infection in > 50% of the cycles, or (2) grade ≥ 2 hemorrhage in association with thrombocytopenia of grade ≥ 3 severity occurred in > 50% of the cycles or (3) non-hematologic toxicity (excluding nausea/vomiting and alopecia) of grade ≥ 3 occurred in > 50% of cycles. The goal was to have a treatment program feasible in 75% or more of the treated patients. The secondary objectives were to determine the toxicities, the complete and partial response rates, and the time to treatment failure (TTF). The trial also attempted to assess the effectiveness of this treatment program in eradicating Bcl-2 rearrangements by PCR, and to assess complete remission duration in relationship to PCR results in patients who respond to this chemotherapy program. Patients were required to have histologically documented non-Hodgkin's lymphoma of the subtypes follicular, predominantly small cleaved cell (IWF-B) or follicular mixed, (IWF-C). Patients were required to have Stage IV disease including histologic evidence of bone marrow involvement. Measurable disease was required and patients were also required to have one of the following risk factors: &ge: 2 extranodal sites, node or nodal group ≥ 5 cm. Submission of fresh bone marrow for molecular genetic studies for the presence of Bcl-2-Ig fusion DNA was mandatory in previously untreated patients. Patients had to be between 18 and physiologic age... [ABSTRACT FROM AUTHOR]
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