Abstract

Incidence of febrile neutropenia following cytotoxic treatment of tumor patients can be reduced by prophylactic G-CSF treatment. We report results of a prospective open non-interventional multicenter observational trial in 2233 patients on lenograstim, a recombinant glycoprotein (rHuG-CSF) expressed and glycosylated in Chinese hamster ovary cells. In total 10 846 courses of chemotherapy followed by G-CSF treatment have been documented for either hematologic or oncologic malignancies (breast and ovarian cancer 4207 courses, Hodgkin’s disease and Non Hodgkin’s lymphoma 4381 courses, lung cancer 780 courses, other malignancies 1478 courses, respectively). Lenogratim was administered either interventionally or to less amount for prophylaxis of granulocytopenia; the mean daily dosage was 263 micrograms subcutaneously. A significant number of patients were treated for stage III or IV disease. Almost 1/3 of the patients (34,2%) were elderly aged at least 65 years old. The patients had not been hospitalized for cytotoxic therapy. Lenograstim treatment was started on day 6 (median 6,8 + 4,0) of chemotherapy regimens for almost 5 days (median duration of treatment 5,2 + 3,1 days). Median leukocyte count was 1,9 × 109/L when lenograstim treatment was started, and 5,9 × 109/L at the end of lenograstim treatment, respectively. Especially supporting the CHOP regimen in lymphoma patients lenograstim was administered prophylactically: in 39,5% of lymphoma patients, but only in 24,1% of patients with gynecologic tumors lenograstim treatment was performed for at least 5 days. The rate of infection or fever reported was 9,8% (7,8% in breast cancer patients, 9,0% in lymphoma patients, respectively). 87,1% of chemotherapy courses (87,5% in lymphoma patients and 86,6% in breast cancer patients) could be performed according to the protocol initially scheduled without reduction of dosage or delay of treatment intervals. We conclude that lenograstim was feasible and efficacious for prophylaxis of neutropenic fever in chemotherapy patients. In 2/3 of the patients daily lenograstim dosage of 263 micrograms was suitable to stimulate granulocytopoiesis after conventional cytotoxic therapy within 5 days. No serious adverse events possibly related to lenograstim were reported.

Author notes

Disclosure:Employment: Dr. Krohn: Chugai Pharma. Membership Information: Dr. Wolf: Chugai Pharma Speaker’s Bureau in 2006.