Abstract
To evaluate the toxicity and efficacy of recombinant human granulocyte-colony-stimulating factor (rh G-CSF) administered with intensive chemotherapy, 39 patients with advanced pulmonary cancers were enrolled in a dose escalation trial of rh G-CSF. Three days after initiation of chemotherapy rh G-CSF was administered i.v. for 14 consecutive days at five dose levels (50–800 µg/m2).
Absolute neutrophil counts showed a dose-dependent increase with an increasing dose of rh G-CSF and the durations of neutropenia (less than 1000/mm3) shortened significantly at doses of 200, 400, and 800 µg/m2 compared to those at 50 µg/m2 (P < 0.01). The duration of neutropenia was shortened significantly at all five dose levels following treatment with rh G-CSF compared to treatment without rh G-CSF (P < 0.05).
Adverse side effects associated with rh G-CSF administration were fever higher than 38°C (21%), chest pain, and low back pain (13%). No intolerable side effects were experienced. It can be concluded that rh G-CSF is effective in shortening the duration of neutropenia following intensive chemotherapy at a dose level of 100 to 200 µg/m2 i.v. a 400-µg/m2 dose of rh G-CSF is recommended in patients with prior treatment because of the possibility of a lower bone marrow response.
Footnotes
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↵1 Supported partly by Grant for Aid of the Comprehensive 10 Year Strategy for Cancer Control Japan.
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↵2 To whom requests for reprints should be addressed.
- Received January 4, 1989.
- Revision received May 23, 1989.
- Accepted June 20, 1989.
- ©1989 American Association for Cancer Research.
Volume 49, Issue 18
