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Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (rhGM-CSF) after Chemotherapy in Patients with Non-Hodgkin's Lymphoma; a Placebo-Controlled Double Blind Phase III Trial
| Content Provider | Scilit |
|---|---|
| Author | Kaku, Kohei Takahashi, Masuhiro Moriyama, Yoshiaki Nakahata, Tatsutoshi Masaoka, Toru Yoshida, Yataro Shibata, Akira Kaneko, Toshio Miwa, Shiro |
| Copyright Year | 1993 |
| Description | To assess the clinical and hematopoietic effects of rhGM-CSF, a placebo-controlled double blind multicenter phase III study was undertaken in patients with non-Hodgkin's lymphoma receiving cytotoxic chemotherapy. Sixty-two patients who had granulocytopenia (<1 × $10^{3}$/μl) after the first cycle of chemotherapy with cyclophosphamide, adriamycin, vincristine, and prednisolone were enrolled. After the second cycle of chemotherapy with the same regimen, patients randomly received either rhGM-CSF (125 $μg/m^{2}$/day) or placebo for 14 days (rhGM-CSF; 31 patients and placebo; 31 patients). Administration of rhGM-CSF induced a significant increase in granulocytes mainly with neutrophils, eosinophils and monocytes, but elevation of lymphocytes, latelets, and reticulocytes was not induced. Median days of granulocytes less than 1 × $10^{3}$/μl in patients receiving rhGM-CSF were significantly shorter than in patients receiving placebo (p = O.001). Adverse reactions encountered with rhGM-CSF, and observed in 58% of the patients were never life-threatening and always rapidly reversible. They included fever, nausea and vomiting, diarrhea, skin eruption, and malaise. These results suggest that rhGM-CSF can be safely administered to prevent neutropenia after chemotherapy in patients with non-Hodgkin's lymphoma. |
| Related Links | https://www.tandfonline.com/doi/pdf/10.3109/10428199309087000 |
| Ending Page | 238 |
| Page Count | 10 |
| Starting Page | 229 |
| ISSN | 10428194 |
| e-ISSN | 10292403 |
| DOI | 10.3109/10428199309087000 |
| Journal | Leukemia & Lymphoma |
| Issue Number | 3-4 |
| Volume Number | 11 |
| Language | English |
| Publisher | Informa UK Limited |
| Publisher Date | 1993-01-01 |
| Access Restriction | Open |
| Subject Keyword | Journal: Leukemia & Lymphoma Surgery Rhgm-csf Non-hodgkin's Lymphoma Granulocytopenia Placebo-controlled Double Blind Trial |
| Content Type | Text |
| Resource Type | Article |
| Subject | Hematology Cancer Research Oncology |
