Cawford, J., Tomita, D.K., Mazanet, R., Glaspy, J., & Ozer, H. (1999). Reduction of oral mucositis by filgrastim (r-metHuG-CSF) in patients receiving chemotherapy. Cytokines, Cellular and Molecular Therapy, 5(4), 187–193.
G-CSF 230 mcg/m2 given days 4–17 unless the post-nadir neutrophil count exceeded 10x109/1 after day 12. Treatment repeated every 21 days for up to six cycles of chemotherapy (cyclophosphamide, doxorubicin, and etoposide).
Control was placebo injection.
Patients in the placebo group crossed over to G-CSF after episode of febrile neutropenia.
The study was comprised of 199 patients, of the 211 patients who had enrolled.
G-CSF = 95
Placebo = 101
Small-cell lung cancer
Randomized, prospective, control phase III trial
Febrile neutropenia was the primary endpoint. Also looked at infectious complications and oral mucositis.
Oral candidiasis included as mucositis incidence, severity, and time to onset.
Duration of mucositis was determined by a combination of patient reporting and clinical examination findings.
54% versus 72% episode of mucositis in G-CSF versus placebo group. Most episodes were grade I–II. Median duration of mucositis was the same for both groups (eight days).
First-cycle mucositis: 28% versus 47% (p = 0.041)
Difficult to determine some results because of cross-over nature of study. Also allowed dose reduction in treatment group, which decreased mucositis; confounding results.
Trials with nonmyelosuppressive therapy are needed to determine effect.