Study objectives: The purpose of this study is to determine whether co-administration of granulocyte colony stimulating factor (G-CSF) and bleomycin results in enhanced pulmonary toxicity compared with bleomycin alone.
Design: A retrospective analysis comparing two groups of patients with advanced germ cell tumors receiving combination chemotherapy that includes bleomycin with or without G-CSF.
Setting: Indiana University Medical Center.
Patients: Group A consisted of 29 patients with advanced-stage germ cell tumors who were treated with combination chemotherapy that included bleomycin. All patients received concurrent prophylactic G-CSF. Group B consisted of 57 patients with advanced-stage germ cell tumors who were treated on a phase 3 study comparing standard BEP (bleomycin, etoposide, cisplatin) to BEP with twice the cisplatin dose. None of these patients received growth factor.
Results: Of the 29 patients who received concurrent chemotherapy and G-CSF, ten (34%; 95% confidence interval [CI], 17.9 to 54.3%) were believed to have clinically significant bleomycin toxicity. Of the 57 patients who did not receive growth factor, 19 (33%; 95% CI, 21.4 to 47.1%) had bleomycin-related toxicity. There was no difference in the incidence of pulmonary toxicity between the groups (p=1.00 by Fisher's Exact Test).
Conclusions: There is no increase in pulmonary toxicity with co-administration of G-CSF and bleomycin compared to bleomycin alone in patients with advanced germ cell tumors.