Safety and Efficacy of a Mouth-Rinse with Granulocyte Colony Stimulating Factor in Patients with Chemotherapy-Induced Oral Mucositis.

OBJECTIVE To assess the safety and effectiveness of a mouth-rinse with G-CSF (JiSaiXin, produced by NCPC Biotechnology Co., Ltd) in treating patients with chemotherapy-induced oral mucositis (CIM). METHOD A consecutive cohort of patients with advanced cancers and CIM were treated with mouth-rinse G-CSF. All chemotherapy for patients with advanced cancers was adopted from regimens suggested by NCCN guidelines. The mouth-rinse with G-CSF at a dose of 150-300ug plus 100ml-500ml normal saline was started from the time of oral mucositis was confirmed and continuously used for at least 7 days as one course. After at least two courses of treatment, safety and efficacy were evaluated. RESULTS There were 7 female and 7 male patients with advanced cancer and CIM recruited into this study, including 5 with colorectal, 2 with lung, 1 patient with gastric, 1 with cervical and 1 with pancreatic cancer, as well as 2 patients with diffuse large B cell lymphomas, 1 with nasopharyngeal and 1 with gastric cancer. The median age was 57 (41-79) years. Grade 1 to 2 myelosuppression was observed in 3/14 patients, and Grade 4 myelosuppression in 1/14. Adverse effects on the gastrointestinal tract were documented in 5/14 patients, and were Grade 1 to Grade 3. No treatment related death was documented. Regarding CIM, the median response time to mouth rinse of G-CSF was 2 (1-5) days, and all patients with CIM demonstrated a positive response. CONCLUSIONS Mouth-rinse with G-CSF proved to be safe and effective in treating patients with advanced cancers and CIM. However, further randomized controlled studies should be conducted to clarify the effectiveness of this treatment with other lesions.