Mouth-washings with recombinant human granulocyte–macrophage colony stimulating factor (rhGM-CSF) do not improve grade III–IV oropharyngeal mucositis (OM) in patients with hematological malignancies undergoing stem cell transplantation. Results of a randomized double-blind placebo-controlled study

Abstract

Summary:We investigated whether daily oral washings with recombinant human granulocyte-macrophage colonystimulating factor (rhGM-CSF) solution improved grade III-IV oropharyngeal mucositis (OM) in patients with hematological malignancies undergoing stem cell transplantation. Forty-one consecutive patients (21 males and 20 females, median age (range) 44 (16-69) years) were prospectively randomized to perform daily mouth-washes with either a 400 g rhGM-CSF (Molgramostin, Schering-Plough) solution (group A, n ‫؍‬ 18) or with a saline solution (group B, n ‫؍‬ 23). Primary end-points were the intensity of OM, night rest quality and characteristics of food intake. Secondary end-points were need for and duration of parenteral nutrition, oral and intravenous analgesic requirements, incidence of viral or fungal oral infections and development of neutropenic fever. No differences were found between the placebo and rhGM-CSF-treated groups regarding overall duration of OM, maximum grade, reduction in at least one grade of OM (nine patients (56%) in group A vs 13 patients (68%) in group B), reduction of spontaneous or swallowing-induced pain, improvement in oral food intake, use of parenteral nutrition or use of systemic analgesics. In conclusion, mouth-washings with a 400 g of rhGM-CSF solution do not improve severe OM in hematological patients undergoing stem cell transplantation.

Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients

“…In sum, the panel concluded that the available evidence did not allow a guideline for the use of systemic GM-CSF to prevent oral mucositis associated with any of these cancer treatments. Several studies addressed the use of GM-CSF mouthwashes for the treatment of established mucostitis in patients receiving (C)RT for H&N tumors [60,72], HSCT [73,74], and CT [75,76]. Due to insufficient and conflicting evidence, no guideline was possible for the use of GM-CSF mouthwashes for the treatment of oral mucositis in any of these settings.…”

Tratamento da mucosite em pacientes submetidos a transplante de medula óssea: uma revisão sistemática

“…No relevant statistical difference was observed reducing oral mucositis (12)(13)(14) . Granulokine® (Filgrastim G-CSF), a human granulocyte colony stimulating factor whose action over the bone marrow increases the production and mobilization of neutrophils, did not present a significant statistical difference reducing the mucositis seriousness (15)(16)(17)(18) . A study which compared the intensive oral hygiene regime (IOH) with limited oral hygiene (LOH) did not present significant statistical difference (19) .…”

Treatment of severe oral mucositis in a pediatric patient undergoing chemotherapy

“…By the time the lesions had healed, the number of leukocytes had risen to 38,600/mm 3 in response to filgrastim, a human granulocyte colony-stimulating factor that acts on the bone marrow to increase neutrophil production 11 . However, filgrastim is not associated with lower oral mucositis severity [12][13] . Moreover, the number of red blood cells and platelets increased between the two complete blood counts but remained below the ideal: 4,500-5,900 million/mm 3 for red blood cells and 150,000-450,000/mm 3 for platelets.…”