Annals of Oncology 14:559-563, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Prophylaxis with GM-CSF mouthwashes does not reduce frequency and duration of severe oral mucositis in patients with solid tumors undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue: a double blind, randomized, placebo-controlled study
1 Oncology and Hematology Department, 2 Istituto Oncologico Romagnolo Unit of Biostatistics and 3 Pharmacy Unit, City Hospital, Ravenna, Italy
Received 29 November 2002; revised 7 January 2003; accepted 27 January 2003
Background:
The aim of this study was to evaluate the effectiveness of granulocyte–macrophage colony-stimulating factor (GM-CSF) mouthwashes in the prevention of severe mucositis induced by high doses of chemotherapy.
Patients and methods:
Ninety consecutive patients affected by solid tumors and undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue were randomized to receive placebo versus GM-CSF mouthwash 150 µg/day. Patients were stratified on the basis of the conditioning treatment and the consequent different risk of severe oral mucositis. Treatment was administered from the day after the end of chemotherapy until the resolution of stomatitis and/or neutrophil recovery.
Results:
The statistical analyses were intention-to-treat and involved all patients who entered the study. The severity of stomatitis was evaluated daily by the physicians according to National Cancer Institute Common Toxicity Criteria. Both study and control groups were compared with respect to the frequency [30% versus 36%, 
2 exact test, not significant (NS)] and mean duration (4.8 ± 4.7 versus 4.4 ± 2.7 days, t-test, NS) of severe stomatitis (grade 
3). Oral pain was evaluated daily by patients themselves by means of a 10 cm analog visual scale: the mean (± standard error of the mean) maximum mucositis scores were 4.8 ± 3.5 versus 4.2 ± 3.5 cm (t-test, NS). Furthermore, 15/46 patients in the study group (33%) and 19/44 patients in the control group experienced pain requiring opioids (2 exact test, NS).
Conclusion:
We did not find any evidence to indicate that prophylaxis with GM-CSF mouthwash can help to reduce the severity of mucositis in the setting of the patients we studied.
Key words: GM-CSF, mouthwash, mucositis, prophylaxis
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