Subcutaneous Granulocyte-Macrophage Colony-Stimulating Factor in Mucositis Induced by an Adjuvant 5-Fluorouracil plus Leucovorin Regimen
A Phase II Study and Review of the LiteratureRossi A. · Rosati G. · Colarusso D. · Manzione L.
aUO Oncologia Medica, Azienda Ospedaliera ‘San G. Moscati’, Avellino, bUO Oncologia Medica, Azienda Ospedaliera ‘San Carlo’, Potenza, cDivisione di Medicina, Ospedale Civile, Lagonegro, Italy
Objective: To test the activity of subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF) administration in patients with colorectal cancer treated with adjuvant 5-fluorouracil (5-FU) plus leucovorin (LV) and suffering from mucositis. Methods: Thirty-one patients treated with adjuvant 5-FU 370 mg/m2 and LV 100 mg/m2 for 5 days every 4 weeks and reporting grade ≧2 mucositis participated in the study. Subcutaneous GM-CSF 4 µg/kg/day from days 6 to 10 was administered without chemotherapy dose reductions in the cycle that followed the cycle during which mucositis was reported. The disappearance of mucositis or a decrease by ≧1 grade was recorded as a therapeutic success. Baseline toxicity was: grade 2 stomatitis in 12 patients and grade 3 in 9; grade 4, 3 and 2 diarrhoea in 1, 4 and 8 patients, respectively. Results: Seventy-seven GM-CSF cycles were administered. A success was achieved in 20 (64.5%) patients. The efficacy was assessable in 5 (16.1%) patients with grade 2 and in 8 (25.8%) with grade 3 stomatitis, respectively, as well as in 1 (3.2%) and 5 (16.1%) patients with grade 3 and 2 diarrhoea, respectively. Success (3.2%) was reported in 2 patients suffering from both grade 2 stomatitis and diarrhoea. In 7 (22.5%) patients there was no evidence of efficacy. In 4 (12.9%) patients the treatment was stopped after the first administration of GM-CSF due to a grade 2 allergic reaction. Conclusions: The subcutaneous administration of GM-CSF relieved patients from symptoms of 5-FU/LV-induced mucositis with acceptable side effects permitting the maintenance of full-dose chemotherapy.
Antonio Rossi, MD
UO Oncologia Medica, Azienda Ospedaliera ‘San G. Moscati’
Via Circumvallazione, 68
I–83100 Avellino (Italy)
Tel. +39 0825 203573, Fax +39 0825 203556, E-Mail firstname.lastname@example.org
Number of Print Pages : 8
Number of Figures : 0, Number of Tables : 4, Number of References : 33
Oncology (International Journal of Cancer Research and Treatment)
Founded 1948 as ‘Oncologia’ by H.R. Schinz; Continued by V. Richards (1967–1975), H. Wrba (1976–1992), P.P. Carbone (1993–2002)
Vol. 64, No. 4, Year 2003 (Cover Date: Released May 2003)
Journal Editor: D.L. Trump, Buffalo, N.Y.
ISSN: 0030–2414 (print), 1423–0232 (Online)
For additional information: http://www.karger.com/onc