255 Comparison between RHGM-CSF and RHG-CSF administered during radiotherapy and after prolonged carboplatin infusion in preventing leukopenia and mucosytes produced by chemoradiotherapy in advanced head and neck cancer

Abstract

Concomitant radio-chemotherapy is considered the therapy able to increase the percentage of positive responses in advanced head and neck cancer patients. Nevertheless the related toxicity can become important from the clinical point of view, specially the haematological and mucosa one. In order to reduce the severity of the foreseen haematological and mucosa toxicity, a pilot study with haematological growth factors (G-CSF and GM-CSF) has been performed. Both growth factors were given at the end of the chemotherapy schedule and throughout the radiotherapy programme prosecution. Patients were exposed to infusional chemotherapy for 14 days on end with Carboplatin 30mg/m² and concomitant radiotherapy at the dose of 180 cGy/5 d/w on T and N (<i>Proc</i> ASCO 1993, 12:902,). G and GM were given at the dose of 3μg/kg starting 24 h since the end of the CBD CA infusion for 14 days. Five patients received G-CSF and 6 patients GM-CSF. All patients gave their informed consent to take part in this pilot study. Results were considered according to the incidence of leukopenia, thrombocytopenia and mucosytes severity, in comparison with a previous group of 28 patients treated with radio-chemotherapy (5th International Congress on Anti-cancer Chemotherapy, Paris, 0–536, 1995).GMGControlMean peak valueWBC11.63022.146(9.390–14.400)(6.150–31.400)Mean nadir valueWBC2.4733.0122.010 (median 1.921)Neutropils1.3792.2541.051 (median 943)Platelets76.90091.46080.400 (median 74.000)Mean day to nadirWBC/Neutr.453740Platelets352732Mucosytes grade14/6 (67%)1/5 (20%)35.7%22/6 (33%)2/5 (40%)50%302/5 (40%)14.3% In conclusion these preliminary data show that both GM and G slightly reduce the severity of Leukopenia but GM-CSF delays the nadir mean day. Moreover GM-CSF, given during radiotherapy remarkably reduces the severity of mucosytes in comparison both with the G-CSF and the historical group. These data are very encouraging and support the elaboration of a further and larger clinical trial in order to confirm the important clinical role of GM-CSF in preventing patients, subjected to a radiochemotherapy programme, from the arising of mucosytes problems.