TY - JOUR
T1 - 13-cis retinoic acid in head and neck cancer chemoprevention
T2 - Results of a randomized trial from the Italian Head and Neck Chemoprevention Study Group
AU - Toma, Salvatore S.
AU - Bonelli, Luigina
AU - Sartoris, Alberto
AU - Mira, Eugenio
AU - Antonelli, Antonio
AU - Beatrice, Fabio
AU - Giordano, Carlo
AU - Benazzo, Marco
AU - Caroggio, Angelo
AU - Cavalot, Andrea Luigi
AU - Gandolfo, Sergio
AU - Garozzo, Aldo
AU - Margarino, Giovanni
AU - Schenone, Guido
AU - Spadini, Nicoletta
AU - Sirotovà, Zuzana
AU - Zibordi, Francesco
AU - Balzarini, Fabrizio
AU - Serafini, Italo
AU - Miani, Piero
AU - Cortesina, Giorgio
PY - 2004/6
Y1 - 2004/6
N2 - Patients with squamous cell carcinoma of the head and neck (HNSCC) after being treated radically remain at high risk for both recurrent and second primary tumours. 13-cis retinoic acid (13-cRA) was demonstrated to reverse premalignant lesions of the oral cavity and to reduce the incidence of second primary tumours in patients treated radically for HNSCC. Synergism between retinoids and interferon in tumoural cell lines have been demonstrated. Based on these data, the Italian Head and Neck Chemoprevention Study Group started a randomized chemoprevention study in patients radically treated for stage III and IV HNSCC. From February 1992 to January 1996, 267 patients were randomized: 126 were allocated to the control group, 126 were randomized to receive 13-cRA at a dose of 0.5 mg/kg per day per os and 15 patients have been assigned to the group of 13-cRA plus interferon α2a (IFN-α2a) at a dose of 3,000,000 UI 3 times a week (randomization in this arm interrupted due to administrative financial problems). The mean follow-up was 39 months. The 5-year actuarial survival was 58.9% for patients of the 13-cRA group and 57.2% for those of the control group (P=0.94). Among evaluable patients, disease progression was observed in 45 of 123 patients (36.6%) of the 13-cRA group and in 42 of 124 (33.9%) of the control group. The 5-year actuarial relapse-free survival was 48.9% for the 13-cRA group and 55.6% for the control group (P=0.62). Adverse effects, mostly of grade I were reported in 69.4% of treated patients (haematologic disorders, mucositis, conjunctivitis, cutaneous toxicity, hypertriglyceridemia and hypercholesterolemia). Only 5 patients (4.1%) reported grade III-IV toxicity. Low-dose of 13-cRA given for 1 year is ineffective as chemoprevention in patients with radically treated HNSCC.
AB - Patients with squamous cell carcinoma of the head and neck (HNSCC) after being treated radically remain at high risk for both recurrent and second primary tumours. 13-cis retinoic acid (13-cRA) was demonstrated to reverse premalignant lesions of the oral cavity and to reduce the incidence of second primary tumours in patients treated radically for HNSCC. Synergism between retinoids and interferon in tumoural cell lines have been demonstrated. Based on these data, the Italian Head and Neck Chemoprevention Study Group started a randomized chemoprevention study in patients radically treated for stage III and IV HNSCC. From February 1992 to January 1996, 267 patients were randomized: 126 were allocated to the control group, 126 were randomized to receive 13-cRA at a dose of 0.5 mg/kg per day per os and 15 patients have been assigned to the group of 13-cRA plus interferon α2a (IFN-α2a) at a dose of 3,000,000 UI 3 times a week (randomization in this arm interrupted due to administrative financial problems). The mean follow-up was 39 months. The 5-year actuarial survival was 58.9% for patients of the 13-cRA group and 57.2% for those of the control group (P=0.94). Among evaluable patients, disease progression was observed in 45 of 123 patients (36.6%) of the 13-cRA group and in 42 of 124 (33.9%) of the control group. The 5-year actuarial relapse-free survival was 48.9% for the 13-cRA group and 55.6% for the control group (P=0.62). Adverse effects, mostly of grade I were reported in 69.4% of treated patients (haematologic disorders, mucositis, conjunctivitis, cutaneous toxicity, hypertriglyceridemia and hypercholesterolemia). Only 5 patients (4.1%) reported grade III-IV toxicity. Low-dose of 13-cRA given for 1 year is ineffective as chemoprevention in patients with radically treated HNSCC.
KW - 13-cis retinoic acid
KW - Chemoprevention
KW - Head and neck
KW - Interferon
UR - http://www.scopus.com/inward/record.url?scp=16544372656&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=16544372656&partnerID=8YFLogxK
M3 - Article
C2 - 15138569
AN - SCOPUS:16544372656
VL - 11
SP - 1297
EP - 1305
JO - Oncology Reports
JF - Oncology Reports
SN - 1021-335X
IS - 6
ER -