Induction chemotherapy with cisplatin, fluorouracil, and high-dose leucovorin for squamous cell carcinoma of the head and neck: long-term results.

PURPOSE: A phase II trial of cisplatin, fluorouracil, and leucovorin (PFL) induction chemotherapy in patients with locally advanced squamous cell carcinomas of the head and neck region (HNCA). PATIENTS AND METHODS: One hundred two patients (stage III/IV, previously untreated) were treated with induction PFL. Patients with resectable primary tumor site lesions and clinical complete response (CR) were offered radiotherapy (RT) without surgery to the primary tumor site. Response, toxicity, local-regional therapy, survival, and preservation of the primary tumor site were assessed. RESULTS: Among 279 courses, the overall response rate was 81%. Nineteen (19%) failed to respond, including three who died during therapy. Sixty-seven (69%) of 97 with assessable primary lesions had a clinical CR at the primary tumor site. Pathologic CR was recorded in 46 of 55 (84%) clinical CR patients who had biopsies performed on the primary tumor site. Toxicities resulted in unexpected hospitalizations in 19% of cases. After definitive local-regional therapy, 84 (82%) were disease-free including 71 (69%) with preserved primary tumor site anatomy. With a median follow-up time of 63 months, the cause-specific, overall (OS), and failure-free survival (FFS) rates at 5 years are 58%, 52%, and 51%. Local failure occurred in 29 of 102 (29%) and the local control rate at 5 years was 68%. CONCLUSION: PFL has significant activity with acceptable toxicity in patients with advanced disease who have a good performance status. Preservation of the primary tumor site could be achieved without apparent loss of local control or survival. Management of neck disease by surgery or RT must be individualized and separate from management of primary tumor. Survival compares favorably with similar trials of induction chemotherapy or chemoradiotherapy.

[Preventive effect of thymomodulin in recurrent respiratory infections in children]. / Effetto preventivo della timomodulina nelle infezioni respiratoirie ricorrenti del bambino.

Recurrent respiratory infections (RRI) are a common occurrence in early childhood. Several investigations report the primary role of environmental factors (as early social mixing and passive smoking) in inducing RRI. In RRI children immunological defects, transient and not typical, have been often observed, but it is reasonable to suppose that they are essentially secondary to infections. Since immune modifications involve essentially cell-mediated immunity, several therapeutical attempts with thymic hormones have been carried out. In the present study the efficacy of thymomodulin was evaluated in a clinical trial in a group of children with RRI. Forty-six children suffering from RRI were enrolled on the basis of RI number in the previous year. Twenty-three children were treated with thymomodulin, twenty-three were not treated and were studied as control group. A significant reduction in the frequency of RI was noted only in treated children. Interleukin-2 production was assayed in all children before and after the trial, but not significant modification was observed in this immunological parameter. This study confirms the effectiveness of treatment with thymomodulin in RRI children, even though immunological background of clinical improvement remains to be elucidated.