152. Concomitant chemo-radiotherapy in patients with advanced, pimary unrespectable head and neck cancers preliminary results of phase II study

Background & Aim Our experience with CAIR fractionation, recognized as an effective organ preservation treatment for moderately advanced head and neck cancer, have induced us to idea on concomitant combination of continuous radiotherapy (7 fractions in 7 days) with chemotherapy, dedicated for advanced, stage III and IV, patients. This report evaluates early results of toxicity and cure of patients treated during the years 1999–2003. Material 47 male patients with median age 51 years were prospectively evaluated-36 patients (77%) with stage IV and 11 (23%) with stage III. Oropharynx was the most freaquent tumour location-16 patients (34%). Chemotherapy, four cycles of cisplatinum and vinorelbin given in 1-day schedule, started on the day 1st, each 21 days. CAIR-scheme radiotherapy started on the 22nd day to the total dose of 68Gy. Compliance to the RT protocol was 98%. During the first year 57% of patients completed 4 courses of chemo, 11 (24%)-3 cycles and 9 (19%)-2 courses. After reduction the doses of cisplatinum (100 to 70 mg/m 2 ) and vinorelbine (30 to 20 mg/m 2 ) chemotherapy was conducted with at least 3 cycles. One patient died because the treatment toxicity. All patients developed confluent mucositis lasted medially 60 days. Grade IV and III of leucopenia were found in 4 (8%) and 15 (32%) patents. Median follow up was 446 days (ranged from 7 to 1486 days). Results CR was observed in 38 (81%) patients. The rates of LC, DSF and OS were 81%, 62% and 80% respectively after 2 years. On univariate analysis N3 stage was significantly associated with decreased rates of all survival criteria; the higher LC and DSF rates were also found for patients receiving all 4 courses of chemotherapy and with egzophitic tumour-growth pattern. Multivariate analysis revealed that N3 stage and necrosis in metastatic Iymph nodes were the idependent negative prognostic factors influencing LC and DSF. Conclusions Chemo-CAIR produces promising early results of cancer cure. Treatment toxicity is high, but satisfactorily tolerated and did not affect the ability to deliver planned doses of radiotherapy. The most important factor affected treatment outcome were N3 stage and necrosis in Iymphatic nodes.