High dose intra-arterial cisplatin with concomitant accelerated radiotherapy for patients with T4 and selected T3, N0–3, M0 head and neck cancer

Abstract

5528 Background: This phase I trial was developed to assess the feasibility of combining high dose intra-arterial cisplatin with concurrent accelerated concomitant boost radiotherapy for patients with previously untreated T4 and select T3,N0–3,M0 squamous cell carcinoma of the upper aerodigestive tract. Methods: Between July 1999 and February 2002, 19 patients were treated with 3 or 4 weekly cycles of intra-arterial cisplatin (150 mg/m2) with concurrent accelerated concomitant boost radiotherapy (72 Gy in 42 fractions over 6 weeks). Results: Two patient deaths occurred within the first 15 patients enrolled (at 27 Gy and 39 Gy). Both patients presented with febrile neutropenia. Both died of complications related to infection. The number of cycles of intra-arterial cisplatin was reduced and an additional 4 patients were treated. The fourth patient treated on the modified protocol developed febrile neutropenia, sepsis, and a thromboemobolic event which resulted in lower extremity amputations. The maximum acute toxicity experienced was grade 2 in 6 patients, grade 3 in 5 patients, grade 4 in 6 patients, and grade 5 in 2 patients. With a median follow-up period of 34.7 months (range 19.9 to 48.0 months), the overall survival at two years is 78.6% (95% CI 62.0%–99.6%). At two years 70.6% of the patients are free from progression (95% CI 51.9% to 95.9%). Conclusion: Despite the encouraging survival and tumor control rates, results of this study suggest that concurrent intra-arterial cisplatin at 150 mg/m2 with accelerated concomitant boost radiotherapy is not feasible due to excessive acute toxicity. No significant financial relationships to disclose.