A phase I/II trial of induction chemotherapy followed by concomitant docetaxel with concomitant boost radiotherapy (CBR) for cancer of the head and neck

Abstract

5593 Background: The addition of chemotherapy to XRT has generally resulted in reduced local-regional recurrence. However, the optimal manner in which to integrate chemotherapy has been undefined. This study evaluates the toxicity and response to induction chemotherapy followed by aggressive radiation using CBR and concurrent docetaxel in patients with locally advanced squamous cell carcinoma of the head and neck. Subcutaneous (SC) amifostine was used during CBR to reduce xerostomia. Methods: Patients with stage III/IV nonmetastatic SCCHN were treated with induction docetaxel and cisplatin for 3 cycles, each at a dose of 75 mg/m2. Patients then received weekly docetaxel at 20 mg/m2 concurrently with concomitant boost radiation therapy. SC amifostine was delivered in daily doses of 500 mg during radiotherapy. Results: From the phase I study, 11 patients are evaluable for toxicity and response. Induction chemotherapy was well tolerated with significant clinical regression noted. 8 patients received induction chemotherapy followed by 6 cycles of concurrent chemotherapy with CBR. During chemoradiotherapy, toxicities included ≥ Grade 3 mucositis in 7 patients, ≥ Grade 3 skin toxicity in 4 patients, XRT breaks for 5 patients and 2 patients did not complete the XRT. The protocol was amended to remove chemotherapy during the concomitant boost phase of XRT. 3 patients have been treated with the amended regimen. No patients on this regimen developed greater than grade 2 skin toxicity and only 1 patient developed grade 3 mucositis. Overall, 2 patients recurred locally: 1 died of progressive disease and 1 underwent salvage surgery. 10 patients received ≥ 25 of the 30 planned daily amifostine injections with minimal side effects. Conclusions: This intensive regimen produced a disease-free survival of 80% at 1 year follow-up, but weekly chemotherapy during the concomitant boost phase resulted in excessive toxicity. Accrual will continue with the modified dose. Amifostine was well tolerated during concomitant chemoradiotherapy No significant financial relationships to disclose.