Phase II trial of concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): Results of RTOG 9911

Abstract

5509 Background: Recurrent SCCHN, if not curable by surgery or RT, is almost always fatal. Chemotherapy (CTx) alone (eg. DDP, 5FU) yields median survival times (MST) of 8–10 mos and 1 yr survival (OS) of ≤ 35% at best. For limited relapse or patients (pts) with new unresectable SCCHN within previous RT portals, a potential role for re-irradiation combined with radiosensitizing CTx, exists. In a prior phase I trial of HFx RT/ DDP/ P, we observed ≥ 2 yr disease-free survival in 5 of 31 pts (ASCO 1999, A-1551), and therefore exported this regimen to RTOG for broader assessment. Methods: Eligibility stipulated recurrent SCCHN or second 1° tumors (SPT) in a previous RT field; measurable tumor; ≥ 75% of tumor volume previously treated to 45 Gy-75 Gy; ≥ 6 mos elapsed from prior RT, ECOG PS 0–1; ANC ≥1500, plts ≥ 100K, bili ≤1.5 mg/dl, creat ≤ 1.5 mg/dl, and absence of distant mets. Pts received HFx RT (1.5 Gy/Fx BID x 5d every 2 wks x 4), in combination with DDP 15 mg/m2 IV QD x 5 and P 20 mg/m2 IV QD x 5 q 2 wk...