Chemoradiation or Cetuximab/Radiation Versus Induction Chemotherapy Followed by Chemoradiation in Locally Advanced SCCHN
Platinum-based chemoradiation therapy (CRT) is the current standard treatment for locally advanced SCCHN, and induction docetaxel/cisplatin/5-fluorouracil (TPF) is superior to cisplatin/5-fluorouracil alone, but it has not been tested when added to concomitant therapy. NCT01086826 was an open-label multicenter study to assess 2 primary endpoints: overall survival (OS) of induction versus no induction and grade 3/4 mucosal toxicity of CRT in 421 patients with locally advanced SCCHN (stage III-IV squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx) (Ghi MG, et al. ASCO 2014. Abstract 6004). Patients were randomized to 1 of 4 treatment arms: Arm A1 = cisplatin/5-fluorouracil plus concomitant RT fractionation (CRT); Arm A2 = cetuximab plus RT (CET/RT); Arm B1 = 3 cycles of TPF followed by the same CRT; Arm B2 = 3 cycles of TPF followed by CET/RT. At a median follow-up of 41.3 months, radiologic complete response was observed in 44% in the induction arms (B1 + B2) and 28% in the concomitant arms (A1 + A2) (P = .002). Median progression-free survival (PFS) was 29.7 months in the B arms versus 18.5 months in the A arms, with a 3-year PFS of 47% versus 37%, respectively (P = .015). Perhaps most importantly, median OS in the induction B arms was 53.7 months compared with 30.3 months in the concomitant A arms, with a 3-year OS of 58% and 46%, respectively (P = .025). Thus, induction TPF followed by CRT or CET/RT significantly improved PFS and OS independently from the type of concomitant strategy in these patients without compromising compliance to the concomitant treatments. Based on these results, induction TPF followed by CRT with docetaxel/cisplatin/5-fluorouracil or cetuximab should now become the standard treatment for locally advanced SCCHN.