Induction Chemotherapy Plus Simultaneous Modulated Accelerated Radiation Therapy in Non-operative Hypopharyngeal and Supraglottic Laryngeal Squamous Cell Carcinoma: Preliminary Results of a Prospective Phase 2 Study

Abstract

To evaluate the toxicities and short-term outcome of induction chemotherapy (ICT) plus high biological effective dose (BED) simultaneous modulated accelerated radiotherapy (SMART) in non-operative hypopharyngeal and supraglottic laryngeal squamous cell carcinoma (SCCH/L). Patients diagnosed SCCH/L, aged from 18 to 75, either staged retrospectively from III to IV B, in accordance with the AJCC 2010 criteria,or refused operation were eligible. The patients were treated with 2 cycles of docetaxel-cisplatin based ICT, and 2-3 cycles cisplatin-based concurrent chemotherapy combined SMART.The prescription dose of pGTV was 69 Gy, in 30 fractions, 2.30 Gy per fraction.The BED is equivalent to 70Gy, in 33 fractions, 2.12 Gy per fraction.This study began enrolling patients since February 2013,and was registered with number ChiCTR-ONRC-14004240. Between February 2013 and June 2015, 60 newly diagnosed SCCH/L patients were enrolled. Xerostomia > grade 2 was not noted. The incidences of grade 3 skin reaction, oral mucositis and pharyngo-esophagitis were low, 11.7%(7/60), 3.3% (2/60) and 11.7% (7/60),respectively.Two patients had tracheotomy due to severe larynx toxicity. The main adverse reaction was hoarseness or sore throat, the incidence was 30% (18/60).Biopsy confirmed radiation injury in 3 cases.The 1-and 2-year local control rates(LC), progression free survival (PFS) and overall survival (OS) was 90.0% and 70.5%,90.0% and 70.7%, 90.0% and 71.9%,respectively.Patients with severe pharyngo-esophagitis had poor prognosis,it was independent factor of OS(p=0.03,95%CI 1.104-7.202). The ICT plus SMART regimen of 69Gy/30f in the treatment of SCCH/L demonstrated minor severe toxicities and satisfied short-term outcome.But we should pay attention to choose the appropriate crowd with high BED radiotherapy.