摘要:
Purpose/Objective(s) Approximately 30-40% of patients irradiated for HNSCC will develop locoregional recurrence or second primary tumors (RSPT). Treatment of RSPT originating within a previously radiated field presents a technical challenge and typically portends worse outcomes than an initial course of RT. Anti-PD-1 therapy has shown promise in the treatment of advanced HNSCC. CA209-9KY aimed to investigate the potential benefit of nivo during and after IMRT based re-irradiation in RSPT. We report here the toxicity and QOL data for 44 enrolled patients. Materials/Methods Following IRB approval at 3 participating institutions, patients were enrolled if they had RSPT arising in a previously irradiated field (> 40 Gy) and met criteria for reirradiation classes I or II (Ward et al, IJROBP 2018); prior salvage resection was allowed regardless of HPV status provided patients had positive margins, extranodal extension, gross residual disease, N2/3 or T3/4 disease, multifocal perineural invasion , and/or lymphovascular space invasion. IMRT reirradiation with photons was delivered in 60-66 Gy in 30-33 daily fractions over 6-6.5 weeks with Nivo (240 mg) two weeks prior to and every 2 weeks during IMRT for a total of 5 doses then at 480 mg every 4 weeks for a total of 52 weeks. The Functional Assessment of Cancer Therapy (FACT-G) (Version 4) was assessed pre-therapy and weeks 6, 18, 30 and 52. The sum of FACT-G subscales (SUMQOL) score was also computed. Median and interquartile range (IQR) for each subscale and SUMQOL were recorded per cycle visit. FACT-HN was assessed at the same time intervals. Internal consistency reliability was measured using Cronbach's alpha and reported for each FACT sub-scale at each cycle Results As of 1/2021, a total of 44 patients have completed IMRT with nivolumab with a median follow up duration of 6.3 mos [95% CI (4.5-11.2)]. The most common toxicities of any grade-(CTCAE version 4.0) were fatigue (77%), dermatitis (54%), and dysphagia (52%). G