SummaryBackground. Prognostic data on Japanese patients receiving durvalumab after chemoradiotherapy (CRT) for locally advanced non-small cell lung cancer (LA-NSCLC) are insufficient. Whether pneumonitis has prognostic implications in patients with LA-NSCLC who have received durvalumab also remains unclear. Methods. We retrospectively assessed the data of 82 consecutive patients who had received durvalumab after CRT at our institution between May 2018 and August 2020. A multi-state model was used to establish the associations between co-variables and progression-free survival (PFS). Results. The median observation period for all the censored cases was 14.5 months (5.7–28.9 months), the median PFS was 22.7 months, and the 12-month PFS rate was 62.3% (95% CI: 50.2%-72.3%). The median percentage of the lung volume receiving a radiation dose in excess of 20 Gray (V20) was 22% (4%-35%). Thirteen patients (16%) had Grade 1 pneumonitis before receiving durvalumab, and 62 patients developed pneumonitis after durvalumab (Grades 1, 2, and 3 in 25 [30%], 32 [39%], and 4 [5%], respectively). Twenty-four patients (29%) completed the 1-year durvalumab treatment period, 16 patients (20%) were continuing to receive treatment, and 42 (51%) had discontinued treatment. In a multi-state analysis, patients with pneumonitis before durvalumab therapy had a poorer PFS than those without pneumonitis (HR: 4.29, p = 0.002). The development of Grade 2 or higher pneumonitis after durvalumab was not a significant prognostic factor for PFS (HR: 0.71, p = 0.852). Conclusion. Grade 2 or higher pneumonitis after durvalumab was not a prognostic factor of PFS in LA-NSCLC patients received durvalumab.
Introduction:
Dysphagia is often caused by radiotherapy (RT) in patients with head and neck cancer (HNC), and reduced tongue pressure (TP) is often associated with swallowing dysfunction in the oral stage. However, the evaluation of dysphagia by measuring TP has not yet been established in HNC patients. Herein, we conducted a clinical trial to evaluate the usefulness of TP measurement using a TP-measuring device as an objective indicator of dysphagia induced by RT in HNC patients.
Methods and Analysis:
This ELEVATE trial is a prospective, single-center, single-arm, non-blind, non-randomized trial to evaluate the usefulness of a TP measurement device for dysphagia associated with the treatment of HNC. Eligible participants include patients with oropharyngeal or hypopharyngeal cancer (HPC) undergoing RT or chemoradiotherapy (CRT). The TP measurements are conducted before, during, and after RT. The primary endpoint is the change in the maximum TP values from before RT to 3 months after RT. Moreover, as secondary endpoints, the correlation between the maximum TP value and the findings of video-endoscopic and video-fluoroscopic examinations of swallowing will be analyzed at each evaluation point, as well as changes in the maximum TP value from before RT to during RT and at 0, 1, and 6 months after RT.
Discussion:
This trial aimed to investigate the usefulness of evaluation by measuring TP for dysphagia associated with HNC treatment. We expect that an easier evaluation for dysphagia will improve rehabilitation programs for dysphagia. Overall, we expect this trial to contribute to the improvement of patients’ quality of life (QOL).
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