University of North Carolina School of Medicine, Chapel Hill, NC
Swathi Eluri , Vivek Kaul , Neil R. Sharma , Stuart R. Gordon , Toufic Kachaamy , George Smallfield , Jason Samarasena , Arvind Trindade , Shivangi Kothari , Jeffrey Weber , Kenneth J. Chang , Petros Benias , Matthew J. McKinley , Nicholas Shaheen
Background: Progressive dysphagia in locally advanced esophageal cancer worsens quality of life (QOL). Endoscopic cryoablation may effectively palliate dysphagia. Aim: To study the effect of palliative cryoablation with trūFreeze Spray Cryotherapy (SCT) in patients with esophageal cancer. Methods: This is an interim analysis of a multi-center prospective study of esophageal cancer patients who are non-surgical candidates, not on active systemic therapy, without esophageal stents, or prior SCT. SCT is an endoscopic ablation modality using liquid nitrogen (LN2) delivered by catheter. SCT occurred at 6 week intervals or as indicated at a dose of 2x30 or 3x30 secs/treatment site. Dysphagia and esophageal symptoms were assessed at baseline and after treatment with a 5-point Dysphagia score and the EORTC-QLQ-OES18 (higher score = more symptoms). Results: 39 subjects (mean age 74.4 ±12.2; 87% men, Table) had 182 treatment sessions over a mean follow-up of 206.9 days, and received a median 3 SCT sessions with an average dose of 90 (3x30) secs/site. There was 1 procedure related SAE (2.6% of patients and 0.5% procedures). Mean follow-up dysphagia score was 1.6 ±0.8 and 90% had same or improved dysphagia score after SCT treatment, p<0.01. On average, treated patients maintained the same or improved levels of dysphagia for 117 days. Esophageal QOL was maintained with improvement in “eating problems” (24.4 before treatment to 18.2 after, p=0.01). Only 4 subjects needed an esophageal stent (n=2) or gastrostomy tube (n=2) for nutrition. Conclusions: SCT for palliation of esophageal cancer was effective in limiting progression of dysphagia, while maintaining esophageal QOL. Only 10% required either esophageal stenting or feeding tube at >6 month follow-up. Clinical trial information: NCT03243734
Age, mean ± SD | 74.4 ± 12.2 |
---|---|
Cancer Type, n (%) | |
Adenocarcinoma | 35 (90) |
Squamous | 4 (10) |
Tumor stage, n (%) | |
Stage 1 | 9 (30) |
Stage 2 | 3 (10) |
Stage 3 | 15 (50) |
Stage 4 | 3 (10) |
Esophagectomy, n (%) | 8 (21) |
Chemoradiation, n (%) | 27 (69) |
Luminal obstruction, n (%) | |
None | 8 (21) |
<50% | 22 (56) |
³ 50% | 9 (23) |
Follow-up time, mean days (SD) | 206.9 ± 161.1 |
SCT sessions, median (IQR) | 3 (1-6) |
Total freeze time/session, sec, median (IQR) | 3x30 secs/site, 90 sec (71-160) |
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Abstract Disclosures
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