3437 - PLDR Chemoradiation for Esophageal and Lung Cancer is Associated with Low Rates of Severe Esophagitis

02:30pm - 03:45pm PT

Hall F

Screen: 8

POSTER

Presenter(s)

Joshua Meyer, MD, FASTRO - Fox Chase Cancer Center, Philadelphia, PA

J. E. Meyer¹, J. Hasler², Y. Dong³, M. A. Hallman¹, R. A. Price Jr¹, E. Mikkelsen², K. Bynum², S. B. Hayes¹, R. J. Cohen¹, C. Denlinger², H. Borghaei², S. Su², and C. M. C. Ma¹; ¹Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA, ²Fox Chase Cancer Center, Philadelphia, PA, ³Baystate Medical Center, Springfield, MA, United States

Purpose/Objective(s):

Chemoradiation (CRT) for esophageal (E) and non-small cell lung (L) cancer can produce high rates of severe esophagitis (SE) during and immediately following treatment. Pulsed low dose rate (PLDR) radiation is a technique primarily used to decrease toxicity in the re-irradiation setting. With a single-arm prospective study, we investigated the ability of CRT to decrease the rate of SE without compromising tumor response in the curative setting.

Materials/Methods: A single-arm phase I study treated pts with carboplatin and paclitaxel weekly with 50.4 (E) or 60 Gy (L), delivered in 1.8 – 2 Gy fractions using pulses of 0.2 Gy every 3 minutes. SE was defined as initiation of or increase by 25% of narcotic doses or dysphagia requiring transition from solids to liquids or liquids to minimal oral intake occurring after week 1 of treatment and up to 4 weeks after completion of treatment. The primary endpoint, the proportion (p) of patients experiencing SE, was examined using a one-sided exact binomial test at the ? = 0.1 significance level with the null rate (38%) determined based on historical chart review (H0:p=0.38 vs H1:p<0.19). Quality of life (QOL) was assessed using QLQ-C30.

Results: 39 patients (pts) were enrolled - 35 E (29 adenocarcinoma [ACA], 5 squamous cell carcinoma [SCC], 1 other) and 4 L (2 ACA, 1 SCC, 1 other). After initial poor accrual for L pts, the study was closed to L pts. Median age was 65, 74% were male and 90% were white. All pts had ECOG PS 0 (56%) or 1 (44%). All patients were considered locally advanced (T1-4,N0-2,M0). SE occurred in 20% (7) of the E pts and 75% (3) of the L pts, overall 26% (p=0.075), meeting the pre-specified definition of success. 31/35 E pts underwent resection; 19% had a pathologic complete response (CR), and an additional 23% had a near CR. 50% of L pts (all clinically N2) were pathologically LN negative. Median progression-free survival was 45 months and median overall survival was 45 months. QOL measures showed stability overall, including physical functioning, pain and global scores.

Conclusion: In E and possibly L pts, PLDR CRT is a promising technique that can produce the expected pathologic response with lower than typical rates of SE. This trial provides evidence supporting the use of PLDR in the upfront RT setting. In cases where toxicity is expected to be high, this technique offers promise and warrants further investigation.