Dataset Information

Randomized phase II trial of sulindac for lung cancer chemoprevention.

ABSTRACT:

Introduction

Sulindac represents a promising candidate agent for lung cancer chemoprevention, but clinical trial data have not been previously reported. We conducted a randomized, phase II chemoprevention trial involving current or former cigarette smokers (≥30 pack-years) utilizing the multi-center, inter-disciplinary infrastructure of the Cancer Prevention Network (CPN).

Methods

At least 1 bronchial dysplastic lesion identified by fluorescence bronchoscopy was required for randomization. Intervention assignments were sulindac 150mg bid or an identical placebo bid for 6 months. Trial endpoints included changes in histologic grade of dysplasia (per-participant as primary endpoint and per lesion as secondary endpoint), number of dysplastic lesions (per-participant), and Ki67 labeling index.

Results

Slower than anticipated recruitment led to trial closure after randomizing participants (n=31 and n=30 in the sulindac and placebo arms, respectively). Pre- and post-intervention fluorescence bronchoscopy data were available for 53/61 (87%) randomized, eligible participants. The median (range) of dysplastic lesions at baseline was 2 (1-12) in the sulindac arm and 2 (1-7) in the placebo arm. Change in dysplasia was categorized as regression:stable:progression for 15:3:8 (58%:12%:31%) subjects in the sulindac arm and 15:2:10 (56%:7%:37%) subjects in the placebo arm; these distributions were not statistically different (p=0.85). Median Ki67 expression (% cells stained positive) was significantly reduced in both the placebo (30 versus 5; p=0.0005) and sulindac (30 versus 10; p=0.0003) arms, but the difference between arms was not statistically significant (p=0.92).

Conclusions

Data from this multi-center, phase II squamous cell lung cancer chemoprevention trial do not demonstrate sufficient benefits from sulindac 150mg bid for 6 months to warrant additional phase III testing. Investigation of pathway-focused agents is necessary for lung cancer chemoprevention.

SUBMITTER: Limburg PJ

PROVIDER: S-EPMC3566344 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Randomized phase II trial of sulindac for lung cancer chemoprevention.

Limburg Paul J PJ Mandrekar Sumithra J SJ Aubry Marie Christine MC Ziegler Katie L Allen KL Zhang Jun J Yi Joanne E JE Henry Michael M Tazelaar Henry D HD Lam Stephen S McWilliams Annette A Midthun David E DE Edell Eric S ES Rickman Otis B OB Mazzone Peter P Tockman Melvyn M Beamis John F JF Lamb Carla C Simoff Michael M Loprinzi Charles C Szabo Eva E Jett James J

Lung cancer (Amsterdam, Netherlands) 20121220 3

<h4>Introduction</h4>Sulindac represents a promising candidate agent for lung cancer chemoprevention, but clinical trial data have not been previously reported. We conducted a randomized, phase II chemoprevention trial involving current or former cigarette smokers (≥30 pack-years) utilizing the multi-center, inter-disciplinary infrastructure of the Cancer Prevention Network (CPN).<h4>Methods</h4>At least 1 bronchial dysplastic lesion identified by fluorescence bronchoscopy was required for rando ...[more]

PMID: 23261228

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Dataset Information

Randomized phase II trial of sulindac for lung cancer chemoprevention.

Introduction

Methods

Results

Conclusions

Publications

Randomized phase II trial of sulindac for lung cancer chemoprevention.

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