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Ann Thorac Surg 1995;60:584-585
© 1995 The Society of Thoracic Surgeons

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Discussion

Discussion

The first 300 words of the full text of this article appear below.

See also page 580.

DR JOEL D. COOPER (St. Louis, MO): I congratulate Dr Keenan and his colleagues on their excellent work, and I appreciate the opportunity to review the manuscript. I cannot recall another so well constructed randomized, prospective clinical trial of immunotherapy after lung transplantation, and I think this is absolutely the way to do it. This type of trial is the only way to answer some of the very pressing questions directed at the currently biggest obstacle to long-term survival after lung transplantation. The early results seem encouraging, perhaps less so than many of us would have hoped, given the urgency of this problem. I also congratulate Dr Keenan and colleagues on their restraint in interpreting their intermediate results.

In my comments I will focus on clinical trials in general, particularly some of the pitfalls of clinical trials, as they may apply to this particular study.

One pitfall is the timing of the evaluation. Most of these patients had a follow-up of less than 2 years after transplantation and the mean follow-up was less than 2 years. My colleague, Dr Sundaresan, reported our own analysis of this problem yesterday by dividing our overall experience with 187 patients into four quartiles: the most recent group of patients, the second most recent, the third most recent, and the most remote group. In the first quartile, our initial experience, the patients all have more than 4 years' follow-up; in the next quartile, the patients have more than 2 years' follow-up; and the first two groups, the most recent patients, represent those with less follow-up.

As Dr Sundaresan pointed out, the incidence or the prevalence of bronchiolitis oblitereus syndrome rises significantly after the 2 -year mark compared with the early results. So again I emphasize that these are early results and . . . [Full Text of this Article]