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In Reply

The Mount Sinai Comprehensive Cancer Center, Miami Beach, FL

Mark Socinski

University of North Carolina, Chapel Hill, NC

We appreciate the opportunity to comment on the work discussed in the letter by Gradilone and colleagues. Their contention that increased expression of multidrug resistance-associated protein 4 induced by celecoxib may compromise the efficacy of irinotecan, but not other chemotherapeutic agents, in non–small-cell lung cancer (NSCLC) is provocative and merits further research. It adds to an already large body of literature that attempts to provide a scientific basis for the use of cyclooxygenase (COX)-2 inhibitors in the treatment of NSCLC, yet to be proven in the clinical arena.

A few comments and clarifications about our study.¹ Firstly, the trial did not have sufficient power to address survival. A trend toward a detriment in survival was indeed observed for patients treated with celecoxib and chemotherapy, but it did not reach statistical significance and should not be interpreted as definitive. Nonetheless, the statement that our results were "strongly conflicting with other clinical studies" is incorrect, since no clinical trial has yet conclusively shown a positive impact of celecoxib in the treatment of NSCLC patients.

Secondly, and regrettably, our trial did not include a correlative science component. At the time it was designed, it addressed a rapidly growing sentiment among oncologists that celecoxib was potentially useful in the treatment of NSCLC patients. Our results showed that, at least in unselected patients with advanced disease, the use of celecoxib in combination with chemotherapy was of no benefit. Essentially, our trial sent a cautionary message against the use of celecoxib without more carefully predefined criteria, akin to the combination of tyrosine kinase inhibitors with chemotherapy in advanced NSCLC. However, our trial did not exclude the possibility that in selected patients, such as those with overexpression of COX-2, or other molecular features yet to be defined, celecoxib might have a positive impact. Clearly, as indicated at the end of our article, additional work is warranted.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

REFERENCE

1. Lilenbaum R, Socinski MA, Altorki NK, et al: Randomized phase II trial of docetaxel/irinotecan and gemcitabine/irinotecan with or without celecoxib in the second-line treatment of non-small-cell lung cancer. J Clin Oncol 24:4825-4832, 2006[Abstract/Free Full Text]

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