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Editorials |
Received August 13, 2008; accepted for publication August 13, 2008.
In the Letters to the Editor section of this issue, we call your attention to further questions raised by Dr. Peter Bach [1], a pulmonologist and cancer epidemiologist at Memorial Sloan-Kettering Cancer Center, who has previously written about inconsistencies in the data presented by Dr. Claudia Henschke and colleagues in their recent articles in the New England Journal of Medicine (NEJM) and in The Oncologist [2]. Bach now points out that the number of patients in the "untreated" lung cancer group of the Henschke study totals 13 in The Oncologist, while the NEJM paper, describing the same trial, noted only 8 such patients. This "untreated" group assumes considerable importance, in that all of these patients subsequently died of lung cancer, a fact that the authors use to bolster their argument that CT screening, if followed by aggressive treatment, can save lives. It appears that most of the Henschke 8 "untreated" patients had advanced disease at diagnosis, and were, therefore, irrelevant to the argument [2]. In a letter to the NEJM published online July 30, 2008, Henschke formally revealed that only 3 of the 8 "untreated" patients had clearly treatable stage I disease [3]. We find it interesting that this "correction" was published as a letter to the NEJM, rather than as a formal correction or retraction. Given the importance of this recent revelation, either would have seemed more appropriate.
To add to the confusion, Henschke further explains that one of her sites did not follow eligibility criteria as outlined in and as required by the protocol, but despite these revelations, the results are unchanged [3]. Thus, the results of this key lung cancer prevention trial, heralded as evidence for the value of CT screening for lung cancer, have become increasingly ambiguous, a situation that can only be dispelled by auditing the trial.
We have previously called for an audit [4] and now more than ever, it is in the interests of all concerned, including the authors, the sponsors (i.e., National Cancer Institute, American Cancer Society, as well as an independent foundation that derived its major support from a tobacco company) that an impartial audit be conducted expeditiously.
The bond that clinical investigators make with cancer patients who volunteer their enrollment is sacred. These patients have made the most significant contribution to the I-ELCAP trial; the investigators in turn must honor their commitment to provide an accurate analysis of the trial's results. Given the confusion that reigns, only with a thorough, complete, and impartial audit can this bond, the cornerstone of clinical research, be restored and preserved.
Bruce A. Chabner
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