麻豆果冻传媒影音

NEW YORK, Oct. 2 -- Key data were incorrectly reported in two recent publications by the International Early Lung Cancer Action Project (I-ELCAP), according to the investigators, possibly undermining their positive conclusions.

The papers' lead author, radiologist Claudia Henschke, M.D., Ph.D., of Weill Cornell Medical College here, acknowledged that most patients serving as controls in a crucial comparison failed to meet criteria for inclusion in the group.

The acknowledgment calls into question one of the studies' main conclusions, that early treatment of lung cancer made possible by early low-dose CT screening leads to better outcomes.

Dr. Henschke's acknowledgment was contained in letters appearing recently in the New England Journal of Medicine and The Oncologist, where the two I-ELCAP papers were published in October 2006 and January 2008, respectively.

At issue were patients described as having untreated stage I lung cancer -- eight in the NEJM paper and 13 in the update reported in The Oncologist.

In her letter to the NEJM, published Aug. 21, Dr. Henschke said five of these patients did not have their tumor stage pathologically confirmed until they had progressed to stage IV. Their CT screening scans indicated a stage I diagnosis, but because the I-ELCAP protocol required pathological confirmation, they should not have been classified as stage I patients.

Her letter to The Oncologist, published this week, said "the same reclassification issue" applied to the additional five patients included in their January update.

The number of untreated stage I patients matters because their early deaths were key to what many considered the original papers' main conclusion -- that early-stage patients who receive treatment fare better than those who don't.

The I-ELCAP study involved more than 30,000 patients, including 412 with stage I disease whose lesions were resected within one month of diagnosis. (See: Spiral CT Screening for Lung Cancer Detects Early Curable Disease)

Peter B. Bach, M.D., of Memorial Sloan-Kettering Cancer Center, said that if there were just three patients in the untreated comparison group, "that's pretty thin stuff."

Added Dr. Bach, a long-time critic of the I-ELCAP studies, "I question making a clinical decision with such an underpowered control group."

Neither Dr. Henschke nor her co-author on The Oncologist paper, David Yankelevitz, M.D., also of Cornell, responded to requests for comment.

The authors were also in the spotlight in April, when it was revealed that their published papers had not disclosed that Drs. Henschke and Yankelevitz held patents related to CT-based lung cancer screening, or that a major backer of I-ELCAP received funding from a tobacco company. (See: Lung Cancer Investigator 'Discloses' Funding of Tobacco Money)

The Oncologist's editor, Bruce Chabner, M.D., said in an editorial that the revelations called all of the I-ELCAP findings into question. He called for a complete audit of the data.