Audit of Breast Cancer Study Confirms Lumpectomy’s Value

An exhaustive audit of a fraud-tainted cancer study has confirmed the original results: Breast cancer is as effectively treated with a breast-saving procedure as with surgery in which the whole breast is removed.

A report released Tuesday by a team of experts at the National Cancer Institute concluded that removing the tumor and then treating with radiation is just as likely to result in long-term survival as is mastectomy--removal of the entire breast.

The breast-saving procedure, called lumpectomy, has been in use for some time, but its validity was thrown into question earlier this year when NCI officials announced that a major study that supported lumpectomy was based, in part, on fraud.

Officials learned that a researcher at St. Luc’s Hospital in Montreal had falsified data for some of the patients that he had enrolled in the study.

The study, called the National Surgical Adjuvant Breast and Bowel Cancer Project, had been key research in establishing the value of lumpectomy.

NCI removed the St. Luc’s data from the study last spring and did a cursory recomputation that found the fraud did not affect the conclusion about lumpectomy.

The agency also undertook a detailed audit in which researchers re-examined hospital data for 1,554 patients in the studies and were able to find the original charts to verify data for 1,390 of the enrollees.

“We audited 86% of all of the data in the original study and found that the conclusion was not changed,” said Dr. Jeffrey S. Abrams of the NCI therapy evaluation program.

Though some of the 484 institutions in the original study were left out of the audit, Abrams said, the experts got enough data to construct a statistically powerful verification of the original findings.

The audit found that breast cancer patients who chose lumpectomy and radiation had a 10-year survival rate of 71%, versus a survival rate of 66% for those who chose mastectomy. Abrams said the results, from a statistical viewpoint, show no significant difference between the two therapies.

The reports were delivered at a meeting of cancer clinicians organized by the NCI.