Lumpectomy Effectiveness Reaffirmed by 3 Studies
Settling a nasty controversy over treating early stage breast cancer, newly updated and revised studies involving thousands of women show that the procedure called lumpectomy--cutting out the tumor and minimal adjacent tissue--coupled with radiation therapy, is as effective as removing the entire afflicted breast.
That conclusion, reached by three studies appearing in today’s New England Journal of Medicine, should reassure women and their doctors, giving them more confidence in the less disfiguring treatment.
Although cancer surgeons have performed lumpectomies since the mid-1980s, the rationale for doing them was suddenly called into question last year, when it was publicly reported that the largest study supporting the procedure was based partly on half a dozen falsified cases from St. Luc Hospital in Montreal.
At the time, participating researchers across North America insisted that the compromised cases did not undermine the basic conclusion of the study, which drew on more than 2,100 patients. Still, amid questions about the multimillion-dollar, federally funded study, Congress and the General Accounting Office investigated the widely publicized incident in 1994, which not only aroused additional fear of the already dreaded disease but eroded public trust in medical science.
The Montreal hospital forced the retirement of Dr. Roger Poisson, who admitted to falsifying the patient records, and the National Cancer Institute ousted the study’s chairman, Dr. Bernard Fisher, a distinguished cancer specialist at the University of Pittsburgh.
Fisher, a 20-year veteran of the National Surgical Adjuvant Breast and Bowel Project, was not accused of misconduct but was criticized for, in effect, allowing the Montreal fakery to occur on his watch, despite the fact that he promptly reported it to the institute after learning of the problems in 1991.
Now the project’s “medical director,” Fisher is the lead author of a study this week that reanalyzed and updated the original lumpectomy patient data, leaving out the tainted Montreal cases. “I think we can really put this to rest now,” he said of the controversy. “The findings indicate very conclusively that lumpectomy followed by breast radiation is the appropriate therapy for most women with breast cancer.”
In the new analysis of the original 2,100 patients, the researchers found that women who underwent lumpectomy and radiation therapy lived as long as those treated by a total mastectomy, long regarded as the most effective available therapy. After an average of 12 years since surgery, about 60% of patients in both treatment groups were still alive.
Underscoring the importance of the follow-up radiation, the researchers found that a subgroup of women who received only lumpectomy were three times more likely to suffer a recurrence of breast cancer than women treated by lumpectomy and radiation.
Dr. David McFadden, a surgeon at UCLA’s Jonsson Cancer Center, said the updated study was a “confirmation” of lumpectomy-radiation therapy and a “consolation” to patients. “One isolated example of scientific fraud shouldn’t upset people’s faith in clinical research,” he said.
Another study this week validated Fisher’s reanalysis. National Cancer Institute researchers checked more than 1,500 of the original patient records at 37 U.S. and Canadian hospitals.
The institute’s audit uncovered no evidence of additional fraud and corroborated 97.5% of the data entries examined. The researchers said they regarded the relatively few lapses and discrepancies as bookkeeping errors not unexpected in a large, complex study. “The results are secure,” said the institute’s Dr. Jeffrey S. Abrams, who participated in the audit. “The data have been verified. I’m satisfied that we’ve settled the issue.”
On the other hand, the audit revealed that up to one-third of the patients may have taken part in the study without being fully informed of the risks ahead of time. Dr. John C. Bailar III of the University of Chicago called that finding “disheartening.”
Nevertheless, Abrams said: “We were very pleased that even in a trial that is 20 years old, we were able to find and verify the vast majority of data. That made us feel confident that we were not dealing with a problem that is widespread in clinical trials.”
In this week’s third study, public health experts at Oxford University in England combined the results of 64 clinical trials involving 29,000 breast cancer patients treated with surgery and radiation before 1985.
The Oxford researchers also found that lumpectomy-radiation reduced the recurrence of breast cancer by a third, compared with surgery alone. And they found that mastectomy and lumpectomy with radiation offered women the same chance of surviving 10 years: about 70%.
Commenting on the three New England Journal studies, Bailar suggested in an accompanying editorial that the “evidence is now persuasive” that lumpectomy-radiation is as effective as any treatment available. And it has the advantage of “sparing” breast tissue, he said.
