The only trial showing that bone marrow transplants for breast cancer could prolong life is now being sharply questioned after the study's lead investigator was accused of serious scientific misconduct.
The trial, led by Werner Bezwoda, of the University of Witwatersrand, Johannesburg, South Africa, looked at high dose chemotherapy followed by bone marrow transplantation in women whose cancer had spread to 10 or more lymph nodes.
The results of Bezwoda's research were presented last year at the American Society of Clinical Oncology's annual meeting, and his was the only study to show clearly a survival benefit in the high dose regimen.
The University of Witwatersrand has accused Bezwoda of “misrepresenting results of a clinical trial” after an investigation aimed at substantiating Bezwoda's findings failed to produce records needed to confirm his data. Bezwoda denied that there was “any falsification of the data” but refused to elaborate and referred additional questions to the university.
Previously, the results of four breast cancer studies comparing high dose chemotherapy plus either bone marrow or stem cell transplant with standard chemotherapy found no conclusive benefits from the more aggressive treatment.
The research now in question was the only rigorous study to show any significant benefit to patients who underwent the high dose treatment plus bone marrow transplants. Bezwoda's study involved 154 South African women. After 5 years, 25% of women in the high dose group had relapsed, compared with 66% in the group receiving standard treatment. In the high dose group, 17% had died, compared with 35% in the standard group.
“Certainly it's upsetting,” said Joseph Bailes, president of the American Society for Clinical Oncology. “Obviously it concerned the University in South Africa enough that they brought it to our attention,” he said.
Doctors involved in the research into the transplants had known for several months that a team of US doctors was going to South Africa to audit the data from Bezwoda's study, according to Eric Weiner, director of the Breast Oncology Center at the Dana Farber Cancer Institute in Boston. “My understanding is that they were unable to find the records that would substantiate the results,” he said.
Figure 1.
Williams Peters, Jonas Bergh, and Werner Bezwoda (l to r) discuss value of chemotherapy and bone marrow transplants in fighting breast cancer