Bezwoda high-risk primary HDC study (reviewed on site)
Study of high-dose chemotherapy in high-risk primary breast cancer, reviewed on site in 2000
Research misconduct
The Lancet on-site review (Weiss et al., 2000) reports that limited numbers of records were made available, much disparity between the reviewed records and data presented at two international meetings, no signed informed consent and no institutional review committee record of approval for the investigational therapy, and states that after the site visit Bezwoda 'admitted scientific misconduct by using a different control chemotherapy regimen from that described in presented data'. The reviewers conclude the study should not be used as the basis for further trials of that regimen. No results from this study are recorded.
Source: Weiss RB, Rifkin RM, Stewart FM, Theriault RL, Williams LA, Herman AA, et al. High-dose chemotherapy for high-risk primary breast cancer: an on-site review of the Bezwoda study. Lancet. 2000;355(9208):999-1003.
The reported results are not shown as evidence.
- Population
- High-risk primary breast cancer
- Design
- Study comparing high-dose with conventional-dose (control) chemotherapy in women with high-risk primary breast cancer, presented at two international meetings. A US team did an on-site review of the records; the review is published in The Lancet (2000). No efficacy results are recorded here.
- Arms
- High-dose chemotherapy with progenitor-cell rescue (experimental): High-dose cyclophosphamide, mitoxantrone and etoposide regimen with progenitor-cell rescue (as named in the Lancet review)
- Control chemotherapy (control): Control chemotherapy; the Lancet review states the regimen used differed from the one described in presented data
- People
- Weiss RB, senior author Beveridge RA