False Hope: Bone Marrow Transplantation for Breast Cancer

Ninety women were recruited onto the study and they were randomly allocated to receive either 2 cycles of high doses of three cytotoxic anti-cancer drugs cyclophosphamide, mitoxantrone and etoposide or six to eight cycles of more conventional doses of three drugs cyclophosphamide, mitoxantrone and vincristine. All of those receiving the high dose therapy were given either transplants of their own bone marrow or stem cells derived from their peripheral blood.

The results reported for the two groups were strikingly different with 23 out of 45 of the HDC group achieving complete response but this was only achieved in 2 out of 45 of the conventional dose group. All of the HDC patients required haematopoietic rescue but otherwise the side effects were described as moderate with mucositis listed specifically as a universal side effect of this therapy.

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The length of response and survival time were significantly larger in the HDC group and so this paper, published in a major international cancer journal, appeared to be a clear evidence-based endorsement of HDC as an effective treatment for advanced breast cancer and that their particular regimen:. Up until February this paper was cited no less than times and so it was clearly attracting the attention of oncologists around the world and thus indirectly their patients.

In this article there is an updated graph of patient survival from the study. There is also no indication of any extra treatment deaths in the HDC group. Bezwoda reported a clear advantage of the HDC therapy in terms of survival time and unlike the other trials he reported no treatment-associated deaths.

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In a report on the conference by Katherine Arnold published in in the Journal of the National Cancer Institute , the views of some of the participants are summarised and discussed. Dr Gabriel Hortobagyi one of those in the Texas group that had earlier published the data which suggested that positive results from phase II trials were probably due to biased selection of subject is quoted as saying that:.

Dr William Peters, an ardent longstanding advocate of HDC, highlighted the better survival rates in both arms of the clinical trials HDC and conventional dose therapy compared to women who were treated outside of clinical trials. This is an important point to remember if results from uncontrolled clinical trials are compared to historical outcomes for the condition as phase II trials often were; people treated as part of a clinical trial in specialist units tend to have better survival rates than women treated elsewhere.

The five studies reporting summary results at the conference had variations in their methodology and the most significant of these was that Bezwoda was using HDC as a first treatment for metastatic breast cancer whereas all of the others used it after patients had already been treated with conventional doses of chemotherapy. The difference between the South African results of Bezwoda and the four other groups were discussed and one contributor highlighted the fact that Bezwoda was using HDC as a primary treatment and suggested that the difference in his results might suggest that standard treatment made cells resistant to chemotherapy and added that:.

False Hope: Bone Marrow Transplantation for Breast Cancer - Richard A. Rettig - Google Книги

In this conference report in an academic journal there was no hint of any suspicions about the results of Bezwoda. Once again experts attending the conference were quoted voicing a range of different conclusions about the usefulness of HDC as a result of the conference presentations. Again the possibility that Bezwoda got better results because he gave patients HDC without any previous use of lower doses of chemotherapy was given as one possible reason for his success.

In the Lancet article reviewing the data presented at the Atlanta conference a number of serious problems with the work were found and some of these are summarised below. The review team concluded that their audit did not confirm the validity of what was done and what was reported and that:.

This review team went on to recommend that the South African results should not be used to justify the conduct of further clinical trials. The conclusions of the second audit Weiss et al, into the trial was published in the Journal of Clinical Oncology and many of the findings are similar to those noted above, some of these are listed below. There were numerous other inconsistencies between what was reported and what was found by the audit team. Given that figure 1 was published in as an updated survival log of this study then it is inconceivable that if it is correct then the reviewers would not have found evidence in early of substantial numbers of patients still alive after Taken together, these audits suggest that Bezwoda wrote protocols for the two studies only after he knew his work was to be audited, that he failed to obtain ethical approval or patient consent and that the published results bear no resemblance to what was actually done or what results if any were actually obtained.

In a September article by Michelle Mello and Troyen Brennan published in the journal Health Affairs there is an extended discussion of some of the legal, political and economic aspects of the HDC controversy and some of the lessons that should be learned from the case study and some of these are briefly outlined below.

Six patients started on this regimen before the trial was abandoned. Four patients experienced severe symptomatic cardiac toxicity. Two died of cardiomyopathy, the other two had suffered permanent cardiac impairment requiring intensive medical management one had died of her cancer by September when this was reported in the American Journal of Clinical Oncology Gralow and Livingston, Arnold, K High-dose chemo and breast cancer: Journal of the National Cancer Institute 91, Journal of Clinical Oncology 13, Bezwoda, WR High dose chemotherapy with haematopoietic rescue in breast cancer.

Haematology and Cell Therapy 41, Brownlee, S and Winters, D Bad science and breast cancer. Discover magazine August issue. Farquhar, C, Marjoribanks, J, Basser, R, Hetrick, SE and Lethaby, A High dose chemotherapy and autologous bone marrow or stem cell transplantation versus conventional chemotherapy for women with metastatic breast cancer. Grady, D Conference divided over high-dose breast cancer treatment. The New York Times May 18 th Gralow, JR and Livingston, RB University of Washington high-dose cyclophosphamide, mitoxantrone, and etoposide experience in metastatic breast cancer: Mello, MM and Brennan, TB The controversy over high-dose chemotherapy with autologous bone marrow transplant for breast cancer.

by Richard A. Rettig

Health Affairs 20, Journal of Clinical Oncology 11, Journal of Clinical Oncology 19, Journal of Clinical Oncology 15, Behind the Headlines Dr Geoff. You are commenting using your WordPress. You are commenting using your Twitter account. You are commenting using your Facebook account.

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False Hope: Bone Marrow Transplantation for Breast Cancer

Breast cancer cells grow much less quickly than those that cause lymphomas and leukaemias and so it is more difficult to kill all of the cancer cells and prevent cancer recurrence. This also means that the speed of recurrence of breast cancer is likely to be slower than in leukaemia or lymphoma thus sometimes raising false hopes that the treatment had brought about a cure.

And when health insurers demurred, state legislatures passed mandates requiring that they cover transplantation for breast cancer. It is not surprising that it was extremely difficult in this climate to get women to voluntarily enter clinical trials in which half of them would not receive a transplant. But eventually several trials were completed, and the results, presented at the meeting of the American Society for Clinical Oncology, were a bombshell. Bone marrow or stem cell transplantation provided no better survival for advanced breast cancer and, due to its toxicity, at times killed women early in their treatment.

One study that showed a survival advantage for transplantation was eventually shown to be fraudulent, a harrowing story that the authors tell quite well. Having thoroughly documented such a lapse in the evaluation of technology, Rettig and colleagues conclude with a sound recommendation for preventing similar events in the future: If you would like to authenticate using a different subscribed institution that supports Shibboleth authentication or have your own login and password to Project MUSE, click 'Authenticate'. View freely available titles: Book titles OR Journal titles.

Project MUSE promotes the creation and dissemination of essential humanities and social science resources through collaboration with libraries, publishers, and scholars worldwide. Forged from a partnership between a university press and a library, Project MUSE is a trusted part of the academic and scholarly community it serves. Built on the Johns Hopkins University Campus. On content, I think the book would have benefited if it addressed the technical questions more thoroughly and perhaps been a little less gossipy.

A more thorough chapter devoted to the differences between Phase II and Phase III randomized trials -- something more technical, and co-written with an epidemiologist would have been beneficial chapter could have also included a discussion on biomarkers and end points.

Also, there was a lot of inside-baseball on the procedure from the oncology community -- but we don't hear anything at all regarding financial analysis run by insurance companies on the procedure. We only hear details regarding the technology assessments. I also though that it was hard to understand the problem they are trying to address access vs. AIDS drugs in trials? This was tangentially mentioned, but not really adequately compared to. The last chapter on their solution to the problem was poorly done and I think would have tremendously benefited from feedback from people who are a little more critical.

First -- their explanation for the failure of medical journalists sounds reasonable -- just like HDC to cure breast cancer sounds reasonable -- but if you think about the stellar job journalists did on WMDs and the financial crisis it seems more like a deeper institutional problem with journalism itself, then minor technical problems with medical journalism in particular that resulted in shoddy reporting. Second, there are some rather inflamatory comments in this part, that are contradicted by other parts of the book e. Also suggesting ASCO do more in terms of patient advocacy while ignoring other institutions that already issue guidelines and seem more prone to that kind of work, such as the NCCN -- seems like a blunder.

Only other stylistic point would be it gets a bit redundant at times.

False Hope: Bone Marrow Transplantation for Breast Cancer

Overall a good read, if a little tedious, -- especially for future oncologists or anyone in medicine. Niet ingeschakeld Word Wise: Niet ingeschakeld Verbeterd lettertype: Schrijf als eerste een recensie over dit item. Waar zijn mijn items? Je recente bestellingen traceren.



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