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|Controversy about Neoadjuvant (pre-op) Chemotherapy Protocol|
PRO: Trial Results Report that M-VAC Before Surgery Increases Survival
Long awaited results from a 14 year long clinical trial conducted by the Soutwest Oncology Group [ref.#8710) were published in 2001. The study reported a 2.4 year survival advantage for people with locally advanced (stages T2-T4a, no metastases) who had been given 3 cycles of MVAC (methotrexate, vinblastine, adriamycin, doxorubicin, and cisplatin before having a radical cystectomy vs. radical cystectomy with no other treatment. The trial results were presented, discussed and debated between international oncologists at the ASCO meeting, May 15, 2001.
317 bladder cancer patients participated; median follow-up was 7.1 years. Median survival for patients having received the MVAC regimen was 6.2 years vs. 3.8 years for those patients undergoing cystectomy alone. Survival at 7 years was 57.2% in the MVAC/cystectomy arm and 42.1% in the cystectomy arm.
These results differ from seven previously conducted clinical trials which had shown that there was no benefit derived from receiving MVAC before surgery.
The study was based on the concept that such patients harbor microscopic
cancer cells and that chemotherapy in the weeks before surgery, rather
than after it, is more likely to prevent the spread of cancer cells. The
phase III trial was conducted by Ronald B. Natale, MD, acting medical
director, Cedars-Sinai Medical Center, Los Angeles. Dr. Natale claims
that other potential advantages of MVAC as neoadjuvant (pre-surgery) chemotherapy
Dr. Natale said, doctors can address the question of whether they can forgo bladder removal, or at least delay removal, for many patients. Such a step would require further study. "The results of a single trial shouldn't change the standard of care, he added, but "the striking results of this study require that patients at least be informed that preoperative chemotherapy might significantly change their survival."
CON: Too many flaws in the trial design, results are not convincing enough
Dr. Cora N. Sternberg, one of the pioneers of the original MVAC regimen
which was first developed at Memorial Sloane Kettering Cancer Center,
NYC, questioned many of the assumptions put forth by Dr. Natale, such
Dr. Sternberg questioned whether the study actually proved a survival
benefit, and said that a larger group was needed for statistical analysis,
thus making the findings misleading.
The National Cancer Institute and the Society for Urologic Oncology published
along with same slides of Dr. Harry Herr's presentation to fellow professionals
at the 'State of the Science' lecture. He discusses some of the issues
around the SWOG8710 trial. Some excerpts:
New England Journal of Medicine - SWOG 8710, Trial update, Sept. 2003
The September New England Journal of Medicine published an update about
the progress of the ongoing randomized phase III clinical trial SWOG 8710,
studying the use neo-adjuvant chemo with MVAC followed by cystectomy.
The article made headlines in print and on internet medical news sites
stating that the pre-op chemo regimen considerably improves the survival
rates for invasive bladder cancer. The article gives the strong impression
that a survival advantage of +/- 33 months was extended to the chemotherapy
The Lancet article: a difference of 5% survival at 5 years; a new standard of treatment?
As reported in The Lancet ( Volume 361, Number 9373 ) in June, 2003,
researchers from the Advanced Bladder Cancer Meta-analysis Collaboration,
based in London, publushed combined results from 10 clinical trials to
assess whether or not pre-op chemotherapy had an effect on outcome. Examining
data from more than 2,600 patients, the researchers found that combination
chemotherapy (using more than one drug as opposed to only one) improved
five-year survival by 5%.
Another European Opinion on the subject
A survival advantage of 5% at 5 years must be balanced by clear explanations of risk vs benefit. Little attention seems to have been given regarding quality of life issues from the viewpoint of patient. Given the lack of alternatives at this point, any advantage is welcome in the world of invasive and metastatic bladder cancer.
Fortunately, there are many plans being made now, with experts collaborating on new trial designs. See National Cancer Institute - Priorities of the Kidney/Bladder Cancers Progress Review Group
back to chemos used for invasive bladder cancer