MONDAY, July 7 (HealthDay News) -- Outcomes are poorer in women who receive transplanted kidneys from male donors, suggesting that an immunological H-Y effect occurs in kidney transplantation, but outcomes are the same in patients who receive either vitespen -- an adjuvant autologous therapeutic vaccine -- or observation after nephrectomy for renal cell carcinoma, according to two studies published online July 4 in The Lancet.
In one study, Alois Gratwohl, M.D., of University Hospital Basel in Switzerland, and colleagues studied 1985-2004 data on 195,516 recipients of allografts from deceased donors. In women who received male donor kidneys, they found an increased risk of graft failure during the first year and between years two and 10 (hazard ratio, 1.08 and 1.06, respectively).
In a second study, funded by Antigenics, Inc., which several co-authors disclosed having financial ties to, Christopher Wood, M.D., of the University of Texas M.D. Anderson Cancer Center in Houston, and colleagues randomly assigned 818 patients to receive either vitespen or observation alone after nephrectomy. After a median follow-up of 1.9 years, they found that recurrence rates were similar in both groups (37.7 percent for the vitespen group versus 39.8 percent for the observation-alone group). Continued follow-up showed a similar number of deaths (70 versus 72, respectively).
"A challenge of future trials of adjuvant agents -- especially immunotherapies -- will be how to efficiently incorporate an objective, more reliable determination of disease response earlier in the data collection process," Wood and colleagues conclude. "Lack of established surrogate markers, such as immune response, makes the difficulty of establishing efficacy of an adjuvant immunotherapy even more formidable and merits continued research."
Abstract - Gratwohl
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Abstract - Wood
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