Archive | September, 2011

Prostate Cancer Survival Rate Improves with Short Term Hormone Therapy Coupled with Radiation Therapy

A new study published by the Radiation Therapy Oncology Group (RTOG) in the New England Journal of Medicine and supported by grants from the National Cancer Institute found that short-term hormone therapy (androgen deprivation therapy –ADT) given in combination with radiation therapy for me in early-state prostate cancer increases their chance of surviving longer and not dying from the cancer.  This was the largest randomized trial of its kind, enrolling almost 2,000 men at low and intermediate risk of prostate cancer progression and following their health status from October 1994 to April 2001 at 212 centers throughout the United States and Canada.

Male hormones (androgens) including testosterone increase the growth of prostate cancer cells.  Therapy that decreases the body’s levels of androgens (particularly four months of ADT starting two months prior to radiation therapy in this study) removes the strongest growth factor for prostate cancer cells.  Authors of the study report that adding short-term ADT to radiation therapy significantly improved the overall survival rate at 10 years from 57 to 62 percent.  Additionally, in a trial of different treatments on each of the patients’ two arms, the radiation therapy coupled with short-term ADT arm was associated with four percent fewer prostate cancer-related mortalities compared with the radiation therapy-alone arm.  More importantly, the reduction in disease-specific deaths was accounted for by the intermediate-risk study participants in the radiation therapy plus ADT arm (10 percent as opposed to three percent in radiation only arm at 10 years) while no reduction in deaths was seen among low-risk participants at 10 years.  These benefits were achieved with a mild increase in patient-reported erectile dysfunction at one year but no increase in observed long-term bowel or bladder toxicities.

About 240, 890 Americans will be diagnosed with prostate cancer in 2011 and almost 9 out of 10 will have early-stage disease.

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Mismatch Could Lead to Rejection in Pediatric Kidney Transplants

Researchers found that antigen incompatibility hurts pediatric transplant outcomes but may often be unavoidable unless changes are made to the organ allocation system.  Peter G. Stock, MD, PhD, of the University of California San Francisco (UCSF), and colleagues found in a retrospective cohort study that one or two mismatches for human leukocyte antigen (HLA)-DRB1 between the donor and pediatric recipient increased risk of rejection by 70%.  In a recent issue of the Archives of Surgery, the team reported that the chances of a perfect match were small under the current local organ-sharing scheme.  The study included 178 patients younger than 21 who had successful kidney transplantation at UCSF with daclizumab (Zenapax) induction therapy from 1997 to 2006.

It is estimated that the chance of finding a donor without any HLA-DRB1 mismatch was also compatible for blood type was less than two per 100 local donors for most patients in the study.  The chances were even lower for Asian minorities.

Stock’s team stated that longer waiting time on dialysis can mean severe growth retardation and greater risk of dying for children who need a kidney.  They recommended moving beyond local boundaries for organ sharing to a regional donor poor to give children a better chance of finding their best HLA-DRB1 match.  The team also recommended calculating the frequency of a donor without any HLA-DRB1 mismatch for each patient on the waiting list.  They suggested that those with a higher probability of a perfect match could benefit from waiting, and those with a very low probability, such as ethnic minorities, should undergo transplantation regardless of HLA-DRB1 mismatch.  One- and five-year rates for graft outcomes were 97% and 82% for graft survival and 35% and 55% for rejection.

The team acknowledged that the study could not control for potential confounding from unmeasured factors like medication adherence, but restricting the sample to those on daclizumab precluded confounding from different immunosuppression regimens.  One of the study’s other limitations was the use of medical record review and examination of available blood samples for diagnosis of rejection and sensitization, which may have underestimated outcomes.

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Prostate Cancer Patients on ADT Not Affected by Provenge

A recent study, led by Tomasz Beer, MD, Professor of Medicine at Oregon Health & Science University (OHSU) in Portland, Oregon, found that prostate cancer (PCa) patients on androgen deprivation therapy (ADT) and receiving sipuleucel-T (Provenge) have no adverse outcomes in terms of quality of life.  These findings were presented at the 47th Annual Meeting of the American Society of Clinical Oncology.

The study involved 176 men who were placed on ADT for three to four months after experiencing PSA recurrence after radical prostatectomy.  Sipuleucel-T, which received FDA approval for the treatment of late-stage PCa last year, is not usually used in men with earlier states of prostate cancer.  This is the first study to explore the effect of the autologous cellular immunotherapy on quality of life.

After three to four months, ADT was stopped and all men were randomized to treatment with sipuleucel-T (117 patients) or control (59 patients). Using survey techniques, the researchers assessed quality of life at baseline (following ADT and prior to randomization) and at weeks 13 and 26 after treatment.  Ninety-eight percent of subjects completed baseline quality of life assessment and 92% had at least one post-treatment assessment.  During ADT in the three months before sipuleucel-T treatment, quality of life measures decreased comparably in both study arms.  After the start of the study treatment, there were no significant differences found in the quality of life between the two groups.

Dr. Beer emphasized that the results from the study suggest that a larger study in early disease patients is needed.

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Radiotherapy And Androgen Deprivation More Beneficial Than Radiotherapy Alone in Some Prostate Cancer Patients

In a recent study funded by grants from the National Cancer Institute and published in the New England Journal of Medicine, it was reported that short-term androgen-deprivation therapy improves survival in men with intermediate-risk, localized prostate cancer.  From 1994 to 2001, one thousand seventy nine men with localized prostate cancer and prostate-specific antigen levels of 20 ng/mL or less were randomized to receive radiotherapy alone (992 patients) or radiotherapy plus four months of androgen-deprivation therapy (987 patients).

The overall ten-year survival rate was significantly higher with combination therapy than with radiation alone, and combination therapy decreased disease-specific deaths.  The median follow-up period was 9.1 years, and the ten-year rate of overall survival was 62% among patients receiving radiotherapy plus short-term ADT (the combined-therapy group), as compared with 57% among patients receiving only radiotherapy.  The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from eight percent to four percent. Biochemical failure, distant metastases, and the rate of positive findings on repeat prostate biopsy at two years were significantly improved with radiotherapy plus short-term ADT.  In the two groups, acute and late radiation-induced toxic effects were similar.

The study was carried out because it had not been known whether short-term androgen-deprivation therapy (ADT) before and during radiotherapy improves cancer control and overall survival among patients with early, localized prostate adenocarcinoma.

It was found in a post-hoc analysis that the benefits of combination therapy were limited to men with intermediate-risk disease rather than men with low-risk cancer.

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Men’s Expections for Urinary and Sexual Function After Prostate Surgery Are Not Met

A recent study in the Journal of Urology, led by Daniela Wittmann at the University of Michigan, found that man’s expectations to have better urinary and sexual function a year after the surgery than before it went unmet.

The study used a survey of 152 men, recruited between June 2007 and November 2008, undergoing radical prostatectomy before the surgery after they had received counseling on the risks of the procedure.

Of the patients 36% and 40% expected the same as baseline function at one year in urinary incontinence and sexual function, respectively, and 17%, 45%, 39%, 15% and 32% expected worse than baseline function at one year in urinary incontinence, urinary irritable symptoms, bowel function, hormonal function and sexual function, respectively. One year after prostatectomy fewer than 22% of patients attained lower than expected urinary irritable symptoms, and bowel and hormonal function, but 47% and 44% of patients attained lower than expected function for urinary incontinence and sexual function, respectively. Twelve percent and 17% of patients expected better than baseline urinary incontinence and sexual function at one year after surgery.

Other recent studies have shown that about one in four men recovered the ability to have intercourse one year after surgery and that some amount of incontinence was common even though men were generally not significantly bothered by it.

Tracey Krupski of the University of Virginia, who wrote an editorial that was published with the study, said that a support network may help new cancer patients understand the realities of life after surgery, while Wittmann said that involving patients’ partners is important to successfully regaining sexual function.

Although the study did not examine whether men would make a different treatment decision given what they know after the surgery, Wittmann said that she thinks that only a small proportion of these men would choose not to have surgery given the cancer-related risks.

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