Thursday’s news reports: February 19, 2009

Today’s important news reports address:

  • 5- and 7-year survival data following iodine-125 permanent implant brachytherapy
  • Risks associated with low levels of lymphocyte apoptosis in patients receiving radiation therapy
  • Stiffening of the large arteries in men receiving antiandrogen therapy
  • The status of the toremifene and denosumab applications for approval for marketing in the USA

Morris et al. have reported data on the long-term follow-up of 1,006 consecutive patients treated with iodine-125 brachytherapy between July 20, 1998 and October 23, 2003. All men werediagnosed with low-risk and “low-tier” intermediate-risk prostate cancer. Most patients (65%) were also treated with 6 months of androgen deprivation therapy (ADT). Supplemental external beam radiotherapy was not used. The median patient age at treatment was 66 years. The median follow-up was 54 months for biochemical outcomes and 66 months for survival. The actuarial freedom from biochemical recurrence rate was 95.6 ± 1.6 percent at 5 years and 94.0% ± 2.2 percent at 7 years. The pretreatment PSA level and ADT use were predictive of the freedom from biochemical recurrence. The actuarial rates of distant metastasis and disease-specific death at 5 years were both < 1 percent. The overall survival rate at 5 years was 95.2 ± 1.4 percent and was 93.4 ± 1.8 percent at 7 years. Only the patient’s age was predictive of overall survival.

Schnarr et al. have reported that, in men receiving external beam radiation therapy as treatment for localized disease, the occurrence of high levels of lymphocyte apoptosis (programmed cell death of white cells known as lymphocytes found in the bloodstream and the lymph) after treatment with just 8 Gy of radiation has the potential to predict which patients will be spared late toxicity after completion of radiation therapy. The clinical implications of this finding will need to be investigated: for example, does this imply that men with low lovels of lymphocyte apoptosis after 8 Gy of radiation should abandon this form of treatment to protect themselves from post-treatment toxicities?

Dockery et al. have shown that antiandrogen treatment (with bicalutamide) in men with prostate cancer may increase stiffness of the large arteries, which is an adverse cardiovascular risk factor. The also noted that this effect was not maintained with testosterone receptor blockade (with goserelin acetate) in the longer term but tended to be sustained with suppression therapy. This adverse reaction may have some association to different effects of the two therapies on levels of sex hormones.

A media release from GTx, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s submission of a New Drug Application (NDA) for the use of toremifene 80 mg in the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT). Similarly, Amgen Inc. issued a media release announcing that the FDA has accepted Amgen’s submission and filed a Biologics License Application (BLA) for denosumab, the company’s investigational RANK ligand inhibitor. Amgen is seeking FDA approval of denosumab for treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer (in addition to approval for treatment and prevention of postmenopausal osteoporosis in women).

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