If you think we missed anything we should be thankful for from a prostate cancer point of view, please feel free to express your viewpoint using the comment box below.
In January this year, the National Comprehensive Cancer Network issued new treatment guidelines for prostate cancer that specifically recommended active surveillance as a highly appropriate form of management for carefully selected patients with very-low-risk and low-risk disease, and the promising investigational drug MDV3100 started to enroll US patients into its first Phase III clinical trial — becoming the second truly novel form of hormone therapy (after abiraterone actetate) to achieve this stage of development.
Also in January, Bianco et al. clearly demonstrated, for the first time, the degree of variation in outcomes obtained by even experienced prostate cancer surgeons. This is, of course, a mixed blessing, but it does ensure that patients have very clear evidence for the fact that even the supposedly best prostate cancer specialists do not necessarily get “the best” results.
In February, the American Heart Association, in association with the American Society for Clinical Oncology and the American Urological Association issued a “science advisory” commentary on the cardiovascular risks associated with inappropriate use of androgen deprivation therapy (ADT).
In March, at the Genitourinary Cancers Symposium, Sartor et al., presented data showing that a “second generation” taxane — cabazitaxel — was able to extend the survival of men with progressive, metastatic, castration-resistant prostate cancer (mCRPC) after prior treatment with a docetaxel regimen, becoming just the second chemotherapeutic agent to demonstrate a survival benefit in mCRPC. In addition, new data continued to confirm the promise of ipilimumab as a possible treatment for patients with high-risk and progressive forms of prostate cancer.
In April, Katz et al. published data on the use of CyberKnife stereotactic body radiation therapy (SBRT) from a 300+ series of patients with localized prostate cancer, representing the first large case series evaluating the potential of CyberKnife therapy. Then at the end of the month, after all of the ups and downs, the FDA finally approved sipuleucel-T (Provenge) for the treatment of men with minimally symptomatic mCRPC. Meanwhile, “under the radar” CMS rescinded the “least costly alternative” policy that had limited payments for drugs like the LHRH agonists.
May was a relatively quiet month, but then in June the FDA approved cabazitaxel, based on the data presented at the Genitourinary Cancers Symposium. This is the first time that two new drugs for prostate cancer treatment have ever been approved in the same year. In addition, Oncogenix started a Phase III trial of custirsen sodium (OGX-011) in men with mCRPC.
July started off with a bang when Hugosson et al. published data from a 14-year-long trial of prostate cancer screening in Göteborg, Sweden, offering fascinating data from men in a previously unscreened population. Later in the month we saw publication of data on 12-year follow-up after brachytherapy and 10-year follow-up after cryotherapy.
On August 20, 2010, Us TOO International officially celebrated its 20th birthday — with an “educational party” in Chicago. And then on August 31, President Obama marked the beginning of Prostate Cancer Awareness Month (on September 1) with a Presidential Proclamation.
By early September, we knew that the first Phase III clinical trial of abiraterone acetate had produced a positive result in men with mCRPC — but we had to wait until Octoberto get the actual data. In addition, new Phase III trials of MDV3100 and OGX-011 were also initiated.
At the end of October, Sylvester et al. reported 15-year follow-up data on treatment of a consecutive series of 200+ early brachytherapy patients.
Finally, just this month, we have seen the start of a Phase III clinical trial of TAK-700 in patients with chemotherapy-naïve mCRPC; we have seen additional data from Lilja et al. on the ability to project 20 to 30-year risk for prostate cancer; we have seen a CMS panel recommend national coverage for Provenge for Medicare patients; and we have seen the approval of denosumab to prevent fractures and other prostate cancer-related skeletal events.
On the whole, it seems to have been a pretty good past 12 months since last Thanksgiving … so for our American readers, make the most of your Thanksgiving turkey on Wednesday. For everyone else, we look forward to a similarly positive report a year from now — hopefully to include the approval of dutasteride in the prevention of prostate cancer and abiraterone acetate to extend the survival of men who have already stopped responding to docetaxel-based chemotherapy.
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