The American Society of Clinical Oncology's 2010 Genitourinary Cancers Symposium took place March 5 to 7 in San Francisco and attracted over 2,000 participants from around the world. Highlights included recent advances in prostate cancer diagnostic approaches, targeted therapies for metastatic prostate cancer, and approaches for high-risk penile cancer patients.
Robert Dreicer, M.D., of the Cleveland Clinic Taussig Cancer Institute presented data from a clinical study showing that TAK-700, a selective 17,20 lyase inhibitor, is active and well-tolerated at a dose of greater than or equal to 300 mg twice daily in patients with castration-resistant, metastatic prostate cancer. In this phase I to II, open-label, dose-escalation study, the researchers evaluated 26 patients receiving TAK-700 at five dose levels or a combination of TAK-700 and prednisone.
The authors noted that, as of September 2009, 16 patients remained in the study, with 10 discontinuing treatment, including five due to adverse events, three due to objective disease progression, and one due to prostate-specific antigen (PSA) progression. The phase I results showed that 96 percent of patients experienced at least one treatment-related adverse event, with 88 percent being TAK-700 related and 50 percent being greater than or equal to grade 3 toxicity. The most common side effect was fatigue, followed by non-dose related gastrointestinal adverse events. All patients receiving greater than or equal to the 300 mg dose of TAK-700 experienced a decrease in PSA level.
"The recommended phase II dose is 400 mg twice daily. The safety and efficacy of TAK-700 and the necessity for use of concomitant prednisone are being further assessed in the phase II portion of the study," the authors write.
One or more authors of the study reported financial relationships with Takeda/Millennium, including employment.
John R. Day, Ph.D., of Gen-Probe Inc. in San Diego presented results from a prospective, multi-center study evaluating a gene fusion urine assay, TMPRSS2:ERG (T2:ERG). The study evaluated 463 patients with specimens that yielded sufficient RNA for T2:ERG analysis, and prostate cancer gene 3 (PCA3), serum PSA (sPSA) and percent free PSA (fPSA) test results were obtained for 453 subjects.
The assay showed high specificity for predicting prostate cancer biopsy outcomes. In addition, when used in combination with other prostate cancer tests (PCA3, sPSA, percent fPSA) and other clinical factors, including race, family history, prostate volume, digital rectal exam result, prior prostate biopsy and age, the approach led to significantly improved diagnostic accuracy, per the researchers.
"The assay also appeared to be [a] strong indicator of tumor aggressiveness, including pathological tumor grade and extent of disease in the biopsy. Right now, a large prospective clinical trial is warranted, as T2:ERG is a very promising biomarker," co-author, Joseph B. Amberson, M.D., of DIANON Systems in Stratford, Conn., said in a statement.
One or more authors of the study reported financial relationships with Gen-Probe, including employment.
Matthew K. Tollefson, M.D., of the Mayo Clinic in Rochester, Minn., presented results from a phase II, single-center study that randomized 108 patients with advanced prostate cancer to a single dose of 3 mg/kg ipilimumab with androgen ablation or androgen ablation alone from June 2005 to April 2009. The primary outcome measures were safety and initial efficacy as measured by PSA and clinical response.
The study found that patients receiving ipilimumab plus androgen ablation were more likely to experience undetectable PSA by three months as compared to androgen ablation alone (55 versus 38 percent), and some patients treated with ipilimumab were found to have significant clinical response and disease downstaging.
"Overall, this is still a work in progress, as we are currently tracking the radiographic responses for certain patients and 15 patients to date [who] have undergone an off-study prostatectomy. Some of these patients experienced a robust clinical response with disease downstaging, and the results are promising, although this was not the study's intent," co-author, R. Jeffrey Karnes, M.D., also of the Mayo Clinic, said in a statement.
One or more authors of the study reported financial relationships with Medarex.
Viraj A. Master, M.D., of Emory University in Atlanta presented data on the frequency of inguinal lymphadenectomy in high-risk penile cancer patients and the impact on survival. The study included 593 patients with grade 3 and pT2-4 penile cancer without distant metastases.
Despite established guidelines, the researchers showed that only a small percentage of high-risk penile cancer patients (26.5 percent) received inguinal lymphadenectomy, with increasing age decreasing the likelihood of patients undergoing inguinal lymphadenectomy.
"Of patients receiving lymphadenectomy, those involving examination of eight of more lymph nodes experienced significantly higher overall five-year survival. Guidelines should not only be more emphasized, but these guidelines should be updated to reflect the benefit of extensive lymph node dissection in older penile cancer patients," the authors write.
The 2010 Genitourinary Cancers Symposium was supported by Sanofi Aventis.
ASCO: Drug Prolongs Survival in Metastatic Prostate Cancer
THURSDAY, March 4 (HealthDay News) -- While the investigational drug cabazitaxel (Cbz) prolongs survival in men with metastatic prostate cancer progressing after treatment with a docetaxel-containing regimen, hormone therapy plus radiation improves survival and reduces recurrence in men with intermediate-risk early-stage prostate cancer, according to two studies presented at the 2010 Genitourinary Cancers Symposium, held from March 5 to 7 in San Francisco.
ASCO: Cystoscopy Alone More Cost-Effective in Surveillance
THURSDAY, March 4 (HealthDay News) -- Follow up screening for non-muscle-invasive bladder cancer (NMIBC) recurrence with only cystoscopy is more cost-effective than combined cystoscopy with urinary biomarker detection, and is associated with a lower incidence of false-positive results, according to research presented at the 2010 Genitourinary Cancers Symposium, held from March 5 to 7 in San Francisco.
ASCO: Urine Test Could Guide Prostate Biopsy Decisions
THURSDAY, March 4 (HealthDay News) -- A new urine test for prostate cancer detection, the PCA3 (prostate cancer gene 3) test, may reduce the need for repeat prostate biopsies, as the novel test was shown to accurately predict whether a biopsy will indicate prostate cancer in research presented at the 2010 Genitourinary Cancers Symposium, held from March 5 to 7 in San Francisco.
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