PSA Is Not Enough to Assess Prostate Cancer Risk

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      22 Renal & Urology News                 JULY 2009                                                                                       www.renalandurologynews.com


       n   2009 Genitourinary Cancers Symposium, Orlando




       Unresectable RCC Tumors                                                                                                              PSADT
                                                                                                                                            Predicts
       Respond to Sunitinib                                                                                                                 Mortality
       BY JOHN SCHIESZER                             Patients enrolled in this trial had      Clinic’s Glickman Urological & Kid-
       SUNITINIB MAY have antitumor                histologically confirmed RCC with          ney Institute, said nearly all 13 patients    AMONG MEN who experience PSA
       activity against unresectable primary       an unresectable primary tumor, with        have multiple considerations.                 recurrence following radical prostatec-
       renal cell carcinoma (RCC), permit-         or without distant metastasis. All           Three patients have undergone pri-          tomy (RP) for prostate cancer, a PSA
       ting resection in some patients, ac-        patients received 50 mg of sunitinib       mary tumor resection, he noted. Vi-           doubling time (PSADT) of less than nine
       cording to preliminary results from         continuous dosing in repeated six-         able RCC was found in all specimens,          months at the time of recurrence is
       an ongoing phase 2 trial.                   week cycles. Staging was performed         with no unexpected surgical morbid-           associated with a significantly increased
         “In this small series of patients, we     at baseline and again after every two      ity. The median best-percentage re-
                                                                                                                                            risk of death, according to a study.
       found that about one in five patients       cycles. A Simon two-stage design was       duction in tumor size was 11% for
                                                                                                                                              Compared with men whose PSADT
       who had an unresectable primary                                                        primary tumors (range 43% reduction
                                                                                                                                            was nine months or more, those
       tumor had a response to systemic ther-                                                 to 8% increase). In addition, the medi-
       apy that was sufficient to allow subse-    For primary tumors,                         an best-percentage reduction for non-         with a PSADT less than three months
                                                                                                                                            had a nearly 10-fold greater risk
       quent resection,” said study investiga-    the median best-                            primary tumors was 16% (range 90%
       tor Brian Rini, MD, an attending                                                       reduction to 29% increase).                   of all-cause mortality; a PSADT of
       physician in the Department of Solid       percentage reduction                          Two patients (15%) had an objective         3-8.9 months was associated with a
       Tumor Oncology at Cleveland Clinic                                                     partial response per Response Eval-
       in Ohio. “These data may help to es-
                                                  in size was 11%.                            uation Criteria in Solid Tumors. Ten
                                                                                                                                            2.3 times increased risk.
                                                                                                                                              The study, led by Stephen J.
       tablish a new paradigm of integrating                                                  patients have discontinued therapy
                                                                                                                                            Freedland, MD, of the Duke Prostate
       systemic therapy and surgery in pa-         used by the investigators to test the      (nine because of disease progression
                                                                                                                                            Center at Duke University Medical
       tients with advanced RCC.”                  alternative hypothesis of conversion       and one because of thrombocytope-
                                                                                                                                            Center in Durham, N.C., included
         Tyrosine kinase inhibitors (TKIs)         to resectability rate of 20% vs. the       nia). Seven patients (53%) have expe-
       like sunitinib are approved for treat-      null hypothesis of 5%.                     rienced grade 3 toxicity, including           360 men who underwent RP between
       ing patients with metastatic RCC              To date, 13 patients are evaluable.      thrombocytopenia (four patients), fa-         1988 a
				
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