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GUsymposium0709.qxp 6/24/09 2:07 PM Page 2 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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