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This month we will be focusing on data from the recent 2009 Genitourinary Cancers Symposium. This meeting was held on February 26-28, 2009 in Orlando, FL and co-sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Therapeutic Radiology and Oncology (ASTRO), and the Society of Urologic Oncology (SUO). The following topics were presented as part of educational sessions along with oral abstract presentations.

 

Renal Cancer
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Updates in Therapeutic Agents

Several presentations were delivered regarding the mTOR inhibitors everolimus and temsirolimus.

Kay and colleagues presented updated data from a phase III randomized trial of everolimus (RAD001) versus placebo in metastatic renal cell carcinoma.15 In this trial, 416 patients with clear-cell renal cell carcinoma (RCC) whose disease progressed on sunitinib and/or sorafenib were randomized 2:1 to everolimus or placebo. The median progression-free survival (PFS) of 4.9 months for everolimus was significantly better than the PFS of 1.9 months for placebo. Improvement of PFS was seen in all prognostic subgroups. Twenty-five percent of the everolimus group was still progression-free at 10 months. Commonly reported adverse events included stomatitis, rash, fatigue, asthenia, and diarrhea.

Logan, et al presented an exploratory analysis on the influence of nephrectomy status on the efficacy of temsirolimus in patients with advanced renal cell carcinoma and poor-risk features.16 In 2007, it was reported that the mTOR inhibitor temsirolimus demonstrated a significantly longer PFS and OS when compared to interferon alfa (IFN) in patients with previously untreated advanced renal cell carcinoma with poor features. This study used Kaplan-Meier analysis and Cox proportional hazards model to analyze OS and PFS for the patient subsets of nephrectomy or no nephrectomy. The study showed that OS was longer and hazard of death was lower for temsirolimus versus IFN in both patient subsets. Similar findings were also reported for PFS. The authors concluded that temsirolimus benefits patients with advanced RCC and poor-prognostic features regardless of nephrectomy status and displays activity against primary kidney tumors as well.

Bhargava and colleagues presented the results of a phase II trial using AV-951, a potent and selective inhibitor of the VEGFR-1, 2, & 3 kinases.17 In this trial, 272 patients with locally advanced or metastatic RCC and no prior VEGF-targeted therapy were enrolled and received 16 weeks of therapy. Further treatment was then based on the response at that point. At 16 weeks, 1 patient had a complete response (CR) and 67 patients had a partial response (PR) based on RECIST criteria. Stable disease was reported in 161 patients and 29 patients had disease progression. Hypertension and dysphonia were the most commonly reported side effects. The authors reported that phase III trials with this agent were planned and that updated results and PFS for the entire patient population will be available later in 2009.

Update on Adjuvant therapy and toxicity

Dr Naomi Hass from the University of Pennsylvania presented in the Renal Cell Cancer educational session, a thoughtful update on the adjuvant therapy trials in renal cell carcinoma with emphasis on the toxicities of the various multi-targeted tyrosine kinase inhibitors (TKIs) and mTOR inhibitors.18 She described 4 ongoing phase III trials that are being undertaken and the recent reports of cardiac toxicity with the TKIs. She described cardiac toxicity as abnormalities in left ventricular ejection fraction (LVEF), prolonged QT interval, hypertension, and clinical congestive heart failure (CHF). The ASSURE ECOG 2805 trial is prospectively assessing the incidence of cardiac toxicity in 1332 patients with resected RCC at high-risk for recurrence, and on sunitinib, sorafenib, or placebo. The primary endpoint is to determine the LVEF decline within 6 months. Other endpoints include the assessment of degree of reversibility of any changes in LVEF and whether reversibility is associated with an intervention. Although clinicians and patients may be willing to be exposed to agents causing cardiac toxicity in the metastatic setting, the use of these agents in the adjuvant setting is more critical. It is important to truly understand the short and long-term toxicity of these agents in patients who may otherwise be cured of their cancer with their initial surgical intervention.

Great Debates and Updates in Breast Cancer
GREAT DEBATES AND UPDATES IN BREAST CANCER
“Physicians absent from this conference are missing a massive amount of new information and not getting the benefit of the superb faculty,” according to 1 attendee from last year. Didactic presentations and a debate format in which leading experts discuss some of the most challenging topics in breast cancer provide a thorough analysis of current data as well as new areas of research and emerging data.
June 19-20, 2009 in San Francisco, California.

References:

  1. Crook J, Fleshner N, Jewett M, et al. Squamous cell carcinoma of the penis: Results of brachytherapy as primary management for 74 patients over an 18-year period. 2009 Genitourinary Cancers Symposium. Abstract 227.
  2. Pagliaro LC. Advanced primary and concurrent bulky nodes in penile cancer that may or may not be resectable. 2009 Genitourinary Cancers Symposium: Penile Cancer Educational Session.
  3. Nichols CR. Challenges in the management of advanced germ cell tumors. 2009 Genitourinary Cancers Symposium: Testis Cancer Educational Session.
  4. Kollmannsberger C and Bokemeyer C. Relapsing disease: Second-line therapy and beyond. 2009 Genitourinary Cancers Symposium: Testis Cancer Educational Session.
  5. Townsend J, Richardson LC, German RR, et al. Incidence of testicular cancer in the United States, 1999-2004. 2009 Genitourinary Cancers Symposium. Abstract 232.
  6. Dreicer R. Targeted therapeutics for advanced urothelial cancer: early results. 2009 Genitourinary Cancers Symposium: Bladder Cancer Educational Session.
  7. Siefker-Radtke AO, Kamat AM, Williams DL, et al. A phase II randomized 4-regimen selection trial incorporating response for sequential chemotherapy in metastatic, unresectable urothelial cancer: Final results from the MD Anderson Cancer Center. 2009 Genitourinary Cancers Symposium. Abstract 238.
  8. Apolo AB, Riches J, Boyle MG, et al. Clinical value of 18F-2 deoxyglucose positron emission tomography (FDG PET) in bladder cancer. 2009 Genitourinary Cancers Symposium. Abstract 239.
  9. Klein EA, Lippman SM, Goodman PJ, et al. The selenium and vitamin E cancer prevention trial (SELECT): SWOG study S0000. 2009 Genitourinary Cancers Symposium. Abstract 1.
  10. Roobol MJ, Gray A, Schröder FH, et al. The value of PSA and other risk factors in determining the future risk of prostate cancer: Data from the Rotterdam section of the European randomized study of screening for prostate cancer. 2009 Genitourinary Cancers Symposium. Abstract 13.
  11. Groskopf J, Siddiqui J, Sefton-MillerL, et al. Feasibility and clinical utility of a TMPRSS2:ERG gene fusion urine test. 2009 Genitourinary Cancers Symposium. Abstract 3.
  12. Ryan CJ, Efstathiou E, Smith M, et al. Abiraterone acetate plus prednisone in chemotherapy (chemo)-naïve castration-resistant prostate cancer (CRPC) patients no exposed to ketoconazole: Results of a multicenter phase II study. 2009 Genitourinary Cancers Symposium. Abstract 159.
  13. Scher HI, Beer TM, Higano CS, et al. Phase I-II study of MDV3100 in castration-resistant prostate cancer (CRPC). 2009 Genitourinary Cancers Symposium. Abstract 151.
  14. Araujo J, Gallick G, Trudel G, et al. Dasatinib and docetaxel combination treatment for patients with castration-resistant progressive prostate cancer: A phase I/II study. 2009 Genitourinary Cancers Symposium. Abstract 177.
  15. Kay A, Motzer R, Figlin R, et al. Updated data from a phase III randomized trial of everolimus (RAD001) versus PBO in metastatic renal cell carcinoma (mRCC). 2009 Genitourinary Cancers Symposium. Abstract 278.
  16. Logan T, McDermott D, Dutcher J, et al. Exploratory analysis of the influence of nephrectomy status on temsirolimus efficacy in patients with advanced renal cell carcinoma and poor-risk features. 2009 Genitourinary Cancers Symposium. Abstract 281.
  17. Bhargava B, Esteves B, Lipatove ON, et al. Activity and safety of AV-951, a potent and selective VEGFR1, 2, and 3 kinase inhibitor, in patients with renal cell carcinoma (RCC): Interim results of a phase II randomized discontinuation trial. 2009 Genitourinary Cancers Symposium. Abstract 283.
  18. Haas NB. Update on adjuvant therapy and toxicity: cardiac toxicity. 2009 Genitourinary Cancers Symposium. Renal Cell Cancer Educational Session.
    19.

 

 

OncoFacts™ Editor:

Christy Russell, MD

Christy Russell, MD

 

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