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| |  Docetaxel Plus Estramustine Can Improve Response in High-Risk Localised Prostate Cancer: Presented at ASCO-GU By Fred Gebhart SAN FRANCISCO -- March 7, 2010 -- Adding docetaxel and estramustine to standard therapy shows promise for high-risk localised prostate cancer, according to a study presented here at the 2010 Genitourinary Cancers Symposium (ASCO-GU). Clinicians have long searched for a treatment regimen that might help the roughly 18% of men who are found to have high-risk localised prostate cancer on diagnosis. Predictors of poor outcome in these men include a higher T stage, higher Gleason score, and higher prostate-specific antigen (PSA) levels at diagnosis. Typical treatment choices include some combination of radiation and androgen deprivation therapy, said Karim Fizazi, MD, Institut Gustave-Roussy, Villejuif, France, but response can be short-lived. Once radiation and chemical castration fail, treatment options are limited. “We know from the breast and colorectal cancer models that systemic chemotherapy in addition to localised treatment can help prolong survival, even in the case of localised tumours,” Dr. Fizazi told attendees on March 6. “The phase 3 GETUG [Groupe d’Etude des Tumeurs Uro-Génitales] 12 trial was designed to test this model in high-risk localised prostate cancer and to assess patients’ quality of life compared with chemical castration plus localised treatment alone.” Researchers at multiple centres in France accrued 413 patients between November 2002 and December 2006. All of the patients had high-risk localised prostate cancer with more than 1 of the following risk factors: T3 or T4 tumours, Gleason score of >=8, PSA >20, and positive nodes. All patients had undergone a radical prostatectomy and pelvic lymph node dissection. Patients were randomised to 2 groups. The active treatment arm received goserelin, a gonadotropin releasing hormone super-agonist, every 3 months for 3 years and 4 cycles of docetaxel plus estramustine. The control arm received goserelin alone. Patients in both arms also received local treatment. Most of the patients, 87%, had radiotherapy using a median dose of 74 Gray. The primary endpoint of the trial is progression-free survival. Dr. Fizazi presented preliminary data from the trial. He said that 4-year data on progression-free survival should be ready for release during 2011. Treatment was well tolerated, he reported. In the treatment arm, 95% of patients received the planned 4 cycles of docetaxel and 91% received the planned 4 cycles of estramustine. The adverse event profile was acceptable, with 27% grade 3 or grade 4 neutropenia and just 2% febrile neutropenia. Other grade 3 or 4 toxicities included diarrhoea (5%), nausea (2%), alopecia (2%), asthenia (2%), thrombosis (2%), and skin toxicity (1%). There were no deaths related to treatment toxicity. Men in the treatment arm reported fewer hot flashes than men in the control arm (2% vs 22%). Serum PSA was tested after 3 months of treatment. In the treatment arm, 34% of men showed a PSA <=0.2 compared with 15% of men in the control arm (P = .0001). Men in the chemotherapy arm initially reported lower quality of life scores than men in the control arm, including global health status (P = .01), fatigue (P = .003), and role functioning (P = .003), but the negative impact of treatment had disappeared when quality of life was assessed again after 1 year. “These early results are promising,” Dr. Fizazi concluded. “We have found that docetaxel and estramustine can be added to standard therapy with safety and a promising PSA response in high-risk localised prostate cancer. We are looking forward to the progression-free survival data next year.” [Presentation title: A Phase III Trial of Docetaxel-Estramustine in High-Risk Localized Prostate Cancer (GETUG 12 trial): Design, Tolerance, Response, and Quality of Life (QOL). Abstract 7]
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