Prostate Program

Milano, Italy

Prostate Program

Milano, Italy
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Procopio G.,Fondazione Instituto Nazionale Tumori | Giganti M.O.,Prostate Program | Mariani L.,Unit of Medical Statistics | Salvioni R.,Urologic | And 3 more authors.
BJU International | Year: 2011

OBJECTIVE To assess the efficacy of ketoconazole in patients with castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS From April 2008 to November 2009, 37 patients with CRPC have been treated with ketoconazole. The primary endpoint was the prostate-specific antigen (PSA) response; the secondary endpoints were progression-free survival and safety profile. Ketoconazole was administered by oral route at a dose of 200 mg every 8 h continuous dosing until the onset of serious adverse events or disease progression. The study was based on a two-step design with an interim efficacy analysis carried out on the first 12 patients accrued. RESULTS Main characteristics of population were: median age 75 years (range 60-88); baseline mean PSA 28.8 ng/mL (4.3-1000); 30 patients previously challenged with at least two lines of hormone therapy; 15 patients previously treated with chemotherapy. Biochemical responses accounted for: two complete responses (5%), six partial responses (16%), 13 patients with stable disease (35%), and 14 with progressive disease (38%). Of 15 patients resistant to chemotherapy, overall disease control (complete plus partial responses plus stable disease) was recorded in seven of them. Treatment was feasible without inducing grade 3-4 adverse events. The most common grade 1-2 adverse events were asthenia (27%), vomiting (8%) and abdominal pain (8%). CONCLUSION Treatment with low-dose ketoconazole is feasible and well tolerated. The efficacy was satisfactory in patients previously treated with chemotherapy. © 2010 BJU INTERNATIONAL.


Valdagni R.,Prostate Program | Valdagni R.,Fondazione IRCCS Instituto Nazionale Dei Tumori | Nahum A.E.,Clatterbridge Center for Oncology | Magnani T.,Prostate Program | And 6 more authors.
Radiotherapy and Oncology | Year: 2011

Background and purpose: To report the long-term biochemical control of a non-randomized trial comparing standard (STD) and hyper-fractionated (HFX) radiation schedules for prostate cancer treatment. Materials and methods: Between 1993 and 2003, 370 patients entered the study; 330/370 (STD: 179; HFX: 151) were evaluable for current analysis. Median doses were 79.2 Gy and 74 Gy for HFX (1.2 Gy/fr, two daily fractions) and STD (2 Gy/fr), respectively; median follow-up was 7.5 yr. The two regimens were compared in terms of biochemical relapse-free survival (according to ASTRO definition, bRFS) by univariate (log-rank test) and multivariate analyses (Cox regression hazard model). Based on published relationships between EQD2 and 5-yr biochemical control, α/β values for each subgroup could be estimated. Results: 7.5 yr bRFS were 53.4% (±4.4%, 95% CI) and 65.4% (±4.0%) for HFX and STD, respectively (p = 0.13); HFX was associated with a poorer outcome in NCCN low + intermediate patients (7.5 yr bRFS: 56.6% vs 73.5%, p = 0.048) while no differences were seen for high-risk patients (7.5 yr bRFS: 44.1% vs 45.3%). Multivariate analysis revealed that NCCN risk grouping (high vs low + intermediate; OR: 0.59, p = 0.009) and age (< vs ≥70 yr; OR: 0.67, p = 0.03) were the main predictors of worse bRFS. In the subgroups of low + intermediate-risk patients <70 yr, the poorer outcome of HFX was more evident (7.5 yr bRFS: 47.1% vs 70.9%, p = 0.078) while no difference was seen for older patients (7.5 yr bRFS: 69.4% vs 72.0%, p = 0.76). Our α/β estimates differ between low + intermediate-risk and high-risk patients. Conclusions: The bRFS long-term results of this non-randomized trial are consistent with different sensitivities to fractionation depending on NCCN risk grouping. The impact of age on the outcome of HFX for younger low + intermediate patients is consistent with an incomplete repair effect in older patients. © 2011 Elsevier Ireland Ltd. All rights reserved.

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