Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial
| Autor: | Michele Gnech, Fabio Zattoni, Gianluca Giannarini, Pirus Ghadjar, Vito Palumbo, Filiberto Zattoni, Andrea Guttilla, A. Garbeglio, Francesca Valent, Roberto Bortolus |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Male
Risk Oncology medicine.medical_specialty Intensity-modulated medicine.medical_treatment 610 Medicine & health Docetaxel Androgen deprivation therapy Study Protocol Prostate cancer Internal medicine medicine Clinical endpoint Chemotherapy Humans Radiology Nuclear Medicine and imaging Survival rate Aged Prostatectomy Radiotherapy Toxicity Dose-Response Relationship Drug business.industry Carcinoma Prostatic Neoplasms Androgen Antagonists Radiotherapy Dosage Common Terminology Criteria for Adverse Events Chemoradiotherapy Middle Aged medicine.disease Combined Modality Therapy Phase II Clinical trial Radiation therapy Radiology Nuclear Medicine and imaging Radiotherapy Adjuvant Taxoids Radiotherapy Intensity-Modulated business medicine.drug |
| Zdroj: | Guttilla, Andrea; Bortolus, Roberto; Giannarini, Gianluca; Ghadjar, Pirus; Zattoni, Fabio; Gnech, Michele; Palumbo, Vito; Valent, Francesca; Garbeglio, Antonio; Zattoni, Filiberto (2014). Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial. Radiation oncology, 9(24), p. 24. BioMed Central 10.1186/1748-717X-9-24 Radiation Oncology (London, England) |
| Popis: | BACKGROUND The optimal management of high-risk prostate cancer remains uncertain. In this study we assessed the safety and efficacy of a novel multimodal treatment paradigm for high-risk prostate cancer. METHODS This was a prospective phase II trial including 35 patients with newly diagnosed high-risk localized or locally advanced prostate cancer treated with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel-based chemotherapy and long-term androgen deprivation therapy. Primary endpoint was acute and late toxicity evaluated with the Common Terminology Criteria for Adverse Events version 3.0. Secondary endpoint was biochemical and clinical recurrence-free survival explored with the Kaplan-Meier method. RESULTS Acute gastro-intestinal and genito-urinary toxicity was grade 2 in 23% and 20% of patients, and grade 3 in 9% and 3% of patients, respectively. Acute blood/bone marrow toxicity was grade 2 in 20% of patients. No acute grade ≥ 4 toxicity was observed. Late gastro-intestinal and genito-urinary toxicity was grade 2 in 9% of patients each. No late grade ≥ 3 toxicity was observed. Median follow-up was 63 months (interquartile range 31-79). Actuarial 5-year biochemical and clinical recurrence-free survival rate was 55% (95% confidence interval, 35-75%) and 70% (95% confidence interval, 52-88%), respectively. CONCLUSIONS In our phase II trial testing a novel multimodal treatment paradigm for high-risk prostate cancer, toxicity was acceptably low and mid-term oncological outcome was good. This treatment paradigm, thus, may warrant further evaluation in phase III randomized trials. |
| Databáze: | OpenAIRE |
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