Abstract
BackgroudThe European Organization for Research and Treatment of Cancer (EORTC) trial 22,911 reported 74% 5-year biochemical disease-free survival (bDFS) in patients with prostate carcinoma treated with radical prostatectomy (RP) followed by postoperative radiotherapy (RT). This study aimed to improve these outcomes by using a combined-intensified-modulated-adjuvant treatment, including RT and hormone therapy (HT) after RP.Materials and methodsThis phase I/II trial treatment was designed to improve 5-year bDFS from ~ 75 to 90%. Patients were consecutively enrolled using the following inclusion criteria: age < 80 years, histological diagnosis of prostate adenocarcinoma without known metastases, stage pT2-4N0-1, and Eastern Cooperative Oncology Group performance status of 0–2. All patients had at least one of these pathologic features: capsular perforation, positive surgical margins, seminal vesicle invasion, and pelvic lymph nodes involvement. A minimum dose of 64.8 Gy to the tumor bed was delivered in all patients. Depending on tumor characteristics at diagnosis, patients received a higher dose (70.2 Gy; 85.4%) and/or prophylactic pelvic lymph nodes irradiation (57.7%) and/or HT (69.1%). Biochemical relapse was defined as two consecutive rising prostate-specific antigen (PSA) values > 0.2 ng/ml.ResultsA total of 123 patients were enrolled in the study and completed the scheduled treatment. Median preoperative and postoperative PSA were: 8.8 and 0.06 ng/mL, respectively. The percentages of patients with pathologically involved nodes and positive resection margins were: 14.6% and 58.5%, respectively. With a median follow-up of 67 months (range: 37–120 months), the actuarial 5-year bDFS, local control, metastasis-free survival, and overall survival (OS) were: 92.9%, 98.7%, 96.1%, and 95.1%, respectively.ConclusionA higher 5-year bDFS (92.9%) was recorded compared to studies based on standard adjuvant RT, even though patients with nodal disease and detectable postoperative PSA were enrolled. Clinical end points, as long-term disease-free survival and OS, will require further assessments. (ClinicalTrials.gov: NCT03169933)
Highlights
Despite a progressive decrease in mortality rates, prostate cancer (PCa) still represents the third cause of cancer-An improvement in biochemical disease-free survival was first reported by EORTC 22,911 trial in 2005 [9]
Based on the results of that study, we hypothesized that RT dose escalation to tumor bed, pelvic lymph node irradiation (PNI) in selected patients with higher risk of regional failures, and adjuvant hormone therapy (HT) for those with a higher risk of distant metastases could further reduce the recurrence rates
We evaluated the impact of these factors on biochemical disease-free survival (bDFS)
Summary
Despite a progressive decrease in mortality rates, prostate cancer (PCa) still represents the third cause of cancer-An improvement in biochemical disease-free survival (bDFS) was first reported by EORTC 22,911 trial in 2005 [9]. Based on the results of that study, we hypothesized that RT dose escalation to tumor bed, pelvic lymph node irradiation (PNI) in selected patients with higher risk of regional failures, and adjuvant hormone therapy (HT) for those with a higher risk of distant metastases could further reduce the recurrence rates. Patients at high risk of local failures such as those with positive surgical margins and/or perineural invasion may benefit from further increased doses (up to 70.2 Gy), to minimize recurrence rates [11, 12]. PNI may reduce regional recurrences in selected patients at high risk for nodal involvement [13]. Improved bDFS in patients with a high risk of recurrence after RP with the combination of adjuvant HT and RT have been reported [17, 18]
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