Abstract
Backgroud: The 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 methods: This 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. Results: A 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. Conclusion: A 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).
| Original language | English |
|---|---|
| Pages (from-to) | 564-572 |
| Number of pages | 9 |
| Journal | Prostate Cancer and Prostatic Diseases |
| Volume | 21 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Nov 1 2018 |
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ASJC Scopus subject areas
- Oncology
- Urology
- Cancer Research
Cite this
Tailored postoperative treatment of prostate cancer : final results of a phase I/II trial. / Mantini, Giovanna; Siepe, Giambattista; Alitto, Anna Rita; Buwenge, Milly; Nguyen, Nam P.; Farioli, Andrea; Schiavina, Riccardo; Catucci, Francesco; Deodato, Francesco; Fionda, Bruno; Frascino, Vincenzo; Macchia, Gabriella; Ntreta, Maria; Padula, Gilbert D.A.; Arcelli, Alessandra; Cammelli, Silvia; Rambaldi, Giuseppe Zanirato; Cilla, Savino; Valentini, Vincenzo; Morganti, Alessio G.
In: Prostate Cancer and Prostatic Diseases, Vol. 21, No. 4, 01.11.2018, p. 564-572.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Tailored postoperative treatment of prostate cancer
T2 - final results of a phase I/II trial
AU - Mantini, Giovanna
AU - Siepe, Giambattista
AU - Alitto, Anna Rita
AU - Buwenge, Milly
AU - Nguyen, Nam P.
AU - Farioli, Andrea
AU - Schiavina, Riccardo
AU - Catucci, Francesco
AU - Deodato, Francesco
AU - Fionda, Bruno
AU - Frascino, Vincenzo
AU - Macchia, Gabriella
AU - Ntreta, Maria
AU - Padula, Gilbert D.A.
AU - Arcelli, Alessandra
AU - Cammelli, Silvia
AU - Rambaldi, Giuseppe Zanirato
AU - Cilla, Savino
AU - Valentini, Vincenzo
AU - Morganti, Alessio G.
PY - 2018/11/1
Y1 - 2018/11/1
N2 - Backgroud: The 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 methods: This 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. Results: A 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. Conclusion: A 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).
AB - Backgroud: The 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 methods: This 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. Results: A 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. Conclusion: A 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).
UR - http://www.scopus.com/inward/record.url?scp=85050385062&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85050385062&partnerID=8YFLogxK
U2 - 10.1038/s41391-018-0064-7
DO - 10.1038/s41391-018-0064-7
M3 - Article
C2 - 30038390
AN - SCOPUS:85050385062
VL - 21
SP - 564
EP - 572
JO - Prostate Cancer and Prostatic Diseases
JF - Prostate Cancer and Prostatic Diseases
SN - 1365-7852
IS - 4
ER -