Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (the ASCENDE-RT Trial): An Analysis of Survival Endpoints for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost to a Dose-Escalated External Beam Boost for High- and Intermediate-risk Prostate Cancer
To report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer. ASCENDE-RT enrolled 398 men, with a median age of 68 years; 69%...
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| Vydáno v: | International journal of radiation oncology, biology, physics Ročník 98; číslo 2; s. 275 |
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| Hlavní autoři: | , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
United States
01.06.2017
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| Témata: | |
| ISSN: | 1879-355X, 1879-355X |
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| Abstract | To report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer.
ASCENDE-RT enrolled 398 men, with a median age of 68 years; 69% (n=276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a low-dose-rate prostate brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years.
In an intent-to-treat analysis, men randomized to DE-EBRT were twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P=.004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P<.001). The LDR-PB boost benefited both intermediate- and high-risk patients. Because the b-PFS curves for the treatment arms diverge sharply after 4 years, the relative advantage of the LDR-PB should increase with longer follow-up. On MVA, the only variables correlated with reduced overall survival were age (MVA HR 1.06/y; P=.004) and biochemical failure (MVA HR 6.30; P<.001). Although biochemical failure was associated with increased mortality and randomization to DE-EBRT doubled the rate of biochemical failure, no significant overall survival difference was observed between the treatment arms (MVA HR 1.13; P=.62).
Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years. |
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| AbstractList | To report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer.PURPOSETo report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer.ASCENDE-RT enrolled 398 men, with a median age of 68 years; 69% (n=276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a low-dose-rate prostate brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years.METHODS AND MATERIALSASCENDE-RT enrolled 398 men, with a median age of 68 years; 69% (n=276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a low-dose-rate prostate brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years.In an intent-to-treat analysis, men randomized to DE-EBRT were twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P=.004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P<.001). The LDR-PB boost benefited both intermediate- and high-risk patients. Because the b-PFS curves for the treatment arms diverge sharply after 4 years, the relative advantage of the LDR-PB should increase with longer follow-up. On MVA, the only variables correlated with reduced overall survival were age (MVA HR 1.06/y; P=.004) and biochemical failure (MVA HR 6.30; P<.001). Although biochemical failure was associated with increased mortality and randomization to DE-EBRT doubled the rate of biochemical failure, no significant overall survival difference was observed between the treatment arms (MVA HR 1.13; P=.62).RESULTSIn an intent-to-treat analysis, men randomized to DE-EBRT were twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P=.004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P<.001). The LDR-PB boost benefited both intermediate- and high-risk patients. Because the b-PFS curves for the treatment arms diverge sharply after 4 years, the relative advantage of the LDR-PB should increase with longer follow-up. On MVA, the only variables correlated with reduced overall survival were age (MVA HR 1.06/y; P=.004) and biochemical failure (MVA HR 6.30; P<.001). Although biochemical failure was associated with increased mortality and randomization to DE-EBRT doubled the rate of biochemical failure, no significant overall survival difference was observed between the treatment arms (MVA HR 1.13; P=.62).Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years.CONCLUSIONSCompared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years. To report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer. ASCENDE-RT enrolled 398 men, with a median age of 68 years; 69% (n=276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a low-dose-rate prostate brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years. In an intent-to-treat analysis, men randomized to DE-EBRT were twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P=.004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P<.001). The LDR-PB boost benefited both intermediate- and high-risk patients. Because the b-PFS curves for the treatment arms diverge sharply after 4 years, the relative advantage of the LDR-PB should increase with longer follow-up. On MVA, the only variables correlated with reduced overall survival were age (MVA HR 1.06/y; P=.004) and biochemical failure (MVA HR 6.30; P<.001). Although biochemical failure was associated with increased mortality and randomization to DE-EBRT doubled the rate of biochemical failure, no significant overall survival difference was observed between the treatment arms (MVA HR 1.13; P=.62). Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years. |
| Author | Morris, W James Rodda, Sree Halperin, Ross McKenzie, Michael Pai, Howard Murray, Nevin Duncan, Graeme Hamm, Jeremy Tyldesley, Scott Morton, Gerard |
| Author_xml | – sequence: 1 givenname: W James surname: Morris fullname: Morris, W James email: jmorris@bccancer.bc.ca organization: Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada; BC Cancer Agency-Vancouver Centre, Vancouver, British Columbia, Canada. Electronic address: jmorris@bccancer.bc.ca – sequence: 2 givenname: Scott surname: Tyldesley fullname: Tyldesley, Scott organization: Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada; BC Cancer Agency-Vancouver Centre, Vancouver, British Columbia, Canada – sequence: 3 givenname: Sree surname: Rodda fullname: Rodda, Sree organization: Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada – sequence: 4 givenname: Ross surname: Halperin fullname: Halperin, Ross organization: Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada; BC Cancer Agency-Centre for the Southern Interior, Vancouver, British Columbia, Canada – sequence: 5 givenname: Howard surname: Pai fullname: Pai, Howard organization: Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada; BC Cancer Agency-Vancouver Island Centre, Vancouver, British Columbia, Canada – sequence: 6 givenname: Michael surname: McKenzie fullname: McKenzie, Michael organization: Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada; BC Cancer Agency-Vancouver Centre, Vancouver, British Columbia, Canada – sequence: 7 givenname: Graeme surname: Duncan fullname: Duncan, Graeme organization: Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada; BC Cancer Agency-Vancouver Centre, Vancouver, British Columbia, Canada – sequence: 8 givenname: Gerard surname: Morton fullname: Morton, Gerard organization: Department of Radiation Oncology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada – sequence: 9 givenname: Jeremy surname: Hamm fullname: Hamm, Jeremy organization: Department of Population Oncology, BC Cancer Agency, Vancouver, British Columbia, Canada – sequence: 10 givenname: Nevin surname: Murray fullname: Murray, Nevin organization: BC Cancer Agency-Vancouver Centre, Vancouver, British Columbia, Canada; Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28262473$$D View this record in MEDLINE/PubMed |
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| SubjectTerms | Age Factors Aged Aged, 80 and over Androgen Antagonists - therapeutic use Brachytherapy - methods Combined Modality Therapy - methods Disease-Free Survival Follow-Up Studies Gonadotropin-Releasing Hormone - therapeutic use Humans Intention to Treat Analysis Iodine Radioisotopes - therapeutic use Kaplan-Meier Estimate Lymphatic Irradiation - methods Male Middle Aged Pelvis Prostate-Specific Antigen - blood Prostatic Neoplasms - blood Prostatic Neoplasms - drug therapy Prostatic Neoplasms - mortality Prostatic Neoplasms - radiotherapy Radiotherapy Dosage Re-Irradiation - methods Re-Irradiation - statistics & numerical data Time Factors |
| Title | Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (the ASCENDE-RT Trial): An Analysis of Survival Endpoints for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost to a Dose-Escalated External Beam Boost for High- and Intermediate-risk Prostate Cancer |
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