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Adjuvant androgen suppression with goserelin and radiotherapy at doses of 70-78 Gy improved biochemical disease-free survival of men with intermediate- and high-risk localized prostate cancer when compared against radiotherapy alone, according to results of the EORTC 22991 trial.
“Our results suggest that adding 6-month AS as a concomitant and adjuvant modality improves biochemical disease-free survival even at a dose of 78 Gy, with acceptable adverse effects. Furthermore, for patients with low-volume high-risk localized prostate cancer, our results pave the way to using a combination approach with 78-Gy RT plus a short AS duration. Such an approach should be formally compared with long-term or intermediate duration of AS,” wrote Dr. Michel Bolla, professor of radiation oncology at Grenoble University Hospital, France, and colleagues.
The 5-year biochemical disease-free survival (DFS) for radiotherapy (RT) plus androgen suppression (AS), compared with RT alone, was 82.6% (95% CI, 78.4-86.1) vs. 69.8% (95% CI, 64.9-74.2), corresponding to a hazard ratio of 0.52 (95% CI, 0.41-0.66; P less than .001). At a median follow up of 7.2 years, 118 of 410 patients (28.8%) in the RT plus AS arm and 201 of 409 patients (49.1%) in the RT arm reported events for the primary endpoint of biochemical DFS. Radiation dose had no statistically significant impact on the unadjusted treatment affect, according to exploratory heterogeneity tests (J Clin Oncol. 2016 Mar 14. doi: 10.1200/JCO.2015.64.8055).
The European Organisation for Research and Treatment of Cancer (EORTC) trial 22991 recruited 819 men, median age 70 years, from 37 centers in 14 countries during 2001-2008. Patients had prostate adenocarcinoma T1b to T2a with PSA greater than 10 ng/mL or Gleason score of 7 or higher. External radiation dose levels were selected by the centers: 70 Gy (24.6%), 74 Gy (51.1%), and 78 Gy (24.2%).
There was no significant interaction between RT dose and AS (P greater than .1) in a multivariate analysis. The two arms had similar proportions of second cancers: 57 of 410 patients (13.9%) in the RT plus AS group and 46 of 409 patients (11.2%) in the RT alone group.
The study was supported in part by AstraZeneca. Dr. Bolla reported consulting or advisory roles with Janssen and AstraZeneca. Several of his coauthors reported financial ties to industry sources.
The study by Dr. Bolla and colleagues adds to the body of evidence in support of including short-term adjuvant androgen suppression (AS) when external-beam radiation therapy (EBRT) is selected as the primary treatment for intermediate- to high-risk prostate cancer.
While dose-escalated EBRT has been shown to improve biochemical disease-free survival in intermediate- and high-risk disease, the impact of AS added to EBRT has been much more consistent and pronounced.
The dose escalation component of the study addresses the question of the balance between AS and radiation dose. In the exploratory analysis, each dose level showed benefit from AS, but multivariate analysis showed no significant interaction with EBRT dose. The results seem to support that addition of AS to dose-escalated EBRT is beneficial, but whether dose-escalated EBRT plus AS is superior to standard-dose EBRT plus AS was not demonstrated.
Another consideration is the impact of AS on micrometastasis. Previous studies showed a reduction in micrometastatic disease in patients with 6 months of AS plus EBRT, compared with 3 months of AS plus EBRT. High radiation doses would not be expected to confer such benefit as AS given for a sufficient duration.
Although eliminating AS is highly desirable due to morbidity associated with the therapy, it is not advisable for the vast majority of patients with intermediate- to high-risk prostate cancer.
Dr. Alan Pollack and Dr. Matthew Abramowitz are with the department of radiation oncology at the University of Miami (Fla.). These remarks were part of their editorial accompanying Dr. Bolla and colleagues’ report (J Clin Oncol. 2016 Mar 14. doi: 10.1200/JCO.2015.66.2320).
The study by Dr. Bolla and colleagues adds to the body of evidence in support of including short-term adjuvant androgen suppression (AS) when external-beam radiation therapy (EBRT) is selected as the primary treatment for intermediate- to high-risk prostate cancer.
While dose-escalated EBRT has been shown to improve biochemical disease-free survival in intermediate- and high-risk disease, the impact of AS added to EBRT has been much more consistent and pronounced.
The dose escalation component of the study addresses the question of the balance between AS and radiation dose. In the exploratory analysis, each dose level showed benefit from AS, but multivariate analysis showed no significant interaction with EBRT dose. The results seem to support that addition of AS to dose-escalated EBRT is beneficial, but whether dose-escalated EBRT plus AS is superior to standard-dose EBRT plus AS was not demonstrated.
Another consideration is the impact of AS on micrometastasis. Previous studies showed a reduction in micrometastatic disease in patients with 6 months of AS plus EBRT, compared with 3 months of AS plus EBRT. High radiation doses would not be expected to confer such benefit as AS given for a sufficient duration.
Although eliminating AS is highly desirable due to morbidity associated with the therapy, it is not advisable for the vast majority of patients with intermediate- to high-risk prostate cancer.
Dr. Alan Pollack and Dr. Matthew Abramowitz are with the department of radiation oncology at the University of Miami (Fla.). These remarks were part of their editorial accompanying Dr. Bolla and colleagues’ report (J Clin Oncol. 2016 Mar 14. doi: 10.1200/JCO.2015.66.2320).
The study by Dr. Bolla and colleagues adds to the body of evidence in support of including short-term adjuvant androgen suppression (AS) when external-beam radiation therapy (EBRT) is selected as the primary treatment for intermediate- to high-risk prostate cancer.
While dose-escalated EBRT has been shown to improve biochemical disease-free survival in intermediate- and high-risk disease, the impact of AS added to EBRT has been much more consistent and pronounced.
The dose escalation component of the study addresses the question of the balance between AS and radiation dose. In the exploratory analysis, each dose level showed benefit from AS, but multivariate analysis showed no significant interaction with EBRT dose. The results seem to support that addition of AS to dose-escalated EBRT is beneficial, but whether dose-escalated EBRT plus AS is superior to standard-dose EBRT plus AS was not demonstrated.
Another consideration is the impact of AS on micrometastasis. Previous studies showed a reduction in micrometastatic disease in patients with 6 months of AS plus EBRT, compared with 3 months of AS plus EBRT. High radiation doses would not be expected to confer such benefit as AS given for a sufficient duration.
Although eliminating AS is highly desirable due to morbidity associated with the therapy, it is not advisable for the vast majority of patients with intermediate- to high-risk prostate cancer.
Dr. Alan Pollack and Dr. Matthew Abramowitz are with the department of radiation oncology at the University of Miami (Fla.). These remarks were part of their editorial accompanying Dr. Bolla and colleagues’ report (J Clin Oncol. 2016 Mar 14. doi: 10.1200/JCO.2015.66.2320).
Adjuvant androgen suppression with goserelin and radiotherapy at doses of 70-78 Gy improved biochemical disease-free survival of men with intermediate- and high-risk localized prostate cancer when compared against radiotherapy alone, according to results of the EORTC 22991 trial.
“Our results suggest that adding 6-month AS as a concomitant and adjuvant modality improves biochemical disease-free survival even at a dose of 78 Gy, with acceptable adverse effects. Furthermore, for patients with low-volume high-risk localized prostate cancer, our results pave the way to using a combination approach with 78-Gy RT plus a short AS duration. Such an approach should be formally compared with long-term or intermediate duration of AS,” wrote Dr. Michel Bolla, professor of radiation oncology at Grenoble University Hospital, France, and colleagues.
The 5-year biochemical disease-free survival (DFS) for radiotherapy (RT) plus androgen suppression (AS), compared with RT alone, was 82.6% (95% CI, 78.4-86.1) vs. 69.8% (95% CI, 64.9-74.2), corresponding to a hazard ratio of 0.52 (95% CI, 0.41-0.66; P less than .001). At a median follow up of 7.2 years, 118 of 410 patients (28.8%) in the RT plus AS arm and 201 of 409 patients (49.1%) in the RT arm reported events for the primary endpoint of biochemical DFS. Radiation dose had no statistically significant impact on the unadjusted treatment affect, according to exploratory heterogeneity tests (J Clin Oncol. 2016 Mar 14. doi: 10.1200/JCO.2015.64.8055).
The European Organisation for Research and Treatment of Cancer (EORTC) trial 22991 recruited 819 men, median age 70 years, from 37 centers in 14 countries during 2001-2008. Patients had prostate adenocarcinoma T1b to T2a with PSA greater than 10 ng/mL or Gleason score of 7 or higher. External radiation dose levels were selected by the centers: 70 Gy (24.6%), 74 Gy (51.1%), and 78 Gy (24.2%).
There was no significant interaction between RT dose and AS (P greater than .1) in a multivariate analysis. The two arms had similar proportions of second cancers: 57 of 410 patients (13.9%) in the RT plus AS group and 46 of 409 patients (11.2%) in the RT alone group.
The study was supported in part by AstraZeneca. Dr. Bolla reported consulting or advisory roles with Janssen and AstraZeneca. Several of his coauthors reported financial ties to industry sources.
Adjuvant androgen suppression with goserelin and radiotherapy at doses of 70-78 Gy improved biochemical disease-free survival of men with intermediate- and high-risk localized prostate cancer when compared against radiotherapy alone, according to results of the EORTC 22991 trial.
“Our results suggest that adding 6-month AS as a concomitant and adjuvant modality improves biochemical disease-free survival even at a dose of 78 Gy, with acceptable adverse effects. Furthermore, for patients with low-volume high-risk localized prostate cancer, our results pave the way to using a combination approach with 78-Gy RT plus a short AS duration. Such an approach should be formally compared with long-term or intermediate duration of AS,” wrote Dr. Michel Bolla, professor of radiation oncology at Grenoble University Hospital, France, and colleagues.
The 5-year biochemical disease-free survival (DFS) for radiotherapy (RT) plus androgen suppression (AS), compared with RT alone, was 82.6% (95% CI, 78.4-86.1) vs. 69.8% (95% CI, 64.9-74.2), corresponding to a hazard ratio of 0.52 (95% CI, 0.41-0.66; P less than .001). At a median follow up of 7.2 years, 118 of 410 patients (28.8%) in the RT plus AS arm and 201 of 409 patients (49.1%) in the RT arm reported events for the primary endpoint of biochemical DFS. Radiation dose had no statistically significant impact on the unadjusted treatment affect, according to exploratory heterogeneity tests (J Clin Oncol. 2016 Mar 14. doi: 10.1200/JCO.2015.64.8055).
The European Organisation for Research and Treatment of Cancer (EORTC) trial 22991 recruited 819 men, median age 70 years, from 37 centers in 14 countries during 2001-2008. Patients had prostate adenocarcinoma T1b to T2a with PSA greater than 10 ng/mL or Gleason score of 7 or higher. External radiation dose levels were selected by the centers: 70 Gy (24.6%), 74 Gy (51.1%), and 78 Gy (24.2%).
There was no significant interaction between RT dose and AS (P greater than .1) in a multivariate analysis. The two arms had similar proportions of second cancers: 57 of 410 patients (13.9%) in the RT plus AS group and 46 of 409 patients (11.2%) in the RT alone group.
The study was supported in part by AstraZeneca. Dr. Bolla reported consulting or advisory roles with Janssen and AstraZeneca. Several of his coauthors reported financial ties to industry sources.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Adding 6-month androgen suppression (AS) to radiotherapy (RT) at doses of 70 Gy, 74 Gy, or 78 Gy improved biochemical disease-free survival (DFS) in men with intermediate- and high-risk localized prostate cancer.
Major finding: The 5-year biochemical DFS for RT plus AS, compared with RT alone, was 82.6% (95% CI, 78.4-86.1) vs. 69.8% (95% CI, 64.9-74.2), corresponding to a hazard ratio of 0.52 (95% CI, 0.41-0.66; P less than .001).
Data sources: During 2001-2008, the European Organisation for Research and Treatment of Cancer (EORTC) trial 22991 randomized 409 patients to RT and 410 patients to RT plus AS.
Disclosures: The study was supported in part by AstraZeneca. Dr. Bolla reported consulting or advisory roles with Janssen and AstraZeneca. Several of his coauthors reported financial ties to industry sources.
