Highlights
- •The phase 3 study includes only patients with intermediate risk prostate cancer.
- •The addition of short-course hormonal therapy leads to improved outcomes.
- •Short-term ADT combined with lower dose of radiotherapy is feasible and yields to a better toxicity profile.
Abstract
Background
The role of androgen deprivation therapy (ADT) in combination with radiotherapy (RT)
in intermediate-risk prostate cancer (IRPC) remains controversial, particularly in
patients receiving dose-escalated RT (DERT). We compared outcomes between patients
with IRPC treated with ADT and two different doses of RT vs. RT alone.
Methods
From December 2000 to September 2010, 600 patients with IRPC were randomised to a
three-arm trial consisting of 6 months of ADT plus RT 70 Gy (ADT + RT70) vs. ADT plus
a DERT of 76 Gy (ADT + DERT76) vs. DERT of 76 Gy alone (DERT76). Primary end-point
was biochemical failure (BF), and secondary end-points were overall survival (OS)
and toxicity. RT toxicity was assessed by Radiation Therapy Oncology Group/European
Organisation for Research and Treatment of Cancer criteria.
Findings
With a median follow-up of 11.3 years (interquartile range: 10.9–11.7), patients receiving
DERT76 alone, compared with patients receiving ADT + RT70 and ADT + DERT76, had higher
rates of BF (32%, 18% and 14%, respectively, p < 0.001), higher rates of prostate
cancer progression (12%, 4.5% and 3.3%, respectively, p = 0.001) and more deaths due
to prostate cancer (6.5%, 3.0% and 1.5%, respectively, p = 0.03) with no significant
difference seen between ADT + RT70 and ADT + DERT76. There was no significant difference
in OS between the 3 arms. A higher dose of RT (76 Gy) increased late gastrointestinal
(GI) toxicity grade ≥ II compared with lower dose (70 Gy) (16% vs 5.3%, p < 0.001)
with no statistical difference for late genitourinary toxicity.
Interpretation
In IRPC, the addition of 6 months of ADT to RT70 or DERT76 significantly improves
BF and appears to decrease the risk of death from prostate cancer compared with DERT76
alone with no difference in OS. In the setting of IRPC, ADT plus RT 70 Gy yields effective
disease control with a better GI toxicity profile.
Clinicaltrials.gov#NCT00223145.
Keywords
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Article info
Publication history
Published online: December 03, 2020
Accepted:
October 25,
2020
Received in revised form:
October 2,
2020
Received:
April 29,
2020
Identification
Copyright
© 2020 Elsevier Ltd. All rights reserved.
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- Reply to comment on: Androgen deprivation therapy and radiotherapy in intermediate-risk prostate cancer: A randomised phase III trialEuropean Journal of CancerVol. 167
- PreviewThe authors thank Drs. Guler and Onal for their interest in our article ‘Androgen deprivation therapy and radiotherapy in intermediate-risk prostate cancer: A randomised phase III trial’ [1]. The authors think it is important to clarify some misunderstanding that Drs. Guler and Onal may have had when interpreting our results. In our study, in patients with only intermediate-risk prostate cancer (IRPC), the addition of a short course of androgen suppression therapy (ADT) to conventional fractionation radiotherapy to 70 Gy (RT70) or dose-escalated radiotherapy to 76 Gy did impact on biochemical control and prostate cancer specific mortality compared to dose-escalated radiotherapy alone (DERT76 Gy).
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- Re: Androgen deprivation therapy and radiotherapy in intermediate risk prostate cancer: A randomized phase III trialEuropean Journal of CancerVol. 167
- PreviewThe article by Nabid et al. [1] on the role of androgen deprivation therapy (ADT) in intermediate-risk prostate cancer (IRPC) with two different radiotherapy (RT) fractionation schemes piqued our interest. When compared to ADT plus conventional fractionation radiotherapy (RT70) and ADT plus dose escalated radiotherapy (DERT76), the DERT76 only arm had statistically significant higher rates of biochemical failure (BF), prostate cancer progression, and disease-related deaths. There was no statistically significant difference between patients who received ADT with conventional or dose-escalation RT.
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